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- Triglycerides are a type of blood fat.
- High levels of triglycerides are associated with increased risk of heart disease.
- Two recent studies found that injectable experimental drugs significantly lower levels.
- The drug, called olearsen, may be particularly useful for people with rare conditions that cause elevated triglyceride levels.
Two recent studies published in New England Medical Journalstudied a new drug called olearsen, which is designed to lower levels of “bad” fats in the blood called triglycerides.
Both studies found that olearsen significantly lowered triglyceride levels.
Olezarsen, made by Ionis Pharmaceuticals, also lowered levels of other blood fats associated with disease risk.
The drug may soon be approved for people with a rare condition called familial chylomicronemia syndrome, the people most likely to benefit from it.
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Once there, they travel to the muscles to be used for energy or to the liver and fat cells for storage.
Triglycerides are essential for health, and high levels are associated with health.
When levels of triglycerides are particularly high, doctors call it hypertriglyceridemia. In severe cases, this can lead to:
Familial chylomicronemia syndrome is a rare condition that causes elevated triglyceride levels. People living with this condition live egalitarian lives.
Estimation
Some of these people respond well to drugs such as statins. However, treatments that directly affect triglycerides are
Certain lifestyle interventions, such as a healthy diet, regular physical activity, and smoking cessation, can also help lower triglyceride levels.
However, said Kenneth Feingold, MD, a professor emeritus at the University of California, San Francisco, who was not involved in the study. Today’s medical news For people with familial chylomicronemia syndrome, it is “very difficult to make lifestyle changes.” They must follow an extremely low-fat diet. ”
“Thus, it is very difficult to satisfactorily lower triglyceride levels through lifestyle.” While some people experience success, “in other patients, elevated triglyceride levels are primarily due to genetic factors.” , and lifestyle changes are only moderately effective, he said.
The first study recruited 154 participants with severe or moderate hypertriglyceridemia and increased cardiovascular risk.
They received monthly olearsen injections or a placebo. Patients who received olearsen were further divided into two groups, with the first group receiving a dose of 50 milligrams (mg) and the second group receiving a dose of 80 mg.
Compared to placebo, people taking olearsen reduced triglyceride levels by 49.3% (50 g group) and 53.1% (80 mg group).
We also observed significant reductions in other blood fats associated with cardiovascular risk, namely APOC3, apolipoprotein B, and non-HDL cholesterol.
In the second study, scientists recruited 66 patients with familial chylomicronemia syndrome. Participants were divided into three groups and received either a placebo, 50 mg of olearsen every four weeks, or 80 mg of olearsen every four weeks. The study was conducted for 53 weeks.
After six months, the scientists found that the 80 mg dose significantly reduced triglyceride levels, but the 50 mg dose did not.
Importantly, acute pancreatitis was also reduced.
MNT I contacted Ionis Pharmaceuticals. They explained that he was the only patient in the 80 mg group. [â¦] Compared to 11 people in the placebo group who experienced an episode of acute pancreatitis, this important finding supports the potential for olearsen to become a standard of care for patients with: [familial chylomicronemia syndrome].
MNT They contacted a number of experts, none of whom were involved in the study, but all of whom had similar ideas about the study.
For example, Chen-Han Chen, M.D., a board-certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, Calif., said: MNT “Olesarsen appears to be much more effective than current treatments at lowering triglyceride levels in patients with significantly elevated triglyceride levels.”
Gerald Watts, professor of internal medicine at the University of Western Australia Winthrop, wrote an editorial about two new studies.
MNT I asked if the drug had any chance of being approved. Watts said he expects olearsen to be approved soon for familial chylomicronemia syndrome, but further studies are needed in people with moderate to high triglycerides.
Although oleersen may be effective in people with elevated triglycerides, most experts believe it is primarily used in people with familial chylomicronemia syndrome.
“For these people,” Feingold explained, “there are currently no effective medications in the United States to lower triglyceride levels and reduce the risk of pancreatitis, a rare disease that causes significant morbidity.” There is a great need for drugs to treat this.”
He called the drug “a major advance in the treatment of patients with this disease.”
MNT We contacted Dr. Joanna Gouni-Bertholt, Professor of Internal Medicine and Director of the Lipid Research Clinic at the University of Cologne in Germany. Similarly, she believes that olearsen “will definitely be a great addition to the treatment of familial chylomicronemia syndrome.”
These results are particularly interesting for people with familial chylomicronemia syndrome, but the overall benefit for people with moderately high triglycerides is less clear.
“For patients with moderate hypertriglyceridemia, the reduction in triglycerides was surprising and superior to other drugs. Remarkably, olearsen not only lowers triglyceride levels; , also reduced non-HDL cholesterol and apolipoprotein B levels,” Feingold said.
However, he added the following warning: “Previous studies using other triglyceride-lowering drugs in patients receiving statin therapy have failed to demonstrate that lowering triglyceride levels reduces the risk of cardiovascular disease. ”
Therefore, before olearsen can be recommended for these people, Feingold says, “studies are needed to demonstrate that treatment with this drug reduces the risk of developing atherosclerosis and cardiovascular events.” Stated.
Cheng agreed, saying, “Long-term safety and efficacy studies will be needed before this treatment becomes mainstream.”
Feingold also called for longer, larger studies to confirm the drug’s safety. He explained that there is evidence to suggest that olearsen “may affect platelets in certain patients.”
Watts had the same idea. “Because trial participants were primarily adult Caucasians and the duration of the trial was relatively short, additional long-term trials that include people with non-European ancestry are needed,” he wrote in an editorial. .
But overall, he believes the drug will be helpful. “[C]”Current treatments for severely elevated triglyceride levels are ineffective and there is an ongoing risk of life-threatening acute pancreatitis, a gap that olearsen likely fills,” Watts said.
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