Evidence concerning the safety of rosiglitazone continues to evolve
In February 2010, the United States Senate Committee on Finance released a report on the safety of rosiglitazone.1 The report concluded that there were possible cardiac risks associated with rosiglitazone and that the manufacturer, GlaxoSmithKline (GSK), was aware of this well before it became public. The authors further stated that, rather than warn patients and regulatory authorities promptly, GSK executives chose to intimidate independent physicians who publicised the possible risks, minimise the impact of adverse findings, and downplay the possibly beneficial cardiovascular effects of the other available drug in the class, pioglitazone.1
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- 1. United States Senate Committee on Finance. Staff report on GlaxoSmithKline and the diabetes drug Avandia. Washington, DC: US Government Printing Office, 2010.
- 2. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-2471.
- 3. Nissen SE. The rise and fall of rosiglitazone [editorial]. Eur Heart J 2010; 31: 773-776. Epub 12 Feb 2010.
- 4. Komajda M, McMurray JJV, Beck-Nielsen H, et al. Heart failure events with rosiglitazone in type 2 diabetes: data from the RECORD clinical trial. Eur Heart J 2010; 31: 824-831. Epub 29 Jan 2010.
- 5. Home PD, Pocock SJ, Beck-Nielsen H, et al; RECORD Study Team. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial. Lancet 2009; 373: 2125-2135.
- 6. Harris G. Research ties diabetes drug to heart woes. New York Times 2010; 19 Feb. http://www.nytimes.com/2010/02/20/health/policy/20avandia.html (accessed Mar 2010).
- 7. Slaoui M. The rise and fall of rosiglitazone: reply. Eur Heart J 2010; 31: 1282-1284. Epub 23 Apr 2010.
- 8. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 2010 Jun 28 [Epub ahead of print]. DOI: 10.1001/jama.2010.920.
- 9. Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 2010 Jun 28 [Epub ahead of print]. DOI: 10.1001/archinternmed.2010.207.
- 10. Stiles S. BARI 2D analysis enters rosiglitazone debate, finds no MI hazard. heartwire 2010; 29 Jun. http://www.theheart.org/article/1093045.do (accessed June 2010, registration required).
- 11. GlaxoSmithKline. Product information: Avandia (rosiglitazone). http://www.gsk.com.au/resources.ashx/prescriptionmedicinesproductschilddataproinfo/926/FileName/D26272E950C16A44EFF9C9648312FAE7/PI_Avandia.pdf (accessed Mar 2010).
- 12. Friedrich JO, Beyene J, Adhikari NK. Rosiglitazone: can meta-analysis accurately estimate excess cardiovascular risk given the available data? Re-analysis of randomized trials using various methodologic approaches. BMC Res Notes 2009; 2: 5.
- 13. Schwartz AV. TZDs and bone: a review of the recent clinical evidence. PPAR Res 2008; 2008: 297893.
Timothy Davis has served on advisory boards for Eli Lilly (which markets pioglitazone in Australia) and GSK, has had the costs of attendance at national and international scientific meetings covered by both companies, and has received lecture fees from GSK. Johannes Prins has served on advisory boards for GSK, and has had the costs of attendance at national and international scientific meetings covered and received lecture fees from both GSK and Eli Lilly.