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Evolocumab (Repatha, Amgen) in combination with optimized statin therapy significantly improved certain features of plaque stability in patients with coronary artery disease (CAD) compared to patients receiving optimized statin therapy alone, according to data presented at ESC Congress 2021.
The investigators noted that heart attacks are often caused by the rupturing of vulnerable plaques, defined as plaques with a large lipid core with a thin fibrous cap that serves as a wall or barrier around the plaque to keep it intact. The study assessed whether evolocumab could improve plaque stability through increasing the thickness of the fibrous caps.
The randomized, double-blind, 52-week study found that the combination therapy of evolocumab and optimized statin therapy resulted in an increase of 75% in fibrous cap thickness compared to 39% on optimized statin therapy alone. Further, adding evolocumab to optimized statin therapy improved all of the study’s secondary endpoints, including a decrease in the maximum lipid arc by -57.5° compared to -31.4°.
“The majority of acute coronary syndrome events are caused by plaque rupture, and those who have had a heart attack are especially vulnerable to additional episodes of plaque rupture, demonstrating the importance of maintaining the thickness of the fibrous cap to help stabilize plaques,” said Stephen J. Nicholls, MD, PhD, professor of Cardiology and director of the Monash University Victorian Heart Institute, in a press release. “These encouraging results reaffirm the potential of Repatha and highlight the benefits of Repatha in ACS patients who initiated treatment early.”
No new safety risks were identified in the study. According to the investigators, the most common treatment-emergent adverse events were angina pectoris, myalgia, hypertension, diarrhea, fatigue, and cough. The study also demonstrated that treatment with evolocumab initiated within a week after the ACS event reduced low-density lipoprotein cholesterol by 80%, compared to 39% on statin optimization alone.
“Amgen continues to build a body of evidence to support the clinical profile of Repatha and demonstrate its benefit in patients at elevated risk of suffering another heart attack or stroke,” said David M. Reese, MD, executive vice president of Research and Development at Amgen. “This study builds on the findings from the GLAGOV study and provides evidence that low LDL-C levels can change characteristics of coronary plaque, which may explain the biology of cardiovascular event reduction we saw in the FOURIER study.”
REFERENCE
New data at ESC Congress 2021 shows Repatha® (evolocumab) improves features of plaque stability in patients with acute coronary syndrome (ACS) [news release]. Amgen; August 27, 2021. Accessed September 2, 2021. https://wwwext.amgen.com/newsroom/press-releases/2021/08/new-data-at-esc-congress-2021-shows-repatha-evolocumab-improves-features-of-plaque-stability-in-patients-with-acute-coronary-syndrome-acs