Safety assessment of an anti-obesity drug (sibutramine): A retrospective cohort study

Drug Safety

Volumn 35, Issue 8, 2012, Pages 629-644

  Tyczynski, Jerzy E ^a   Oleske, Denise M ^b   Klingman, David ^c   Ferrufino, Cheryl P ^d   Lee, Won Chan ^d  

^a ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^b ABBOTT LABORATORIES   (United States)

^c IMS Health Inc ^*

^d IQVIA   (United States)

Author keywords

Cardiovascular disorders; Diabetes mellitus; Myocardial infarction; Obesity; Orlistat; Overweight; Pharmacoepidemiology; Rimonabant; Sibutramine; Weight loss

Indexed keywords

SIBUTRAMINE;

ACUTE HEART INFARCTION; ADULT; AGED; ARTICLE; BODY MASS; CARDIOVASCULAR RISK; CLINICAL PRACTICE; COMORBIDITY; CONTROLLED STUDY; DRUG CONTRAINDICATION; DRUG SAFETY; FEMALE; GERMANY; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; OBESITY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; STROKE; UNITED KINGDOM;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-OBESITY AGENTS; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; CYCLOBUTANES; FEMALE; GERMANY; GREAT BRITAIN; HUMANS; INFANT; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; OBESITY; REGRESSION ANALYSIS; RETROSPECTIVE STUDIES; RISK FACTORS; STROKE; YOUNG ADULT;

EID: 84863845156     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11599220-000000000-00000     Document Type: Article

References (33)

