Endocrine Society Releases Guidelines on Pituitary Incidentalomas

Wednesday, April 20, 2011 - Elsevier Global Medical News
BY ELIZABETH MECHCATIE

Surgical treatment of a pituitary incidentaloma is recommended when the lesion is causing a visual field deficit or other visual abnormalities, such as ophthalmoplegia “or neurological compromise,” according to evidence-based clinical practice guidelines published by the Endocrine Society.

Surgery is also recommended when the lesion is abutting or compressing the optic nerves or chiasm on MRI, when a patient is experiencing pituitary apoplexy with visual disturbance, or if a patient has a hypersecreting tumor other than a prolactinoma, according to the guidelines, which appear in the society’s journal (J. Clin. Endocrinol. Metab. 2011;96:894-904).

The guidelines pertain to adults, as there are no available data on these lesions in the pediatric population.

A pituitary incidentaloma is defined as “a previously unsuspected pituitary lesion that is discovered on an imaging study performed for an unrelated reason.” That does not include a symptom such as visual loss that is related to the lesion, “but rather [a study done] for the evaluation of symptoms such as headache, or other head or neck neurological or CNS complaints or head trauma.”

Such surprise findings are not uncommon, according to a statement from the society, which noted that small incidentalomas were discovered in as many as 20% of adults who had head imaging with MRI or CT scans for unrelated reasons.

“Fortunately, incidentalomas are almost always benign and usually do not need surgery,” Dr. Pamela Freda, an endocrinologist at Columbia University in New York who chaired the task force that wrote the guidelines, said in the statement. The guidelines make recommendations about evaluating and treating such patients, “indicating when surgical therapy may be necessary,” she added.

Surgery may be considered for patients with pituitary incidentalomas if there is clinically significant growth of the lesion, loss of endocrinologic function, or an “unremitting headache,” or if a patient is planning a pregnancy and has a lesion close to the optic chiasm.

The guidelines include recommendations on the initial evaluation of patients, follow-up testing of patients who do not meet criteria for surgical removal of the lesion, and medical therapy. For example, after an incidentaloma is identified, a patient should undergo a complete history and physical examination “that includes evaluations for evidence of hypopituitarism and a hormone secretion syndrome,” as well as biochemical evaluations, if there is evidence for either of these conditions, the guidelines state.

None of the seven authors of the guidelines declared a “significant financial interest” or a “leadership position” within the pharmaceutical industry. Dr. Freda’s disclosure states that she has “financial, business or organization interests” in Novartis, Ipsen, and Pfizer. Other authors also disclosed financial, business, or organization interests in those three companies, and/or in Novo Nordisk, Tercica/Ipsen, or no relevant financial interests.

The guidelines are cosponsored by the European Society of Endocrinology.

The society’s patient-education affiliate, the Hormone Foundation, is publishing a related patient guide that can be found at www.hormone.org/Resources/upload/Pituitary-Incidentaloma-Web.pdf.

From http://www.medconnect.com.au/tabid/84/s22/neurology/ct1/c340891/Endocrine-Society-Releases-Guidelines-on-Pituitary-Incidentalomas-/Default.aspx

Corcept Therapeutics Submits NDA for Corlux in Cushing’s Syndrome

By Trevor Sherwood, on April 15th, 2011

 

Getting in just under the wire on its second self-imposed deadline, Corcept Therapeutics (Nasdaq: CORT) finally announced submission of its NDA for Corlux (mifepristone) in Cushing’s Syndrome, a disease characterized by high levels of circulating cortisol resulting in glucose intolerance, hypertension, depression, and obesity. Corlux is a glucocorticoid receptor-II (GR-II) antagonist which can block the effects of the glucocorticosteroid cortisol. The company has Orphan Drug Designation for Corlux in Cushing’s Syndrome and is hoping to secure priority review if the FDA accepts their submission. There are currently no therapies approved in the United States exclusively for Cushing’s Syndrome, and care typically revolves around symptom management. Corcept believes (quite logically) that focusing on the underlying biochemical problem will be a better way of treating this disease.

Corcept announced positive Phase 3 data at the end of 2010 and beginning of 2011, with both primary and secondary endpoints being reached. The trial was conducted in two groups of Cushing’s patients who were either glucose-intolerant or hypertensive and who had failed, relapsed from, or were ineligible for surgery on cortisol-producing tumors.

The glucose intolerant group’s primary endpoint was a 25% or better improvement in glucose tolerance, and a response rate of 60% was achieved in this arm of patients. The primary endpoint for the hypertensive group was an improvement of 5mm or greater in diastolic blood pressure, and 43% of patients achieved this level. Both response rates are considered statistically significant (above the 20% “hurdle rate”), the drug was well tolerated in the trials, and no major side effects were reported. Furthermore, the secondary endpoint of “global clinical improvement” was met by 87% of patients in the study as analyzed by a data review board comprised of three academic physicians with clinical Cushing’s Syndrome experience.

Commonly observed side effects were adrenal insufficiency, endometrial thickening, and hypokalemia. The majority of serious adverse events were determined not to be drug-related, and any adverse effects that were drug-related were resolved with clinical management. It is worth noting that 88% of the patients involved in the study opted to enter into a long-term extension study, which can be seen as a vote of confidence by the patient population in Corlux’s efficacy and tolerability. Corcept plans to present detailed trial data at the Endocrine Society Annual Meeting in June which will likely allow a more comprehensive analysis of its approval odds. As of right now, Corlux’ chances look good.

Corcept originally announced plans to submit the NDA by the end of March; hopefully the two week extension needed to submit to the FDA means the company took extra care in finalizing its application. Stay tuned for updates on Corcept Therapeutics as the regulatory fate of their first clinical candidate unfolds.

From http://biotechinvestmentparadigm.com/?p=1558

Random postoperative day 3 cortisol as a predictor of hypothalamic-pituitary-adrenal axis integrity after transsphenoidal surgery

Journal	Endocrine Practice
Publisher	American Association of Clinical Endocrinologists
ISSN	1530-891X (Print) 1934-2403 (Online)
Subject	Health Services, Medical Sciences and Endocrinology
Pages	1-25
DOI	10.4158/EP11013.OR

 

PDF (194.7 KB)

Authors

Maryam I. Khan, MD^{1, 2}, Mouhammed A. Habra, MD, FACE¹, Ian E. McCutcheon, MD³, Graciela M. Nogueras-González, MPH⁴, Jessica K. Devin, MD¹, Naifa L. Busaidy, MD¹, Nicholas B. Levine, MD³, Wayne Lindstrom, MD¹, David Kagan, MD¹, Camilo Jimenez, MD¹, Steven G. Waguespack, MD, FAAP, FACE¹

¹Department of Endocrine Neoplasia and Hormonal Disorders, University of Texas M. D. Anderson Cancer Center, Houston, TX, USA
²Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine, Houston, Texas, USA
³Department of Neurosurgery, University of Texas M.D. Anderson Cancer Center, Houston, TX, USA
⁴Division of Quantitative Sciences, University of Texas M.D. Anderson Cancer Center, Houston, TX, USA

Abstract

Objective: To determine if a random postoperative day 3 (POD3) cortisol ≥10μg/dl is predictive of adrenal sufficiency (AS) at 3-10 weeks after transsphenoidal surgery (TSS) and during long-term clinical follow up.

