Amgen recently released new, detailed information about its phase-three GAUSS-3 trial, showing that Repatha (evolocumab) can be used to help patients who have high cholesterol but cannot take statins reduce their chances of low-density lipoprotein cholesterol (LDL-C).
The study, titled "Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects," compared Repatha with ezetimibe. Repatha showed a greater ability of reducing LDL-C chances.
"Statin-associated muscle symptoms represent a major unresolved challenge in the care of patients with cardiovascular disease," Dr. Sean Harper, executive vice president of research and development at Amgen, said. "These findings are promising, demonstrating safety and efficacy results consistent with the other GAUSS studies."
Study participants showed that Repatha reduced the risks after just 24 weeks of treatments -- significantly better than ezetimibe.
"By employing a unique crossover design, these study results provide insights into our understanding of statin intolerance, which can be difficult to define from patient-reported symptoms alone," Dr. Erik Stroes, coauthor of the study and professor in the Department of Vascular Medicine at the Academic Medical Center (AMC), Amsterdam, said. "This rigorously designed trial clearly shows that in carefully selected patients, statin intolerance withstands the placebo-controlled test. These often high-risk patients truly experience muscle-related side effects while on statin therapy and may therefore benefit from an alternative treatment like evolocumab to lower their LDL cholesterol."