Evaluation of the cardiovascular risk of naltrexone-bupropion: A study interrupted

JAMA - Journal of the American Medical Association

Volumn 315, Issue 10, 2016, Pages 984-986

  Sharfstein, Joshua M ^a   Psaty, Bruce M ^b,c  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c CENTER FOR HEALTH STUDIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; NALTREXONE; PLACEBO; ANTIOBESITY AGENT;

ADVERSE OUTCOME; BODY MASS; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; DIABETES MELLITUS; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEART INFARCTION; HUMAN; MORBIDITY; OBESITY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; RISK FACTOR; WEIGHT CHANGE; CARDIOVASCULAR DISEASE; CHEMICALLY INDUCED; EARLY TERMINATION OF CLINICAL TRIAL; FEMALE; MALE;

ANTI-OBESITY AGENTS; BUPROPION; CARDIOVASCULAR DISEASES; EARLY TERMINATION OF CLINICAL TRIALS; FEMALE; HUMANS; MALE; NALTREXONE; OBESITY;

EID: 84960925181     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2016.1461     Document Type: Review

References (17)

1. Nissen SE, Wolski KE, Prcela L, et al. Effect of naltrexone-bupropion on major adverse cardiovascular events in overweight and obese patients with cardiovascular risk factors: a randomized clinical trial. JAMA. doi:10.1001/jama.2016.1558.
2. Pollack A. FDA declines to approve diet drug. New York Times. February 1, 2011. http://www.nytimes.com/2011/02/02/business/02drug.html?-r=0. Accessed February 11, 2016.
3. Guidance for Industry: Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. FDA website. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf. December 2008. Accessed February 11, 2016.
4. Fleming TR. Protecting the confidentiality of interim data: addressing current challenges. Clin Trials. 2015;12(1):5-11.
5. Confidentiality of interim results in cardiovascular (CV) outcomes safety trials; part 15-public hearing before the commissioner. FDA website. http://www.fda.gov/Drugs/NewsEvents/ucm405023.htm. August 11, 2014. Accessed January 23, 2016.
6. Bethel MA, Sourij H. Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice. Curr Cardiol Rep. 2012;14(1):59-69.
7. Scirica BM, Bhatt DL, Braunwald E, et al; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369(14):1317-1326.
8. Zannad F, Cannon CP, Cushman WC, et al; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin vs placebo in EXAMINE. Lancet. 2015;385 (9982):2067-2076.
9. Center for Drug Evaluation and Research, FDA. Summary review of application number 2000063Orig1s000. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/200063Orig1s000SumR.pdf. Accessed January 23, 2016.
10. Zhang JJ, Blumenthal GM, He K, et al. Overestimation of the effect size in group sequential trials. Clin Cancer Res. 2012;18(18):4872-4876.
11. US Securities and Exchange Commission. Form 8K [filed by Orexigen Therapeutics Inc]. http://www.sec.gov/Archives/edgar/data/1382911/000119312515074251/d882841d8k.htm. March 3, 2015. Accessed January 23, 2016.
12. Cleveland Clinic. Clinical trial testing safety of obesity drug Contrave halted; 50 percent interim data released by the study's executive committee. http://my.clevelandclinic.org/about-cleveland-clinic/newsroom/releases-videos-newsletters/2015-5-12-clinical-trial-testing-safety-of-obesity-drug-contrave-halted. May 12, 2015. Accessed January 23, 2016.
13. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35(3): 549-556.
14. O'Riordan M. LIGHT stopped: Contrave CVD safety study halted following premature release of data. http://www.medscape.com/viewarticle/844575. May 12, 2015. Accessed January 23, 2016.
15. Psaty BM, Rennie D. Stopping medical research to save money: a broken pact with researchers and patients. JAMA. 2003;289(16):2128-2131.
16. Fleming TR. Response. Clin Trials. 2015;12(1):21-23.
17. Helfand C. Orexigen picks up new trial tab to settle Contrave dispute with marketing partner Takeda. http://www.fiercepharma.com/story/orexigen-picks-new-trial-tab-settle-contrave-dispute-partner-takeda/2015-08-07. August 7, 2015. Accessed February 14, 2016.