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      A Randomized, Phase 3 Trial of Naltrexone SR/Bupropion SR on Weight and Obesity-related Risk Factors (COR-II)

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          Abstract

          Objective

          To examine the effects of naltrexone/bupropion (NB) combination therapy on weight and weight-related risk factors in overweight and obese participants.

          Design and Methods

          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. The co-primary endpoints were percent weight change and proportion achieving ≥5% weight loss at week 28.

          Results

          Significantly ( P < 0.001) greater weight loss was observed with NB32 versus placebo at week 28 (−6.5% vs. −1.9%) and week 56 (−6.4% vs. −1.2%). More NB32-treated participants ( P < 0.001) experienced ≥5% weight loss versus placebo at week 28 (55.6% vs. 17.5%) and week 56 (50.5% vs. 17.1%). NB32 produced greater improvements in various cardiometabolic risk markers, participant-reported weight-related quality of life, and control of eating. The most common adverse event with NB was nausea, which was generally mild to moderate and transient. NB was not associated with increased events of depression or suicidality versus placebo.

          Conclusion

          NB represents a novel pharmacological approach to the treatment of obesity, and may become a valuable new therapeutic option.

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          Most cited references16

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          How can drug addiction help us understand obesity?

          Nora D Volkow, Roy A Wise (2005)
          Article 0 comments Cited 209 times – based on 0 reviews     Review now
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            Long term pharmacotherapy for obesity and overweight: updated meta-analysis.

            S. Li, Diana Rucker, Raj Padwal … (2007)
            To summarise the long term efficacy of anti-obesity drugs in reducing weight and improving health status. Updated meta-analysis of randomised trials. Medline, Embase, the Cochrane controlled trials register, the Current Science meta-register of controlled trials, and reference lists of identified articles. All data sources were searched from December 2002 (end date of last search) to December 2006. Double blind randomised placebo controlled trials of approved anti-obesity drugs used in adults (age over 18) for one year or longer. 30 trials of one to four years' duration met the inclusion criteria: 16 orlistat (n=10 631 participants), 10 sibutramine (n=2623), and four rimonabant (n=6365). Of these, 14 trials were new and 16 had previously been identified. Attrition rates averaged 30-40%. Compared with placebo, orlistat reduced weight by 2.9 kg (95% confidence interval 2.5 kg to 3.2 kg), sibutramine by 4.2 kg (3.6 kg to 4.7 kg), and rimonabant by 4.7 kg (4.1 kg to 5.3 kg). Patients receiving active drug treatment were significantly more likely to achieve 5% and 10% weight loss thresholds. Orlistat reduced the incidence of diabetes and improved concentrations of total cholesterol and low density lipoprotein cholesterol, blood pressure, and glycaemic control in patients with diabetes but increased rates of gastrointestinal side effects and slightly lowered concentrations of high density lipoprotein. Sibutramine improved [corrected] concentrations of high density lipoprotein cholesterol and triglycerides [corrected] Rimonabant improved concentrations of high density lipoprotein cholesterol and triglycerides, blood pressure, and glycaemic control in patients with diabetes but increased the risk of mood disorders. Orlistat, sibutramine, and rimonabant modestly reduce weight, have differing effects on cardiovascular risk profiles, and have specific adverse effects.
            Article 0 comments Cited 153 times – based on 0 reviews     Review now
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              Meta-analysis: pharmacologic treatment of obesity.

