Page last updated: 2024-10-17

bupropion and Overweight

bupropion has been researched along with Overweight in 23 studies

Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring.

Overweight: A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat.

Research Excerpts

ExcerptRelevanceReference
"A reduction in BMI z-score during smoking cessation with bupropion has important implications for the future of adolescent smoking cessation."9.22BMI changes in adolescents treated with bupropion SR for smoking cessation. ( Floden, L; Leischow, SJ; Muramoto, ML; Taren, DL, 2016)
"To determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events (MACE, defined as cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction) compared with placebo in overweight and obese patients."9.22Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. ( Bakris, G; Buse, JB; Nissen, SE; Perez, A; Prcela, L; Smith, SR; Wadden, T; Wolski, KE, 2016)
"CONTRAVE Obesity Research-II (COR-II) was a double-blind, placebo-controlled study of 1,496 obese (BMI 30-45 kg/m(2) ) or overweight (27-45 kg/m(2) with dyslipidemia and/or hypertension) participants randomized 2:1 to combined naltrexone sustained-release (SR) (32 mg/day) plus bupropion SR (360 mg/day) (NB32) or placebo for up to 56 weeks."9.17A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). ( Apovian, CM; Aronne, L; Burns, C; Dunayevich, E; Kim, D; Rubino, D; Still, C; Wyatt, H, 2013)
" The objective of this study was to perform a randomized placebo-controlled trial to evaluate the short-term efficacy of bupropion for the treatment of BED in overweight and obese women."9.17Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. ( Grilo, CM; White, MA, 2013)
"To assess the efficacy and safety of 32 mg naltrexone sustained-release (SR)/360 mg bupropion SR (NB) in overweight/obese individuals with type 2 diabetes with or without background oral antidiabetes drugs."9.17Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. ( Bays, H; Burns, C; Fujioka, K; Greenway, F; Gupta, AK; Hollander, P; Klassen, P; Plodkowski, R, 2013)
"A combination of sustained release (SR) naltrexone (32 mg/day) and bupropion SR (360 mg/day) plus behavioral counseling was evaluated for the treatment of smoking cessation and mitigation of nicotine withdrawal and weight gain."9.14An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects. ( Billes, SK; Dunayevich, E; Erickson, JS; Katz, BB; Oskooilar, N; Tollefson, G; Wilcox, CS, 2010)
"A sustained-release combination of naltrexone plus bupropion could be a useful therapeutic option for treatment of obesity."9.14Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. ( Dunayevich, E; Erickson, J; Fujioka, K; Greenway, FL; Guttadauria, M; Kim, DD; Mudaliar, S; Plodkowski, RA, 2010)
"This review covers the development of naltrexone/bupropion combination therapy for obesity, as well as the published clinical trials on the safety and efficacy of the combination in overweight and obese humans."8.87Combination therapy with naltrexone and bupropion for obesity. ( Billes, SK; Greenway, FL, 2011)
"To investigate the changes of circulating levels of all proglucagon-derived peptides (PGDPs) in individuals with overweight or obesity receiving liraglutide (3 mg) or naltrexone/bupropion (32/360 mg), and to explore the association between induced changes in postprandial PGDP levels and body composition, as well as metabolic variables, after 3 and 6 months on treatment."8.31Circulating levels of proglucagon-derived peptides are differentially regulated by the glucagon-like peptide-1 agonist liraglutide and the centrally acting naltrexone/bupropion and can predict future weight loss and metabolic improvements: A 6-month long ( Argyrakopoulou, G; Bontozoglou, N; Kalra, B; Kokkinos, A; Konstantinidou, SK; Kouvari, M; Kumar, A; Kumar, M; Kyriakopoulou, K; Mantzoros, CS; Simati, S; Stefanakis, K, 2023)
"A reduction in BMI z-score during smoking cessation with bupropion has important implications for the future of adolescent smoking cessation."5.22BMI changes in adolescents treated with bupropion SR for smoking cessation. ( Floden, L; Leischow, SJ; Muramoto, ML; Taren, DL, 2016)
"To determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events (MACE, defined as cardiovascular death, nonfatal stroke, or nonfatal myocardial infarction) compared with placebo in overweight and obese patients."5.22Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. ( Bakris, G; Buse, JB; Nissen, SE; Perez, A; Prcela, L; Smith, SR; Wadden, T; Wolski, KE, 2016)
