Genetic cholesterol eliminated by new drug, reducing heart attack risk, study finds
Many Americans are unaware that elevated levels of this particle — known as lipoprotein(a) or Lp(a) — are circulating in their blood.
Elevated Lp(a) cannot be modified with lifestyle changes, and has been called "one of the last untreatable frontiers of cardiovascular risk" by Cleveland Clinic, who led the study.
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This new research confirmed earlier findings showing that the experimental drug — lepodisiran, made by Eli Lilly, who funded the study — can "silence" the main gene responsible for synthesizing Lp(a).
(Other experimental gene therapies with a similar mechanism of action are also in development, according to Cleveland Clinic.)
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The findings were published in The New England Journal of Medicine and were also presented at the annual meeting of the American College of Cardiology on March 30.
Lipoprotein(a) levels are elevated in approximately 20-25% of people worldwide, according to the American Heart Association.
This equates to approximately 64 million people in the U.S. and 1.4 billion people globally.
Lp(a) shares similarities with another lipoprotein that doctors target to reduce the risk of heart disease, known as low-density lipoprotein (LDL) – often referred to as "bad cholesterol."
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But lipoprotein(a) is more prone to plaque buildup and clots in the arteries than LDL, according to lead author Steven Nissen, M.D., chief academic officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic.
"Lipoprotein(a) is an independent risk factor for heart disease that is largely determined by genetics — that is, it is inherited," added Dr. Deepak L. Bhatt, director of Mount Sinai Fuster Heart Hospital and a professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai in New York, told Fox News Digital. (He was not part of the study.)
Lp(a) is primarily determined by differences in one gene, while LDL cholesterol levels are influenced by multiple genes.
"That's a very big difference, and LDL has a much larger environmental component," Nissen noted.
Diet, exercise and weight loss can help decrease LDL levels, but they do not have an impact on Lp(a) levels, experts say.
And unlike LDL, which can be reduced with medications like statins, there are currently no approved drug treatments that lower Lp(a).
"There is no approved pharmacotherapy for lipoprotein(a) by regulatory authorities in any country in the world," Nissen confirmed.
The researchers performed a clinical trial of 320 individuals from Argentina, China, Denmark, Germany, Japan, Mexico, the Netherlands, Romania, Spain and the U.S. from Nov. 11, 2022, to April 17, 2023.
The participants were randomly assigned to receive either a placebo or one or two subcutaneous injections of lepodisiran.
The normal level of Lp(a) is less than 75 nanomoles per liter and the average level for people in the trial was about 250 nanomoles per liter, Nissen told Fox News Digital.
"They were very high — more than three times the upper limit of normal," he added.
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After one injection of the highest dose, participants showed a nearly 100% reduction in levels of lipoprotein(a) at six months.
Those who received a second dose at six months maintained an almost 100% reduction at the one-year mark.
In other words, the therapy removed virtually all lipoprotein(a) from the blood, according to Nissen.
Cardiologists say these findings may ultimately help treat millions of Americans who have elevated levels of Lp(a).
"The results are very impressive," Bhatt said.
The researchers noted that there were no major safety concerns, but 12% of participants reported mild reactions at the injection site.
The study had only a few Black participants — a population that needs more research, as they are more likely to have elevated lipoprotein(a) concentrations than White persons, according to previous studies.
(To address this concern, the researchers are enrolling many more Black patients in their larger phase 3 clinical trial.)
Another limitation was that only two doses of lepodisiran were administered in the trial, so the effect of more doses is not known.
The study also did not show that reducing Lp(a) levels also reduces the risk of heart attacks and strokes, outside experts noted.
"A phase 3 trial testing the clinical impact of this drug is needed to see if the large reduction of Lp(a) translates into lower rates of heart attack," Bhatt said.
Nissen confirmed that the phase 3 trial to address this question is already underway.
The European Society of Cardiology and the National Lipid Association in the U.S. both recommend that all adults check their Lp(a) levels.
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"I have been checking Lp(a) levels in all patients for many years," Bhatt said.
But unlike traditional cholesterol, which doctors typically monitor over time, Nissen pointed out that lipoprotein(a) only needs to be checked once in a lifetime.
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"Whatever your level is when you're 24 years old is the level when you're 64 years old – it doesn't change, because it's genetic," he said.
