avandia:
some more info:
"We screened 116 phase 2, 3, and 4 trials for inclusion. Of these, 48 trials met the predefined inclusion criteria of having a randomized comparator group, a similar duration of treatment in all groups, and more than 24 weeks of drug exposure. Six of the 48 trials did not report any myocardial infarctions or deaths from cardiovascular causes and therefore were not included in the analysis because the effect measure could not be calculated. Of the remaining 42 studies, 38 reported at least one myocardial infarction, and 22 reported at least one death from cardiovascular causes. In these trials, 15,560 patients were randomly assigned to regimens that included rosiglitazone, and 12,283 were assigned to comparator groups with regimens that did not include rosiglitazone."
...
"Myocardial Infarction and Death
Table 3 reports the myocardial infarction events and deaths from cardiovascular causes that were reported in the 42 clinical trials we reviewed. There were 86 myocardial infarctions in the rosiglitazone group and 72 in the control group. There were 39 deaths from cardiovascular causes in the rosiglitazone group and 22 in the control group. Table 4 lists the odds ratios, 95% confidence intervals, and P values for myocardial infarction and death from cardiovascular causes for the rosiglitazone group and the control group. The summary odds ratio for myocardial infarction was 1.43 in the rosiglitazone group (95% confidence interval [CI], 1.03 to 1.98; P=0.03). The odds ratio for death from cardiovascular causes in the rosiglitazone group, as compared with the control group, was 1.64 (95% CI, 0.98 to 2.74; P=0.06). Table 4 also lists odds ratios and 95% confidence intervals for the pooled group of trials that were smaller and of shorter duration; results for the DREAM and ADOPT studies are shown separately."
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As an aside, I think the FDA has to get serious about defining real risk - benefit ratios for drugs, especially ones that treat large populations. People like Nissen are making it a habit of scouring databases for their AE of choice. He's a CV guy who searches all drugs for CV events, some diabetes guy is going to search all drugs for signs of diabetes progression, etc... etc... |