"CONTRAVE Obesity Research-II (COR-II) was a double-blind, placebo-controlled study of 1,496 obese (BMI 30-45 kg/m(2) ) or overweight (27-45 kg/m(2) with dyslipidemia and/or hypertension) participants randomized 2:1 to combined naltrexone sustained-release (SR) (32 mg/day) plus bupropion SR (360 mg/day) (NB32) or placebo for up to 56 weeks."5.17A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). ( Apovian, CM; Aronne, L; Burns, C; Dunayevich, E; Kim, D; Rubino, D; Still, C; Wyatt, H, 2013)
" The objective of this study was to perform a randomized placebo-controlled trial to evaluate the short-term efficacy of bupropion for the treatment of BED in overweight and obese women."5.17Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. ( Grilo, CM; White, MA, 2013)
"To assess the efficacy and safety of 32 mg naltrexone sustained-release (SR)/360 mg bupropion SR (NB) in overweight/obese individuals with type 2 diabetes with or without background oral antidiabetes drugs."5.17Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. ( Bays, H; Burns, C; Fujioka, K; Greenway, F; Gupta, AK; Hollander, P; Klassen, P; Plodkowski, R, 2013)
" Here, we explore combination therapy with bupropion (BUP), a putative stimulator of melanocortin pathways, and an opioid antagonist, naltrexone (NAL), to antagonize an inhibitory feedback loop that limits sustained weight reduction."5.14Rational design of a combination medication for the treatment of obesity. ( Anderson, JW; Atkinson, RL; Cowley, MA; Dunayevich, E; Fujioka, K; Gadde, KM; Greenway, FL; Gupta, AK; Guttadauria, M; O'Neil, P; Schumacher, D; Smith, D; Tollefson, GD; Weber, E; Whitehouse, MJ, 2009)
"A combination of sustained release (SR) naltrexone (32 mg/day) and bupropion SR (360 mg/day) plus behavioral counseling was evaluated for the treatment of smoking cessation and mitigation of nicotine withdrawal and weight gain."5.14An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects. ( Billes, SK; Dunayevich, E; Erickson, JS; Katz, BB; Oskooilar, N; Tollefson, G; Wilcox, CS, 2010)
"A sustained-release combination of naltrexone plus bupropion could be a useful therapeutic option for treatment of obesity."5.14Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. ( Dunayevich, E; Erickson, J; Fujioka, K; Greenway, FL; Guttadauria, M; Kim, DD; Mudaliar, S; Plodkowski, RA, 2010)
"This review covers the development of naltrexone/bupropion combination therapy for obesity, as well as the published clinical trials on the safety and efficacy of the combination in overweight and obese humans."4.87Combination therapy with naltrexone and bupropion for obesity. ( Billes, SK; Greenway, FL, 2011)
"Contrave is an investigational fixed-dose combination drug of naltrexone and bupropion currently in Phase III clinical trials for the treatment of obesity."4.87ACS chemical neuroscience molecule spotlight on contrave. ( Mercer, SL, 2011)
"To investigate the changes of circulating levels of all proglucagon-derived peptides (PGDPs) in individuals with overweight or obesity receiving liraglutide (3 mg) or naltrexone/bupropion (32/360 mg), and to explore the association between induced changes in postprandial PGDP levels and body composition, as well as metabolic variables, after 3 and 6 months on treatment."4.31Circulating levels of proglucagon-derived peptides are differentially regulated by the glucagon-like peptide-1 agonist liraglutide and the centrally acting naltrexone/bupropion and can predict future weight loss and metabolic improvements: A 6-month long ( Argyrakopoulou, G; Bontozoglou, N; Kalra, B; Kokkinos, A; Konstantinidou, SK; Kouvari, M; Kumar, A; Kumar, M; Kyriakopoulou, K; Mantzoros, CS; Simati, S; Stefanakis, K, 2023)
"The recent approval of liraglutide, lorcaserin, naltrexone/bupropion extended-release, and phentermine/topiramate extended-release, brings the number of medications for long-term weight loss to 5 (including orlistat)."3.83Answers to Clinical Questions in the Primary Care Management of People with Obesity: Pharmacologic Management. ( Braverman-Panza, J; Fujioka, K, 2016)
" Lorcaserin (Belviq(®)), phentermine/topiramate combination (Qsymia(®)), and bupropion/naltrexone combination have been demonstrated to be effective for the treatment of obesity, as an adjunct to a reduced-calorie diet and physical activity, although their absolute safety has yet to be established with more widespread use or longer use."3.79Therapies for obesity and medication-associated weight gain. ( Howland, RH, 2013)
" However, they are costly and may have adverse effects in some individuals."2.72Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand? ( Lee, SY; Tak, YJ, 2021)
" Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo."1.51Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis. ( Acevedo, LM; Apovian, CM; Dunayevich, E; Greenway, FL; McElroy, SL; Pi-Sunyer, X, 2019)

