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

PLoS Medicine

Volumn 13, Issue 8, 2016, Pages

  Schroll, Jeppe Bennekou ^a   Penninga, Elisabeth I ^a   Gøtzsche, Peter C ^a  

^a Rigshospitalet   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; TETRAHYDROLIPSTATIN; ANTIOBESITY AGENT; LACTONE;

ARTICLE; CLINICAL STUDY; CLINICAL TRIAL (TOPIC); CONTROLLED CLINICAL TRIAL (TOPIC); DIARRHEA; FECES INCONTINENCE; GASTROINTESTINAL DISEASE; HEART RATE; HUMAN; LIVER FUNCTION TEST; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PHASE 3 CLINICAL TRIAL (TOPIC); QUALITY OF LIFE; TREATMENT DURATION; VITAMIN DEFICIENCY; BIBLIOMETRICS; CLINICAL PROTOCOL; PUBLICATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME;

ANTI-OBESITY AGENTS; BIBLIOMETRICS; CLINICAL PROTOCOLS; HUMANS; LACTONES; OBESITY; PERIODICALS AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84988915868     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1002101     Document Type: Article

References (43)

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.2009.17556220551194
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.x18754841
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.38973.444699.0B17028106
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/NEJMe06805416495386
10. Harris G, Pfizer says internal studies show no Celebrex risks. New York Times. 2May2005. 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.b344319726462
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.004117422911755
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.d268621558364
17. Curfman GD, Diet pills redux. N Engl J Med. 1997;337: 629–630. doi: 10.1056/NEJM1997082833709099271487
18. Curfman GD, Morrissey S, Drazen JM, Sibutramine—another flawed diet pill. N Engl J Med. 2010;363: 972–974. doi: 10.1056/NEJMe100799320818908
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;21Suppl 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.x19207292
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: 10.1159/00034158922854341
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 Obes2005. 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-2012-00249623447465
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.g351024899650
43. Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, Ghersi D, et al. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. PLoS Med. 2013;10: e1001526. doi: 10.1371/journal.pmed.100152624115912