Methods: We retrospectively reviewed the case records of 466 patients who underwent TSS at our institution between 1991 and 2008. Eighty-three patients met inclusion criteria for the study: random cortisol measured on the morning of POD3, adrenal dynamic testing performed 3-10 weeks after TSS, and clinical assessment of the hypothalamic-pituitary-adrenal (HPA) axis at least 6 months after TSS.

Results: The sensitivity of a random POD3 serum cortisol ≥10μg/dl for the prediction of AS at a median follow up of 42 days was 64.81% (95% CI: 50.6-77.32), with an odds ratio of 3.1 (95% CI: 1.08-8.58). The specificity was 62.1% (95% CI: 42.3-79.3). At a median follow up of 500 days, only 2 patients with a POD3 cortisol ≥10μg/dl required hydrocortisone replacement, both of whom had multiple anterior pituitary hormone deficiencies and evidence of pituitary dysfunction during the perioperative period.

Conclusions: In the appropriate clinical context, a POD3 cortisol ≥10μg/dl accurately predicts the integrity of the HPA axis. The final decision regarding corticosteroid replacement should be individualized, taking into consideration the POD3 cortisol level, the clinical context in which the measurement was obtained, and any evidence of concomitant pituitary dysfunction in the perioperative period.

Keywords

transsphenoidal resection, adrenal insufficiency, pituitary adenoma, hydrocortisone replacement

Show References

From http://aace.metapress.com/content/p06h145283m27102/

Obesity is a Predictor of Morbidity in 1,629 Patients Who Underwent Adrenalectomy

World Journal of Surgery

DOI: 10.1007/s00268-011-1070-2

Hadiza S. Kazaure, Sanziana A. Roman and Julie A. Sosa

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Abstract

Background  

We examined the impact of obesity on 30-day outcomes of adrenalectomy using a multi-institutional database.

Methods  

Patients who underwent adrenalectomy in 2005–2008 according to the American College of Surgeons-National Surgical Quality Improvement Project (ACS-NSQIP) data set were grouped by body mass index (BMI): normal weight (BMI = 18.5–24.9 kg/m²), overweight (BMI = 25.0–29.9 kg/m²), obese (BMI = 30.0–34.9 kg/m²), and morbidly obese (BMI ≥ 35 kg/m²). Outcomes of the higher BMI groups were compared to those of the normal BMI group using χ², analysis of variance (ANOVA), and multivariate regression.

Results  

There were 1,629 patients in the study: 22% were normal weight, 31% overweight, 22.2% obese, and 24.7% morbidly obese. Compared to normal-weight patients, obese and morbidly obese patients had a 12.5 and 16.7% increase in operation times (129 vs. 145 and 150 min, respectively, p ≤ 0.01) and sustained more wound complications (0.2 vs. 0.4 and 1.2%, p < 0.001), including superficial and deep wound infections (p < 0.001 and p < 0.01, respectively). Morbid obesity independently predicted overall complications (odds ratio [OR] 2.9, 95% confidence interval [CI]: 1.7–5.7), wound complications (OR 6.1, 95% CI: 2.0–18.9), and septic complications (OR 3.1, 95% CI: 1.1–8.8). Obesity independently predicted longer total time in the operating room (p < 0.006). There were no differences in rates of reoperation and length of hospital stay by BMI category.

Conclusion  

Obesity is an independent risk factor that needs to be considered in surgical decisions regarding adrenalectomy. Morbidly obese adrenalectomy patients are particularly at risk for wound and septic complications.

Presented in part at the 6th Annual Academic Surgical Congress, Huntington Beach, CA, 1 February 2011.

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From http://www.springerlink.com/content/w6n2p554w72wru47/

Treatment Guidelines for Pituitary Incidentalomas Issued

Emma Hitt, PhD

April 12, 2011 — The Endocrine Society has issued clinical guidelines for the endocrine assessment and treatment of pituitary incidentaloma that indicates surgical therapy under some conditions.

Pamela U. Freda, MD, with the Columbia College of Physicians & Surgeons in New York, NY, led the panelists who developed the guidelines, which were reported in the April 2011 issue of the Journal of Clinical Endocrinology & Metabolism.

The 7-member panel sought to develop practice guidelines for the endocrine evaluation and treatment of pituitary incidentalomas through the evaluation of systematic reviews of evidence. They also participated in conference calls and email discussions to develop the guidelines.

The panel recommends that patients with a pituitary incidentaloma undergo a complete history and physical examination, laboratory evaluations screening for hormone hypersecretion and hypopituitarism, and a visual field examination if the lesion abuts the optic nerves or optic chiasm.

They also recommend that patients with incidentalomas who do not meet criteria for surgical removal be monitored with clinical assessments and neuroimaging, which should include a magnetic resonance imaging (MRI) scan at 6 months for macroincidentalomas, 1 year for a microincidentaloma, and thereafter progressively less frequently if the incidentaloma is unchanged in size.

Patients should also undergo visual field examinations if they have incidentalomas that abut or compress the optic nerve and optic chiasm (6 months and yearly), as well as endocrine testing in the case of macroincidentalomas (6 months and yearly) after initial evaluation.

According to the study authors, the evidence for or against a recommendation for surgery because of growth of a pituitary incidentaloma is limited. The panel suggests that surgery is indicated if patients have a visual field deficit resulting from the lesion; other visual abnormalities, such as ophthalmoplegia or neurologic compromise from compression by the lesion; a lesion abutting or compressing the optic nerves or optic chiasm on MRI; pituitary apoplexy with visual disturbance; or hypersecreting tumors other than prolactinomas as recommended by other Endocrine and Pituitary Society guidelines.

In addition, surgery should be considered in patients with a pituitary incidentaloma if there is clinically significant growth of the pituitary incidentaloma, if there is loss of endocrinologic function, if a patient is planning pregnancy with a lesion close to the optic chiasm, or if a patient has unremitting headache.

The study authors add that the "success of surgery for hormone secreting tumors is highly dependent on the expertise, skill, and case volume of a pituitary surgeon supported by an experienced team."

Medical therapy for pituitary incidentalomas has not been systematically studied, the authors note. "In patients with incidentalomas and hyperprolactinemia that may be due to tumoral compression of the hypothalamic-pituitary stalk, symptomatic hyperprolactinemia may be treated with a dopamine agonist," they write. However, they add that incidentalomas other than a prolactinoma are unlikely to shrink, and lesions should still be monitored regardless of changes in prolactin levels.

The study authors have disclosed various financial relationships with Novartis, Ipsen, Pfizer, Novo Nordisk, Tercica/Ipsen, and/or KER Unit (Mayo Clinic).

J Clin Endocrinol Metab. 2011;96:894-904. Abstract

From http://www.medscape.com/viewarticle/740672

 

Pituitary hyperplasia secondary to acquired hypothyroidism: case report

Roberto Franceschi , Umberto Rozzanigo , Riccarda Failo , Maria Bellizzi and Annunziata Di palma

Italian Journal of Pediatrics 2011, 37:15doi:10.1186/1824-7288-37-15

Published:	7 April 2011

Abstract (provisional)

Objective and Importance: despite recent progress in imaging, it is still difficult to distinguish between pituitary adenoma and hyperplasia, even using Magnetic Resonance Imaging (MRI) with gadolinium injection. We describe an example of reactive pituitary hyperplasia from primary hypothyroidism that mimicked a pituitary macroadenoma in a child.

