Pemafibrate Lowers Triglyceride Levels Among Adults with Type 2 Diabetes, Does Not Decrease Risk of Cardiovascular Events, Death
Approximately 10% of patients in trial experienced a heart attack, stroke, blocked arteries requiring treatment, or death from cardiovascular disease.
Pemafibrate, a relatively new cholesterol medication, was found to significantly lower triglyceride levels among adults with type 2 diabetes, although it had no impact on the risk of cardiovascular events or death. These study results were presented at the American Heart Association 2022 Scientific Sessions.1
Triglycerides are a fatty substance found in the blood and high levels of them can heighten the risk of cardiovascular disease, according to presenter Aruna Pradhan, MD, MPH, MSc, who was lead investigator in the PROMINENT trial. This risk is particularly heightened when high triglyceride levels are found in conjunction with high low-density lipoprotein (LDL) and low high-density lipoprotein (HDL) levels. Type 2 diabetes also increases the risk of cardiovascular disease.1
“Triglyceride levels are commonly measured as part of routine preventive care in the [United States],” Pradhan said in a press release. “Understanding the best course of treatment for elevated triglyceride levels has been a major challenge due to limited data to support specific treatment options.”2
Despite the known risks associated with cardiovascular disease, investigators did not know whether lowering triglyceride levels could protect against cardiovascular disease among patients with type 2 diabetes.1
In the trial, nearly 10,500 adults with high triglyceride levels, low HDL levels, and type 2 diabetes were enrolled in the study. Study sites spanned 24 countries and one-fifth of the participants were in the United States. They were randomly assigned to receive either pemafibrate or placebo for an average of 3 years.1
Participants had an average age of 64 years, slightly more than 25% were women, approximately 20% were Hispanic, and 3% were Black. Nearly all participants were receiving a statin to lower cholesterol and at the time of the study, and 50% had type 2 diabetes for more than 10 years.1
After 3 years of treatment, the investigators found that pemafibrate reduced triglyceride levels by 26% compared to placebo; however, there was no apparent reduction in the risk of cardiovascular disease. Approximately 10% of patients in both groups experienced a heart attack, stroke, blocked arteries requiring treatment, or death from cardiovascular disease during the 3 years. Pemafibrate was also associated with an increase in LDL cholesterol levels during the trial.1
“We need to find another solution to this problem,” Pradhan said in the press release. “This medication class is the second most commonly used group, after statins, to lower lipid levels and while the medication did not increase cardiovascular risk, the study raises new questions about the best way to treat patients with type 2 diabetes and hypertriglyceridemia who continue to experience a high rate of cardiovascular events.”2
Pradhan did note several limitations of the trial, including that the medication did not lower triglycerides or increase high-density lipoprotein levels as significantly as investigators expected. This could potentially be due to the high proportion of statin use. Furthermore, Black adults were underrepresented in the trial.1
“We were very surprised by our findings,” Pradhan said in the press release. “Many of us in the scientific community thought lowering triglycerides with this medication class in this population should have worked because high triglycerides are a pretty good marker of who’s at risk. Unfortunately, our results showed no lowering of cardiovascular event rates.”2
- Pradhan, A. A randomized trial of pemafibrate for triglyceride reduction in the prevention of cardiovascular disease. Presented at: American Heart Association 2022 Scientific Sessions. November 5, 2022.
- New medicine reduces triglyceride by 25%, no change in CVD risk in people with type 2 diabetes. News release. American Heart Association; November 5, 2022. https://newsroom.heart.org/news/new-medicine-reduces-triglyceride-by-25-no-change-in-cvd-risk-in-people-with-type-2-diabetes