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Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study.
Am J Clin Nutr. 2012 Feb; 95(2):297-308.AJ

Abstract

BACKGROUND

Obesity is a serious chronic disease. Controlled-release phentermine/topiramate (PHEN/TPM CR), as an adjunct to lifestyle modification, has previously shown significant weight loss compared with placebo in a 56-wk study in overweight and obese subjects with ≥2 weight-related comorbidities.

OBJECTIVE

This study evaluated the long-term efficacy and safety of PHEN/TPM CR in overweight and obese subjects with cardiometabolic disease.

DESIGN

This was a placebo-controlled, double-blind, 52-wk extension study; volunteers at selected sites continued with original randomly assigned treatment [placebo, 7.5 mg phentermine/46 mg controlled-release topiramate (7.5/46), or 15 mg phentermine/92 mg controlled-release topiramate (15/92)] to complete a total of 108 wk. All subjects participated in a lifestyle-modification program.

RESULTS

Of 866 eligible subjects, 676 (78%) elected to continue in the extension. Overall, 84.0% of subjects completed the study, with similar completion rates between treatment groups. At week 108, PHEN/TPM CR was associated with significant, sustained weight loss (intent-to-treat with last observation carried forward; P < 0.0001 compared with placebo); least-squares mean percentage changes from baseline in body weight were -1.8%, -9.3%, and -10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more PHEN/TPM CR-treated subjects at each dose achieved ≥5%, ≥10%, ≥15%, and ≥20% weight loss compared with placebo (P < 0.001). PHEN/TPM CR improved cardiovascular and metabolic variables and decreased rates of incident diabetes in comparison with placebo. PHEN/TPM CR was well tolerated over 108 wk, with reduced rates of adverse events occurring between weeks 56 and 108 compared with rates between weeks 0 and 56.

CONCLUSION

PHEN/TPM CR in conjunction with lifestyle modification may provide a well-tolerated and effective option for the sustained treatment of obesity complicated by cardiometabolic disease. This trial was registered at clinicaltrials.gov as NCT00796367.

Authors+Show Affiliations

Department of Nutrition Sciences, UAB Diabetes Research and Training Center, University of Alabama at Birmingham, 35294-3360, USA. garveyt@uab.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22158731

Citation

Garvey, W Timothy, et al. "Two-year Sustained Weight Loss and Metabolic Benefits With Controlled-release Phentermine/topiramate in Obese and Overweight Adults (SEQUEL): a Randomized, Placebo-controlled, Phase 3 Extension Study." The American Journal of Clinical Nutrition, vol. 95, no. 2, 2012, pp. 297-308.
Garvey WT, Ryan DH, Look M, et al. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012;95(2):297-308.
Garvey, W. T., Ryan, D. H., Look, M., Gadde, K. M., Allison, D. B., Peterson, C. A., Schwiers, M., Day, W. W., & Bowden, C. H. (2012). Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. The American Journal of Clinical Nutrition, 95(2), 297-308. https://doi.org/10.3945/ajcn.111.024927
Garvey WT, et al. Two-year Sustained Weight Loss and Metabolic Benefits With Controlled-release Phentermine/topiramate in Obese and Overweight Adults (SEQUEL): a Randomized, Placebo-controlled, Phase 3 Extension Study. Am J Clin Nutr. 2012;95(2):297-308. PubMed PMID: 22158731.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. AU - Garvey,W Timothy, AU - Ryan,Donna H, AU - Look,Michelle, AU - Gadde,Kishore M, AU - Allison,David B, AU - Peterson,Craig A, AU - Schwiers,Michael, AU - Day,Wesley W, AU - Bowden,Charles H, Y1 - 2011/12/07/ PY - 2011/12/14/entrez PY - 2011/12/14/pubmed PY - 2012/3/7/medline SP - 297 EP - 308 JF - The American journal of clinical nutrition JO - Am. J. Clin. Nutr. VL - 95 IS - 2 N2 - BACKGROUND: Obesity is a serious chronic disease. Controlled-release phentermine/topiramate (PHEN/TPM CR), as an adjunct to lifestyle modification, has previously shown significant weight loss compared with placebo in a 56-wk study in overweight and obese subjects with ≥2 weight-related comorbidities. OBJECTIVE: This study evaluated the long-term efficacy and safety of PHEN/TPM CR in overweight and obese subjects with cardiometabolic disease. DESIGN: This was a placebo-controlled, double-blind, 52-wk extension study; volunteers at selected sites continued with original randomly assigned treatment [placebo, 7.5 mg phentermine/46 mg controlled-release topiramate (7.5/46), or 15 mg phentermine/92 mg controlled-release topiramate (15/92)] to complete a total of 108 wk. All subjects participated in a lifestyle-modification program. RESULTS: Of 866 eligible subjects, 676 (78%) elected to continue in the extension. Overall, 84.0% of subjects completed the study, with similar completion rates between treatment groups. At week 108, PHEN/TPM CR was associated with significant, sustained weight loss (intent-to-treat with last observation carried forward; P < 0.0001 compared with placebo); least-squares mean percentage changes from baseline in body weight were -1.8%, -9.3%, and -10.5% for placebo, 7.5/46, and 15/92, respectively. Significantly more PHEN/TPM CR-treated subjects at each dose achieved ≥5%, ≥10%, ≥15%, and ≥20% weight loss compared with placebo (P < 0.001). PHEN/TPM CR improved cardiovascular and metabolic variables and decreased rates of incident diabetes in comparison with placebo. PHEN/TPM CR was well tolerated over 108 wk, with reduced rates of adverse events occurring between weeks 56 and 108 compared with rates between weeks 0 and 56. CONCLUSION: PHEN/TPM CR in conjunction with lifestyle modification may provide a well-tolerated and effective option for the sustained treatment of obesity complicated by cardiometabolic disease. This trial was registered at clinicaltrials.gov as NCT00796367. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/22158731/Two_year_sustained_weight_loss_and_metabolic_benefits_with_controlled_release_phentermine/topiramate_in_obese_and_overweight_adults__SEQUEL_:_a_randomized_placebo_controlled_phase_3_extension_study_ L2 - https://academic.oup.com/ajcn/article-lookup/doi/10.3945/ajcn.111.024927 DB - PRIME DP - Unbound Medicine ER -