Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Journal Title:	The Lancet (British edition) 2010, Vol.376 (9741), p.595-605
Main Author:	Greenway, Frank L, Prof
Other Authors:	Fujioka, Ken, MD , Plodkowski, Raymond A, Prof , Mudaliar, Sunder, Prof , Guttadauria, Maria, MD , Erickson, Janelle, PhD , Kim, Dennis D, MD , Dunayevich, Eduardo, MD
Format:	Electronic Article
Language:	English
Subjects:	Abridged Index Medicus Addictive behaviors Adult Adult and adolescent clinical studies Adults Alcohol use Analysis Anti-Obesity Agents - administration & dosage Biological and medical sciences blood pressure body mass Bupropion Bupropion - administration & dosage Clinical medicine Delayed-Action Preparations Diet Diet (weight control) Diets Dosage and administration Double-Blind Method Drug addiction Drug therapy Drug Therapy, Combination Drugs Energy conservation Female Gastrointestinal surgery General aspects Grants Humans Hypertension Internal Medicine Male Measurement Medical sciences Metabolic diseases Mortality Mouth Naltrexone Naltrexone - administration & dosage Nutrition research Obesity Obesity - drug therapy Observation Overweight - drug therapy Pharmaceuticals Physical fitness Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Public health Quality of life Side effects Studies suicide Weight control Weight loss Weight Loss - drug effects
Quelle:	Alma/SFX Local Collection
Publisher:	Kidlington: Elsevier Ltd
ID:	ISSN: 0140-6736
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title:	Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
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creator:	Greenway, Frank L, Prof Fujioka, Ken, MD Plodkowski, Raymond A, Prof Mudaliar, Sunder, Prof Guttadauria, Maria, MD Erickson, Janelle, PhD Kim, Dennis D, MD Dunayevich, Eduardo, MD
subjects:	Abridged Index Medicus Addictive behaviors Adult Adult and adolescent clinical studies Adults Alcohol use Analysis Anti-Obesity Agents - administration & dosage Biological and medical sciences blood pressure body mass Bupropion Bupropion - administration & dosage Clinical medicine Delayed-Action Preparations Diet Diet (weight control) Diets Dosage and administration Double-Blind Method Drug addiction Drug therapy Drug Therapy, Combination Drugs Energy conservation Female Gastrointestinal surgery General aspects Grants Humans Hypertension Internal Medicine Male Measurement Medical sciences Metabolic diseases Mortality Mouth Naltrexone Naltrexone - administration & dosage Nutrition research Obesity Obesity - drug therapy Observation Overweight - drug therapy Pharmaceuticals Physical fitness Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Public health Quality of life Side effects Studies suicide Weight control Weight loss Weight Loss - drug effects
ispartof:	The Lancet (British edition), 2010, Vol.376 (9741), p.595-605
description:	Summary Background Despite increasing public health concerns regarding obesity, few safe and effective drug treatments are available. Combination treatment with sustained-release naltrexone and bupropion was developed to produce complementary actions in CNS pathways regulating bodyweight. The Contrave Obesity Research I (COR-I) study assessed the effect of such treatment on bodyweight in overweight and obese participants. Methods Men and women aged 18–65 years who had a body-mass index (BMI) of 30–45 kg/m2 and uncomplicated obesity or BMI 27–45 kg/m2 with dyslipidaemia or hypertension were eligible for enrolment in this randomised, double-blind, placebo-controlled, phase 3 trial undertaken at 34 sites in the USA. Participants were prescribed mild hypocaloric diet and exercise and were randomly assigned in a 1:1:1 ratio to receive sustained-release naltrexone 32 mg per day plus sustained-release bupropion 360 mg per day combined in fixed-dose tablets (also known as NB32), sustained-release naltrexone 16 mg per day plus sustained-release bupropion 360 mg per day combined in fixed-dose tablets (also known as NB16), or matching placebo twice a day, given orally for 56 weeks. The trial included a 3-week dose escalation. Randomisation was done by use of a centralised, computer-generated, web-based system and was stratified by study centre. Co-primary efficacy endpoints at 56 weeks were percentage change in bodyweight and proportion of participants who achieved a decrease in bodyweight of 5% or more. The primary analysis included all randomised participants with a baseline weight measurement and a post-baseline weight measurement while on study drug (last observation carried forward). This study is registered with ClinicalTrials.gov , number NCT00532779. Findings 1742 participants were enrolled and randomised to double-blind treatment (naltrexone 32 mg plus bupropion, n=583; naltrexone 16 mg plus bupropion, n=578; placebo, n=581). 870 (50%) participants completed 56 weeks of treatment (n=296; n=284; n=290, respectively) and 1453 (83%) were included in the primary analysis (n=471; n=471; n=511). Mean change in bodyweight was −1·3% (SE 0·3) in the placebo group, −6·1% (0·3) in the naltrexone 32 mg plus bupropion group (p
language:	eng
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identifier:	ISSN: 0140-6736
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Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

