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Recent research has unveiled a promising experimental drug that significantly lowers levels of a cholesterol-like particle associated with an increased risk of heart attacks and strokes. This particle, known as lipoprotein(a) or Lp(a), often goes unnoticed by many Americans, who may be unaware of its potential dangers.
According to a study led by the Cleveland Clinic, elevated levels of Lp(a) cannot be modified through lifestyle changes. The condition has been described as “one of the last untreatable frontiers of cardiovascular risk.” The team ascertained that lepodisiran, an innovative medication developed by Eli Lilly and funded by the company, effectively “silences” the primary gene responsible for producing Lp(a).
This study’s findings, which were published in The New England Journal of Medicine and shared during the annual meeting of the American College of Cardiology on March 30, reinforce previous results about the drug’s effects.
Understanding Lipoprotein(a)
About 20-25% of the global population experiences elevated levels of Lp(a), which translates to roughly 64 million individuals in the United States and approximately 1.4 billion worldwide. While Lp(a) resembles low-density lipoprotein (LDL), commonly referred to as “bad cholesterol,” it poses an increased risk for arterial plaque accumulation and clot formation, as noted by Steven Nissen, M.D., the lead author of the study and chief academic officer at Cleveland Clinic.
The genetic predisposition to high Lp(a) levels differentiates it from LDL, which is influenced by multiple factors, including lifestyle choices. Dr. Deepak L. Bhatt, a cardiovascular medicine expert at Mount Sinai, emphasized that Lp(a) is primarily hereditary, asserting its classification as an independent risk factor for cardiovascular disease.
Diet and exercise may lower LDL levels but do not impact Lp(a). Currently, no approved treatments exist for reducing Lp(a) levels, making this research even more significant.
Details of the Study
The clinical trial included 320 participants from diverse countries, including the U.S., Japan, and Germany, conducted between November 2022 and April 2023. Participants were randomly assigned to receive either a placebo or one to two subcutaneous injections of lepodisiran.
Normal Lp(a) levels should be under 75 nanomoles per liter, whereas the trial’s participants had an average level of around 250 nanomoles per liter, significantly above the normal threshold. Remarkably, just one injection of the highest dose led to nearly a 100% reduction in Lp(a) after six months. Those receiving a second dose maintained this reduction after a year.
Cardiologists believe that these findings could potentially offer new treatment avenues for millions of Americans grappling with high Lp(a) levels.
Addressing Potential Limitations
The study’s authors reported minimal safety concerns, though 12% of participants experienced mild reactions at the injection sites. Notably, the study included fewer Black participants, a group that research indicates may have higher Lp(a) levels compared to White individuals. This concern is being addressed in the ongoing phase 3 trial, which aims to enroll more Black participants.
This trial only administered two doses of lepodisiran, leaving questions about the effects of additional doses unanswered. Furthermore, while Lp(a) levels decreased significantly, the trial has yet to establish a direct correlation between reduced Lp(a) and lower rates of heart attacks or strokes. Future research, particularly phase 3 trials, will be critical to determining this link.
Both the European Society of Cardiology and the National Lipid Association in the United States advocate for all adults to check their Lp(a) levels, emphasizing the importance of early detection. Unlike LDL cholesterol, which requires ongoing monitoring, Lp(a) levels are stable across a person’s lifetime, warranting a single test during early adulthood.
As researchers continue to explore this novel treatment, the implications of reduced Lp(a) levels for heart disease prevention remain a vital area of interest in cardiovascular medicine.
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