Research Highlights:
- A new cholesterol drug, pemafibrate, reduced triglyceride levels among adults with type 2 diabetes, but there was no reduction in the risk of cardiovascular events or death.
- The drug reduced triglyceride levels by more than a quarter, and the patients were followed 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.
This research is scheduled to be published simultaneously in the New England Journal of Medicine.
CHICAGO, Nov. 5, 2022 — A new drug, pemafibrate, lowered triglyceride levels among adults with type 2 diabetes but did not lower their cardiovascular risk, according to state-of-the-art research presented today at the sessions American Heart Association Scientific Conference 2022. Held in person in Chicago and virtually, November 5-7, 2022, the meeting is a premier global exchange of the latest scientific advances, research and updates on evidence-based clinical practice in cardiovascular science.
“Triglyceride levels are routinely measured as part of routine preventive care in the U.S. Understanding the best course of treatment for elevated triglyceride levels has been a significant challenge because of limited data to support specific treatment options ” said the study’s principal investigator, Aruna D. Pradhan. , MD, MPH, M.Sc., Associate Professor of Medicine at Harvard Medical School and Associate Physician in the Division 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 thought that lowering triglycerides with this class of drugs in this population should have worked because high triglycerides are a good marker of who is at risk. Unfortunately, our results showed no reduction in rates of cardiovascular events.”
Triglycerides are a fatty substance in the blood. High triglyceride levels can increase the risk of cardiovascular disease, especially in combination 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 United States, 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 the Update American Heart and Stroke Association 2022 statistics.
What was not clear was whether reducing triglyceride levels can protect against cardiovascular disease among people with type 2 diabetes. This study, Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT), looked at the effects of pemafibrate, a new drug designed to lower triglycerides and raise 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 participants in the US. They were randomly assigned to receive pemafibrate or a placebo for an average of three years, and neither the researchers nor the study participants knew which group was getting the drug or the placebo.
The average age of the participants was 64 years. Just over a quarter of the study participants were women, and approximately 20% were Hispanic adults and 3% were black adults. Almost all were taking a statin 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 indicate:
- Pemafibrate reduced triglyceride levels by 26% compared to placebo. However, the drug does 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 trials.
“We have to find another solution to this problem,” Pradhan said. “This class of medication is the second most commonly used group, after statins, to lower lipid levels, and although the medication did not increase the risk of CVD, the 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: 1 in 10 by 3 years despite being on statin therapy and having fairly good LDL control.”
The study had several limitations: the medication did not lower triglycerides or raise HDL levels as much as expected, potentially due to the high proportion of statin use, and black adults were underrepresented in the study
Co-authors are Paul Ridker, MD, MPH, FAHA, and PROMINENT Study Investigators. Author disclosures 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 representation or warranty as to its accuracy or reliability. Abstracts presented at the Association’s scientific meetings are not peer-reviewed, but rather are curated by independent review panels and considered based on their potential to add to the diversity of scientific issues and views addressed at the meeting. The findings are considered preliminary until they are published as a full manuscript in a peer-reviewed scientific journal.
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