MONDAY, Oct. 21 (HealthDay News) -- Over two years, phentermine and topiramate extended-release (PHEN/TPM ER) treatment plus lifestyle changes lead to significant weight loss and a considerable reduction in progression to type 2 diabetes in high-risk, overweight/obese individuals, according to a study published online Oct. 8 in Diabetes Care.
W. Timothy Garvey, M.D., from the University of Alabama at Birmingham, and colleagues conducted subanalysis of a phase 3, randomized, double-blind study of overweight/obese subjects (BMI ≥27 to ≤45 kg/m²) with two or more comorbidities. Participants were randomized to receive placebo, PHEN 7.5 mg/TPM ER 46 mg (7.5/46), or PHEN 15 mg/TPM ER 92 mg (15/92) plus lifestyle modifications for 108 weeks.
The researchers found that, at baseline, 475 participants had prediabetes and/or metabolic syndrome (MetS). The mean percent weight loss for these participants was 2.5, 10.9, and 12.1 percent, respectively, in the placebo, 7.5/46, and 15/92 groups after 108 weeks. Compared with placebo, there were reductions of 70.5 and 78.7 percent in the annualized incidence rate of type 2 diabetes for the 7.5/46 and 15/92 groups, respectively. The reductions correlated with the degree of weight loss and were accompanied by significant cardiometabolic parameter improvements. Over two years, PHEN/TPM ER was well tolerated.
"PHEN/TPM ER plus lifestyle modification produced significant weight loss and markedly reduced progression to type 2 diabetes in overweight/obese patients with prediabetes and/or MetS," the authors conclude.
Several authors disclosed financial ties to pharmaceutical companies, including VIVUS, which funded the study and manufactures PHEN/TPM ER.
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