Authors call for sharing of individual patient data to strengthen meta-analyses focused on safety
THURSDAY, Feb. 6, 2020 (HealthDay News) — Rosiglitazone seems to be associated with an increased cardiovascular risk, particularly heart failure, according to data from a systematic review and meta-analyses published online Feb. 5 in The BMJ.
Joshua D. Wallach, Ph.D., from the Yale School of Public Health in New Haven, Connecticut, and colleagues conducted a systematic review and individual patient-level data (IPD) and summary-level meta-analyses of randomized, controlled, phase II to IV clinical trials that compared rosiglitazone to any control in adults. Data were included from 33 eligible trials for which IPD were available (21,156 patients). Data from 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction and cardiovascular-related death (23,683 and 22,772 patients, respectively).
The researchers found that when analyses were limited to trials with IPD and trials with zero events in only one arm were accounted for, the risk for the composite outcome (acute myocardial infarction, heart failure, cardiovascular-related death, and non-cardiovascular-related death) was increased for rosiglitazone-treated patients versus controls (odds ratio, 1.33; 95 percent confidence interval, 1.09 to 1.61). The odds ratios were 1.17 (0.92 to 1.51) for myocardial infarction, 1.54 (1.14 to 2.09) for heart failure, 1.15 (0.55 to 2.41) for cardiovascular-related death, and 1.18 (0.60 to 2.30) for non-cardiovascular-related death. The odds ratios for myocardial infarction and cardiovascular-related death were attenuated for analyses including trials for which IPD were not available.
“This finding suggests that IPD might be necessary to accurately classify all adverse events when performing meta-analyses focused on safety,” the authors write.
Several authors disclosed financial ties to the pharmaceutical, medical device, legal, and medical technology industries.
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