Amgen (NASDAQ:AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with 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. Additionally, data from the Getting to an ImprOved Understanding of Low-Density Lipoprotein and Dyslipidemia Management (GOULD) Registry reflect a disconnect between physician perception of lipid-lowering therapies (LLTs) and their actual use, and highlight both a need for improved patient awareness of the goals of LLT and a need to address barriers to use of medications like Repatha.
In an effort to help more patients bring down the risk of heart attack and stroke, Amgen recently made Repatha available in the United States (U.S.) at a 60 percent reduced list price to address concerns over high out-of-pocket costs for patients. The results of all analyses were presented at the American Heart Association’s Scientific Sessions 2018 in Chicago.
OSLER-1 is a five-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).1-6Patients treated with Repatha achieved a 59 percent reduction in mean LDL-C from baseline during the first year of treatment (n=785). With Repatha, the mean LDL-C reductions at years two, three, four and five were: 56 percent (n=1,071), 57 percent (n=1,001), 56 percent (n=943) and 56 percent (n=803), respectively. Adverse events (AE) were reported in 80 percent, 74 percent, 71 percent, 67 percent, and 65 percent of patients, respectively; serious AEs were reported in seven percent, seven percent, eight percent, seven percent, and seven percent of patients each year (years one through five, respectively).
‘Amgen is pleased to present the results of OSLER-1, the longest study of a PCSK9 inhibitor to date, which clearly demonstrate the durable, long-term efficacy and safety of Repatha in reducing LDL-C levels,’ said David M. Reese, M.D., executive vice president of Research and Development at Amgen. ‘These findings are consistent with those observed in the Repatha cardiovascular outcomes study (FOURIER) and other Phase 3 trials, reinforcing Repatha’s role in the treatment of high-risk patients who are unable to achieve sufficient LDL-C reduction through other means.’
Analyses of data from GOULD, a multicenter, observational registry of people with atherosclerotic cardiovascular disease (ASCVD) designed to describe LDL-C treatment patterns in the U.S. over time (N= 5,006), 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 percent among physicians and actual observed use of 50 percent and 10 percent, respectively. While many physicians had prescribed a PCSK9 inhibitor, those who had not, cited cost and hassle associated with prior authorization requirements from payers as important reasons for not prescribing.
Furthermore, among patients receiving any LLT, more than 70 percent did not know the main goal of this treatment was prevention of cardiovascular events and nearly half 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 ASCVD risk, LDL-C levels, or therapy goals. This highlights an educational gap, which if addressed, may impact shared healthcare decision making and treatment adherence.
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