"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 50 times in current journal articles
indexed by Clarivate during September-October 2008. Repeating its
performance from the previous count for July-August, this report currently
stands as the third-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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