Research

Studies (23)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (4.35)29.6817
2010's20 (86.96)24.3611
2020's2 (8.70)2.80

Authors

AuthorsStudies
Stefanakis, K1
Kokkinos, A1
Argyrakopoulou, G1
Konstantinidou, SK1
Simati, S1
Kouvari, M1
Kumar, A1
Kalra, B1
Kumar, M1
Bontozoglou, N1
Kyriakopoulou, K1
Mantzoros, CS1
Tak, YJ1
Lee, SY1
Guerdjikova, AI1
Walsh, B1
Shan, K1
Halseth, AE2
Dunayevich, E6
McElroy, SL2
Jha, MK1
Wakhlu, S1
Dronamraju, N1
Minhajuddin, A1
Greer, TL1
Trivedi, MH1
Pi-Sunyer, X1
Apovian, CM2
Acevedo, LM1
Greenway, FL4
Aronne, L1
Rubino, D1
Still, C1
Wyatt, H1
Burns, C2
Kim, D1
Howland, RH1
White, MA1
Grilo, CM1
Hollander, P1
Gupta, AK2
Plodkowski, R1
Greenway, F1
Bays, H1
Klassen, P1
Fujioka, K5
Nau, JY1
Greig, SL1
Keating, GM1
McGinty, EE1
Baller, J1
Azrin, ST1
Juliano-Bult, D1
Daumit, GL1
Floden, L1
Taren, DL1
Muramoto, ML1
Leischow, SJ1
Nissen, SE1
Wolski, KE1
Prcela, L1
Wadden, T1
Buse, JB1
Bakris, G1
Perez, A1
Smith, SR1
Hong, K1
Herrmann, K1
Dybala, C1
Lam, H1
Foreyt, JP1
Braverman-Panza, J1
Whitehouse, MJ1
Guttadauria, M2
Anderson, JW1
Atkinson, RL1
Gadde, KM1
O'Neil, P1
Schumacher, D1
Smith, D1
Tollefson, GD1
Weber, E1
Cowley, MA1
Wilcox, CS1
Oskooilar, N1
Erickson, JS1
Billes, SK2
Katz, BB1
Tollefson, G1
Plodkowski, RA1
Mudaliar, S1
Erickson, J1
Kim, DD1
Calandra, C1
Russo, RG1
Luca, M1
Mercer, SL1

Clinical Trials (5)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects[NCT00567255]Phase 31,496 participants (Actual)Interventional2007-12-31Completed
Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder[NCT00414167]Phase 2/Phase 361 participants (Actual)Interventional2005-12-31Completed
A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release (SR)/Bupropion 360 mg Sustained Release (SR) and Placebo in Obese Subjects With Type 2 Diabetes Mellitus[NCT00474630]Phase 3505 participants (Actual)Interventional2007-05-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR[NCT01601704]Phase 38,910 participants (Actual)Interventional2012-06-30Terminated
A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects[NCT00532779]Phase 31,742 participants (Actual)Interventional2007-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Body Weight- Mean Percent Change From Baseline to Week 56

