This article is more than 5 years old. Information may no longer be current.
Mifepristone demonstrated safety, efficacy in Cushing’s syndrome trials
Click Here to Manage Email Alerts
Phase 3 study data indicate that mifepristone alleviated hypertension, improved glucose intolerance and was well tolerated by patients with Cushing’s syndrome.
The safety and efficacy of mifepristone (Corlux, Corcept Therapeutics) was evaluated in patients with Cushing’s syndrome who were glucose intolerant or hypertensive. According to a company press release, 60% of patients in the glucose-intolerant group demonstrated at least a 25% improvement in glucose tolerance (P<.0001), and 43% of patients in the hypertension group improved diastolic blood pressure by 5 mm Hg or better (P<.01).
Results also showed that 87% of the patients demonstrated global clinical improvement, as determined by an independent data review board, with positive changes in diabetes, hypertension medications, HbA1c levels, insulin sensitivity, metabolic function, weight, body composition, Cushingoid appearance, cognitive and psychiatric evaluations, and overall quality of life.
Detailed safety data remain unavailable, but researchers said patients in the study appear to tolerate mifepristone well. Adverse events, such as adrenal insufficiency, endometrial thickening and hypokalemia, were experienced by some patients. However, these events are consistent with previously published reports, according to the press release.
Further, most serious adverse events reported were unrelated to the mifepristone, the researchers said, and all were resolved with clinical management.
Ninety percent of patients who completed the phase 3 study also enrolled in the long-term extension trial.
“We remain on track to submit a New Drug Application to the FDA for Corlux in Cushing’s syndrome by the end of the first quarter of 2011 and continue to work toward our goal of making Corlux available to patients with this severe disease,” Joseph Belanoff, MD, CEO of Corcept Therapeutics, said in the press release.
Disclosure: This study was funded by Corcept Therapeutics.
 |
Follow EndocrineToday.com on Twitter. |