- The FDA has approved two new non-statin drugs that clinical trials indicated can help reduce high cholesterol.
- Nexletol and Nexlizet can be used with statins that have moderate or minimal side effects.
- The two new drugs have some side effects different from those associated with statins.
The last time the Food and Drug Administration (FDA) approved a new non-statin cholesterol drug, Saddam Hussein still ran Iraq and ’N Sync remained a pop culture powerhouse.
The pharmaceutical industry has been relatively slow in giving medical professionals and consumers new tools to fight high cholesterol, which can lead to heart disease and other serious health conditions.
But that changed in the past couple weeks.
In late February, the FDA approved a pair of new drugs that work differently than statins, the typical medication used to treat high cholesterol.
“The cholesterol industry has remained relatively stagnant with oral consumables for several decades,” Ross Goetz, PharmD, a pharmacist for HealthWarehouse Pharmacy, told Healthline.
“Cholesterol medications have worked their way into significance for treatment outside of cholesterol therapy alone, yet development has not expanded,” he said.
Nexletol was approved by the FDA on Feb. 21, and Nexlizet was approved Feb. 26. They’re produced by Michigan-based Esperion Therapeutics.
Both treatments are taken orally once a day to reduce LDL cholesterol. They contain bempedoic acid.
“The difference between Nexletol and Nexlizet is the latter contains ezetimibe — a cholesterol-lowering agent that has been available for many years that works by preventing the absorption of cholesterol from foods,” Dr. Richard C. Becker, a professor of cardiovascular health and diseases at University of Cincinnati in Ohio, told Healthline.
“While statins have been available for decades and used to treat millions of people, bempedoic acid is a new chemical entity drug that has been tested in only several thousand people to date,” he added.
It’s recommended the new drugs be taken with a statin that has moderate or minimal side effects.
But these new drugs also have some side effects of their own.
Whether they’re the right drug for a particular person may depend on a person’s tolerance for statins and how effective those medications have been.
Cholesterol is a waxy, fat-like substance essential for the human body. It helps form cells, hormones, bile acids, and vitamin D.
But if low-density lipoprotein (LDL), or the “bad” kind of cholesterol, builds up in human arteries, blood flow and oxygen can become restricted.
Introduced in the 1980s, statins are a class of drugs prescribed to lower cholesterol levels in the blood.
Studies show that statins can
With common brands names like Lipitor, Crestor, Zocor, and Lescol, statins can also reduce the chance of recurrent strokes or heart attacks.
Humans also get cholesterol from food, which is why doctors recommend people with high cholesterol exercise, abstain from smoking, and follow a healthy diet.
“Despite the measure, many patients will still have high LDL cholesterol,” Dr. Allan Stewart, the medical director for HCA East Florida’s Miami-Dade cardiovascular surgery program, told Healthline.
“Statins are an effective class of medicine for lowering blood levels of cholesterol. Unfortunately, they have a high incidence of side effects that limit long-term compliance with the treatment, including headaches, difficulty sleeping, flushing of the skin, and muscle cramps,” he explained.
In other words, statins don’t work for everyone.
“While the recipe for cholesterol medication therapy is often straightforward, some patients are left out due to intolerance,” Goetz said. “Statins have long been considered the cholesterol therapy, but what about those with statin intolerance? Now they have an option.”
The new non-statin drugs also have reported side effects.
They include the risk of excessive uric acid in the blood (hyperuricemia), which can contribute to kidney stones or gout, and risk of tendon rupture, according to Dr. Laxmi Mehta, a professor of medicine at The Ohio State University.
Mehta told Healthline that other side effects include “respiratory infections, anemia, and elevated liver enzymes.”
Nexletol and Nexlizet are recommended to be taken with statins, if possible, based on the user’s statin tolerance.
According to a press release from Esperion, a phase III clinical trial of Nexletol “provided an average of 18 percent placebo corrected LDL-C lowering” in people who also took a statin.
Nexlizet can be taken with ezetimibe, the last non-statin pill the FDA approved in 2002.
According to an Esperion press release, Nexlizet “lowered LDL-C by a mean of 38 percent compared to a placebo when added on to moderately tolerated statins” in a phase III clinical trial.
“While (the two new drugs) wouldn’t likely be used together, both work to accomplish the LDL-C lowering goals,” an Esperion representative told Healthline. “As far as what treatment someone would use, some physicians will want to use one or another, depending on what’s right for their patients.”
Stewart says that even with a variety of drugs available, the battle against high cholesterol starts with one thing.
“Lifestyle modification remains the mainstay of treatment,” he said.