"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)." (NCT00567255)
Timeframe: Baseline, 56 weeks

Interventionpercentage of body weight (Least Squares Mean)
NB32-6.40
Placebo-1.23

Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercentage of participants (Number)
NB3227.27
Placebo7.02

Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56

"Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.~Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48)." (NCT00567255)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB3250.48
Placebo17.11

Change in Diastolic Blood Pressure

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionmm Hg (Least Squares Mean)
NB320.20
Placebo-0.67

Change in Fasting Blood Glucose Levels

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionmg/dL (Least Squares Mean)
NB32-2.11
Placebo-1.73

Change in Fasting HDL Cholesterol Levels

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionmg/dL (Least Squares Mean)
NB321.19
Placebo-1.40

Change in Fasting Insulin Levels, Using Log-transformed Data

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercent change (Least Squares Mean)
NB32-14.14
Placebo-0.50

Change in Fasting LDL Cholesterol Levels

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionmg/dL (Least Squares Mean)
NB32-4.36
Placebo0.00

Change in Fasting Triglycerides Levels, Using Log-transformed Data

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercent change (Least Squares Mean)
NB32-7.32
Placebo-1.36

Change in Food Craving Inventory Carbohydrates Subscale Score

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). (NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-2.68
Placebo-2.20

Change in Food Craving Inventory Sweets Subscale Score

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). (NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-3.20
Placebo-3.18

Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercent change (Least Squares Mean)
NB32-9.38
Placebo-1.14

Change in HOMA-IR Levels, Using Log-transformed Data

HOMA-IR= Homeostasis Model Assessment-Insulin Resistance (NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercent change (Least Squares Mean)
NB32-16.44
Placebo-4.15

Change in IDS-SR Total Score

IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression. (NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-0.23
Placebo-0.28

Change in IWQOL-Lite Total Scores

IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment (NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionunits on a scale (Least Squares Mean)
NB329.94
Placebo6.17

Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire

Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult (NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-18.32
Placebo-11.09

Change in Systolic Blood Pressure

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionmm Hg (Least Squares Mean)
NB32-0.93
Placebo-1.23

Change in Waist Circumference

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventioncm (Least Squares Mean)
NB32-6.16
Placebo-2.74

Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercentage of body weight (Least Squares Mean)
NB32-6.45
Placebo-1.89

Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28

(NCT00567255)
Timeframe: Baseline, 28 weeks

Interventionpercentage of participants (Number)
NB3255.64
Placebo17.54

Frequency of Binge Eating Episodes

(NCT00414167)
Timeframe: One week (at post treatment)

Interventionepisodes/week (Mean)
Bupropion0.8
Placebo1.0

Percent BMI Loss

Percent loss in Body Mass Index (NCT00414167)
Timeframe: 8 weeks (baseline and 8 weeks)

InterventionPercent loss (Mean)
Bupropion1.8
Placebo0.6

Body Weight- Proportion of Subjects With ≥10% Decrease

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB3218.49
Placebo5.66

Change in Diastolic Blood Pressure

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionmm Hg (Least Squares Mean)
NB32-1.06
Placebo-1.47

Change in Fasting Blood Glucose Levels

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionmg/dL (Least Squares Mean)
NB32-11.87
Placebo-4.02

Change in Fasting HDL Cholesterol Levels

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionmg/dL (Least Squares Mean)
NB323.03
Placebo-0.29

Change in Fasting Insulin Levels, Using Log-transformed Data

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB32-13.48
Placebo-10.35

Change in Fasting LDL Cholesterol Levels

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionmg/dL (Least Squares Mean)
NB32-1.44
Placebo-0.01