source

Alma/SFX Local Collection

creator

Greenway, Frank L, Prof ; Fujioka, Ken, MD ; Plodkowski, Raymond A, Prof ; Mudaliar, Sunder, Prof ; Guttadauria, Maria, MD ; Erickson, Janelle, PhD ; Kim, Dennis D, MD ; Dunayevich, Eduardo, MD

creatorcontrib

Greenway, Frank L, Prof ; Fujioka, Ken, MD ; Plodkowski, Raymond A, Prof ; Mudaliar, Sunder, Prof ; Guttadauria, Maria, MD ; Erickson, Janelle, PhD ; Kim, Dennis D, MD ; Dunayevich, Eduardo, MD ; for the COR-I Study Group ; COR-I Study Group

description

Summary Background Despite increasing public health concerns regarding obesity, few safe and effective drug treatments are available. Combination treatment with sustained-release naltrexone and bupropion was developed to produce complementary actions in CNS pathways regulating bodyweight. The Contrave Obesity Research I (COR-I) study assessed the effect of such treatment on bodyweight in overweight and obese participants. Methods Men and women aged 18–65 years who had a body-mass index (BMI) of 30–45 kg/m2 and uncomplicated obesity or BMI 27–45 kg/m2 with dyslipidaemia or hypertension were eligible for enrolment in this randomised, double-blind, placebo-controlled, phase 3 trial undertaken at 34 sites in the USA. Participants were prescribed mild hypocaloric diet and exercise and were randomly assigned in a 1:1:1 ratio to receive sustained-release naltrexone 32 mg per day plus sustained-release bupropion 360 mg per day combined in fixed-dose tablets (also known as NB32), sustained-release naltrexone 16 mg per day plus sustained-release bupropion 360 mg per day combined in fixed-dose tablets (also known as NB16), or matching placebo twice a day, given orally for 56 weeks. The trial included a 3-week dose escalation. Randomisation was done by use of a centralised, computer-generated, web-based system and was stratified by study centre. Co-primary efficacy endpoints at 56 weeks were percentage change in bodyweight and proportion of participants who achieved a decrease in bodyweight of 5% or more. The primary analysis included all randomised participants with a baseline weight measurement and a post-baseline weight measurement while on study drug (last observation carried forward). This study is registered with ClinicalTrials.gov , number NCT00532779. Findings 1742 participants were enrolled and randomised to double-blind treatment (naltrexone 32 mg plus bupropion, n=583; naltrexone 16 mg plus bupropion, n=578; placebo, n=581). 870 (50%) participants completed 56 weeks of treatment (n=296; n=284; n=290, respectively) and 1453 (83%) were included in the primary analysis (n=471; n=471; n=511). Mean change in bodyweight was −1·3% (SE 0·3) in the placebo group, −6·1% (0·3) in the naltrexone 32 mg plus bupropion group (p<0·0001 vs placebo) and −5·0% (0·3) in the naltrexone 16 mg plus bupropion group (p<0·0001 vs placebo). 84 (16%) participants assigned to placebo had a decrease in bodyweight of 5% or more compared with 226 (48%) assigned to naltrexone 32 mg plus bupropion (p<0·0001 vs placebo) and 186 (39%) assigned to naltrexone 16 mg plus bupropion (p<0·0001 vs placebo). The most frequent adverse event in participants assigned to combination treatment was nausea (naltrexone 32 mg plus bupropion, 171 participants [29·8%]; naltrexone 16 mg plus bupropion, 155 [27·2%]; placebo, 30 [5·3%]). Headache, constipation, dizziness, vomiting, and dry mouth were also more frequent in the naltrexone plus bupropion groups than in the placebo group. A transient increase of around 1·5 mm Hg in mean systolic and diastolic blood pressure was followed by a reduction of around 1 mm Hg below baseline in the naltrexone plus bupropion groups. Combination treatment was not associated with increased depression or suicidality events compared with placebo. Interpretation A sustained-release combination of naltrexone plus bupropion could be a useful therapeutic option for treatment of obesity. Funding Orexigen Therapeutics.

