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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

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 Contra... Full description

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 Electronic Article
Language: English
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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
format: Article
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
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
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titleEffect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
sourceAlma/SFX Local Collection
creatorGreenway, 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
creatorcontribGreenway, 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
descriptionSummary 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.
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3PMID: 20673995
4CODEN: LANCAO
languageeng
publisherKidlington: Elsevier Ltd
subjectAbridged 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
ispartofThe Lancet (British edition), 2010, Vol.376 (9741), p.595-605
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5Copyright Elsevier Limited Aug 21-Aug 27, 2010
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1Fujioka, Ken, MD
2Plodkowski, Raymond A, Prof
3Mudaliar, Sunder, Prof
4Guttadauria, Maria, MD
5Erickson, Janelle, PhD
6Kim, Dennis D, MD
7Dunayevich, Eduardo, MD
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0Effect 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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descriptionSummary 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.
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1Addictive behaviors
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3Adult and adolescent clinical studies
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5Alcohol use
6Analysis
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9blood pressure
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14Delayed-Action Preparations
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20Drug addiction
21Drug therapy
22Drug Therapy, Combination
23Drugs
24Energy conservation
25Female
26Gastrointestinal surgery
27General aspects
28Grants
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30Hypertension
31Internal Medicine
32Male
33Measurement
34Medical sciences
35Metabolic diseases
36Mortality
37Mouth
38Naltrexone
39Naltrexone - administration & dosage
40Nutrition research
41Obesity
42Obesity - drug therapy
43Observation
44Overweight - drug therapy
45Pharmaceuticals
46Physical fitness
47Psychology. Psychoanalysis. Psychiatry
48Psychopathology. Psychiatry
49Public health
50Quality of life
51Side effects
52Studies
53suicide
54Weight control
55Weight loss
56Weight Loss - drug effects
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titleEffect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial
authorGreenway, 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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47Psychology. Psychoanalysis. Psychiatry
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49Public health
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52Studies
53suicide
54Weight control
55Weight loss
56Weight Loss - drug effects
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eissn1474-547X
codenLANCAO
abstractSummary 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.
copKidlington
pubElsevier Ltd
pmid20673995
doi10.1016/S0140-6736(10)60888-4