Change in Fasting Triglycerides Levels, Using Log-transformed Data

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB32-11.20
Placebo-0.80

Change in Food Craving Inventory Carbohydrates Subscale Score

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-1.48
Placebo-1.52

Change in Food Craving Inventory Sweets Subscale Score

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-1.97
Placebo-2.40

Change in HbA1c Levels

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercent (Least Squares Mean)
NB32-0.63
Placebo-0.14

Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB32-20.91
Placebo-13.29

Change in HOMA-IR Levels, Using Log-transformed Data

HOMA-IR= Homeostasis Model Assessment-Insulin Resistance (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB32-20.56
Placebo-14.67

Change in IDS-SR Total Scores

IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression. (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB320.01
Placebo-1.60

Change in IWQOL-Lite Total Scores

IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB329.27
Placebo7.90

Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire

Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB32-11.89
Placebo-6.91

Change in Systolic Blood Pressure

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionmm Hg (Least Squares Mean)
NB320.03
Placebo-1.12

Change in Waist Circumference

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventioncm (Least Squares Mean)
NB32-4.97
Placebo-2.89

Co-primary: Body Weight- Mean Percent Change

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of body weight (Least Squares Mean)
NB32-5.03
Placebo-1.75

Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB3244.53
Placebo18.87

HbA1c- Proportion of Subjects With HbA1c <6.5% at Endpoint

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB3220.72
Placebo10.22

HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB3244.14
Placebo26.28

Percent of Subjects Discontinuing Due to Poor Glycemic Control

Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed. Odds ratio not calculated as there were no subjects in the NB32 group that discontinued due to poor glycemic control. (NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB320
Placebo1.89

Percent of Subjects Requiring Rescue Medications for Diabetes

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB3222.26
Placebo35.22

Percent of Subjects With Dose Increase in Oral Antidiabetes Medications

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB323.02
Placebo1.26

Percent of Subjects With Dose Reduction in Oral Antidiabetes Medications

(NCT00474630)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB321.89
Placebo1.26

Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)

Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. (NCT01601704)
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

InterventionParticipants (Count of Participants)
NB3217
Placebo34

Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization

Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. (NCT01601704)
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

InterventionParticipants (Count of Participants)
NB32133
Placebo142

Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)

The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed. (NCT01601704)
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

InterventionParticipants (Count of Participants)
NB3290
Placebo102

Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)

Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. (NCT01601704)
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

InterventionParticipants (Count of Participants)
NB3255
Placebo57

Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)

Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. (NCT01601704)
Timeframe: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

InterventionParticipants (Count of Participants)
NB3222
Placebo21

Body Weight- Proportion of Subjects With ≥10% Decrease

(NCT00532779)
Timeframe: Baseline, 56 weeks

InterventionPercentage of participants (Number)
NB1620.17
NB3224.63
Placebo7.44

Change in Diastolic Blood Pressure

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionmm Hg (Least Squares Mean)
NB160.09
NB320.04
Placebo-0.86

Change in Fasting Blood Glucose Levels

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionmg/dL (Least Squares Mean)
NB16-2.39
NB32-3.24
Placebo-1.30

Change in Fasting HDL Cholesterol Levels

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionmg/dL (Least Squares Mean)
NB163.36
NB323.42
Placebo-0.06

Change in Fasting Insulin Levels, Using Log-transformed Data

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB16-11.84
NB32-17.14
Placebo-4.57

Change in Fasting LDL Cholesterol Levels

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionmg/dL (Least Squares Mean)
NB16-3.67
NB32-4.41
Placebo-3.28

Change in Fasting Triglycerides Levels, Using Log-transformed Data

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB16-7.96
NB32-12.69
Placebo-3.08

Change in Food Craving Inventory Carbohydrates Subscale Score

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). (NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB16-1.85
NB32-2.11
Placebo-1.84

Change in Food Craving Inventory Sweets Subscale Score

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome). (NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB16-2.08
NB32-2.62
Placebo-2.77

Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB16-28.02
NB32-28.98
Placebo-16.66

Change in HOMA-IR Levels, Using Log-transformed Data

HOMA-IR= Homeostasis Model Assessment-Insulin Resistance (NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionpercent change (Least Squares Mean)
NB16-14.33
NB32-20.19
Placebo-5.90

