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Cited by 224Pharmacology and Obesity TreatmentBariatric Surgery and OutcomesRegulation of Appetite and Obesity

A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects

for the OBES-002 Study Group, Wilding, J, Gaal, L Van, Rissanen, A, Vercruysse, F, Fitchet, M·2004·International Journal of Obesity
DOI 10.1038/sj.ijo.0802783
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Abstract

Background Treatment of obese subjects with topiramate has recently been associated with significant weight loss in a 6-month dose-ranging study.Objective To investigate the long-term efficacy and safety of topiramate in obese subjects.Design Randomised, double-blind, placebo-controlled study investigating three doses of topiramate: 96, 192, and 256 mg/day. All subjects also participated in a nonpharmacological weight-loss programme.Subjects The study included 1289 subjects 18-75 y with a body mass index >/=30 kg/m(2) and <50 kg/m(2) in the absence of comorbidities, or >/=27 kg/m(2) and <50 kg/m(2) in the presence of controlled hypertension and/or dyslipidaemia.Duration The original study design was for a 6-week, single-blind, placebo run-in phase followed by an 8-week titration phase and 2 y of maintenance at the assigned dose. Sponsor ended study early in order to develop a new controlled-release formulation with the potential to enhance tolerability and simplify dosing in this patient population. Therefore, none of the subjects completed the full 2 y of treatment. Efficacy results are based on subjects who were enrolled early enough to have had an opportunity to complete 1 y at their assigned dose (modified intent-to-treat population, MITT) before learning of the decision to terminate the study. Safety results are based on all subjects who took at least one dose of study medication.Results The safety population consisted of 1282 subjects, and the MITT efficacy population was 854 subjects. At 60 weeks, subjects in the placebo group lost 1.7% of their baseline body weight, while subjects in the topiramate 96, 192, and 256 mg/day treatment groups lost 7.0, 9.1, and 9.7%, respectively (P<0.001, MITT, last observation carried forward). Weight loss >/=5% of baseline weight was achieved by 18% of subjects in the placebo arm vs 54, 61, and 67% of subjects receiving topiramate 96, 192, and 256 mg/day, respectively; weight loss >/=10% was achieved by 6 vs 29, 40, and 44%, respectively (P<0.001). Weight loss was accompanied by significant improvements in blood pressure (systolic/diastolic changes of +0.4/+1.0, -3.1/-1.3, -5.7/-3.4, and -4.6/-2.4 mmHg were observed for placebo, topiramate 96 mg/day, 192 mg/day, and 256 mg/day, respectively, P<0.001) and glucose and insulin. The most common adverse events more frequently observed in topiramate-treated subjects occurred mostly during the titration phase and were related to the central or peripheral nervous system and included paresthesia, difficulty with concentration/attention, depression, difficulty with memory, language problems, nervousness, and psychomotor slowing.Conclusion Topiramate treatment of obese subjects over the course of 1 y resulted in clinically significant weight loss. Improvements were also observed in blood pressure and glucose tolerance.

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Crossref · 10.1038/sj.ijo.0802783

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  • Topiramate results in 36-67% of patients achieving 5% weight loss.

    “36-67”

    From Effectiveness and safety of drugs for obesity (2024) · cites this paper as [50]

  • Topiramate produces a placebo-subtracted weight loss of 2.4-8.0% at 6 months depending on dose and study.

    “2.4-8.0 at 6 months depending study 49 50 on dose and”

    From Effectiveness and safety of drugs for obesity (2024) · cites this paper as [50]

  • Topiramate results in 29-44% of patients achieving 10% weight loss depending on dose.

    “10% weight loss achieved by 29-44% of patients, depending on dose”

    From Effectiveness and safety of drugs for obesity (2024) · cites this paper as [50]

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Authors
for the OBES-002 Study Group, Wilding, J., Gaal, L. V., Rissanen, A., Vercruysse, F., & Fitchet, M.
Affiliations
  • Aintree University Hospital (GB)
  • Helsinki University Hospital (FI)
  • Janssen Research & Development (United States) (US)
Corresponding author
Wilding, J
ORCID
Venue
International Journal of Obesity
Publisher
Springer Science and Business Media LLC
Published
2004-09-21
Volume
28
Issue
11
Pages
1399-1410
ISSN
  • 0307-0565 (ISSN-L)
  • 1476-5497
DOI
10.1038/sj.ijo.0802783
OpenAlex
W1980235427
Cited by
224
References
37
Citations by year
2026: 2 · 2025: 9 · 2024: 5 · 2023: 9 · 2022: 6 · 2021: 6 · 2020: 2 · 2019: 7 · 2018: 5 · 2017: 6 · 2016: 7 · 2015: 10 · 2014: 13 · 2013: 15 · 2012: 10
FWCI
12.77
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • International Journal of Obesity (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
  • Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
Keywords
topiramate, obesity, weight loss, anti-obesity drugs, long-term efficacy, drug safety, dose titration, controlled-release formulation, body mass index, hypertension, dyslipidemia, adverse events, tolerability, early trial termination, dose-ranging, antiepileptic drugs
MeSH terms
Topiramate, Adult, Blood Glucose, Blood Pressure, Depression, Diet, Reducing, Double-Blind Method, Drug Administration Schedule, Exercise Therapy, Female, Follow-Up Studies, Fructose, Glucose Tolerance Test, Humans, Male, Middle Aged, Obesity, Paresthesia, Suicide, Anti-Obesity Agents

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