The New England Journal of Medicine has potentially good news this month for patients struggling with elevated LDL cholesterol levels and are sensitive to the side effects of statin drugs (of which there are many). It concerns a new medication that has been under investigation for the treatment of high cholesterol since December of 2016, known as bempedoic acid.
The most recent clinical trials have demonstrated this novel treatment to be as effective as statin drugs – but does not cause the same side effects. Lead author of the study, Dr. Kausik Ray, said, “Bempedoic acid could be another addition to the arsenal of cholesterol-lowering treatments available to patients.”
In the U.S., approximately 20% of people between the ages of 40 and 75 are prescribed one or more statin drugs in order to control their levels of LDL, or “bad” cholesterol – which, untreated, can lead to cardiovascular disease and increase the chances of suffering a stroke. The most successful drug of the statin class has been Lipitor (atorvastatin). At one point, Lipitor was the best-selling prescription drug in the history of pharmaceuticals, making $12.4 billion in sales revenue for its manufacturer, Pfizer.
While statins are highly effective at controlling LDL cholesterol levels, they are associated with a number of unpleasant side effects. The most severe and common side effect is diabetes. A 2016 study found that among 10,000 patients taking statin drugs, 75 will develop type 2 diabetes within five years. Other side effects include muscle pain, brain hemorrhage, and liver damage, in addition to nerve damage and sexual dysfunction. Side effects are experienced by between 10 and 15 percent of patients. Many simply stop taking them as a result.
According to Dr. Ray, a cardiologist and professor at Imperial College in London, U.K., bempedoic acid operates through the same metabolic pathway as statin drugs but ends up at a different site. The difference is that while statins slow down the action of the enzyme involved in the production of cholesterol, bempedoic acid blocks it altogether. Furthermore, once the new medication is active in the liver, it cannot escape and enter muscle tissue. This, according to Ray, lowers the chances that a patient will experience side effects.
2,230 subjects participated in the clinical trials, primarily white males with an average age of 66 and who had a history of cardiovascular disease. The study was funded by the new drug’s manufacturer, Espirion Therapeutics. The Michigan-based pharmaceutical firm is seeking approval from the U.S. Food and Drug Administration and the European Medicines Agency. Should approval be granted, it is expected that bempedoic acid will be available by prescription sometime in 2020.