ROSIGLITAZONE AND RISK OF CANCER. A META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

Abstract

Background: Despite experimental data suggesting a protective effect of PPAR-γ agonists with respect to malignancies, results of available epidemiological studies on the incidence of cancer in rosiglitazone-treated patients are not univocal. This meta-analysis of randomized clinical trials (RCT) is aimed at assessing the effect of rosiglitazone on the incidence of cancer.

Methods: RCT of rosiglitazone with duration> 24 weeks were retrieved through Medline and from http://ctr.gsk.co.uk/welcome.asp website, which reports main results of all trials sponsored by GlaxoSmithKline; incident malignancies were retrieved from the summary of serious adverse events. Proportions of outcome measures across treatment groups were compared by odds ratios (OR) and 95% confidence intervals (95%CI). Considering differences in the duration of follow-up among treatment arms in some of the trials, the incidence of cancer in rosiglitazone and control groups was also calculated.

Results: Eighty trials, enrolling 16,332 and 12,522 patients in the rosiglitazone and comparator groups, respectively, were retrieved. Rosiglitazone was not associated with a significant modification of the risk of cancer (OR 0.91[0.71-1.16], p=0.44). The incidence of malignancies was significantly lower in rosiglitazone-treated patients than in control groups (0.23[0.19-0.26] vs. 0.44[0.34-0.58] cases/100 patient*years; p<0.05).

Conclusions: The use of rosiglitazone appears to be safe in terms of incidence of cancer, while its possible protective effect needs to be further investigated.