Washington, April 11: A new study, led by an Indian-origin scientist at the Duke University Medical Center, has found that an investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial.

It established that treatment with the controlled-release combination therapy consisting of phentermine and topiramate also achieved significant reductions in blood pressure and hemoglobin A1C.

Participants involved in the study also experienced improvements in cholesterol, triglycerides and inflammatory markers, including C-reactive protein, when taking either of two doses of the combination when compared to placebo.

"Patients receiving this combination experienced 8.6 percent greater weight loss, on average, compared to those patients receiving placebo," said Kishore M. Gadde, director of Duke''s obesity clinical trials program.

"This kind of weight loss, coupled with significant reductions in cardiometabolic risk factors represents a potentially important advancement in the management of obesity.

"The combination drug achieves about 19 pounds of weight loss relative to placebo at one year," he added.

The 56-week, phase 3 study was conducted in 93 U. S. centers with 2487 patients who had a BMI of 27-45kg/m2, and two or more co-morbidities such as diabetes or heart disease.

Patients were randomly assigned to receive either a placebo or one of two low-dose drug combinations. They also received diet and exercise advice.

The study used once-daily oral doses of the combined drugs. Phentermine 7.5mg plus topiramate CR 46mg achieved 7.8 percent weight loss and Phentermine 15mg plus topiramate CR 92mg achieved 9.8 percent weight loss. The placebo group experienced 1.2 percent weight loss.

The greatest improvement in cardiovascular disease and diabetes were seen in high risk patients among the groups given placebo, phentermine 7.5mg plus topiramate 40mg, or phentermine 15mg plus topiramate
92mg respectively:

The study appeared online in The Lancet. (ANI)