Phentermine/Topiramate for the Treatment of Obesity
Abstract
OBJECTIVE: To review the pharmacology, efficacy, and safety of phentermine/topiramate (PHEN/TPM) in the management of obese patients. DATA SOURCES: MEDLINE (1966-July 2012) was searched using the terms weight loss, obesity, phentermine and topiramate, phentermine, topiramate, Qnexa, Qsymia, and VI-0521. Additionally, the new drug application and prescribing information for PHEN/TPM were retrieved. STUDY SELECTION/DATA EXTRACTION: All studies considering the pharmacology, efficacy, and safety of PHEN/TPM were reviewed with a focus on efficacy and safety data from Phase 3 trials. DATA SYNTHESIS: In 3 Phase 3 trials (EQUIP, CONQUER, and SEQUEL), treatment with PHEN/TPM consistently demonstrated statistically significant weight loss compared with placebo. After 56 weeks of treatment, percent weight loss achieved with PHEN/TPM was 10.6%, 8.4%, and 5.1% with 15/92 mg, 7.5/46 mg, and 3.75/23 mg, respectively (p < 0.0001). The 52-week extension study (SEQUEL) showed maintained weight loss over 2 years with 9.3% and 10.5% weight loss from baseline for 7.5/46 mg and 15/92 mg PHEN/TPM (p < 0.0001). A significantly higher proportion of patients achieved greater than 5%, 10%, or 15% weight loss with PHEN/TPM compared with placebo. Significant reductions in waist circumference, fasting triglycerides, and fasting glucoses were also attributable to PHEN/TPM. The drug was generally well tolerated in clinical trials. Adverse reactions occurring in 5% or more of study subjects included paresthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. CONCLUSIONS: PHEN/TPM is a new, once-daily, controlled-release, combination weight-loss product approved as an adjunct to diet and exercise for chronic weight management of obese or overweight patients with weight-related comorbidities. PHEN/TPM is modestly effective and a viable option for patients interested in losing weight, although long-term safety data are lacking.
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In SEQUEL, weight loss was maintained over 2 years at 9.3% and 10.5% from baseline for phentermine/topiramate ER 7.5/46 mg and 15/92 mg, respectively.
“Weight loss was maintained over 2 years at 9.3% and 10.5% from the baseline for 7.5/46 and 15/92 mg doses of phentermine/topiramate ER, respectively [39].”
From Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? (2021) · cites this paper as [39]
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- Authors
- Smith, S. M., Meyer, M., & Trinkley, K. E.
- Affiliations
- University of Colorado Anschutz (US)
- Exempla Saint Joseph Hospital (US)
- University of Colorado Denver (US)
- Corresponding author
- Trinkley, Katy E
- Venue
- Annals of Pharmacotherapy
- Publisher
- SAGE Publications
- Published
- 2013-03
- Volume
- 47
- Issue
- 3
- Pages
- 340-349
- ISSN
- 0012-6578 (ISSN-L)
- 1060-0280
- 1542-6270
- OpenAlex
- W2145130242
- Cited by
- 122
- References
- 12
- Citations by year
- 2026: 9 · 2025: 19 · 2024: 15 · 2023: 18 · 2022: 10 · 2021: 13 · 2020: 6 · 2019: 4 · 2018: 4 · 2017: 8 · 2016: 5 · 2015: 8 · 2014: 2 · 2013: 1
- FWCI
- 3.92
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Pharmacotherapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Obesity, Physical Activity, Diet
- Keywords
- phentermine/topiramate, obesity, weight loss, weight management, efficacy, drug safety, adverse effects, long-term weight maintenance, waist circumference, triglycerides, fasting blood glucose
- MeSH terms
- Topiramate, Drug Combinations, Fructose, Humans, Obesity, Phentermine, Anti-Obesity Agents
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