Abstract 13009: Low-Dose, Controlled-Release Phentermine/Topiramate Significantly Improves Reynolds 10-Year Risk Score in Obese Women and Men
Intro/Purpose: The Reynolds Risk Score (RRS) incorporates high-sensitivity C-reactive protein (hsCRP) into a risk prediction model for cardiovascular disease (CVD) over 10 years. Low-dose, controlled-release phentermine/topiramate (PHEN/TPM CR) was evaluated in two randomized, double-blind, placebo-controlled Phase 3 trials (EQUIP, CONQUER) for the treatment of obesity and weight-related comorbidities. This secondary analysis assessed the effect of weight loss with PHEN/TPM CR on RRS in overweight/obese subjects based on pooled one-year data
Methods: EQUIP evaluated PHEN 3.75 mg/TPM CR 23 mg (3.75/23) and PHEN 15 mg/TPM CR 92 mg (15/92) vs placebo in 1267 obese (BMI >35 kg/m2) adults. CONQUER evaluated PHEN 7.5 mg/TPM CR 46 mg (7.5/46) and 15/92 vs placebo in 2487 overweight/obese (BMI >27 kg/m2 and <45 kg/m2) adults with >2 weight-related comorbidities. One-year data from these two studies were pooled for evaluation of a modified RRS in subjects providing baseline and Week-56 observations. Data were analyzed using a multivariate analysis that considered age, smoking status, systolic blood pressure, family history of premature CVD, total and HDL cholesterol levels, and hsCRP in both women and men; diabetic status was also factored in for women.
Results: In 3652 subjects analyzed (2711 women, 941 men), weight loss with PHEN/TPM CR in all groups (except men treated with 3.75/23) significantly (P<0.05) reduced the 10-year RRS from baseline to Week 56 (Table). Least-squares (LS) mean percent changes were statistically superior to placebo (P<0.05) for all PHEN/TPM CR groups; percent risk increased by 4.0% to 6.1% in the placebo groups but decreased by 5.4 to 16.3% in PHEN/TPM CR groups. Treatment with PHEN/TPM CR was generally well tolerated.
Conclusions: PHEN/TPM CR significantly reduced RRS among obese women and men. These findings suggest that weight loss with PHEN/TPM CR offers the potential to reduce 10-year CVD risk among overweight/obese women and men.
- © 2010 by American Heart Association, Inc.