Clinical Presentation: a 10 year old boy presented with headache and statural growth arrest. MRI revealed an intrasellar and suprasellar pituitary mass. Endocrine evaluation revealed primary hypothyroidism.

Intervention: the patient was started on levothyroxine with resolution of the mass effect.

Conclusion: primary hypothyroidism should be considered in the differential diagnosis of solid mass lesions of the pituitary gland. Examination of thyroid function in patients with sellar and suprasellar masses revealed by MRI may avoid unnecessary operations which can cause irreversible complications.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

From http://www.ijponline.net/content/37/1/15

Clinical Trial: Safety and Efficacy of LCI699 in Cushing's Disease Patients

This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease...

Date First Received: April 6, 2011

Last Updated: April 6, 2011

Verified by: Novartis, April 2011

Clinical Trial Phase: Phase 2 | Start Date: March 2011

Overall Status: Recruiting

Estimated Enrollment: 12

Condition Keyword(s):

• Cushing Disease

Additional Keyword(s) Provided by Clinical Trial Investigators:

• Cushing Disease
• LCI699
• Pituitary Gland
• Adrenocorticotropic Hormone

Intervention(s):

• Drug: LCI699

Condition MeSH Term(s), Assigned with an Experimental Algorithm:

• Cushing Syndrome
• Pituitary ACTH Hypersecretion

Intervention MeSH Term(s), Assigned with an Experimental Algorithm:

• Adrenocorticotropic Hormone

Brief Summary

Official Title: “A Proof of Concept, Open-label, Forced Titration, Multi-center Study to Assess the Safety/Tolerability and Efficacy of 10-weeks Treatment of LCI699 in Patients With Cushing's Disease”

This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease.

Study Type: Interventional

Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

• Drug: LCI699

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: LCI699

Outcome Measures for this Clinical Trial

Primary Measures

• Change in 24 hour urine free cortisol concentration
  • Time Frame: 10 weeks
    Safety Issue?: No

Secondary Measures

• Changes in hormone levels, e.g. testosterone, estradiol
  • Time Frame: 10 weeks
    Safety Issue?: No
• Changes in metabolic abnormalities, e.g. insulin, Hemoglobin A1C (HbA1C)
  • Time Frame: 10 weeks
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

• Patients with confirmed Cushing's Disease with confirmation of pituitary origin of excess Adrenocorticotropic Hormone (ACTH)
• Patients on medical treatment must complete a washout period prior to baseline

Exclusion Criteria:

• Patients treated with mitotane 6 months prior to Visit 1
• Patients with compression of the optic chiasm
• Patients with a known inherited syndrome as the cause for hormone over secretion
• Patients with Cushing's syndrome due to ectopic ACTH secretion or adrenal Cushing's syndrome
• Patients with pseudo-Cushing's syndrome
• Patients who are not biochemically euthyroid
• Diabetic patients with poorly controlled diabetes (HbA1c >9%)
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Overall Contact: Novartis Pharmaceuticals 001-862-778-8300 

Additional Information

Information obtained from ClinicalTrials.gov on April 07, 2011

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01331239

Study ID Number: CLCI699C2201

ClinicalTrials.gov Identifier: NCT01331239

Health Authority: France: Afssaps - French Health Products Safety Agency

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

From http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01331239

Low Incidence of Adrenal Insufficiency after Transsphenoidal Surgery in Patients with Acromegaly: A Long-Term Follow-Up Study

Anne Marij G. Burgers*, Nieke E. Kokshoorn*, Alberto M. Pereira, Ferdinand Roelfsema, Johannes W. A. Smit, Nienke R. Biermasz and Johannes A. Romijn

Department of Endocrinology and Metabolism, Leiden University Medical Center, 2300 RC Leiden, The Netherlands

Address all correspondence and requests for reprints to: N. R. Biermasz, Department of Endocrinology and Metabolic Diseases C4-R, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, The Netherlands. E-mail: nrbiermasz@lumc.nl.

Context: The long-term prevalence of adrenal insufficiency after transsphenoidal surgery for GH-secreting pituitary adenomas is unknown. However, recently a single study reported a high prevalence of adrenal insufficiency in acromegalic patients after surgical and/or medical treatment without postoperative radiotherapy.

Objective: The objective of the study was to assess the prevalence and incidence rates of adrenal insufficiency in consecutive patients during long-term follow-up after successful transsphenoidal surgery for acromegaly.

Design: In 91 consecutive patients in remission after transsphenoidal surgery only, we retrospectively reviewed insulin tolerance tests, CRH stimulation tests, metyrapone tests, and ACTH stimulation tests used to assess corticotrope function.

Results: Early postoperatively, insufficient adrenal function was observed in 16 patients (18%), which was transient in eight and irreversible in eight other patients in the first year of postoperative follow-up. Therefore, after the first year, the prevalence of adrenal insufficiency was 9%. Late, new-onset adrenal insufficiency developed in only three patients 13, 18, and 24 yr after surgery. The incidence rate of late adrenal insufficiency after successful surgery was 2/1000 person-years. After long-term follow-up, a median of 8.1 (1–31 yr), the prevalence of secondary adrenal insufficiency was 12% in patients in remission after surgery for acromegaly.

Conclusion: The prevalence of adrenal insufficiency 1 yr after surgery was 9%, whereas during prolonged follow-up, the incidence rate of adrenal insufficiency was only 2/1000 person-years in patients in remission after surgery. Therefore, development of late-onset adrenal insufficiency is a very infrequent complication in patients with acromegaly in remission after transsphenoidal surgery only.

From http://jcem.endojournals.org/cgi/content/abstract/jc.2010-2673v1

Pituitary tumor: Optician check-up `helped man discover cause of vision problems

By Alexa Kaczka

By paying a visit to an optician in Edinburgh, a man was able to rescue his sight thanks to the detection of a major health problem, it has been revealed.

The Edinburgh Evening News has reported on the experience of 62-year-old Blackhall man Scott Anderson, who found out that he had a pituitary brain tumour after an appointment he had with KD Wallace Optometry.

An appointment with a neurologist was made for Mr Anderson after he went to the optician, which revealed that a tumour was present.

Mr Anderson told the news provider that a number of years had elapsed since his previous trip to an optician.

He stated: "I am embarrassed to recognise that it has been about 15 years since I last went for an eye test."

When it comes to people's eye health, the Prevent Blindness America COO, Jeff Todd, recently encouraged sports players to wear adequate eye protection as the weather improves.

From  http://contactlenses.co.uk/contactlensesnews/article46328/optician-checkup-helped-man-discover-cause-of-vision-problems.html?catid=5&pageNo=1

Cushie warriors: men, women & children who battle Cushing’s numerous times in hopes of winning the war

MelissaTX posted this on the message boards in honor of Cushing's Awareness Day, April 8:

Many of you only know one person with Cushing’s. It is difficult to understand or keep up with ‘your person’ as s/he seeks treatment. You have probably never known someone with Cushing’s before, right? You do know, however, that ‘your person’ talks about Cushing’s a lot or is pretty darned passionate about their Cushie friends. We lean on and help others even as we struggle to find our way through complicated testing, surgery (-ies), and hopefully, cures.

