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New drug lowers triglycerides by 25%, no change in risk of cardiovascular disease in people with type 2 diabetes

New drug lowers triglycerides by 25%, no change in risk of cardiovascular disease in people with type 2 diabetes

Research highlights:

  • A new cholesterol drug, pemafibrate, lowered triglyceride levels in adults with type 2 diabetes, but did not reduce the risk of cardiovascular events or death.

  • The drug reduced the level of triglycerides by more than a quarter, and the patients were monitored for up to 5 years.

  • In this high-risk study population, 1 in 10 participants had a heart attack, stroke, blocked arteries that required treatment, or died of cardiovascular disease after about three years.

Embargoed until 10:02 a.m. CT/11:02 a.m. ET, Saturday, November 5, 2022.

This research is planned to be published simultaneously in the New England Journal of Medicine.

(NewMediaWire) – 05.11.2022. – CHICAGO New drug, pemafibrate, discounted triglycerides levels among adults with type 2 diabetes, yet did not reduce their cardiovascular risk, according to the latest scientific research presented today at the American Heart Association’s 2022 Scientific Sessions. The meeting, held in person in Chicago and virtually, November 5-7, 2022, is the premier global exchange of the latest scientific advances, research and evidence-based clinical practice updates in cardiovascular science.

“Triglyceride levels are commonly measured as part of routine preventive care in the U.S. Understanding the best treatment for elevated triglyceride levels has been a major challenge due to limited data supporting specific treatment options,” said study lead researcher Aruna D. Pradhan, MD, MPH, M.Sc., Associate Professor of Medicine at Harvard Medical School and Associate Physician in the Department of Preventive Medicine at Brigham and Women’s Hospital in Boston.

“We were very surprised by our findings,” Pradhan said. “Many of us in the scientific community believe that lowering triglycerides with this class of drugs in this population should have worked because high triglycerides are a pretty good indicator of who is at risk. Unfortunately, our results did not show a reduction in the rate of cardiovascular events.”

Triglycerides are fatty substances in the blood. High levels of triglycerides can increase the risk of cardiovascular disease, especially when combined with too much “bad” cholesterol, or low-density lipoprotein (LDL), and too little “good” cholesterol, or high-density lipoprotein (HDL).

Likewise, type 2 diabetes also increases the risk of cardiovascular disease. In the US, about 28 million, or more than 1 in 10 adults, have been diagnosed with type 2 diabetes. Type 2 diabetes caused more than 1.6 million deaths worldwide in 2020, according to American Heart Association 2022 Heart and Stroke Statistical Update.

It remains unclear whether lowering triglyceride levels can protect against cardiovascular disease in people with type 2 diabetes. This study, Pemafibrate to Reduce Cardiovascular Outcomes by Lowering Triglycerides in Patients With Diabetes (PROMINENT), examined the effects of pemafibrate, a new drug designed to lower triglycerides and increasing HDL levels.

Between March 2017 and September 2020, nearly 10,500 adults with high triglycerides, low HDL and type 2 diabetes were enrolled in the study in 24 countries, with one-fifth of the participants in the US. They were randomly assigned to receive pemafibrate or a placebo for three years, on average, and neither the researchers nor the study participants knew which group received the drug or the placebo.

The average age of the participants was 64 years. Just over a quarter of the study participants were female, and approximately 20% were Hispanic adults and 3% were black adults. Almost all were taking statins to lower cholesterol. At the time of the study, half of the participants had type 2 diabetes for more than 10 years.

After three years, the results show:

  • Pemafibrate reduced triglyceride levels by 26% compared to placebo. However, the drug did not appear to reduce the risk of cardiovascular disease.

  • About 1 in 10 study participants in both groups – had a heart attack, stroke, blocked arteries that required treatment, or died of cardiovascular disease within three years.

  • The drug was also associated with an increase in LDL cholesterol during the trial.

“We have to find another solution to this problem,” Pradhan said. ‚ÄúThis class of drugs is the second most commonly used group, after statins, to lower lipid levels and while the drug do not increase CVD risk study raises new questions about how best to treat patients with type 2 diabetes and hypertriglyceridemia who continue to experience a high rate of cardiovascular events of 1 in 10 to 3 years despite being on statin therapy and having fairly good LDL control . “

The study had several limitations: the drug did not lower triglycerides or raise HDL levels as much as expected, potentially due to the high rate of statin use, and blacks were underrepresented in the study.

Co-authors are Paul Ridker, MD, MPH, FAHA, and PROMINENT Study Investigators. The authors’ findings are listed in the abstract.

The study was funded by Kowa Company Limited (manufacturer of pemafibrate).

Statements and conclusions of studies presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect the policy or position of the Association. The Association makes no representations or warranties as to their accuracy or reliability. Abstracts presented at the Association’s scientific meetings are not peer-reviewed, but are curated by independent review panels and considered for their potential to contribute to the diversity of scientific issues and views discussed at the meeting. The findings are considered preliminary until they are published as a full manuscript in a peer-reviewed scientific journal.

The association receives funds primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund special programs and events of the Association. The association has strict policies to prevent these relationships from influencing scientific content. Revenues from pharmaceutical and biotechnology companies, device manufacturers and health insurance providers and overall financial information of the Association are available here.

Additional resources:

American Heart Association Scientific Sessions 2022 is the premier global exchange of the latest scientific advances, research and evidence-based clinical practice updates in cardiovascular science. The three-day meeting will feature more than 500 sessions focused on groundbreaking updates in cardiovascular basic, clinical, and population sciences to be held Saturday through Monday, May 5-7. November 2022. Thousands of leading physicians, scientists, cardiologists, advanced practice nurses and allied health professionals from around the world will meet virtually to participate in basic, clinical and population science presentations, discussions and curricula that can shape the future of cardiovascular science and medicine, including prevention and quality improvement. During the three-day meeting, attendees receive exclusive access to more than 4,000 original research presentations and can earn continuing medical education (CME), continuing education (CE), or maintenance of certification (MOC) credits for educational sessions. Join Scientific Sessions 2022 on social media via #AHA22.

About the American Heart Association

The American Heart Association is an unrelenting force for a world of longer, healthier lives. We are committed to ensuring equitable health in all communities. Through cooperation with numerous organizations, with the help of millions of volunteers, we fund innovative research, advocate for public health and share life-saving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1.

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For media inquiries and AHA professional perspective:

AHA Communications & Media Relations in Dallas: 214-706-1173; [email protected]

Bridgette McNeill: 214-706-1135; [email protected]

For public inquiries: 1-800-AHA-USA1 (242-8721)

heart.org and stroke.org





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