There is no paucity of data which shows that PCSK9 inhibitors lower LDL cholesterol– drastically and in a wide variety of different patient populations. Data from a fresh study offers the suggestion that these drugs can improve cardiovascular outcomes. However the author of the study was quick to caution that the trial was not designed or meant to study outcomes and post-hoc analysis of the study must be at the best be considered as purely preliminary and speculative.
4 Phase three trials with the Sanofi and Regeneron PCSK9 inhibitor Alirocumab were presented before the European Society of Cardiology meeting in Barcelona. The data was obtained from the ongoing Odyssey Long Term trial, which is evaluating the long-term safety and effectiveness of Alirocumab in 2,341 high risk patients who were already taking some type of statins or some other lipid lowering therapies. The final report of the Odyssey Long Term was presented by Jennifer Robinson.
The post hoc safety analysis post a mean follow-up of 65 weeks, the rate of Myocardial Infarction, stroke, unstable angina and cardiac death which required hospitalization was 1.4% in the Alirocumab group compared to 3% in the placebo group.
Somewhat similar endpoint is being used in the continuing 18,000 patient ODYSSEY Outcomes trial. There are 46 endpoints in total. Experts have urged caution when interpreting data of this nature with less than 100 events. The final verdict can be given only after the completion of the large outcome trials.
Alirocumab has been found to be very effective in lowering the LDL cholesterol levels. The drug had reduced LDL levels by 61% at the end of 24 weeks and 57% after 52 weeks. This is in comparison with the placebo with a 1% increase and a 4% increase in the placebo arms.