You see, for us, we know MANY people with Cushing’s through cushings-help.com website. Cushing’s is a house guest who ruins our lives and won’t leave us alone. We Cushies all find it incredibly frustrating to have hit the many walls. We see it every day: patients insulted, dismissed, and defeated. When it happens to us, we are often rendered speechless. When we see our fellow Cushies meet the same poor medical treatment, we become incensed. Ultimately, we know our bodies best, and we are found to be correct. We know when we have a disease as devastating as Cushing’s.

For Cushing’s Awareness Day, we compiled this list of Cushing’s patients from all over the world who are fighting Cushing’s and seek treatment and a cure through multiple surgical procedures and even radiation. A glossary of terms is located at the bottom of the list.

Every patient wants to be understood, supported, and cared for. We want you to know that we are one of many who suffer from this ‘rare’ albeit rarely diagnosed disease.

Today, the Cushing community stands before you, asking you to recognize us for the struggles we face and for you to be the most supportive and caring friend or family member you can be to ‘your person.’

(NOTE: This is only a sample collected through a short time on the Cushing’s messages boards. There are many, many more patients like us).

1. Melissa, Texas.
   Pituitary surgery #1: June 2009.
   Pituitary surgery # 2: soon in April 2011.
2. Sarah, Oregon.
   Pituitary surgery #1: Nov 2009.
   Pituitary surgery #2: March 2010.
   Pituitary Surgery #3: Sept 2010.
   BLA: April 2011.
3. Alex B, California
   Pituitary surgery March 2008
   BLA July 2009.
4. Krystine T, Washington
   1st failed Pituitary surgery March 1996
   2nd failed Pituitary surgery Dec 2002
   BLA Dec 2004
   3rd failed Pituitary surgery Sept 2009
   MEGA ONE DAY Radiation ZAP Aug 2010
5. Jill, Denver, Colorado
   left adrenalectomy Nov 2006
   right adrenalectomy Feb 2008
6. Karen, Hinesburg,Vermont
   1st Pituitary surgery in Portland OR, January 9,2006. Not successful.
   2nd Pituitary surgery in Seattle Washington July 9, 2007.
   CSF leak July 13, 2007. I'm in remission.
7. Christy, Oklahoma.
   Pituitary surgery 9-2004 Oklahoma City
   BLA 11-2004 Oklahoma City
   Rest Tissue PIT 9-2006 Pittsburgh
   CSF leak repair with titanium after the last pituitary surgery and it was removed 5-2009.
8. Beth, Winnipeg, Manitoba, Canada.
   Gamma knife December 2006 and again December 2008. Still broken, and if the tumor grows more (it's been stable for a bit now), I'll likely be headed for a 3rd time!
9. Justin K., Kansas
   Pituitary surgery, May 19, 2008.
   BLA, May 6, 2009.
10. Jessica K., Kansas.
    Pituitary surgery, May 16, 2008.
    BLA, May 6, 2009.
11. Bill K., Kansas.
    Pituitary surgery, August 14, 2009.
    BLA, June 2, 2010.
12. Danielle, Massachusetts.
    Pituitary Surgery #1 Dec 16, 2009.
    Pituitary Surgery #2 February 11, 2010.
    BLA Sep 2, 2010
13. Trisha T, Tampa FL
    Pituitary surgery 4/07
    Currently trying to avoid BLA with various meds.
14. Cindy W, Kentucky.
    Pituitary Surgery 11-5-07
    BLA 03-07-08
    CSF Leak repair 10-28-08
15. Lisa, Illinois.
    Pituitary Surgery 5-30-08
    BLA 11-4-09
    Still not cured.
16. Susan G.
    Pituitary Surgery 7/07
    Cleared for 2nd pituitary surgery 10/10.
17. Kimberly, Illinois.
    Pituitary Surgery 11-2-2009
    BLA 2-2-2011.
18. Debra, Virginia
    Debra v. Gallbladder due to Cushings, 1/2005
    root canal due to broken tooth 8/2008
    Pituitary surgery 10/2008
    BLA 6/2010
    Sinus/leak repair 1/2011
    Surgeries offered and rejected == repair of foot muscles, lap band surgery; surgery for excess stomach acid
19. Lisa O, Washington State
    3/25/2009-pituitary surgery
    5/13/2010-BLA
20. April, KY.
    Unsuccessful pituitary surgery 1/15/10.
    Testing again.
21. Elizabeth J, KY
    Pituitary Surgery 7-2-2009
    BLA Sept. 15, 2010
22. Trisha S, Indiana
    Pituitary surgery 11/13/2008.
    Not cured - retesting.
23. Lynne R, Oxford, England.
    Pituitary surgery April 2008
    CSF leak repairs: April 2008, May 2008, May 2008 (3 leaks in the space of 5 weeks), with meningitis as a result of the leaks.
    Issues due to pituitary gland removal: crohns disease, pernicious anaemia, life dependent on multiple medications [hydrocortisone, ddavp, thyroxine, hrt, growth hormone, colestyramine, Vit B12 injections etc, etc. ( oh, and it stole my life- and I'd quite like it back please)]
24. Dara M, Limerick, Ireland.
    Pituitary surgery 29th June 2009
    got MRSA in sinus as a result, had surgery to remove scar tissue.
    MRSA is not for Christmas, for me it's for life xxx
25. Philip B, New Jersey.
    Pituitary surgery at MD Anderson October 31, 2007.
    Testing for Recurrence since Jan. 2011.
    Replacing Growth hormone and Testosterone
26. Donna, Winnipeg, Manitoba, Canada
    Pituitary surgery Aug2009.
    new tumor march 2010 but not told about it until sept2010 when it got to 9mm.
    had gamma knife nov. 2010.
    still waiting to be better. tumor has not shrunk yet
27. Michelle, California.
    Pituitary surgery February 2009.
    BLA February 2010.
    Not cured. Testing. 2 tumors showed on MRI.
28. Shauna N, Washougal, WA.
    Pituitary surgery 8/2/01
    BLA 2/5/02.
29. Robin S, Salem, VA
    Pituitary surgery Dec. 14, 2006
    BLA June 16, 2010
30. Lori, Great Neck, NY
    Diagnosed 12/1994.
    Pituitary surgery 3/1995
    Pituitary surgery 5/1997
    Pituitary surgery 7/1999
    Still sick. Possible Cyclical?
31. Nan, New Jersey
    Pituitary Surgery, October 2010
32. Dan, Delaware.
    Pituitary Surgery #1 August 2009.
    Pituitary Surgery #2 February 2011.
33. Cyndie M, New Jersey
    Pituitary 1-09-2009
    Upcoming BLA 4-28-2011.
34. Kim S., Pennsylvania
    Surgery #1 Jan 2010 positive for Acromegaly but was trying to find a cure for Cushings.
    Testing since Oct 2010 for Cushings.
35. Kay, New Jersey
    1st & 2nd Pituitary surgery June 2008 - in remission
36. Jenny, Iowa.
    Pituitary Surgery #1- May 2008.
    Pituitary Surgery #2- April 2009.
    Currently considering a BLA vs. pituitary surgery #3.
37. Tanya, Buffalo, NY
    Pituitary surgery #1 - February 2010
    currently seeking re-diagnosis
38. Denise P, Dallas,Oregon
    2003 Pituitary surgery Vanderbilt
    2004 canceled pituitary removal after screws were in (I was in pre-op) Vandy
    2004 Stereotactic Radiosurgery- Vanderbilt
    2005 Right half of Pit removed - OHSU
    2005 BLA - OHSU
39. Cate, Georgia
    Pituitary surgery #1 and 2 -- August 2009.
    In remission.
40. Kate, New Jersey
    Pituitary surgery #1 - Jan. 2007 (Failed)
    Pituitary surgery #2 - July 2007 (Total Pit Removal; Failed)
    CSF Leak Surgeries - Oct. 2007 (Failed; still have small leak)
    Open BLA with 18" incision - Sept. 11, 2008
    Gamma Knife Radiosurgery - Oct. 2009
    No pit, no adrenals, radiation damage to hypothalamus (cannot regulate body temp.)
41. Pat, California
    Pituitary Surgery #1: August 2000.
    Pituitary Surgery #2 December 2007.
    Currently testing for surgery #3.
42. Christy, New Mexico
    Pituitary surgery November 2010.
    Considering BLA
43. Brenda, Alberta, Canada
    Pituitary surgery May, 2007
    BLA May, 2007
44. Jamie, Washington State
    Pituitary surgery #1: March 2010.
    Pituitary surgery #2: April 2010.
45. Melissa, Florida
    Pituitary surgery #1: March 2009.
    Pituitary surgery #2: December 2009.
    BLA to come?
46. Vicki, Buffalo, NY
    Pituitary surgery #1: October 2009.
    Pituitary surgery # 2: April 2010.
    BLA soon to come.
47. Gina, Georgia
    Pituitary surgery #1: March 2009.
    Bilateral Adrenalectomy: October 2009.
48. Sherry C, Silverton OR
    1st pituitary surgery 3/2006
    2nd pit surgery 9/2006
    BLA 10/2006.
    Sick since 1999 but diagnosed in 2005.
    Tested for 1 year. Knew I had Cushing's since 2004.
    Still sick....but it's the aftermath of the damage the cortisol did to me and the steroids now.
49. Melyssa, Colorado
    Pituitary Surgery # 1: August 2009.
    Currently testing again.
50. Michaela, Toronto, Ontario, Canada.
    Pituitary surgery 1 -- June 2005
    Pituitary surgery 2 -- Jan 2008
    Pituitary surgery 3 -- July 2008
    BLA -- July 2009
51. Gisella, California
    Pituitary surgery #1: October 2009.
    Pituitary surgery #2: August 2010.
    Pituitary surgery # 3 or BLA to come.
52. (Additions to original list, 4/9/2011)
    Tonya, NW Indiana
    Pituitary Tumor: Transphenoidal Hypophgsectomy - May, 2000
    Gamma Knife - July 2003
    then developed two Anyeurisms and had Anyerism Clippings in Nov., 2007.
    Unfortunately, now th as t I have clips in my head, nobody will run an MRI so now I have no way of monitoring the tumor growth since.
53. AnellH, Dominican Republic
    I'm cured 01 Dec 2009 total pituitary removed.
    

