Positive Results Reported for Evolocumab in Statin-Intolerant Patients With High Cholesterol
Phase III study meets co-primary endpoints of LDL cholesterol reduction (January 23)
The phase III GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin-Intolerant Subjects-2) trial evaluating evolocumab (Amgen) in patients with high cholesterol who cannot tolerate statins has met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.
The mean percent reductions in LDL-C, or “bad” cholesterol, compared with ezetimibe were consistent with results observed in the phase II GAUSS study.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove LDL-C from the blood.
The GAUSS-2 trial evaluated the safety, tolerability, and efficacy of evolocumab in 307 patients with high cholesterol who could not tolerate effective doses of at least two different statins because of muscle-related adverse effects. The patients were randomly assigned to one of four treatment groups: subcutaneous (SC) evolocumab 140 mg every 2 weeks and oral placebo daily; SC evolocumab 420 mg monthly and oral placebo daily; SC placebo every 2 weeks and oral ezetimibe 10 mg daily; or SC placebo monthly and oral ezetimibe 10 mg daily.
Safety was generally balanced across treatment groups. The most common adverse events were headache (7.8% evolocumab vs. 8.8% ezetimibe), myalgia (7.8% vs. 17.6%), pain in an extremity (6.8% vs. 1.0%), and muscle spasms (6.3% vs. 3.9%).
Source: Amgen; January 23, 2014.