Sonal Singh1, Yoon K Loke, Curt D Furberg. 1. Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. sosingh@wfubmc.edu
Abstract
CONTEXT: Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes. OBJECTIVE: To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality. DATA SOURCES: We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007. STUDY SELECTION: Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12 months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events. DATA EXTRACTION: Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n = 14 291, including 6421 receiving rosiglitazone and 7870 receiving control therapy, with a duration of follow-up of 1-4 years). RESULTS: Rosiglitazone significantly increased the risk of myocardial infarction (n = 94/6421 vs 83/7870; RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09; 95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53). There was no evidence of substantial heterogeneity among the trials for these end points (I(2) = 0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascular mortality). CONCLUSION: Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.
CONTEXT: Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes. OBJECTIVE: To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality. DATA SOURCES: We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007. STUDY SELECTION: Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12 months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events. DATA EXTRACTION: Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n = 14 291, including 6421 receiving rosiglitazone and 7870 receiving control therapy, with a duration of follow-up of 1-4 years). RESULTS:Rosiglitazone significantly increased the risk of myocardial infarction (n = 94/6421 vs 83/7870; RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09; 95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53). There was no evidence of substantial heterogeneity among the trials for these end points (I(2) = 0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascular mortality). CONCLUSION: Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.
Authors: Juan J Cabré; Marta Ripoll; Josep M Hernández; Josep Basora; Ferran Bejarano; Victoria Arija Journal: BMC Public Health Date: 2011-06-05 Impact factor: 3.295
Authors: M A Daniels; C Kan; D M Willmes; K Ismail; F Pistrosch; D Hopkins; G Mingrone; S R Bornstein; A L Birkenfeld Journal: Pharmacogenomics J Date: 2016-07-19 Impact factor: 3.550
Authors: Zeina A Habib; Leonidas Tzogias; Suzanne L Havstad; Karen Wells; George Divine; David E Lanfear; Jeffrey Tang; Richard Krajenta; Manel Pladevall; L Keoki Williams Journal: Pharmacoepidemiol Drug Saf Date: 2009-06 Impact factor: 2.890
Authors: Carmella Evans-Molina; Reiesha D Robbins; Tatsuyoshi Kono; Sarah A Tersey; George L Vestermark; Craig S Nunemaker; James C Garmey; Tye G Deering; Susanna R Keller; Bernhard Maier; Raghavendra G Mirmira Journal: Mol Cell Biol Date: 2009-02-23 Impact factor: 4.272
Authors: Matthew J O'Brien; Susan L Karam; Amisha Wallia; Raymond H Kang; Andrew J Cooper; Nicola Lancki; Margaret R Moran; David T Liss; Theodore A Prospect; Ronald T Ackermann Journal: JAMA Netw Open Date: 2018-12-07
Authors: Elizabeth Selvin; Shari Bolen; Hsin-Chieh Yeh; Crystal Wiley; Lisa M Wilson; Spyridon S Marinopoulos; Leonard Feldman; Jason Vassy; Renee Wilson; Eric B Bass; Frederick L Brancati Journal: Arch Intern Med Date: 2008-10-27