The glucose-lowering efficacy of glitazones has allowed the fact that for more than ten years they have been regularly prescribed to type 2 diabetics. Now, we know that they cause or favour heart failure, but recently other negative side effects, independent from cardiac ones, have been discovered. With an observational trial, 227,571 patients assisted by Medicare (averagely 74.4 years of age) have been monitored, who, between summer 2006 and summer 2009, have started taking rosiglitazone. During follow-up, lasted a little more than three months, it was seen that who took rosiglitazone more easily experienced stroke (Hazard Ratio 1.27), heart failure (HR 1.25), death for any cause (HR 1.14) and a composed outcome represented by infarction, stroke, heart decompensation and death all together (HR 1.18). Infarction risk, considered alone, did not result increased. As to the composed endpoint, the NNH has been of 60 patients (that is to say, treating 60 subjects for one year, we obtain the negative endpoint). Through the extension of a meta-analysis published in 2007 and concerning trials on rosiglitazone, 56 trials have been examined, concerning 35,531 patients randomized to receive rosiglitazone or a control therapy for more than 24 weeks. Control therapy included the usual anti-diabetes treatments and also placebo. Compared with controls, the patients in the rosiglitazone group have presented a higher risk of myocardial infarction (OR 1.28) but not of cardiovascular mortality. Subgroup analyses too have led to the same conclusion.
The evidence against rosiglitazone increases: negative cardiovascular effects are frequent and important. We can appeal to criticism of observational studies, to confounders, to meta-analyses limits, but if you want to remember the always effective primum non nocere (first of all, do not harm), rosiglitazone should be withdrawn from the market, since there are much safer alternatives (for example, pioglitazone).
