Among patients with statin intolerance due to muscle pain, taking evolocumab resulted in a significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) compared to ezetimibe, according to the GAUSS-3 study presented on April 3 at ACC.16 in Chicago and published simultaneously in the Journal of the American Medical Association.

The study, led by Steven Nissen, MD, MACC, et al. examined 491 patients with uncontrolled LDL-C and a history of muscle pain with two or more types of statins. Patients in the trial had very high levels of LDL-C, averaging more than 120 mg/dL. During phase A of the trial, 245 patients were randomized to receive atorvastatin before placebo and 246 received statin before atorvastatin. A total of 218 patients with confirmed statin intolerance entered phase B of the trial, with 73 randomized to receive ezetimibe plus subcutaneous placebo and 145 received evolocumab plus oral placebo.

In total, 209 (42.6 percent) of patients who took atorvastatin had a recurrence of symptoms, but did not while taking a placebo. During the 24-week treatment period, patients given evolocumab showed a 52.8 percent reduction in LDL-C compared with a 16.7 percent reduction for patients taking ezetimibe. During weeks 22 and 24, patients taking evolocumab showed a 54.5 percent reduction in LDL-C and patients taking ezetimibe showed a reduction of 16.7 percent.

"These findings provide unique insights into the challenging clinical problem of muscle symptoms in statin treated patients," said Nissen. "Evolocumab substantially lowered LDL cholesterol with few patients experiencing muscle symptoms. The study has important implications for both guidelines and regulatory policy, because it provides strong evidence that muscle-related statin intolerance is a real and reproducible phenomenon."

Keywords: ACC Annual Scientific Session, Antibodies, Monoclonal, Azetidines, Biomarkers, Pharmacological, Cholesterol, Cholesterol, LDL, Coronary Disease, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Proprotein Convertases, Subtilisins

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