‘Repatha shows powerful LDL-C reduction in patients with atherosclerotic cardiovascular disease’

As Amgen’s Repatha, a low-density lipoprotein cholesterol (LDL-C) treatment, marks its seventh year since its introduction in Korea in 2017, the company held a press conference to present significant advancements in cardiovascular disease management and the role of Repatha in the field.

Song Mi-young, the cardiology therapeutic area (TA) lead at Amgen Korea, presented compelling data on the strategic management of low-density lipoprotein cholesterol (LDL-C) to reduce the risk of atherosclerotic cardiovascular disease (ASCVD).

ASCVD occurs when fat and cell masses (plaques) form in the inner lining of arteries, narrowing the vessels and disrupting blood flow. Common manifestations include coronary heart disease, stroke, and peripheral artery disease, primarily caused by high cholesterol levels.

This disease is known for its high recurrence and mortality rates. One in three to four patients who have had a myocardial infarction or stroke is at risk of recurring cardiovascular disease. Patients with a history of stroke are three to four times more likely to suffer a myocardial infarction and up to nine times more likely to have an ischemic stroke.

"ASCVD is a major health concern globally, often leading to complications that can cause recurrent heart attacks or strokes, with an increased mortality rate of up to 85 percent on recurrence," Song said. ”Despite the availability of high-intensity statin treatments, achieving target LDL-C levels remains a challenge, with a study showing a compliance rate of only about 34.1 percent among patients at Asan Medical Center over the years 2000 to 2016."

The goal is to lower the LDL-C as much as possible to reduce the risk of ASCVD linearly, Song added.

In her presentation, Song detailed the benefits of PCSK9 inhibitors, specifically Repatha, in managing LDL-C levels.

She cited the FOURIER clinical trials, which demonstrated that Repatha significantly lowers LDL-C by approximately 60 percent from baseline, greatly reducing the risk of cardiovascular events.

Notably, Song presented a clinical study conducted in Korea where patients treated with Repatha after experiencing ACS who failed to reduce their LDL-cholesterol to below 70mg/dL within 24 weeks of ACS showed a 50.9 percent reduction in LDL-cholesterol levels by the eighth week of treatment.

The rate of achieving the LDL-cholesterol target level was 55.1 percent for levels below 55mg/dL and 78.7 percent for levels below 70mg/dL.

Song also presented data unveiled at the American College of Cardiology Annual Conference (ACC 2024) held from April 6-8 in Atlanta, GA, U.S.

“The study showed that Repatha was proven to effectively reduce LDL-cholesterol across all ages of patients with atherosclerotic cardiovascular disease,” Song said. “The study analyzed long-term efficacy and safety outcomes in patients under and over 75 years old, divided into Repatha and placebo groups.”

The primary endpoints were composite measures of hospitalization due to unstable angina, coronary revascularization, stroke occurrence, and cardiovascular death. The secondary endpoints were composite measures of myocardial infarction, stroke occurrence, and cardiovascular death.

Clinical results showed a 21 percent decrease in the incidence of diseases defined by primary and secondary endpoints in patients over 75 treated with Repatha. In patients under 75, the primary and secondary endpoints decreased by 14 percent and 20 percent, respectively.

“According to Korea's dyslipidemia treatment guidelines, PCSK9 inhibitors are recommended if target LDL-cholesterol levels are not achieved in high-risk patients,” Song said. “It's crucial to use Repatha quickly in high-risk patients as these clinical results suggest that Repatha can be considered as one of the treatment options recommended by the guidelines to achieve target LDL-cholesterol levels."