Final data from a phase 3 trial assessing evolocumab in patients with HIV who have high cholesterol confirmed the safety and efficacy of the drug as a treatment.
Final data from the phase 3 BEIJERINCK trial assessing evolocumab (Repatha, Amgen) in patients living with HIV who have high cholesterol confirmed the safety and efficacy of the drug as a treatment across multiple patient populations, according to a presentation at the American College of Cardiology's 70th Annual Scientific Session & Expo.
In the trial, investigators assessed whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy was able to reduce cardiovascular events (CV).
The primary endpoint in the trial was the period of time to death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whereas the key secondary endpoint was the time to death, myocardial infarction, or stroke.
The participants in the trial had high cholesterol at low-density lipoprotein cholesterol test (LDL) ≥70 mg/dL or non-high-density lipoprotein cholesterol (non-HDL-C) at ≥100 mg/dL and clinically evident atherosclerotic cardiovascular disease.
The participants were based at more than 1300 study sites globally, with each patient randomized to receive evolocumab subcutaneously at 140 mg every 2 weeks or at 420 mg monthly plus a statin dose or placebo subcutaneously every 2 weeks or monthly plus a statin dose.
In order to optimize the efficacy of the statin therapy in the treatment, the investigators set a dose of at least 20 mg of atorvastatin or equivalent with a recommended 40 mg of atorvastatin or equivalent where approved.
Additionally, since the study was event-driven, the investigators continued until at least 1630 patients had experienced a key secondary endpoint.
Data from the trial contribute to Amgen's Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations (PROFICIO). The program consists of both clinical studies and real-world evidence that help to assess the impact of evolocumab when used as a treatment for cardiovascular diseaseacross multiple populations at high CV risk, including patients managed by statins, statin-intolerant patients, those with genetic disorders, and patients with atherosclerosis.
Currently, PROFICIO consists of 50 clinical trials with more than 47,000 participants worldwide and 8 real-world evidence studies. These studies have provided the body of evidence to demonstrate the safety and efficacy of evolocumab for treatment in a variety of high-risk patients, which has led to the approvals of evolocumab in more than 75 countries.
Efficacy Of Repatha® (Evolocumab) Across High-Risk Patient Populations Reinforced At ACC.21. Thousand Oaks, CA: Amgen; May 11, 2021. https://www.prnewswire.com/news-releases/efficacy-of-repatha-evolocumab-across-high-risk-patient-populations-reinforced-at-acc21-301287882.html. Accessed May 17, 2021.
Updated May 21, 2021 at 2:13 pm ET