Statins are one of the biggest success stories of modern medicine, credited with transforming cardiac care. Millions of Americans take them based on scientific evidence that it reduces their risk of heart attack and stroke, but the drugs are not for everyone.
There has been considerable debate about the balance of potential risk and benefit, and a significant percentage of those who take statins have complained of side effects such as muscle pain and cognitive effects like fuzzy memory.
And so the search has been on for a new — and better —class of cholesterol-busting medication.
In recent years, there has been a lot of hope about Amgen’s Repatha (evolocumab) and other PCSK9 drugs (named for proprotein convertase subtilisin/kexin type 9 inhibitors), which were approved by the Food and Drug Administration last year. But uptake of the drugs has been slow because of the expense and because statins seem to have worked so well for so many for such a long time. Insurance coverage has also been an issue, with many patients complaining of lengthy pre-authorization requirements.
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The results of one of the first significant trials of a PCSK9 drug were presented Tuesday at a meeting of the American Heart Association, providing evidence to back some of the promise that has surrounded the medications.
The study involved 968 patients in academic and community hospitals in North America, Europe, South America and Asia who have coronary disease and were already being treated with statins. In this double-blind, randomized trial, they were given either an injection of evolocumab or a placebo for 76 weeks.
Researchers found that not only did the evolocumab group attain very low low-density lipoprotein or “bad” cholesterol levels — the lowest average level in a major trial of cholesterol drugs — the combination also appeared to somehow reverse the amount of plaque in their coronary artery walls.
The authors of the paper noted that the trial has several limitations, with one being its size. Another is that the patients involved already had heart disease and it’s unclear whether there would be a similar effect for those without symptoms taking statins as a preventive measure, like many people do.
They also pointed out that patient retention in the trial was at 87 percent (which is pretty good) but that this may have affected the results. Lastly, the study looked at the volume of plaque rather than other characteristics of coronary artery hardening.
The study, directed by Steve Nissen of the Cleveland Clinic and Stephen Nicholls of the South Australian Health and Medical Research Institute, was funded by Amgen.
The top-line results of a much larger study, known as Fourier or the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects with Elevated Risk, on an estimated 27,500 patients at high risk are expected to be released in early 2017.