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November 12, 2018

OSLER-1 Evaluates Long-Term Safety and Efficacy of Amgen's Repatha

November 12, 2018—Amgen announced the presentation of the final report of the OSLER-1 trial at the American Heart Association (AHA) 2018 scientific sessions held November 10–12 in Chicago, Illinois. The findings demonstrated that long-term treatment with the company's PCSK9 inhibitor, Repatha (evolocumab), was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse events over time and no neutralizing antibodies.

According to Amgen, OSLER-1 is a 5-year, open-label study evaluating the safety and efficacy of Repatha in hypercholesterolemia patients, including those with heterozygous familial hypercholesterolemia, on background statin therapy, and patients with statin intolerance who were previously enrolled in one of five double-blind Repatha trials (N = 1,324).

Patients treated with Repatha achieved a 59% reduction in mean LDL-C from baseline during the first year of treatment (n = 785). With Repatha, the mean LDL-C reductions at years 2, 3, 4, and 5 were: 56% (n = 1,071), 57% (n = 1,001), 56% (n = 943), and 56% (n = 803), respectively. In years 1 through 5 respectively, adverse events (AE) were reported in 80%, 74%, 71%, 67%, and 65% of patients; serious AEs were reported in 7%, 7%, 8%, 7%, and 7% of patients each year.

Also at the AHA conference, data presented from the GOULD registry reflect a disconnect between physician perception of lipid-lowering therapies (LLTs) and their actual use. Additionally, the findings highlight both a need for improved patient awareness of the goals of LLT and a need to address barriers to the use of medications like Repatha.

GOULD is a multicenter, observational registry of patients with atherosclerotic cardiovascular disease designed to describe LDL-C treatment patterns in the United States over time (N = 5,006). Analyses of the GOULD data demonstrated the underutilization of effective LLTs among patients at high risk for cardiovascular events, in those with LDL-C levels ≥ 70 mg/dL. A survey of 110 physicians identified a disconnect between physicians’ perceptions of LLTs and their actual use, with support for high-intensity statins and PCSK9 inhibition use at 75% among physicians and actual observed use of 50% and 10%, respectively. Although many physicians had prescribed a PCSK9 inhibitor, those who had not, cited cost and hassle associated with previous authorization requirements from payers as important reasons for not prescribing.

Furthermore, among patients receiving any LLT, more than 70% did not know the main goal of this treatment was the prevention of cardiovascular events and approximately 50% were unaware of their total lipid levels. GOULD data also demonstrated that regardless of LLT type, a large proportion of patients remain unaware of their atherosclerotic cardiovascular disease risk, LDL-C levels, or therapy goals. This highlights an educational gap, which if addressed, may impact shared health care decision-making and treatment adherence, noted the company.

Amgen advised that it recently made Repatha available in the United States at a 60% reduced list price to address concerns over high out-of-pocket costs for patients.

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