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Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis


In a document analysis, Jeppe B. Schroll and colleagues seek insights into potential bias and underreporting in documentation of adverse events from the mid-1990s clinical trials of the anti-obesity drug orlistat.


Vyšlo v časopise: Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis. PLoS Med 13(8): e32767. doi:10.1371/journal.pmed.1002101
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002101

Souhrn

In a document analysis, Jeppe B. Schroll and colleagues seek insights into potential bias and underreporting in documentation of adverse events from the mid-1990s clinical trials of the anti-obesity drug orlistat.


Zdroje

1. Ioannidis JPA, Evans SJW, Gøtzsche PC, O’Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141: 781–788. 15545678

2. Loke YK, Derry S. Reporting of adverse drug reactions in randomised controlled trials—a systematic survey. BMC Clin Pharmacol. 2001;1: 3. 11591227

3. Olsen H, Klemetsrud T, Stokke HP, Tretli S, Westheim A. Adverse drug reactions in current antihypertensive therapy: a general practice survey of 2586 patients in Norway. Blood Press. 1999;8: 94–101. 10451036

4. de Vries TW, van Roon EN. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials. Arch Dis Child. 2010;95: 1023–1026. doi: 10.1136/adc.2009.175562 20551194

5. Golder S, Loke YK. Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? Br J Clin Pharmacol. 2008;66: 767–773. doi: 10.1111/j.1365-2125.2008.03272.x 18754841

6. Jørgensen AW, Hilden J, Gøtzsche PC. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. BMJ. 2006;333: 782. doi: 10.1136/bmj.38973.444699.0B 17028106

7. FDA. FDA Public Health Advisory: Safety of Vioxx [Internet]. 2004. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm

8. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA J Am Med Assoc. 2001;286: 954–959.

9. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N Engl J Med. 2006;354: 1193. doi: 10.1056/NEJMe068054 16495386

10. Harris G. Pfizer says internal studies show no Celebrex risks. New York Times. 2 May 2005. http://www.nytimes.com/2005/02/05/business/05drug.html?_r=0. Accessed 13 Jun 2014.

11. de Andrade M. Research Ethics. In clear sight. BMJ. 2009;339: b3443. doi: 10.1136/bmj.b3443 19726462

12. Gotzsche PC. Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. London: Radcliffe Publishing; 2013.

13. Dorr DA, Burdon R, West DP, Lagman J, Georgopoulos C, Belknap SM, et al. Quality of reporting of serious adverse drug events to an institutional review board: a case study with the novel cancer agent, imatinib mesylate. Clin Cancer Res Off J Am Assoc Cancer Res. 2009;15: 3850–3855. doi: 10.1158/1078-0432.CCR-08-1811

14. Schroll JB, Maund E, Gøtzsche PC. Challenges in coding adverse events in clinical trials: a systematic review. PLoS ONE. 2012;7: e41174. doi: 10.1371/journal.pone.0041174 22911755

15. Structure and content of clinical study reports. E3. [Internet]. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use; 1995. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf

16. Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ. 2011;342: d2686. doi: 10.1136/bmj.d2686 21558364

17. Curfman GD. Diet pills redux. N Engl J Med. 1997;337: 629–630. doi: 10.1056/NEJM199708283370909 9271487

18. Curfman GD, Morrissey S, Drazen JM. Sibutramine—another flawed diet pill. N Engl J Med. 2010;363: 972–974. doi: 10.1056/NEJMe1007993 20818908

19. The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia [Internet]. EMA; 2008. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/11/WC500014774.pdf

20. FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and severe liver injury [Internet]. FDA; 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm

21. Roche. Clinical Study Report of Orlistat. NM14336-V219 [Internet]. 1992. http://figshare.com/authors/Jeppe_Schroll/767386

22. Finer N, James WPT, Kopelman PG, Lean MEJ, Williams G. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor. Int J Obes Relat Metab Disord. 2000;24.