From Cushings-Help.com Glossary:

Pituitary Adenomas
Several therapies are available to treat the ACTH-secreting pituitary adenomas of Cushing's disease. The most widely used treatment is surgical removal of the tumor, known as transsphenoidal adenomectomy. Using a special microscope and very fine instruments, the surgeon approaches the pituitary gland through a nostril or an opening made below the upper lip. Because this is an extremely delicate procedure, patients are often referred to centers specializing in this type of surgery. The success, or cure, rate of this procedure is over 80 percent when performed by a surgeon with extensive experience. If surgery fails, or only produces a temporary cure, surgery can be repeated, often with good results. After curative pituitary surgery, the production of ACTH drops two levels below normal. This is a natural, but temporary, drop in ACTH production, and patients are given a synthetic form of cortisol (such as hydrocortisone or prednisone). Most patients can stop this replacement therapy in less than a year.

For patients in whom transsphenoidal surgery has failed or who are not suitable candidates for surgery, radiotherapy is another possible treatment. Radiation to the pituitary gland is given over a 6-week period, with improvement occurring in 40 to 50 percent of adults and up to 80 percent of children. It may take several months or years before patients feel better from radiation treatment alone. However, the combination of radiation and the drug mitotane (Lysodren®) can help speed recovery. Mitotane suppresses cortisol production and lowers plasma and urine hormone levels. Treatment with mitotane alone can be successful in 30 to 40 percent of patients. Other drugs used alone or in combination to control the production of excess cortisol are aminoglutethimide, metyrapone, trilostane and ketoconazole. Each has its own side effects that doctors consider when prescribing therapy for individual patients.

CSF, Cerebrospinal fluid leak: A more rare, although sometimes expected, result of surgery is drainage from the nose of a clear, watery liquid called cerebrospinal fluid (CSF), which is a normal fluid that surrounds the brain. Large pituitary tumors lean up against a membrane that separates this fluid space from the nose, and a CSF leak may occur if this membrane is absent or opened during surgery. The surgeon will generally recognize a CSF leak when it occurs and will "repair" the leak by placing a small amount of abdominal fat over the leak. The patient may awake from surgery and find that it was necessary for the surgeon to place a small tube in the lower back to allow CSF to drain into a bag and help the leak to seal. The tube is placed while the patient is still under anesthesia, and it is not painful while in place. The tube (about 3 millimeters in diameter) will remain in the lower back for 3-5 days and the patient will be kept in the hospital during this period. After the tube is removed (a painless, approximately 15-second procedure), the patient usually will be able to leave the hospital later the same day with the leak sealed. In most cases, CSF leakage does not occur and the patient may expect to go home 2 to 4 days after surgery.

BLA, Bilateral Adrenalectomy: Surgical removal of both the adrenal glands.

Gamma Knife: This is a more focused radiation treatment than conventional radiation, which reduces the risk of hypopituitarism. It provides a large dose of radiation to a tumor so that when the tumor cells divide, they die. As this method depends on the rate of cell division, symptoms may persist long after the radiation treatment.