identifier

0	ISSN: 0140-6736
1	EISSN: 1474-547X
2	DOI: 10.1016/S0140-6736(10)60888-4
3	PMID: 20673995
4	CODEN: LANCAO

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eng

publisher

Kidlington: Elsevier Ltd

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Abridged Index Medicus ; Addictive behaviors ; Adult ; Adult and adolescent clinical studies ; Adults ; Alcohol use ; Analysis ; Anti-Obesity Agents - administration & dosage ; Biological and medical sciences ; blood pressure ; body mass ; Bupropion ; Bupropion - administration & dosage ; Clinical medicine ; Delayed-Action Preparations ; Diet ; Diet (weight control) ; Diets ; Dosage and administration ; Double-Blind Method ; Drug addiction ; Drug therapy ; Drug Therapy, Combination ; Drugs ; Energy conservation ; Female ; Gastrointestinal surgery ; General aspects ; Grants ; Humans ; Hypertension ; Internal Medicine ; Male ; Measurement ; Medical sciences ; Metabolic diseases ; Mortality ; Mouth ; Naltrexone ; Naltrexone - administration & dosage ; Nutrition research ; Obesity ; Obesity - drug therapy ; Observation ; Overweight - drug therapy ; Pharmaceuticals ; Physical fitness ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Public health ; Quality of life ; Side effects ; Studies ; suicide ; Weight control ; Weight loss ; Weight Loss - drug effects

ispartof

The Lancet (British edition), 2010, Vol.376 (9741), p.595-605

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0	Elsevier Ltd
1	2010 Elsevier Ltd
2	2015 INIST-CNRS
3	Copyright 2010 Elsevier Ltd. All rights reserved.
4	COPYRIGHT 2010 Elsevier B.V.
5	Copyright Elsevier Limited Aug 21-Aug 27, 2010

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2	Plodkowski, Raymond A, Prof
3	Mudaliar, Sunder, Prof
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5	Erickson, Janelle, PhD
6	Kim, Dennis D, MD
7	Dunayevich, Eduardo, MD
8	for the COR-I Study Group
9	COR-I Study Group

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0	Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
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creationdate	2010
title	Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
author	Greenway, Frank L, Prof ; Fujioka, Ken, MD ; Plodkowski, Raymond A, Prof ; Mudaliar, Sunder, Prof ; Guttadauria, Maria, MD ; Erickson, Janelle, PhD ; Kim, Dennis D, MD ; Dunayevich, Eduardo, MD

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41	Obesity
42	Obesity - drug therapy
43	Observation
44	Overweight - drug therapy
45	Pharmaceuticals
46	Physical fitness
47	Psychology. Psychoanalysis. Psychiatry
48	Psychopathology. Psychiatry
49	Public health
50	Quality of life
51	Side effects
52	Studies
53	suicide
54	Weight control
55	Weight loss
56	Weight Loss - drug effects

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2	Plodkowski, Raymond A, Prof
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5	Erickson, Janelle, PhD
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Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

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The Lancet (British edition)

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Elsevier Ltd

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10.1016/S0140-6736(10)60888-4

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Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial