Rosiglitazone: can meta-analysis accurately estimate excess cardiovascular risk given the available data? Re-analysis of randomized trials using various methodologic approaches.

BMC Research Notes
Jan O FriedrichNeill K J Adhikari

Abstract

A recent and provocative meta-analysis, based on few outcome events, suggested that rosiglitazone increased cardiovascular mortality and myocardial infarction. However, results of meta-analyses of trials with sparse events, often performed when examining uncommon adverse effects due to common therapies, can vary substantially depending on methodologic decisions. The objective of this study was to assess the robustness of the rosiglitazone results by using alternative reasonable methodologic approaches and by analyzing additional related outcomes. In duplicate and independently, we abstracted all myocardial and cerebrovascular ischemic events from all randomized controlled trials listed on the manufacturer's web site meeting inclusion criteria of the original meta-analysis (at least 24 weeks of rosiglitazone exposure in the intervention group and any control group without rosiglitazone). We performed meta-analyses of these data under different methodologic conditions. An unconfounded comparison that includes only trials (or arms of trials) in which medications apart from rosiglitazone are identical suggests higher risks than previously reported, making even the risk of cardiovascular death statistically significant. Alternativel...Continue Reading

References

Oct 23, 1996·JAMA : the Journal of the American Medical Association·J C CappelleriJ Lau
Apr 30, 2004·Statistics in Medicine·Michael J SweetingPaul C Lambert
Apr 6, 2006·Statistics in Medicine·Michael J BradburnA Russell Localio
Dec 6, 2006·The New England Journal of Medicine·Steven E KahnUNKNOWN ADOPT Study Group
May 23, 2007·The New England Journal of Medicine·Steven E Nissen, Kathy Wolski
May 31, 2007·Diabetes Care·Sonal SinghCurt D Furberg
Jun 5, 2007·Lancet· The Lancet
Jun 7, 2007·The New England Journal of Medicine·Philip D HomeUNKNOWN RECORD Study Group
Jul 20, 2007·The Cochrane Database of Systematic Reviews·B RichterS H Ebrahim
Aug 8, 2007·Annals of Internal Medicine·George A DiamondSanjay Kaul
Aug 10, 2007·The New England Journal of Medicine·Clifford J Rosen
Sep 1, 2007·The New England Journal of Medicine·Michael B Bracken
Sep 13, 2007·JAMA : the Journal of the American Medical Association·A Michael LincoffSteven E Nissen
Sep 13, 2007·JAMA : the Journal of the American Medical Association·Sonal SinghCurt D Furberg
Dec 13, 2007·JAMA : the Journal of the American Medical Association·Lorraine L LipscombeDavid A Alter
Aug 30, 2008·Heart·Sonal Singh, Curt D Furberg
Nov 26, 2008·Archives of Internal Medicine·Wolfgang C WinkelmayerDaniel H Solomon
Jun 2, 2009·Primary Care Diabetes·Dominique Simon

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Citations

Apr 21, 2009·Diabetologia·A J Scheen
Oct 28, 2010·Diabetes, Obesity & Metabolism·G Schernthaner, R J Chilton
Apr 15, 2010·Trials·Natalie McGauranThomas Kaiser
Jul 1, 2009·Current Cardiology Reports·M Odette Gore, Darren K McGuire
Jul 14, 2010·Cardiology Clinics·Sandeep A Saha, Katherine R Tuttle
Sep 16, 2010·Cardiovascular Therapeutics·Pantelis A SarafidisAnastasios N Lasaridis
Apr 29, 2015·Biometrical Journal. Biometrische Zeitschrift·Dankmar BöhningAlan Kimber
Dec 2, 2020·Clinical Trials : Journal of the Society for Clinical Trials·Hwanhee HongGary L Rosner
Aug 4, 2010·The Medical Journal of Australia·Timothy M E Davis, Johannes B Prins

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