An Inconvenient Truth about CVOTS

血糖降下薬の心血管アウトカム試験cardiovascular outcome trials (CVOTs) におけるHbA1c群間不均衡問題を論文にしました。

Imbalance in glycemic control between the treatment and placebo groups in cardiovascular outcome trials in type 2 diabetes.
The safety and efficacy of new hypoglycemic agents are potentially inflated because the participants in the placebo groups unexpectedly exhibited inferior glycemic control throughout the trial compared with the outcomes in the treatment groups. This imbalance may distort data interpretation and mask potential risks of the drugs. Re-analysis with adjustment for HbA1c concentrations would determine whether the results of these CVOTs were biased by the difference in glycemic control between the treatment and placebo groups and reveal potential effects of the test drugs independent of glycemic control.


この論文はMedscapeでも取り上げられました。Have the Blockbuster Diabetes Drug Trials Been Biased?