title: Naltrexone/bupropion: an investigational combination for weight loss and maintenance.
abstract: Naltrexone/bupropion is an investigational combination for weight loss and maintenance in patients who are obese or have a BMI ≥ 27 kg/m(2) with comorbid diabetes, hypertension or hyperlipidemia. Pooled results from four phase 3 trials reveal placebo-subtracted mean weight loss of 4.7% (range 3.2-5.2%) with naltrexone/bupropion after 1 year (p < 0.001 vs. placebo in each trial). The placebo-subtracted proportion of patients achieving ≥5% weight loss with naltrexone/bupropion ranged from 26 to 33% (p < 0.001 vs. placebo in each trial). In the majority of phase 3 trials, naltrexone/bupropion significantly improved proportion of patients achieving ≥10% weight loss, waist circumference, triglycerides, high-density lipoprotein, fasting insulin, insulin resistance, and obesity-specific quality of life compared to placebo. In patients with diabetes, naltrexone/bupropion therapy decreased hemoglobin A1c (HbA1c) approximately 0.5% more than placebo (p < 0.001). Common side effects associated with naltrexone/bupropion include nausea, constipation, vomiting, dizziness, and dry mouth. Greater improvement in systolic blood pressure and pulse were seen with placebo compared to naltrexone/bupropion (p < 0.001). Further studies are necessary to determine the effect of naltrexone/bupropion on cardiovascular outcomes. The safety and efficacy of naltrexone/bupropion in weight management is reviewed in this article.
authors.affiliation: Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Science, Wayne State University, Detroit, MI 48201, USA.
authors.forename: Charles T
authors.initials: CT
authors.lastname: Makowski
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Gwinn
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Hurren
mesh_terms: D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016642:Bupropion / Q000009:adverse effects / Q000627:therapeutic use*; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009765:Obesity / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D055105:Waist Circumference / Q000187:drug effects; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D019440:Anti-Obesity Agents; D016642:Bupropion; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008055:Lipids; D009271:Naltrexone