US regulators have approved a new type of cholesterol-lowering drug aimed at millions of people who can't tolerate - or don't get enough help from - widely used statin pills.
The Food and Drug Administration approved Esperion Therapeutics Inc.'s Nexletolfor people genetically predisposed to have sky-high cholesterol and people who have heart disease and need to further lower their bad cholesterol.
The daily pill is to be taken in conjunction with a healthy diet and the highest statin dose patients can handle, the FDA said.
High LDL, or bad cholesterol, is one of the top risks for heart attacks and other problems. Studies showed that Nexletol could lower LDL by about 25 per cent when taken alone and by an additional 18 per cent when combined with a statin.
"This is a nice alternative" to statins, but those medicines will still be the first choice, said Dr. Christie Ballantyne, Baylor College of Medicine's cardiology chief. He consults for Esperion and helped test the drug.
Millions of people take cheap, generic statins, but the medicines don't lower LDL cholesterol enough for many patients and others experience side effects such as muscle pain.
It works in the liver by blocking an enzyme needed to make LDL. Statins also block cholesterol production in the liver, but in a different way, so the drugs together can reduce LDL more.
The new drug "would be valuable to add to treatment" for patients who can't get their LDL down enough with existing drugs or can't afford the injected ones, Duke Heart Center co-director Dr. Manesh Patel said.
Patel, who was not involved in the research, estimated 10 per cent to 15 per cent of his patients might be eligible for Nexletol.
In company-funded studies, common Nexletol side effects included high blood pressure and muscle and joint pain. Serious side effects include tendon rupture. Women who are pregnant or breast-feeding should not take Nexletol because of possible harm to the baby, the FDA said.
In one study of more than 2200 patients, there were several more deaths from heart problems in the Nexletol group than among those given placebo pills. Patel said that's likely just a random imbalance, not a big concern.
The company has a large study underway to see whether Nexletol can lower the risk of heart attacks and other problems, not just cholesterol. Results are expected late in 2022.
Australian Associated Press