Radiotherapy, preferably with stereotactic radiation, is effective in controlling tumor growth in the majority of patients who have residual tumor after surgery.

~~~~~~

MaryO'Note: Thanks for doing all this work, Melissa! You did a fantastic job and the numbers are really telling.

Since you said we could copy it, I'm going to put it on http://www.cushie.info if you don't mind.

If anyone on this list has a bio on the website, and you'd give your permission, I'd like to link your bio to your stats on this list.

Thanks!

Sphenoid sinus pyocele after transsphenoidal approach for pituitary adenoma

Mario Giordano, Venelin M. Gerganov, Wolfgang Draf and Rudolf Fahlbusch

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Abstract

Transsphenoidal pituitary adenoma surgery is related to a low morbidity rate. The complications that can occur are classified as intra- and extracranial. The aim of the study is to discuss one group of these complications involving the sphenoid sinus: mucocele and its possible transformation into pyocele.

We evaluate clinical presentation, management strategy and the outcome after long-term follow-up presenting an explicative case and a review of the literature. A patient presented to our outpatient clinic 8 months after transsphenoidal surgery for selective removal of a pituitary adenoma because of an acute onset of frontal headache during an airplane travel, fever and pulsating sensation in left eye and ear. MRI revealed a contrast-enhancing lesion in the left inferior portion of the sphenoid sinus.

An endonasal endoscopic revision of the sphenoid sinus was performed. After opening of the scar to enter in the left sinus a pyocele was found and treated with drainage and marsupialisation. Development of sphenoid sinus pyocele is an extremely rare postoperative complication of transsphenoidal surgery. This lesion should be taken in consideration in patients presenting with retroorbital headache of acute onset and fever after pituitary surgery. Diagnosis can be suspected on the MRI studies and confirmed by a targeted flexible endoscope examination. Endoscopic drainage with wide opening of the sphenoid sinus and marsupialisation is the treatment of choice to avoid recurrences.

Keywords Pyocele – Transsphenoidal approach – Pituitary adenoma

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From http://www.springerlink.com/content/4jw8120x795316p2/

Expression and Roles of Pannexins in ATP Release in the Pituitary Gland

Shuo Li, Ivana Bjelobaba, Zonghe Yan, Marek Kucka, Melanija Tomi and Stanko S. Stojilkovic

Section on Cellular Signaling (S.L., Z.Y., M.K., M.T., S.S.S.), Program in Developmental Neuroscience, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892-4510; and Department of Neurobiology (I.B.), Institute for Biological Research "Sinisa Stankovic," University of Belgrade, 11000 Belgrade, Republic of Serbia

Address correspondence and reprint requests to: Dr. Stanko Stojilkovic, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Building 49, Room 6A-36, 49 Convent Drive, Bethesda, Maryland 20892-4510. E-mail: stankos@helix.nih.gov or stojilks@mail.nih.gov .

Pannexins are a newly discovered three-member family of proteins expressed in the brain and peripheral tissues that belong to the superfamily of gap junction proteins. However, in mammals pannexins do not form gap junctions, and their expression and function in the pituitary gland have not been studied. Here we show that the rat pituitary gland expresses mRNA and protein transcripts of pannexins 1 and 2 but not pannexin 3. Pannexin 1 was more abundantly expressed in the anterior lobe, whereas pannexin 2 was more abundantly expressed in the intermediate and posterior pituitary. Pannexin 1 was identified in corticotrophs and a fraction of somatotrophs, the S100-positive pituicytes of the posterior pituitary and AtT-20 (mouse pituitary adrenocorticotropin-secreting cells) and rat immortalized pituitary cells secreting prolactin, whereas pannexin 2 was detected in the S100-positive folliculostellate cells of the anterior pituitary, melanotrophs of the intermediate lobe, and vasopressin-containing axons and nerve endings in the posterior lobe. Overexpression of pannexins 1 and 2 in AtT-20 pituitary cells enhanced the release of ATP in the extracellular medium, which was blocked by the gap junction inhibitor carbenoxolone. Basal ATP release in At-T20 cells was also suppressed by down-regulating the expression of endogenous pannexin 1 but not pannexin 2 with their short interfering RNAs. These results indicate that pannexins may provide a pathway for delivery of ATP, which is a native agonist for numerous P2X cationic channels and G protein-coupled P2Y receptors endogenously expressed in the pituitary gland.

From http://endo.endojournals.org/cgi/content/abstract/en.2010-1216v1

Cushing's syndrome in children and adolescents. Presentation, diagnosis, and therapy.

Magiakou MA, et al. Show all

Magiakou MA, Mastorakos G, Oldfield EH, Gomez MT, Doppman JL, Cutler GB Jr, Nieman LK, Chrousos GP.

Affiliation

Developmental Endocrinology Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892.

Journal

N Engl J Med. 1994 Sep 8;331(10):629-36.

Abstract

BACKGROUND AND METHODS: Cushing's syndrome is rare in children and adolescents. We analyzed the clinical presentation, diagnostic evaluation, and treatment of 59 patients with Cushing's syndrome between the ages of 4 and 20 years who were admitted to the National Institutes of Health during the period from 1982 to 1992. The cause of hypercortisolism was identified by low- and high-dose dexamethasone suppression tests, the ovine corticotropin-releasing hormone (CRH) stimulation test, imaging studies, and bilateral sampling of the inferior petrosal sinuses combined with administration of CRH.

RESULTS: Fifty patients had Cushing's disease, six had primary adrenal disease, and three had ectopic corticotropin secretion. The initial signs were excessive weight gain in 90 percent of the patients and growth retardation in 83 percent. Most patients (81 percent) had normal bone age at the time of diagnosis. Forty-seven percent had hypertension, whereas only 19 percent had mental or behavioral problems. The high-dose dexamethasone suppression test and the CRH stimulation test identified 68 and 80 percent, respectively, of the patients with Cushing's disease. Magnetic resonance imaging of the pituitary indicated the presence of tumor in 52 percent of the patients with pituitary adenomas. The maximal central-to-peripheral ratio of plasma corticotropin during sampling of the interior petrosal sinuses was > or = 2.5 in all the patients with Cushing's disease and < 2.5 in those with ectopic corticotropin secretion. Remission of hypercortisolism was achieved in 48 of the 49 patients who underwent transsphenoidal surgery for Cushing's disease, in all 6 of the patients who underwent adrenalectomy for primary adrenal disease, and in the 2 patients in whom the ectopic source of corticotropin could be identified.

CONCLUSIONS: Weight gain and growth retardation are common clinical characteristics of Cushing's syndrome in children and adolescents. Diagnostic evaluation of such patients with CRH stimulation alone and combined with inferior petrosal sinus sampling and imaging studies is accurate, and therapy is usually successful.

PMID

8052272 [PubMed - indexed for MEDLINE]

Free full text: Atypon

From http://www.ncbi.nlm.nih.gov/m/pubmed/8052272/?i=6&from=/7641408/related

April 8 / Cushing's Awareness Day

April 8th is Cushing's Awareness Day. Please wear your Cushing's ribbons, t-shirts, awareness bracelets or Cushing's colors (blue and yellow) and hand out Robin's wonderful Awareness Cards to get a discussion going with anyone who will listen. And don't just raise awareness on April 8.  Any day is a good day to raise awareness.

Famed Neurosurgeons Century-Old Notes Reveal Modern Style Admission of Medical Error

Authors of the article, published in the Feb. Archives of Surgery, suggest that such open documentation may have played an important role in spurring groundbreaking medical treatment advances in Cushing's era -- and could have the same effect today.

"Acknowledging medical errors is evidently something that doctors identified early on as critical to advancement a very long time ago," says principal author Katherine Latimer, B.S., a medical student at the Johns Hopkins University School of Medicine.

Latimer and her colleagues scoured Johns Hopkins' archives to locate operative notes covering 878 of Cushing's patients. The notes, transferred decades ago to microfilm, covered the early years of Cushing's career, from 1896 to 1912, at The Johns Hopkins Hospital. After deciphering the notes -- a monumental task, the authors say, owing to Cushing's poor handwriting, abbreviations, and pages crowded with notes of other physicians, too -- the researchers selected 30 cases in which errors were clearly delineated.

The cases fell into categories of errors similar to those that plague doctors today, the authors said, classifying 11 of the cases as errors of judgment in which Cushing made the wrong choice during a surgery. One example: operating on the wrong side of a patient's brain. Seventeen cases were identified as "human error," mistakes in which Cushing revealed clumsy or careless behavior, such as dropping an instrument into a surgical wound. Three of the errors were considered equipment or tool oversights, such as the case in which a woman's heavy bleeding left Cushing and his colleagues without enough wax, a substance used at the time to seal blood vessels.

