"Effect of rosiglitazone on the risk of myocardial infarction
and death from cardiovascular causes," by
Steven E. Nissen and Kathy Wolski, New England Journal of
Medicine, 356(24): 2457-71, 14 June 2007.
[Authors' affiliation: Cleveland Clinic, OH]
Abstract: "BACKGROUND: Rosiglitazone
is widely used to treat patients with type 2 diabetes mellitus, but its
effect on cardiovascular morbidity and mortality has not been
determined. METHODS: We conducted searches of the
published literature, the Web site of the Food and Drug Administration,
and a clinical-trials registry maintained by the drug manufacturer
(GlaxoSmithKline). Criteria for inclusion in our meta-analysis included
a study duration of more than 24 weeks, the use of a randomized control
group not receiving rosiglitazone, and the availability of outcome data
for myocardial infarction and death from cardiovascular causes. Of 116
potentially relevant studies, 42 trials met the inclusion criteria. We
tabulated all occurrences of myocardial infarction and death from
cardiovascular causes. RESULTS: Data were combined by
means of a fixed-effects model. In the 42 trials, the mean age of the
subjects was approximately 56 years, and the mean baseline glycated
hemoglobin level was approximately 8.2%. In the rosiglitazone group, as
compared with the control group, the odds ratio for myocardial
infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98;
P=0.03), and the odds ratio for death from cardiovascular causes was
1.64 (95% CI, 0.98 to 2.74; P=0.06). CONCLUSIONS:
Rosiglitazone was associated with a significant increase in the risk of
myocardial infarction and with an increase in the risk of death from
cardiovascular causes that had borderline significance. Our study was
limited by a lack of access to original source data, which would have
enabled time-to-event analysis. Despite these limitations, patients and
providers should consider the potential for serious adverse
cardiovascular effects of treatment with rosiglitazone for type 2
diabetes."
This 2007 report from the New England Journal of Medicine was cited 52
times in current journal articles
indexed by Thomson Scientific during November-December 2007. During
that two-month period, only one
other non-review medicine paper published in the last two years
garnered a higher citation total. Prior to the
most recent bimonthly count, citations to the paper have accrued as
follows:
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