"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 73 times in current journal articles
indexed by Clarivate during January-February 2008. As was the case
following the previous two-month tally for November-December 2007, this
report wound up as the second-most-cited medicine paper published in the
last two years, aside from reviews. Prior to the most recent bimonthly
count, citations to the paper have accrued as follows:
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