Language:

Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial

The Lancet (British edition), 2011-04, Vol.377 (9774), p.1341-1352 [Peer Reviewed Journal]

Elsevier Ltd ;2011 Elsevier Ltd ;2015 INIST-CNRS ;Copyright © 2011 Elsevier Ltd. All rights reserved. ;Copyright Elsevier Limited Apr 16-Apr 22, 2011 ;ISSN: 0140-6736 ;EISSN: 1474-547X ;DOI: 10.1016/S0140-6736(11)60205-5 ;PMID: 21481449 ;CODEN: LANCAO

Full text available

Citations Cited by

Actions
1. Add to My Research
2. Remove from My Research
3. E-mail
4. Print
5. Permalink
6. Citation
7. EasyBib
8. EndNote
9. RefWorks
10. Delicious
11. Export RIS
12. Export BibTeX

Title:
Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial
Author: Gadde, Kishore M, Dr ; Allison, David B, Prof ; Ryan, Donna H, MD ; Peterson, Craig A, MS ; Troupin, Barbara, MD ; Schwiers, Michael L, MS ; Day, Wesley W, PhD
Subjects: Adolescent ; Adult ; Adults ; Aged ; Algorithms ; Anti-Obesity Agents - administration & dosage ; Anticonvulsants. Antiepileptics. Antiparkinson agents ; Antidepressants ; Biological and medical sciences ; Blood pressure ; Body weight ; Cancer ; Cardiovascular diseases ; Clinical trials ; Comorbidity ; Constipation ; Controlled release ; Diabetes ; Diabetes mellitus ; Diet (weight control) ; Diets ; Diseases ; Double-Blind Method ; Drug Combinations ; Drug therapy ; Drugs ; Female ; Fructose - administration & dosage ; Fructose - analogs & derivatives ; General aspects ; Humans ; Hypertension ; Intention ; Internal Medicine ; Life span ; Lifestyle ; Male ; Medical sciences ; Metabolic diseases ; Middle Aged ; Morbidity ; Mortality ; Motivation ; Mouth ; Neuropharmacology ; Obesity ; Obesity - drug therapy ; Overweight - drug therapy ; Patients ; Pharmacology. Drug treatments ; Phentermine - administration & dosage ; Review boards ; Risk factors ; Sex ; Side effects ; Sleep disorders ; topiramate ; Triglycerides ; Weight control ; Weight Loss - drug effects ; Young Adult
Is Part Of: The Lancet (British edition), 2011-04, Vol.377 (9774), p.1341-1352
Description: Summary Background Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18–70 years), with a body-mass index of 27–45 kg/m2 and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov , number NCT00553787. Findings Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was −1·4 kg (least-squares mean −1·2%, 95% CI −1·8 to −0·7), −8·1 kg (−7·8%, −8·5 to −7·1; p<0·0001), and −10·2 kg (−9·8%, −10·4 to −9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding Vivus.
Publisher: Kidlington: Elsevier Ltd
Language: English
Identifier: ISSN: 0140-6736
EISSN: 1474-547X
DOI: 10.1016/S0140-6736(11)60205-5
PMID: 21481449
CODEN: LANCAO
Source: ProQuest One Psychology
AUTh Library subscriptions: ProQuest Central
MEDLINE

Back to results list


INSPIRE LIBRARY - TON DUC THANG UNIVERSITY	(84-028) 37 755 057	Feedback
19 Nguyen Huu Tho St. Dist.7, HCM	thuvien@tdtu.edu.vn	Feedback

Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial

Elsevier Ltd ;2011 Elsevier Ltd ;2015 INIST-CNRS ;Copyright © 2011 Elsevier Ltd. All rights reserved. ;Copyright Elsevier Limited Apr 16-Apr 22, 2011 ;ISSN: 0140-6736 ;EISSN: 1474-547X ;DOI: 10.1016/S0140-6736(11)60205-5 ;PMID: 21481449 ;CODEN: LANCAO

Searching Remote Databases, Please Wait