Amid a slew of new data demonstrating yet again that PCSK9 inhibitors lower LDL cholesterol\u2014drastically and in a wide variety of different patient populations\u2014data from one trial offers the first suggestion that the drugs may in fact improve cardiovascular outcomes. But the analysis, the authors cautioned, is\u00a0a post-hoc analysis of a trial neither designed nor powered to study outcomes, so should be considered preliminary and speculative at best.<\/p>\n
Four phase 3 trials with the\u00a0Sanofi\u00a0and Regeneron PCSK9 inhibitor alirocumab (pronounced “allee rock you mab” by Chris Cannon at a news conference) were presented today at the European Society of Cardiology meeting in\u00a0Barcelona. The outcomes data was derived from the ongoing Odyssey Long Term trial, which is evaluating the long-term safety and efficacy of alirocumab in 2,341 high risk patients already taking statins and other lipid-lowering therapies. The results of Odyssey Long Term were presented by\u00a0Jennifer Robinson.<\/p>\n
In the post-hoc safety analysis, after a mean followup of 65 weeks the rate of cardiac death, MI, stroke, and unstable angina requiring hospitalization was 1.4% in the alirocumab group compared to 3% in the placebo group. This is the same composite endpoint that is being used in the ongoing 18,000 patient ODYSSEY Outcomes trial. In total there were 46 endpoint events. In the panel discussion following the trial’s presentation, Robert Califf urged caution when interpreting data like this with less than 100 events. Until the completion of the large outcomes trial, Califf said, it will be “a tough question” for regulators to decide how to handle this information.<\/p>\n