January 7, 2009- The ARBITER 6-HALTS study investigating Zetia and Niaspan was stopped early, confounding the outcome and likely inflating the efficacy of Niaspan. There was no ethical reason to stop the trial early. It is quite possible that there would have been no benefit to Niaspan whatsoever if the trial were carried out to completion.
Dr. Gordon Guyatt discusses the statistical reasons that clinical trials should not be stopped early, in most cases. Early stoppage has been a growing problem in the cardiology and oncology trials.