Latimer and her colleagues say they were surprised by Cushing's frank and copious documentation of his own shortcomings. His notes acknowledged mistakes that may have resulted in patients' deaths, as well as those that didn't seem to harm patients' outcomes. They said the documentation took place in an era in which malpractice litigation was becoming a growing concern for doctors. Though malpractice penalties were substantially smaller in Cushing's day, lawsuits presented a serious risk for physicians' reputations, the authors noted.

The authors also emphasized that Cushing practiced in a time of enormous surgical innovation. For example, patient mortality from surgical treatment of brain tumors fell from 50 percent to 13 percent during his career. While some of this jump ahead was due to improving technology, the authors propose that part of the reason was open documentation of errors, which helped Cushing and other surgeons develop fixes to avoid them.

"People are human and will make medical mistakes," says Latimer, "but being vigilant about your own shortcomings is critical to improving. To keep medical innovation flowing, we need to strive to maintain this same vigilance today."

Alfredo Quinones, M.D., associate professor of neurosurgery at the Johns Hopkins University School of Medicine and senior author of the study, adds that today's medical errors continue to have a tremendous impact on patients and their families. "Recognizing errors and reporting them can help us greatly improve medicine," he says. "After all, we are all working towards the same goal: better patient care."

Source: The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Johns Hopkins Medical Institutions, via EurekAlert!, a service of AAAS.

Corcept Therapeutics Announces NDA Submission to Be Completed the Week of April 11, 2011

MENLO PARK, CA--(Marketwire - March 31, 2011) - Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that it will submit its New Drug Application (NDA) for the use of CORLUX in Cushing's Syndrome to the FDA the week of April 11, 2011.

"We are in the final stages of preparing our NDA submission and are on track to submit our application to the FDA within the next two weeks," said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. "We look forward to submitting our NDA for CORLUX to the FDA, and, if approved by the FDA, providing an important treatment option to patients suffering from Cushing's Syndrome." 

CORLUX in Cushing's Syndrome Regulatory and Commercialization Update

The completion of the NDA submission is a critical milestone for Corcept on our path to making CORLUX available to Cushing's Syndrome patients. Additional initiatives in support of this objective include the following:

• We plan to submit a request to the FDA for Priority Review along with our NDA submission. According to the FDA, "Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists." The FDA's goal for completing a Priority Review is six months. The FDA will notify us within 45 days of our request whether our NDA has been assigned a Priority Review or a Standard Review (for which the FDA's goal is a ten month review time).

• We expect that the FDA will notify us whether our NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of the completeness of our application.

• We expect to make detailed data from our Phase 3 trial of CORLUX in Cushing's Syndrome available to the endocrinologists who treat the disorder at the Endocrine Society Annual Meeting (ENDO), June 4-7 in Boston.

• We are developing plans and engaging third-party vendors to support a commercial launch of CORLUX in the United States, if approved by the FDA.

About Cushing's Syndrome

Endogenous Cushing's Syndrome is caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing's Syndrome is an orphan indication which most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients in the United States. An estimated 20,000 patients in the United States have Cushing's Syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing's Syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About CORLUX

Corcept's first-generation compound, CORLUX, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone (PR) receptor. Intellectual property protection is in place to protect important methods of use for CORLUX. Corcept retains worldwide rights to its intellectual property related to CORLUX.

About Corcept Therapeutics Incorporated

Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. The company has completed its Phase 3 study of CORLUX for the treatment of Cushing's Syndrome, and has an ongoing Phase 3 study of CORLUX for the treatment of the psychotic features of psychotic depression. Corcept also has a Phase 2 program for CORT 108297 and an IND-enabling program for CORT 113083. Both of these novel compounds are selective GR-II antagonists - compounds which block the effects of cortisol but not progesterone. Corcept has developed an extensive intellectual property portfolio that covers the use of GR-II antagonists in the treatment of a wide variety of psychiatric and metabolic disorders, including the prevention of weight gain caused by the use of antipsychotic medication, as well as composition of matter patents for our selective GR-II antagonists.

Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept's clinical development and research programs, the timing of the NDA submission and introduction of CORLUX and future product candidates, including CORT 108297 and CORT 113083, estimates of the timing of enrollment or completion of our clinical trials and the anticipated results of those trials, the ability to create value from CORLUX or other future product candidates and our estimates regarding our capital requirements, spending plans and needs for additional financing. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances with respect to the cost, rate of spending, completion or success of clinical trials; financial projections may not be accurate; there can be no assurances that Corcept will pursue further activities with respect to the development of CORLUX, CORT 108297, CORT 113083 or any of its other selective GR-II antagonists. These and other risk factors are set forth in the Company's SEC filings, all of which are available from our website (www.corcept.com) or from the SEC's website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.

CONTACT:
Caroline Loewy
Chief Financial Officer
Corcept Therapeutics
650-688-8783
Email Contact
www.corcept.com

From http://www.marketwire.com/press-release/Corcept-Therapeutics-Announces-NDA-Submission-Be-Completed-Week-April-11-2011-NASDAQ-CORT-1420946.htm

Cushing's syndrome - Clinical trials

Information provided by WHO International Clinical Trials Registry The clinical trials below are relevant to Cushing's syndrome.

Title	Recruitment status	Location
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion	Recruiting	United Kingdom
Glucocorticoid Receptor Antagonism in Subclinical Cushings	Not recruiting	United Kingdom
Adrenal Tumors - Pathogenesis and Therapy	Recruiting	Germany
Protein turnover and energy expenditure in normal subjects, growth hormone deficiency, acromegaly and Cushing's syndrome	Recruiting	Australia
Insulin Sensitivity and Substrate Metabolism in Patients With Cushing's Syndrome	Recruiting	Denmark
Study of Depression, Peptides, and Steroids in Cushing's Syndrome	Recruiting	United States
Stepwise medical treatment of Cushing's disease	Recruiting	The Netherlands
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion	Recruiting	France
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion	Recruiting	Germany
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion	Recruiting	Italy

Title	Recruitment status	Location
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion	Recruiting	Netherlands
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion	Recruiting	United States
Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex	Recruiting	United States
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders	Recruiting	United States
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome	Recruiting	United States
A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease	Not recruiting	United States
Long Term Post Operative Follow-Up of Cushing Syndrome	Not recruiting	United States
A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia	Not recruiting	United States
Adrenalectomy Versus Follow-up in Patients With Subclinical Cushings Syndrome	Not recruiting	Sweden
Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome	Not recruiting	United States

Title	Recruitment status	Location
Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome	Not recruiting	United States
Study of Cushing's Syndrome Not Related to ACTH Production	Not recruiting	United States
Management of subclinical Cushing's syndrome in adrenal incidentalomas	Not recruiting	Italy
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome	Not recruiting	United States
Diagnostic Performance of Screening Tests for Cushing's Syndrome	Not recruiting	United States
