A new drug lowered triglycerides by 25 percent, but did not change the risk of cardiovascular disease in people with type 2 diabetes

The study is scheduled to be published simultaneously in the New England Journal of
Medicine.

According to the latest scientific research presented today at the American Heart Association's 2022 scientific meeting, a new drug called pipemophenolate lowers triglyceride levels in adults with type 2 diabetes, but does not reduce their cardiovascular risk
.
Held in Chicago on November 5-7, 2022 and conducted online, the conference is an important global exchange
for updates on the latest scientific advances, research, and evidence-based clinical practice in cardiovascular science.

"In the United States, triglyceride levels are often measured
as part of routine preventive care.
Understanding the best treatment options for elevated triglyceride levels has been a major challenge due to limited data to support specific treatment options," said Aruna D.
Pradhan, M.
D.
, M.
S.
, M.
S.
, M.
S.
, M.
S.
, Harvard Medical School, and an associate physician
in the Division of Preventive Medicine at Brigham and Women's Hospital in Boston.

Pradhan said, "We were very surprised
by what we found.
" Many in our scientific community agree that using this drug in this population should be effective in lowering triglycerides because high triglycerides are a good indicator
of who is at risk.
Unfortunately, our findings did not show a reduction
in the incidence of cardiovascular events.
”

Triglycerides are fatty substances in
the blood.
High triglyceride levels increase the risk of cardiovascular disease, especially when
there is too much "bad" cholesterol (LDL) and too little "good" cholesterol (HDL).

Similarly, type 2 diabetes increases the risk of
cardiovascular disease.
In the United States, about 28 million adults (more than one in ten) have been diagnosed with type 2 diabetes
.
According to the American Heart Association's 2022 Heart and Stroke Statistics Update, type 2 diabetes caused more than 1.
6 million deaths
worldwide in 2020.

What is unclear is whether lowering triglyceride levels can prevent cardiovascular disease
in people with type 2 diabetes.
The study, in which Parmafeld lowers cardiovascular outcomes by lowering triglycerides in diabetics (highlighting), examines the effects of Parmafeter, a new drug
designed to lower triglycerides and increase HDL levels.

Between March 2017 and September 2020, nearly 10,500 adults with high triglycerides, low HDL and type 2 diabetes from 24 countries participated in the study, with one in five participants in the United States
.
They were randomly assigned to take either parmafilate or placebo for an average of three years, and neither the researchers nor the study participants knew which group was taking either the drug or the placebo
.

The average age of participants was 64 years
.
Slightly more than a quarter of the study participants were women, about 20 percent were Hispanic adults and 3 percent were black adults
.
Almost everyone is taking statins to lower cholesterol
.
During the study period, half of the participants had type 2 diabetes for more than 10 years
.

Three years later, the results showed that:

• Compared with placebo, Pemafibrate reduced triglyceride levels
  by 26 percent.
  However, this 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, clogged artery or died of a
  condition that required treatment within three years.
  

• During the trial, the drug was also associated
  with an increase in LDL cholesterol.
  

"We need to find another solution
to this problem," Pradhan said.
This class of drugs is the second most commonly used drug after statins to lower blood lipid levels, and while the drug did not increase the risk of cardiovascular disease, the study raised new questions about what is the best way to treat patients with type 2 diabetes and hypertriglyceridemia, who continue to experience a high incidence of cardiovascular events – despite receiving statin therapy, LDL is controlled quite well, but one in ten patients still has cardiovascular events
after 3 years.
”

The study had several limitations: The drug did not lower triglycerides or increase HDL levels as expected, possibly due to the high rate of statin use and the underrepresentation of black adults in the
study.

Co-author is Paul Ridker, MD, Master of Public Health, Federal Medical Association and Distinguished Research Investigator
.
The author's disclosures are listed
in the abstract.

The study was funded
by Kova Ltd.
, the manufacturer of Pemafibrate.

Research statements and conclusions presented at the American Heart Association Scientific Meeting are the views of the study authors only and do not necessarily reflect the policies or positions of
the Association.
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