Alirocumab (Praluent) is a cholesterol-lowering drug that works through a different enzyme system than statins. (Here are the technical details: alirocumab and its cousin evolocumab inhibit an enzyme called PCSK9 that keeps the body from getting rid of LDL cholesterol. All of the statins inhibit an enzyme called HMG-coA reductase that creates LDL cholesterol.) When the FDA approved alirocumab in July, 2015, the manufacturer did not have any data on its potential benefits beyond its ability to lower cholesterol.
Does Alirocumab Prevent Heart Attacks?
Now a study published in The New England Journal of Medicine addresses that question (NEJM, online Nov. 7, 2018). The researchers recruited more than 18,000 patients at very high risk of a heart attack. These participants had recently suffered an acute coronary syndrome. In addition, they had elevated cholesterol despite being on a high-dose statin drug.
The volunteers were randomly assigned to get Praluent or placebo injections in addition to their statins. After approximately three years, 3.5 percent of the individuals on alirocumab had died, compared to 4.1 percent of those on placebo. That works out to approximately 6 people in 1,000 who might benefit, provided they are at comparably high risk to those in the study.
Side Effects of Alirocumab:
Side effects in the two groups were similar, although more people getting Praluent had painful injection site reactions. Roughly one in five of the patients with diabetes reported worsening of that condition on placebo as well as on Praluent. Presumably that is explained in large measure by the high dose statins all the volunteers were taking. Roughly one in ten people who did not have diabetes when the study began developed this condition during the course of the trial. Other side effects included memory problems and/or confusion, liver problems and cataracts. These are side effects that have been previously associated with statin drugs. Other known side effects of Praluent such as allergic reactions, muscle pain and muscle spasms were not reported.
The People’s Pharmacy Bottom Line on Praluent:
While this medication is clearly not appropriate for everyone with high cholesterol, it seems to offer some protection for those who have had acute coronary syndrome. People at such extremely high risk of heart attack might benefit, especially if statins have not lowered their cholesterol effectively.
Others may want to wait before signing up for this extra step on lowering cholesterol. We have not seen evidence that alirocumab would save lives in people at moderate risk of heart attacks. Keep in mind that other factors besides cholesterol may also contribute to heart attack risk.
