If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Phentermine Plus Topiramate Effective, Well Tolerated in Obese Patients: Presented at ECO By Shazia Qureshi AMSTERDAM, Netherlands -- May 10, 2009 -- Patients with obesity who took either of 2 different dose combinations of phentermine plus controlled-release (CR) topiramate (VI-0521) lost more weight than patients taking either drug alone or placebo, according to a study reported here on May 7 at the 17th European Congress on Obesity (ECO). Lead author Donna Ryan, MD, Clinical Research, Pennington Biomedical Research Center, Baton Rouge, Louisiana, noted that both dose combinations were well tolerated over the 6 months of the phase 3, randomised, double-blind, placebo-controlled study. The researchers randomised 756 patients to 1 of 7 treatment groups. The 4 single-drug groups were treated with phentermine at 7.5 or 15 mg, or topiramate CR at 46 or 92 mg. The 2 combination groups received VI-0521 7.5/46, which contained phentermine 7.5 mg plus topiramate CR 46 mg, or VI-0521 15/92, which contained phentermine 15 mg plus topiramate CR 92 mg. A seventh group received placebo. In addition to the drug treatment, all patients were given lifestyle and exercise advice and followed a diet that cut their calories by 500 kcal/day. The mean age of all patients was 45.6 +- 11.9 years and 79% were women. At baseline, the mean weight was 101.3 +- 15.5 kg, mean body mass index (BMI) was 36.3 +- 4.1 kg/m2, and mean waist circumference was 111.1 +- 11.1 cm. There were no significant differences among the 7 groups in any of these baseline measurements. Ninety-six percent (n = 726) of patients were included in the intention-to-treat analysis of efficacy with a last observation carried forward method, while 753 patients were included in the tolerability analysis. One primary efficacy endpoint was the percentage of body weight loss from baseline to week 28. In the group of patients taking VI-0521 7.5/46, mean weight loss was 8.5%, and in the VI-0521 15/92 group it was 9.2%. Both were significant (P < .001) when compared with the placebo group, which showed a weight loss of 1.7%. In addition, both VI-0521 dose combinations resulted in significantly (P < .001) more weight loss compared with each of the single-drug treatment arms. At week 28, the percentage of patients who achieved at least 10% weight loss was 38.8% with VI-0521 7.5/46 and 40.8% with VI-0521 15/92 (both P < .001 vs placebo) and 6.8% with placebo. The most commonly observed adverse events reported by patients taking either dose of VI-0521 included headache, paresthesia, upper respiratory infection, dry mouth, nasopharyngitis, and constipation. No serious adverse events were considered to be treatment related. “Combinations of phentermine and CR topiramate appear to be effective and well tolerated for the treatment of obesity,” concluded Dr. Ryan. Funding for this study was provided by Vivus, Inc. [Presentation title: Weight Loss at 6 Months With VI-0521 (PHEN/TPM Combination) Treatment. Abstract HT:PO.22]
|
