 |
|
Long-term Risk of Cardiovascular Events With RosiglitazoneA Meta-analysis
Sonal Singh, MD;
Yoon K. Loke, MBBS, MD;
Curt D. Furberg, MD, PhD
JAMA. 2007;298:1189-1195.
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 (I2 = 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.
Author Affiliations: Department of Medicine (Dr Singh) and Division of Public Health Sciences (Dr Furberg), Wake Forest University School of Medicine, Winston-Salem, North Carolina; and School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, England (Dr Loke).
RELATED ARTICLES
Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: A Meta-analysis of Randomized Trials
A. Michael Lincoff, Kathy Wolski, Stephen J. Nicholls, and Steven E. Nissen
JAMA. 2007;298(10):1180-1188.
ABSTRACT
| FULL TEXT
Cardiovascular Risk and the Thiazolidinediones: Déjà Vu All Over Again?
Daniel H. Solomon and Wolfgang C. Winkelmayer
JAMA. 2007;298(10):1216-1218.
EXTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Induction of CXCR2 Receptor by Peroxisome Proliferator-Activated Receptor {gamma} in Human Macrophages
Rigamonti et al.
Arterioscler. Thromb. Vasc. Bio. 2008;28:932-939.
ABSTRACT
| FULL TEXT
Diabetic retinopathy and risk of heart failure.
Cheung et al.
J Am Coll Cardiol 2008;51:1573-1578.
ABSTRACT
| FULL TEXT
PROactive: time for a critical appraisal
Betteridge et al.
Eur Heart J 2008;29:969-983.
ABSTRACT
| FULL TEXT
Glitazones in type 2 diabetes: an update
DTB 2008;46:25-29.
ABSTRACT
| FULL TEXT
Meta-analysis of rare events: an update and sensitivity analysis of cardiovascular events in randomized trials of rosiglitazone
Dahabreh
Clin Trials 2008;5:116-120.
ABSTRACT
The year in atherothrombosis.
Sanz et al.
J Am Coll Cardiol 2008;51:944-955.
FULL TEXT
Peroxisome Proliferator-Activated Receptor-{gamma}-Mediated Effects in the Vasculature
Duan et al.
Circ. Res. 2008;102:283-294.
ABSTRACT
| FULL TEXT
Management of Type 2 Diabetes -- Polling Results
Halperin et al.
NEJM 2008;358:e8-e8.
FULL TEXT
Projecting future drug expenditures--2008
Hoffman et al.
Am J Health Syst Pharm 2008;65:234-253.
ABSTRACT
| FULL TEXT
New Drugs for the Treatment of Diabetes: Part II: Incretin-Based Therapy and Beyond
Inzucchi and McGuire
Circulation 2008;117:574-584.
ABSTRACT
| FULL TEXT
New Drugs for the Treatment of Diabetes Mellitus: Part I: Thiazolidinediones and Their Evolving Cardiovascular Implications
McGuire and Inzucchi
Circulation 2008;117:440-449.
FULL TEXT
Glucose-lowering therapy after myocardial infarction: more questions than answers
Radke and Schunkert
Eur Heart J 2008;29:141-143.
FULL TEXT
Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: Update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes
Nathan et al.
Diabetes Care 2008;31:173-175.
FULL TEXT
Standards of Medical Care in Diabetes--2008
American Diabetes Association
Diabetes Care 2008;31:S12-S54.
FULL TEXT
Thiazolidinediones and Cardiovascular Outcomes in Older Patients With Diabetes
Lipscombe et al.
JAMA 2007;298:2634-2643.
ABSTRACT
| FULL TEXT
A Crash Course in Stats
Kirkman
DOC News 2007;4:2-2.
FULL TEXT
Thiazolidinediones and Increased MI Risk: A Class Effect?
Journal Watch Cardiology 2007;2007:3-3.
FULL TEXT
Cardiovascular Risk and the Thiazolidinediones: Deja Vu All Over Again?
Solomon and Winkelmayer
JAMA 2007;298:1216-1218.
FULL TEXT
Thiazolidinediones and Heart Disease Risk
JWatch General 2007;2007:2-2.
FULL TEXT
|