23. Sjöström L, Rissanen A, Andersen T, Boldrin M, Golay A, Koppeschaar HP, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Lancet. 1998;352: 167–172. 9683204

24. Rössner S, Sjöström L, Noack R, Meinders A, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. Obes Res. 2000;8: 49–61. 10678259

25. Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med. 2000;9: 160. 10693734

26. Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. JAMA J Am Med Assoc. 1999;281: 235–242.

27. Hill JO, Hauptman J, Anderson JW, Fujioka K, O’Neil PM, Smith DK, et al. Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study. Am J Clin Nutr. 1999;69: 1108–1116. 10357727

28. Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, et al. Role of orlistat in the treatment of obese patients with type 2 diabetes: a 1-year randomized double-blind study. Diabetes Care. 1998;21: 1288–1294. 9702435

29. James WP, Avenell A, Broom J, Whitehead J. A one-year trial to assess the value of orlistat in the management of obesity. Int J Obes Relat Metab Disord J Int Assoc Study Obes. 1997;21 Suppl 3: S24–30.

30. Karhunen L, Franssila-Kallunki A, Rissanen P, Valve R, Kolehmainen M, Rissanen A, et al. Effect of orlistat treatment on body composition and resting energy expenditure during a two-year weight-reduction programme in obese Finns. Int J Obes Relat Metab Disord J Int Assoc Study Obes. 2000;24: 1567–1572.

31. Zavoral JH. Treatment with orlistat reduces cardiovascular risk in obese patients. J Hypertens. 1998;16: 2013–2017. 9886891

32. Zhi J, Mulligan TE, Hauptman JB. Long-term systemic exposure of orlistat, a lipase inhibitor, and its metabolites in obese patients. J Clin Pharmacol. 1999;39: 41–46. 9987699

33. Heymsfield SB, Segal KR, Hauptman J, Lucas CP, Boldrin MN, Rissanen A, et al. Effects of weight loss with orlistat on glucose tolerance and progression to type 2 diabetes in obese adults. Arch Intern Med. 2000;160: 1321–1326. 10809036

34. Rissanen A, Lean M, Rössner S, Segal KR, Sjöström L. Predictive value of early weight loss in obesity management with orlistat: an evidence-based assessment of prescribing guidelines. Int J Obes. 2003;27: 103–109. doi: 10.1038/sj.ijo.0802165

35. Jacob S, Rabbia M, Meier MK, Hauptman J. Orlistat 120 mg improves glycaemic control in type 2 diabetic patients with or without concurrent weight loss. Diabetes Obes Metab. 2009;11: 361–371. doi: 10.1111/j.1463-1326.2008.00970.x 19207292

36. Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C. Effect of orlistat-assisted weight loss in decreasing coronary heart disease risk in patients with syndrome X. Am J Cardiol. 2001;87: 827–831. 11274935

37. Morris M, Lane P, Lee K, Parks D. An Integrated Analysis of Liver Safety Data from Orlistat Clinical Trials. Obes Facts. 2012;5: 485–494. doi: 10.1159/000341589 22854341

38. Roche. Clinical Study Report of Orlistat. BM 14119B v-238 [Internet]. 1992. http://figshare.com/authors/Jeppe_Schroll/767386

39. Roche. Clinical Study Report of Orlistat. NM14336-V220 [Internet]. 1992. http://figshare.com/authors/Jeppe_Schroll/767386

40. Padwal R, Kezouh A, Levine M, Etminan M. Long-term persistence with orlistat and sibutramine in a population-based cohort. Int J Obes 2005. 2007;31: 1567–1570. doi: 10.1038/sj.ijo.0803631

41. Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open. 2013;3: e002496. doi: 10.1136/bmjopen-2012-002496 23447465

42. Maund E, Tendal B, Hrobjartsson A, Jorgensen KJ, Lundh A, Schroll J, et al. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. BMJ. 2014;348: g3510–g3510. doi: 10.1136/bmj.g3510 24899650

43. Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. Ghersi D, editor. PLoS Med. 2013;10: e1001526. doi: 10.1371/journal.pmed.1001526 24115912

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