Change in IDS-SR Total Scores

IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression. (NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB160.02
NB32-0.27
Placebo-0.72

Change in IWQOL-Lite Total Scores

IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment (NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB1611.68
NB3212.69
Placebo8.55

Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire

Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult (NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionunits on a scale (Least Squares Mean)
NB16-12.49
NB32-14.52
Placebo-8.68

Change in Systolic Blood Pressure

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionmm Hg (Least Squares Mean)
NB160.29
NB32-0.11
Placebo-1.94

Change in Waist Circumference

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventioncm (Least Squares Mean)
NB16-5.04
NB32-6.24
Placebo-2.46

Co-primary: Body Weight- Mean Percent Change

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionpercentage of body weight (Least Squares Mean)
NB16-5.00
NB32-6.14
Placebo-1.33

Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease

(NCT00532779)
Timeframe: Baseline, 56 weeks

Interventionpercentage of participants (Number)
NB1639.49
NB3247.98
Placebo16.44

Reviews

6 reviews available for bupropion and Overweight

ArticleYear
Long-Term Efficacy and Safety of Anti-Obesity Treatment: Where Do We Stand?
    Current obesity reports, 2021, Volume: 10, Issue:1

    Topics: Animals; Anti-Obesity Agents; Benzazepines; Bupropion; Humans; Liraglutide; Naltrexone; Obesity; Orl

2021
Current and emerging medications for overweight or obesity in people with comorbidities.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:11

    Topics: Anti-Obesity Agents; Bupropion; Cinnamates; Comorbidity; Cyclohexanes; Diabetes Mellitus; Dyslipidem

2015
Naltrexone ER/Bupropion ER: A Review in Obesity Management.
    Drugs, 2015, Volume: 75, Issue:11

    Topics: Adult; Animals; Anti-Obesity Agents; Bupropion; Delayed-Action Preparations; Drug Combinations; Huma

2015
Interventions to Address Medical Conditions and Health-Risk Behaviors Among Persons With Serious Mental Illness: A Comprehensive Review.
    Schizophrenia bulletin, 2016, Volume: 42, Issue:1

    Topics: Behavior Therapy; Bipolar Disorder; Bupropion; Cardiovascular Diseases; Diabetes Mellitus; Dopamine

2016
Combination therapy with naltrexone and bupropion for obesity.
    Expert opinion on pharmacotherapy, 2011, Volume: 12, Issue:11

    Topics: Animals; Bupropion; Dopamine Uptake Inhibitors; Drug Combinations; Humans; Naltrexone; Narcotic Anta

2011
ACS chemical neuroscience molecule spotlight on contrave.
    ACS chemical neuroscience, 2011, Sep-21, Volume: 2, Issue:9

    Topics: Anti-Obesity Agents; Bupropion; Clinical Trials, Phase III as Topic; Double-Blind Method; Drug Appro

2011

Trials

11 trials available for bupropion and Overweight

ArticleYear
Validating pre-treatment body mass index as moderator of antidepressant treatment outcomes: Findings from CO-MED trial.
    Journal of affective disorders, 2018, Volume: 234

    Topics: Adult; Antidepressive Agents, Second-Generation; Antidepressive Agents, Tricyclic; Biomarkers; Body

2018
A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II).
    Obesity (Silver Spring, Md.), 2013, Volume: 21, Issue:5

    Topics: Adult; Anti-Obesity Agents; Bupropion; Cardiovascular Diseases; Delayed-Action Preparations; Dopamin

2013
Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial.
    The Journal of clinical psychiatry, 2013, Volume: 74, Issue:4

    Topics: Adult; Body Mass Index; Bulimia; Bupropion; Dopamine Uptake Inhibitors; Double-Blind Method; Female;

2013
Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes.
    Diabetes care, 2013, Volume: 36, Issue:12

    Topics: Adolescent; Adult; Aged; Antidepressive Agents, Second-Generation; Blood Glucose; Body Weight; Bupro

