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Controlled‐Release Phentermine/Topiramate in Severely Obese Adults: A Randomized Controlled Trial (EQUIP)
Author(s) -
Allison David B.,
Gadde Kishore M.,
Garvey William Timothy,
Peterson Craig A.,
Schwiers Michael L.,
Najarian Thomas,
Tam Peter Y.,
Troupin Barbara,
Day Wesley W.
Publication year - 2012
Publication title -
obesity
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.438
H-Index - 199
eISSN - 1930-739X
pISSN - 1930-7381
DOI - 10.1038/oby.2011.330
Subject(s) - phentermine , medicine , placebo , topiramate , weight loss , blood pressure , waist , randomized controlled trial , adverse effect , gastroenterology , endocrinology , obesity , alternative medicine , pathology , psychiatry , epilepsy
A 56‐week randomized controlled trial was conducted to evaluate safety and efficacy of a controlled‐release combination of phentermine and topiramate (PHEN/TPM CR) for weight loss (WL) and metabolic improvements. Men and women with class II and III obesity (BMI ≥ 35 kg/m 2 ) were randomized to placebo, PHEN/TPM CR 3.75/23 mg, or PHEN/TPM CR 15/92 mg, added to a reduced‐energy diet. Primary end points were percent WL and proportions of patients achieving 5% WL. Secondary end points included waist circumference (WC), systolic and diastolic blood pressure (BP), fasting glucose, and lipid measures. In the primary analysis (randomized patients with at least one postbaseline weight measurement who took at least one dose of assigned drug or placebo), patients in the placebo, 3.75/23, and 15/92 groups lost 1.6%, 5.1%, and 10.9% of baseline body weight (BW), respectively, at 56 weeks ( P < 0.0001). In categorical analysis, 17.3% of placebo patients, 44.9% of 3.75/23 patients, and 66.7% of 15/92 patients, lost at least 5% of baseline BW at 56 weeks ( P < 0.0001). The 15/92 group had significantly greater changes relative to placebo for WC, systolic and diastolic BP, fasting glucose, triglycerides, total cholesterol, low‐density lipoprotein (LDL), and high‐density lipoprotein (HDL). The most common adverse events were paresthesia, dry mouth, constipation, dysgeusia, and insomnia. Dropout rate from the study was 47.1% for placebo patients, 39.0% for 3.75/23 patients, and 33.6% of 15/92 patients. PHEN/TPM CR demonstrated dose‐dependent effects on weight and metabolic variables in the direction expected to be beneficial with no evidence of serious adverse events induced by treatment.