Disclosure: Louis J. Aronne, MD, has received grants and consulting fees or honoraria from VIVUS, Inc. He has served as an advisor, board member, and consultant for Amylin Pharmaceuticals Inc., Ethicon Endo-Surgery Inc., GlaxoSmithKline Consumer Healthcare, LP, Novo Nordisk, Orexigen Therapeutics, Inc., VIVUS, Inc., and Zafgen Inc. He has also served as a consultant for Takeda Pharmaceuticals. He has received grants from GI Dynamics, Inc., Novo Nordisk, and Aspire Bariatrics. He owns stocks in CardioMetabolic Support Network LLC, MYOS Corporation, and Zafgen Inc. Thomas Wadden, PhD, has served as a consultant and advisor for VIVUS, Inc. He has participated in clinical trials and has received grants on behalf of the University of Pennsylvania from Merck, Novo Nordisk, NutriSystems, Orexigen Therapeutics, Inc., Weight Watchers, and VIVUS, Inc. He has also served as an advisory board member for Novo Nordisk and Orexigen Therapeutics, Inc. Craig Peterson, MS, is an employee of VIVUS, Inc. David Winslow, MD, has served as an advisor and consultant and has received consulting fees, honoraria, and support for travel to meetings by VIVUS, Inc. He has also participated in clinical studies funded by VIVUS, Inc. Sarah Odeh, BS, CMPP, is an employee of The Lockwood Group. The Lockwood Group provided editorial support for the creation of this manuscript, which was funded by VIVUS, Inc. Kishore M. Gadde, MD, has received grant support and support for travel to meetings by VIVUS, Inc. He has also received grant support and has participated in clinical trials supported by Amylin, Medical University of South Carolina, and VIVUS, Inc. He holds stock in Orexigen Therapeutics, Inc.
Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults
Version of Record online: 17 OCT 2013
Copyright © 2013 The Obesity Society
Volume 21, Issue 11, pages 2163–2171, November 2013
How to Cite
Aronne, L. J., Wadden, T. A., Peterson, C., Winslow, D., Odeh, S. and Gadde, K. M. (2013), Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. Obesity, 21: 2163–2171. doi: 10.1002/oby.20584
Funding agencies: Financial support for the studies and funding for editorial assistance was provided by VIVUS, Inc.
- Issue online: 1 NOV 2013
- Version of Record online: 17 OCT 2013
- Manuscript Accepted: 18 JUL 2013
- Manuscript Revised: 15 JUL 2013
- Manuscript Received: 27 APR 2013
A 28-week, randomized, controlled trial compared the combination of phentermine and topiramate extended-release (PHEN/TPM ER) with its components as monotherapies and with placebo in obese adults.
Design and Methods
Subjects were randomized to placebo, phentermine 7.5 mg, phentermine 15 mg, topiramate ER 46 mg, topiramate ER 92 mg, PHEN/TPM ER 7.5/46 mg, or PHEN/TPM ER 15/92 mg. All subjects received lifestyle intervention counseling. Primary endpoints were percent weight loss (WL) and achievement of ≥5% WL.
At week 28, PHEN/TPM ER 7.5/46 (−8.5%) and 15/92 (−9.2%) achieved greater percentage WL versus placebo (−1.7%; P < 0.0001) and their respective monotherapies (P < 0.05). The percentage of subjects achieving ≥5% WL was 15.5% for placebo, 43.3% for phentermine 7.5, 46.2% for phentermine 15, 39.2% for topiramate ER 46, 48.6% for topiramate ER 92, 62.1% for PHEN/TPM ER 7.5/46, and 66.0% for PHEN/TPM ER 15/92. PHEN/TPM ER was generally well tolerated; comprehensive assessment of cognitive functions with the Repeatable Battery for Assessment of Neuropsychological Status revealed impairment only in the attention domain.
PHEN/TPM ER demonstrated greater WL when used in combination than when used as monotherapies, suggesting enhanced ability of the combination formulation to induce WL at doses lower than with available monotherapies.