Magazine article Clinical Psychiatry News

Weight-Loss Drug Hits Diabetes Target Trifecta

Magazine article Clinical Psychiatry News

Weight-Loss Drug Hits Diabetes Target Trifecta

Article excerpt

AT THE ANNUAL MEETING OF THE ENDOCRINE SOCIETY

HOUSTON--Nearly one-third of obese patients who had type 2 diabetes and were randomized to an extended-release formulation of phentermine plus topiramate for 1 year achieved a rigorous composite diabetes management end point comprising greater-than-10% weight loss, a hemoglobin level lower than 6.5%, and systolic blood pressure lower than 130 mm Hg.

Moreover, almost 40% of patients who were randomized to the full dose of the drug combo achieved a less-rigorous trifecta consisting of the same blood pressure and [HbA.sub.1c] targets, plus a greater-than-5% weight loss, Dr. Donna H. Ryan reported at the meeting.

Based upon favorable feedback from the Food and Drug Administration, Dr. Ryan said that she expected the combination drug (brand name, Qnexa) to receive marketing approval this year--and indeed, the FDA did approve Qnexa on July 17, albeit with a REMS (Risk Evaluation and Mitigation Strategy) stipulation.

The approved indication is for medical weight loss in the treatment of obesity in patients with either a body mass index of at least 30 kg/[m.sup.2], or a BMI of 27 plus a comorbid condition, such as type 2 diabetes, according to Dr. Ryan of the Pennington Biomedical Research Center in Baton Rouge, La.

Qnexa joins lorcaserin (Belviq), which was approved by the FDA in late June and which also is indicated for patients with either a BMI of at least 30, or a BMI of at least 27 plus weight-related comorbidities. More than 25 million Americans have type 2 diabetes, and most of them are obese.

Both the FDA and Vivus (Qnexa's developer) want to avoid the widespread abuse that often has been a problem with diet medications, so the drug will be subject to a risk-management program, and available only through certified mail-order pharmacies that will collect patient data.

"This won't be something you can get over the Internet. Patients won't be able to go to a doc-in-a-box and say, 'I want a diet drug; give me a prescription for this drug I read about in the newspaper.' It won't be like that," she said.

Dr. Ryan presented a secondary analysis from the randomized, double-blind, phase III CONQUER trial that involved roughly 2,500 obese patients (Lancet 2011;377:1341-52).

Her new substudy focused on the 388 CONQUER participants with type 2 diabetes. Like all participants in CONQUER, the diabetic patients were placed on a well-known, structured, lifestyle/behavioral modification program known as the LEARN (lifestyle, exercise, attitudes, relationships, nutrition) program for weight management. …

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