Researchers reported the first evidence that a new class of drugs known to dramatically lower cholesterol may also reduce risk of heart attacks, strokes and other serious consequences of cardiovascular disease.
The U. S. Food and Drug Administration has approved a new drug for treating high cholesterol levels. Evolocumab, called Repatha, is made by Amgen and is the second of a new class of lipid-lowering agents that are hitting the market. The other drug is alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals Inc. The drugs represent the most important new class of cholesterol-lowering medications since the first statin was approved in 1987. They belong to a potent new class of injectable LDL-lowering drugs known as PCSK9 inhibitors.
Although statins will continue to be a mainstay for the management of high levels of bad (LDL) cholesterol and reducing risk of heart attack and stroke, there are two groups of patients who could strongly benefit from having an alternative to statins. One is the group that experiences severe side effects to statins, and as a result may stop taking them. The most common side effect is muscle pain and weakness, which is estimated to affect between 10% and 25% of users. In contrast, clinical trials of alirocumab and evolocumab did not find an increase in muscle pain among study participants taking these drugs for several months compared with those taking a placebo control.
The other group is people whose levels of LDL cholesterol still hover above the desirable range even after taking statins. Although a small subset of this group — about 1 in 500 of all people with high cholesterol — have a genetic predisposition (familial hypercholesterolemia) that could affect their response to statins, it is not clear why others do not get sufficient cholesterol-lowering benefit.
In a study of nearly 4,500 patients, including those who did not tolerate or respond to statins, 90% of patients who took evolocumab along with standard therapy had LDL levels in the optimal range after three months, compared with 26% in the group that took the standard therapy alone (which depending on the care center could include medications and exercise and diet regimens).
In this study, the rates of heart attacks, strokes and other cardiovascular disease were also lower (1%) in the evolocumab group compared with the standard therapy (2.2%). So far, clinical studies of alirocumab suggest it is similar in effectiveness to evolocumab.