bupropion and Dyslipidemia 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.

Research Excerpts

Excerpt	Relevance	Reference
"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."	9.17	A 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)
"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."	5.17	A 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)

Research

Studies (3)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Body Weight- Mean Percent Change From Baseline to Week 56

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	3 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Apovian, CM	1
Aronne, L	1
Rubino, D	1
Still, C	1
Wyatt, H	1
Burns, C	1
Kim, D	1
Dunayevich, E	1
Fujioka, K	1
Hong, K	1
Herrmann, K	1
Dybala, C	1
Halseth, AE	1
Lam, H	1
Foreyt, JP	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
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 3	1,496 participants (Actual)	Interventional	2007-12-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"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

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

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

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

Intervention	percentage of participants (Number)
NB32	27.27
Placebo	7.02

Change in Diastolic Blood Pressure

Change in Fasting Blood Glucose Levels

Change in Fasting HDL Cholesterol Levels

Change in Fasting Insulin Levels, Using Log-transformed Data

Change in Fasting LDL Cholesterol Levels

Change in Fasting Triglycerides Levels, Using Log-transformed Data

Change in Food Craving Inventory Carbohydrates Subscale Score

Intervention	percentage of participants (Number)
NB32	50.48
Placebo	17.11

Intervention	mm Hg (Least Squares Mean)
NB32	0.20
Placebo	-0.67

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

Intervention	mg/dL (Least Squares Mean)
NB32	1.19
Placebo	-1.40

Intervention	percent change (Least Squares Mean)
NB32	-14.14
Placebo	-0.50

Intervention	mg/dL (Least Squares Mean)
NB32	-4.36
Placebo	0.00

Intervention	percent change (Least Squares Mean)
NB32	-7.32
Placebo	-1.36

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

Change in Food Craving Inventory Sweets Subscale Score

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

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

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

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

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

Intervention	percent change (Least Squares Mean)
NB32	-9.38
Placebo	-1.14

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

Change in IDS-SR Total Score

Intervention	percent change (Least Squares Mean)
NB32	-16.44
Placebo	-4.15

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

Change in IWQOL-Lite Total Scores

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

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

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

Intervention	units on a scale (Least Squares Mean)
NB32	9.94
Placebo	6.17

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

Article	Year
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
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

bupropion and Dyslipidemia