              Zhaoping Li, Margaret Maglione, Wenli Tu … (2005)
              In response to the increase in obesity, pharmacologic treatments for weight loss have become more numerous and more commonly used. To assess the efficacy and safety of weight loss medications approved by the U.S. Food and Drug Administration and other medications that have been used for weight loss. Electronic databases, experts in the field, and unpublished information. Up-to-date meta-analyses of sibutramine, phentermine, and diethylpropion were identified. The authors assessed in detail 50 studies of orlistat, 13 studies of fluoxetine, 5 studies of bupropion, 9 studies of topiramate, and 1 study each of sertraline and zonisamide. Meta-analysis was performed for all medications except sertraline, zonisamide, and fluoxetine, which are summarized narratively. The authors abstracted information about study design, intervention, co-interventions, population, outcomes, and methodologic quality, as well as weight loss and adverse events from controlled trials of medication. All pooled weight loss values are reported relative to placebo. A meta-analysis of sibutramine reported a mean difference in weight loss of 4.45 kg (95% CI, 3.62 to 5.29 kg) at 12 months. In the meta-analysis of orlistat, the estimate of the mean weight loss for orlistat-treated patients was 2.89 kg (CI, 2.27 to 3.51 kg) at 12 months. A recent meta-analysis of phentermine and diethylpropion reported pooled mean differences in weight loss at 6 months of 3.6 kg (CI, 0.6 to 6.0 kg) for phentermine-treated patients and 3.0 kg (CI, -1.6 to 11.5 kg) for diethylpropion-treated patients. Weight loss in fluoxetine studies ranged from 14.5 kg of weight lost to 0.4 kg of weight gained at 12 or more months. For bupropion, 2.77 kg (CI, 1.1 to 4.5 kg) of weight was lost at 6 to 12 months. Weight loss due to topiramate at 6 months was 6.5% (CI, 4.8% to 8.3%) of pretreatment weight. With one exception, long-term studies of health outcomes were lacking. Significant side effects that varied by drug were reported. Publication bias may exist despite a comprehensive search and despite the lack of statistical evidence for the existence of bias. Evidence of heterogeneity was observed for all meta-analyses. Sibutramine, orlistat, phentermine, probably diethylpropion, bupropion, probably fluoxetine, and topiramate promote modest weight loss when given along with recommendations for diet. Sibutramine and orlistat are the 2 most-studied drugs.
              Article 0 comments Cited 126 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Obesity (Silver Spring)
                Journal ID (iso-abbrev): Obesity (Silver Spring)
                Journal ID (publisher-id): oby
                Title: Obesity (Silver Spring, Md.)
                Publisher: John Wiley & Sons, Inc. (Hoboken, USA )
                ISSN (Print): 1930-7381
                ISSN (Electronic): 1930-739X
                Publication date (Print): May 2013
                Publication date (Electronic): 14 February 2013
                Volume: 21
                Issue: 5
                Pages: 935-943
                Affiliations
                [1 ]Section of Endocrinology, Diabetes and Nutrition, Department of Medicine, Boston University School of Medicine Boston, Massachusetts, USA
                [2 ]Weill Cornell Medical College New York, New York, USA
                [3 ]Washington Center for Weight Management Arlington, Virginia, USA
                [4 ]Geisinger Health Care System Danville, Pennsylvania, USA
                [5 ]University of Colorado Denver Denver, Colorado, USA
                [6 ]Orexigen Therapeutics, Inc. La Jolla, California, USA
                Author notes
                Correspondence: Dr. Caroline M. Apovian ( Caroline.Apovian@ 123456BMC.org )
                [*]

                Members listed at end of report.

                Dr Kim is currently affiliated with Zafgen, Inc., Cambridge, Massachusetts, USA

                Dr Dunayevich is currently affiliated with Amgen, Inc., Thousand Oaks, California, USA

                Disclosure: C.M.A has participated on advisory boards for Allergan, Amylin, Orexigen, Merck, Johnson and Johnson, Abbott, Arena, Zafgen, Novo Nordisk, and Sanofi-Aventis, and has received research funding from Lilly, Amylin, Pfizer, Sanofi-Aventis, Orexigen, MetaProteomics, and the Dr. Robert C. and Veronica Atkins Foundation. L.J.A. has participated in advisory boards/acted as a consultant for Amylin Pharmaceuticals, Inc., Ethicon Endo-Surgery, Inc., GlaxoSmithKline Consumer Healthcare LP, Novo Nordisk, Orexigen Therapeutics, Inc., VIVUS, Inc., Takeda Pharmaceuticals, and Zafgen, Inc. L.J.A has also performed contracted research for Amylin Pharmaceuticals, Inc., High Point Pharmaceuticals LLC, Medical University of South Carolina (MUSC), and Novo Nordisk, and has ownership interest in Cardiometabolic Support Network, LLC, and Myos Corporation.

                D.M.R. has served as a clinical investigator in clinical drug trials of obesity therapeutics for Orexigen; D.M.R. has not received any financial support as a consultant for Orexigen.

                C.D.S. has participated on advisory boards for Allergan, and Ethicon-Endosurgery. C.D.S. has also received research funding from Ethicon Endo-Surgery Arena and Orexigen Pharmaceuticals.

                H.W. received has served as an advisor for Orexigen Pharmaceuticals, Arena Pharmaceuticals, Wellspring Camps, and Eisai, Inc. H.W. receives royalties from Up to Date and has received grant funding from the NIH, Orexigen, and Novo Nordisk. H.W. has ownership interests in Active Planet LLC and has co-ownership on a patent for a weight loss maintenance strategy.

                C.B. is an employee at Orexigen.

                D.D.K. and E.D. are former employees at Orexigen; D.D.K. is currently employed at Zafgen, Inc., and has acted as a consultant for Orexigen; E.D. is currently an employee of Amgen, Inc.

                Funding agencies: Orexigen Therapeutics, Inc., provided study drug and collaborated with the investigators in the design of the study; interpretation of the data; and the preparation, review, and approval of the manuscript. Metropolitan Research Associates (New York, New York, USA) was responsible for study conduct and monitoring, and inVentiv Clinical Solutions (Hunt Valley, Maryland, USA) was responsible for collection, management, and analysis of the data. The dataset is available at Orexigen Therapeutics, Inc.

                Article
                DOI: 10.1002/oby.20309
                PMC ID: 3739931
                PubMed ID: 23408728
                SO-VID: d2841421-b065-4868-ae96-6f83dbbbc1ac
                Copyright © Copyright © 2013 The Obesity Society
                License:

                Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.

                History
                Date received : 16 October 2012
                Date accepted : 04 December 2012
                Categories
                Subject: Clinical Trials: Behavior, Pharmacotherapy, Devices, Surgery

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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