MONDAY, March 16, 2015 (HealthDay News) -- Evolocumab and alirocumab, monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9), reduce low-density lipoprotein (LDL) cholesterol levels in the longer term, according to two studies published online March 15 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American College of Cardiology, held from March 14 to 16 in San Diego.
Marc S. Sabatine, M.D., M.P.H., from Brigham and Women's Hospital in Boston, and colleagues conducted two extension studies involving 4,465 patients to obtain longer-term data for evolocumab. Eligible patients were randomized in a 2:1 ratio to receive evolocumab plus standard therapy or standard therapy alone. The researchers found that evolocumab reduced the level of LDL cholesterol by 61 percent as compared with standard therapy alone (P < 0.001).
Jennifer G. Robinson, M.D., M.P.H., from the University of Iowa in Iowa City, and colleagues conducted a randomized trial involving 2,341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg/dL or more, and were receiving statins. Patients were randomized in a 2:1 ratio to receive alirocumab or placebo for 78 weeks. At week 24, the researchers found that the difference in the mean percentage change from baseline in calculated cholesterol level between the alirocumab and placebo groups was −62 percentage points (P < 0.001).
"Much work remains to be done, but PCSK9 inhibitors appear on track to become important arrows in our quiver for targeting reduction of cardiovascular events among higher-risk patients when statins are not enough," write the authors of an accompanying editorial.
The Sabatine study was funded by Amgen; the Robinson study was funded by Sanofi and Regeneron Pharmaceuticals.
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