Study: Statin and Antibody Combo Lowered Very High Cholesterol
By Don Rauf
(dailyRx News) For many patients, statins have been an effective therapy for reducing high levels of cholesterol. For some with very high cholesterol, statins may not be enough.
Some individuals with extremely elevated LDL (“bad”) cholesterol levels (190 milligrams per deciliter or higher) may need to take non-statin therapy in addition to statins.
New research has found that adding the human monoclonal antibody evolocumab to statin therapy may bring down cholesterol levels in patients who are receiving moderate- or high-intensity statin dosing but are unable to achieve recommended goals.
Jennifer Robinson, MD, professor in the Department of Epidemiology at The University of Iowa in Iowa City, led this research analyzing the effects of evolocumab and ezetimibe (a non-statin, cholesterol-lowering medication) on 2,067 patients from 17 countries who were taking either moderate- or high-intensity statins.
Those in the moderate-dose statin group received daily treatments of 10 milligrams of atorvastatin (brand name Lipitor), 40 milligrams of simvastatin (brand name Zocor), or 5 milligrams of rosuvastatin (brand name Crestor). Those in the high-intensity statin group took either 80 milligrams of atorvastatin or 40 milligrams of rosuvastatin.
After four weeks, 1,899 participants began to take non-statin therapy as well. Selected individuals received either evolocumab or placebo (mock medication), while a group taking atorvastatin received ezetimibe.
Evolocumab clears LDL (low-density lipoprotein) cholesterol from the blood by blocking the protein PCSK9, which is mainly expressed in the liver and small intestine.
After the 12-week treatment period, Dr. Robinson and her colleagues weighed results from 558 patients in the placebo group, 221 taking ezetimibe, and 1,117 receiving evolocumab either in bi-weekly or monthly treatments.
All participants receiving evolocumab experienced significant drops in cholesterol levels. Those getting injections every two weeks had LDL cholesterol levels go down by 66 to 75 percent, and those getting monthly doses cut LDL by 63 to 75 percent.
Evolocumab outperformed ezetimibe, which lowered LDL up to 24 percent.
The researchers noted that up to 94 percent of evolocumab patients reached desired LDL levels of 70 milligrams per deciliter over the course of treatment.
In this 12-week trial conducted among patients with primary hypercholesterolemia (significantly high cholesterol), “evolocumab added to moderate- or high-intensity statin therapy resulted in additional LDL-C lowering,” the authors concluded. “Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering.”
The study appears in the May 14 issue of JAMA.
The research was funded by Amgen Inc., which was responsible for the design and conduct of the study as well as data collection and interpretation, management and analysis. Dr. Johnson’s institution has received research grants from Amarin, Amgen, AstraZeneca, Daiichi-Sankyo, Esperion, Genentech/Hoffman La Roche, Glaxo-Smith Kline, Merck, Regeneron/Sanofi and Zinfandel/Takeda.
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