1. James PT, RigbyN, Leach R. The obesity epidemic,metabolic syndrome and future prevention strategies. Eur J Cardiovasc Prev Rehabil Feb 2004; 11 (1): 3-8 (Pubitemid 38388918)
2. Guh DP, Zhang W, Bansback N, et al. The incidence of comorbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health 2009; 9: 88
3. Padwal RS, Sharma AM. Prevention of cardiovascular disease: obesity, diabetes and the metabolic syndrome. Can J Cardiol 2010 Aug-Sep; 26 Suppl. C: 18-20C
4. Saavedra LE. Endocannabinoid system and cardiometabolic risk. Clin Pharmacol Ther 2007 Nov; 82 (5): 591-4 (Pubitemid 47622533)
5. OgdenCL, Yanovski SZ,CarrollMD, et al. The epidemiology of obesity. Gastroenterology 2007 May; 132 (6): 2087-102 (Pubitemid 46693751)
6. Nguyen DM, El-Serag HB. The epidemiology of obesity. Gastroenterol Clin North Am 2010 Mar; 39 (1): 1-7
7. Bray GA, Ryan DH, Gordon D, et al. A double-blind randomized placebo-controlled trial of sibutramine. Obes Res 1996 May; 4 (3): 263-70 (Pubitemid 126690229)
8. James WP, Astrup A, Finer N, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Lancet 2000 Dec 23-30; 356 (9248): 2119-25
9. European Medicines Agency, Committee for Proprietary Medicinal Products. Opinion following an article 31 referral. Sibutramine: background information [online]. Available from URL: http://www.ema.europa.eu/pdfs/human/referral/ sibutramine/451402en.pdf [Accessed 2010 Jun 22]
10. Caterson I, Coutinho W, Finer N, et al. Early response to sibutramine in patients not meeting current label criteria: preliminary analysis of SCOUT lead-in period. Obesity (Silver Spring) 2010 May; 18 (5): 987-94
11. James WP, Caterson ID, Coutinho W, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med 2010 Sep 2; 363 (10): 905-17
12. Maggioni AP, Caterson I, Coutinho W, et al. Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) trial. J Cardiovasc Pharmacol 2008 Nov; 52 (5): 393-402
13. Caterson ID, Finer N, Coutinho W, et al. Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial. Diabetes Obes Metab 2012; 14 (6): 523-30
14. Padwal R, Li SK, Lau DC. Long-term pharmacotherapy for obesity and overweight. Cochrane Database Syst Rev 2004; (3): CD004094
15. Scheen AJ. Cardiovascular risk-benefit profile of sibutramine. Am J Cardiovasc Drugs 2010; 10 (5): 321-34
16. Greenland S, Morgenstern H. Matching and efficiency in cohort studies. Am J Epidemiol 1990 Jan; 131 (1): 151-9 (Pubitemid 20014708)
17. Romano PS, Roos LL, Jollis JG. Adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol 1993 Oct; 46 (10): 1075-9; discussion 1081-90
18. Bowker AH. A test for symmetry in contingency tables. J Am Stat Assoc 1948 Dec; 43 (244): 572-4
19. Pearson K. On the criterion that a given system of deviations from the probable in the case of a correlated system of variables is such that it can be reasonably supposed to have arisen from randomsampling. Philos Mag Series 5 1900; 50 (302): 157-75
20. Cox DR. Regression models and life-tables. J R Stat Soc B 1972; 34 (2): 187-220
21. Lavie CJ, Milani RV, Ventura HO. Obesity and cardiovascular disease: risk factor, paradox, and impact of weight loss. J Am Coll Cardiol 2009 May 26; 53 (21): 1925-32
22. Lenz M, Richter T,Muhlhauser I. The morbidity and mortality associated with overweight and obesity in adulthood: a systematic review.Dtsch Arztebl Int 2009 Oct; 106 (40): 641-8
23. Willemen MJ, Mantel-Teeuwisse AK, Straus SM, et al. Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs. Pharmacoepidemiol Drug Saf 2009 Jul; 18 (7): 631-8
24. Harrison-Woolrych M, Ashton J, Herbison P. Fatal and non-fatal cardiovascular events in a general population prescribed sibutramine in New Zealand: a prospective cohort study. Drug Saf 2010 Jul 1; 33 (7): 605-13
25. Perrio MJ, Wilton LV, Shakir SA. The safety profiles of orlistat and sibutramine: results of prescription-event monitoring studies in England. Obesity (Silver Spring) 2007Nov; 15 (11): 2712-22
26. Gaciong Z, Placha G. Efficacy and safety of sibutramine in 2225 subjects with cardiovascular risk factors: short-term, open-label, observational study. J Hum Hypertens 2005 Sep; 19 (9): 737-43 (Pubitemid 43118098)
27. Dean AG, Sullivan KM, Soe MM. OpenEpi: open source epidemiologic statistics for public health, version 2.3.1, updated 2011/23/06 [online]. Available from URL: www. OpenEpi.com [Accessed 2011 Nov 11]
28. Berghofer A, Pischon T, Reinhold T, et al. Obesity prevalence from a European perspective: a systematic review. BMC Public Health 2008; 8: 200
29. Bray GA. Lifestyle and pharmacological approaches to weight loss: efficacy and safety. J Clin Endocrinol Metab 2008 Nov; 93 (11 Suppl. 1): S81-8
30. FDA news. FDA declines to approve Orexigen's Contrave, requests new trial. Drug Daily Bulletin 2011; 8 (24) [online]. Available from URL: http://www.fdanews.com/news letter/article?articleId=133950&issueId=14435 [Accessed 2011 Mar 23]
31. Pollack A. No FDA approval for new diet pill. New York Times, 2010 Oct 23 [online]. Available from URL: http://www.nytimes.com/2010/10/24/business/ 24obesity.html [Accessed 2011 Mar 23]
32. Pollack A. FDA rejects Qnexa, a third weight-loss drug. New York Times, 2010 Oct 28 [online]. Available from URL: http://www.nytimes.com/2010/10/29/ health/policy/29drug.html [Accessed 2011 Mar 23]
33. Pollack A. Diet drug wins panel's approval. The New York Times 2012 May 10 [online]. Available from URL: http://www.nytimes.com/2012/05/11/health/diet- drug-wins-appro val-of-fda-advisers.html [Accessed 2012 Jun 25]