2013
BMI changes in adolescents treated with bupropion SR for smoking cessation.
    Obesity (Silver Spring, Md.), 2016, Volume: 24, Issue:1

    Topics: Adolescent; Body Mass Index; Bupropion; Dose-Response Relationship, Drug; Double-Blind Method; Femal

2016
Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial.
    JAMA, 2016, Mar-08, Volume: 315, Issue:10

    Topics: Aged; Anti-Obesity Agents; Blood Pressure; Body Mass Index; Bupropion; Cardiovascular Diseases; Conf

2016
Naltrexone/Bupropion extended release-induced weight loss is independent of nausea in subjects without diabetes.
    Clinical obesity, 2016, Volume: 6, Issue:5

    Topics: Adult; Anti-Obesity Agents; Body Mass Index; Bupropion; Combined Modality Therapy; Delayed-Action Pr

2016
Rational design of a combination medication for the treatment of obesity.
    Obesity (Silver Spring, Md.), 2009, Volume: 17, Issue:1

    Topics: Adult; Animal Feed; Animals; Antidepressive Agents; Bupropion; Disease Models, Animal; Drug Therapy,

2009
An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects.
    Addictive behaviors, 2010, Volume: 35, Issue:3

    Topics: Adult; Bupropion; Cotinine; Counseling; Dopamine Uptake Inhibitors; Drug Therapy, Combination; Femal

2010
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.
    Lancet (London, England), 2010, Aug-21, Volume: 376, Issue:9741

    Topics: Adult; Anti-Obesity Agents; Bupropion; Delayed-Action Preparations; Double-Blind Method; Drug Therap

2010
Bupropion versus sertraline in the treatment of depressive patients with binge eating disorder: retrospective cohort study.
    The Psychiatric quarterly, 2012, Volume: 83, Issue:2

    Topics: Adult; Antidepressive Agents; Binge-Eating Disorder; Body Mass Index; Bupropion; Depressive Disorder

2012

Other Studies

6 other studies available for bupropion and Overweight

ArticleYear
Circulating levels of proglucagon-derived peptides are differentially regulated by the glucagon-like peptide-1 agonist liraglutide and the centrally acting naltrexone/bupropion and can predict future weight loss and metabolic improvements: A 6-month long
    Diabetes, obesity & metabolism, 2023, Volume: 25, Issue:9

    Topics: Bupropion; Glucagon; Glucagon-Like Peptide 1; Glucagon-Like Peptide 2; Glucagon-Like Peptides; Human

2023
Concurrent Improvement in Both Binge Eating and Depressive Symptoms with Naltrexone/Bupropion Therapy in Overweight or Obese Subjects with Major Depressive Disorder in an Open-Label, Uncontrolled Study.
    Advances in therapy, 2017, Volume: 34, Issue:10

    Topics: Adult; Aged; Aged, 80 and over; Antidepressive Agents, Second-Generation; Binge-Eating Disorder; Bup

2017
Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.
    International journal of obesity (2005), 2019, Volume: 43, Issue:10

    Topics: Anti-Obesity Agents; Bupropion; Double-Blind Method; Drug Combinations; Humans; Mood Disorders; Nalt

2019
Therapies for obesity and medication-associated weight gain.
    Journal of psychosocial nursing and mental health services, 2013, Volume: 51, Issue:5

    Topics: Animals; Appetite Depressants; Bariatric Surgery; Benzazepines; Bupropion; Chronic Disease; Combined

2013
[Mysimba, an American appetite suppressant and the logic of the single European market].
    Revue medicale suisse, 2015, Apr-15, Volume: 11, Issue:470

    Topics: Anti-Obesity Agents; Bupropion; Drug Combinations; Humans; Naltrexone; Obesity; Overweight

2015
Answers to Clinical Questions in the Primary Care Management of People with Obesity: Pharmacologic Management.
    The Journal of family practice, 2016, Volume: 65, Issue:7 Suppl

    Topics: Anti-Obesity Agents; Benzazepines; Body Mass Index; Bupropion; Guidelines as Topic; Humans; Lactones

2016