Cognition, Steroids, and Imaging in Cushings Disease	Not recruiting	United States
A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome	Not recruiting	United States
Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma	Not recruiting	Germany
Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency	Not recruiting	United States
Jugular Vein Sampling for Hormone Levels for the Diagnosis of Cushing Syndrome	Not recruiting	United States

Cushing"s Awareness Day is coming - April 8, 2011

What Can *YOU* Do to help?

Check out these ideas

1) status of the Cushing's Awareness Day legislation... who has signed, who do we need to get? I have contacts to the US congressfolks from Houston, and I wanted to get them to sign if they have not. Can we get someone to testify before Congress? Can we get any federal funding? Can we rally with other rare disease groups to get in front of that mic on CSPAN?

2) can we do a fund drive for the month prior to April 8th in order to fund all of our projects and this site? can we keep track of how much each board member raises with little thermometers that show how much is collected, in order to get people excited about how much money is being generated?

3) can those who have had surgery in the past year right up there story to be published on April 8th for awareness day? I hope that planning this far in advance will allow us to get more articles published. Perhaps those who already had surgery can ask the paper to re-run their story with an update and reminder about awareness day.

4) can someone can write a press release to the news channels to get coverage for awareness day

5) we get someone to create a very nice postcard that we all can print from our home at our expense on card stock. Then we each pay for the postage to send the cards to all of our friends and families. Perhaps we can ask our family and friends to donate money to us that we can then donate to this board...

6) I need a Cushing's bumper sticker! I know there are some for sale on the store site, but I was wondering if we can get some heads on this project to get something really catchy. I would put one on my card if we could get a really cool design going... any graphic artists wanna take this up?

7) I love the radio blog shows. I think they are so great. Perhaps we can add that icon to all of our Myspace, Facebook, and personal websites. Do we have an icon that we can post to get people to this site?

8) Have people set up care pages to keep friends and family informed about all the tests, doctors appts and then following us through surgery and post op. I have over 65 people subscribing to my care page, and I am confident that those 65 people didn't know anything about Cushing's until I told them about it. If we inform little circles of 50 all around the US and world, then we will be doing a great job increasing awareness. It is free, and I love mine. I control the tone of the site, and no one talks back to me there!

9). What can we do in the medical community? I'd like to see us patients doing more to lead the doctors down the proper path. ----- Do we get a booth at a national endocrinologist conference and pass out information we want them to know, with Cushies staffing the booth? ----- Do we develop a pamphlet specifically for doctors? ----- Do we start a partnership with the national association of endocrinologists (not sure if this really exists, but you know what I mean) and work together to get more research done on Cyclic Cushing's by offering ourselves up as research participants?

10) Perhaps we contact every Women's health magazine on the market and submit some articles in February for consideration of their April magazine.

11) Perhaps we buy the google ads based on key words that appears in email. The links pop up on the right side bar while people read their gmail or other online email. If the person says ponch, fat, or other key words, then the side bar will give a link to this site.

12) We can distribute DVDs of Kate's show and the two mystery diagnosis shows (Sam and Sharmyn) to doctors and endos? To new Cushies? This will take some money for DVDs and postage, but if we focus on raising some money, then we can allocated funds to these worthwhile expenses. Now, I am not sure if we need permission from Mystery Diagnosis or Nat Geo for that, but someone can take this project and get all the details.

I'd like to see us set up a goal-driven campaign for Cushing's Awareness Day. This will really help motivate us into seeing how much interest and good we are generating as a group.

# of newspaper articles submitted
# of newspaper articles publised
# of magazine articles submitted
# of magazine articles published
# of dollars raised
# of dollars allocated to outreach (keyword ads in gmail and others, etc)
# of carepages set up
# of care page followers (in friends and family.. I have 65 already) etc.

If we each decide to lead a project to get all of this taken care of, we could be in a very good position to launch a really big Cushing's Day Awareness in April. I am really looking forward to seeing all the creativity that exists of the minds of my brilliant Cushie friends!

So, please, if you could take moment to add suggestions and brain storm here. The list I came up with is right off the time of my head, as I have no knowledge of what's been done before. Please take the list as simple suggestions in an effort to see how many 'stick' and how many we can tweak to produce a great product.

* Sign Amber's Petition. www.ipetitions.com/petition/CushingsDiseaseAwareness

Amber writes:

Thought I would explain what this petition can do....
o First of all, it adds power and substance to our efforts to have a Nationally recognized day if we have an extensive, following.
o Second, this petition and all the signatures can be printed and sent to a Senator, politician, or medical professional that may be will to take on the cause.
o Third, this petition and its list of signatures are IDEAL for releasing to the press and media for coverage and will assist GREATLY in getting the word out there.

It is so simple. The petition has a place to add your name and a comment if you want. PLEASE take a moment to sign and formward it on to all the people in your address book, your friends and family.

We all get forwarded messages all the time, but this one is dear to our hearts and can make a differnce! WHATS STOPPING YOU!?

PLEASE SUPPORT OUT EFFORTS TO RAISE AWARENESS! YOUR HELP IS NEEDED AND IT IS SO EASY!

* Follow Jayne's Lead. She writes:

Of course, I'll be supporting the day and writing letters and emails and making phone calls. I hope to find us a celebrity ribbon wearer.

Something else I am working on is national TV recognition with the major networks and National publications. You can email them as well on their "contact us" info. Contact the hosts of the show and the producers to mention April 8th and Cushing's Awareness.

I am going to find out information on getting money (grant) to publish magazine adds/articles for the April editions, if not this year then for next year. I know they are probably being printed, but I just thought of this idea. My local paper will run a small 2x3 ad for starting at $300. I want the whole page! I thought about having a yard sale to raise money to put in an ad, but doubt that I'd make enough. Oh Well!

Something else I thought about is getting a chain pharmacy to post cushings info for that week prior to the 8th. Medical school journal/papers can also be contacted. I know I must have emails over 100 doctors last year on the 7th (once I know that it had passed). I'll be setting up a booth at the women's Forum again this year. I hope to set up at some health expo's and at the local Hospital or at least make/pass out flyers.

* Wear Cushing's Bracelets or T-Shirts to promote Cushing's Awareness. Cushing's Awareness T-Shirts and other products are available here: Cushie GiftStore.
* Post your ideas and what you have done here: http://cushings.invisionzone.com/index.php?showforum=134

2011 Cushing's Awareness Day at Jimmy Buffett's Margaritaville

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These screen shots above are from the main page at http://www.margaritavillekeywest.com and the Cushing's Awareness Day page at http://www.margaritavillekeywest.com/index.php?page=cushings

Cushing's Awareness Day is coming - April 8, 2011!

Cushing's Awareness Day at Jimmy Buffett's Margaritaville

Why is Jimmy Buffett's Margaritaville interested in Cushing's?  Listen to Melissa's interview.  Her  sister has had 2 Cushing's pituitary surgeries.  There is another family member who was born with Addison's Disease.

Melissa is the Parrot Head Club Liaison for Jimmy Buffett's Margaritaville Key West. In this capacity, she has advanced Cushing's Awareness by adding links and info to the Margaritaville website because they like to highlight worthy and wonderful organizations.  To contact Melissa, put Cushing's as the subject line when you email her at mel@margaritaville.com

From 2010:

The picture in this photo is of Donna Sellers, her son, John, and Sonny Perdue, Governor of the State of Georgia. Donna is the president of John's Foundation for Cushing's Awareness and mother of a Cushing's patient. The foundation can be found at http://www.jfcainc.com/