"So you only need to get it once, and if you get it early in life, then you know you're at risk, and you can live your life accordingly."Original article source: Genetic cholesterol eliminated by new drug, reducing heart attack risk, study finds
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A MAHA Progress Report
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Kennedy Jr.'s Make America Healthy Again movement -- and is suddenly at the forefront of the fertility conversation in the Trump administration and the broader Republican Party. Advertisement Legislation that would fund restorative reproductive medicine has been proposed by Republicans in both the Senate and the House. Arkansas passed a law this spring that requires insurance companies in the state to cover this alternative approach to infertility. The Department of Health and Human Services will soon incorporate restorative reproductive medicine into government-funded health clinics for low-income women. And the approach has featured prominently in an intense series of conversations inside the White House, as top Trump aides have wrestled with what to recommend in a highly anticipated IVF report. 'All of a sudden it has gotten into the discussion,' said Kaylen Silverberg, a leading IVF doctor who has been consulting with the White House. While he has been in the infertility field for more than three decades, he said he had never heard the term 'restorative reproductive medicine' until four months ago. The field of restorative reproductive medicine, which dates back to the early 2000s, is grounded in the idea that infertility is a symptom of an underlying 'root cause.' Physicians who specialize in the approach analyze patients' diet and exercise habits, while helping them 'chart' their menstrual cycles, a process that can help expose certain reproductive health conditions, like endometriosis, that may lead to infertility. Practitioners treat reproductive health conditions but do not offer IVF, a posture that has prompted harsh criticism from leading medical associations. On the campaign trail, Trump did everything he could to signal his full backing for IVF, a procedure supported by 70% of Americans. 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Two Republican senators, Cindy Hyde-Smith of Mississippi and James Lankford of Oklahoma, signed on to introduce a bill that would allot federal funding for research and education on restorative reproductive medicine. But everyone involved understood that the bill had to be framed carefully, according to three people involved in the early stages of the effort. Before agreeing to introduce the legislation, Hyde-Smith wanted to make sure it would not send the message that its supporters were against IVF, according to one of the people involved. Advertisement The legislation fizzled. But it took on symbolic importance among those pushing for a new approach to infertility, prompting conversations on Capitol Hill that were intensely personal and emotional — as well as overwhelmingly female. At a briefing on the topic organized by the Senate Pro-Life Caucus and the Values Action Team last summer, several congressional staff members cried while sharing their experiences with reproductive health conditions and infertility, according to several people who attended. One person in the audience said, 'I think I have endometriosis,' after hearing the presentation, multiple people recalled. 'People came up to me after that and said: 'Can you help me? Can you help my friend?'' said Marguerite Duane, a family physician who specializes in restorative reproductive medicine and has worked with Waters and Dodson. 'There are babies that are here now because of that briefing,' she said, adding that she was referring to 'people who became patients of mine or who I connected to other RRM physicians.' When Trump promised last August to make IVF free if he became president, people at the center of the restorative reproductive medicine effort began to view their work with new urgency. They took Trump's statements as evidence of an 'education gap,' several people said: Like much of the country, he thought IVF was the only way to treat infertility. They hoped their movement would show him that there was another option, the people recalled. Advertisement Once in office, the Trump administration moved swiftly to signal its continued support for IVF, issuing an executive order in February that promised to lower costs and expand access. The order offered no specifics on how the administration would achieve that goal but promised that a detailed report with recommendations on the topic would be prepared by late May. Three months later, the report has not been released. The coalition backing restorative reproductive medicine was diverse but organized, including leading members of the MAHA movement, anti-abortion groups and representatives from the medical field. Connected through regular calls and meetings at the Heritage Foundation's Washington headquarters, led by Waters, they presented a unified vision for what the administration could do on infertility. Many who met with the White House directed Trump aides to the legislation proposed the previous year by Hyde-Smith and Lankford, according to several people at those meetings. Inside the Senate offices, staff members worked throughout the spring to prepare a new version of that bill that incorporated the priorities of each faction of the new coalition -- eager for the White House to review it before the administration issued its report, according to the person involved in early stages of the effort. The updated version of the legislation includes a greater emphasis on lifestyle changes as a solution to infertility, reflecting the priorities of MAHA leaders involved in the conversations. Senator Tammy Duckworth speaks at a press conference concerning access to IVF treatment at the Capitol in Washington, June 12, 2024. TIERNEY L. CROSS/NYT While those central to the restorative reproductive medicine effort say they see potential for bipartisanship, leading Democrats are opposed to Hyde-Smith's legislation. Sen. Tammy Duckworth, D-Ill., said she felt 'sick to my stomach' when she considered the implications of Hyde-Smith's bill. 'They want to delay and delay and delay and essentially come up with fake science and ways to delay so that people can never actually get to the IVF solution,' said Duckworth, who has had two children through IVF. Duckworth, meanwhile, has been working to expand IVF access. She recently added coverage for military families into a draft of the annual defense policy bill. It is not clear whether that provision will survive. Last year, Duckworth added similar language to the same bill, and it was stripped out by Republicans. Hyde-Smith said in a statement that she believed leaders could 'get past the politics' and 'come together in support of genuine solutions.' Her legislation, she added, 'is not in opposition to IVF; it is a separate and potentially complementary effort to address fertility concerns in a cost-effective manner that focuses on healing couples and empowering them with autonomy over how they build their families.' At a recent event on women's fertility in downtown Washington, Waters expressed optimism that the administration would prioritize the alternative approach she had been pushing for. 'This is a historic political moment,' Waters said at the event, co-hosted by the Heritage Foundation and the MAHA Institute. 'For the first time, the White House and top political leaders are directly spotlighting family formation, real reproductive health and root cause infertility care as national priorities.' This article originally appeared in .
