Trial Explores Use of Bempedoic Acid to Reduce LDL Cholesterol
MARCH 13, 2019
Kausik Ray, MD
According to the international team of investigators to conduct the study, little is known about the long-term impacts of bempedoic acid as a treatment for elevated cholesterol levels in regard to both safety and efficacy. As such, outcomes for both benefits were assessed in the trial.
Kausik Ray, MD, a professor of Public Health at the School of Public Health of Imperial College, London, told MD Magazine®the biggest surprise was that the drug—which works through the same pathway as statins—was capable of reducing LDL-C by another 18% without muscle or liver issues due to high-dose statin regimen.
“When you double statin doses, you only get 6% lowering in LDL,” Ray explained. “Safety is limited by the top doses of statins. So, to get the amount of extra lowering with no liver and muscle adverse events was the most novel and reassuring finding.”
Similar studies previously examined smaller groups of 250 patients through 12 weeks, whereas Ray and colleagues included 2230 patients over the course of a year. Investigators randomized patients 2:1 ratio to receive bempedoic acid or placebo. Of the 2230 patients that participated, 1488 of them received therapy, while 742 received placebo.
Patients were given bempedoic acid, along with maximally tolerated statin therapy, and results were measured at the 12-week mark to determine the impact of the bempedoic acid on LDL-C levels. Investigators examined the number of adverse events through the duration of the study in both groups to further determine the safety of bempedoic acid as a treatment method.
Those who received therapy exhibited a greater decrease in LDL-C than those who received the placebo. Patients that were part of the bempedoic group saw a 16.5% decrease in LDL-C levels at the 12-week mark than when compared to baseline statistics. The number of adverse events and serious adverse events among patients between the bempedoic group and the placebo group were similar, falling within half of a percent of each other in both instances.
However, patients who received bempedoic acid during the study saw a higher number of incidents leading to discontinuation of the regime than their counterparts, with 162 patients in the bempedoic group versus 53 in the placebo group. The bempedoic acid group also exhibited more instances of gout (n= 18) than the placebo group (2).
Results indicated that bempedoic acid, when added to maximally tolerated statin therapy, proved to be a more effective method for treating elevated LDL-C in patients versus placebo.
Ray noted the results of the trial are promising for those who may not be able to tolerate or afford other treatment methods for LDL-C reduction.
“There are patients who don’t get to cholesterol goals or can’t tolerate statins,” Ray said. “PCSK9 inhibitors are expensive and not always reimbursed, so many people are left with higher cholesterol levels than ideal.”
Common cholesterol therapies such as ezetimibe are capable of lowering LDL-C by about 20%, he noted. For some patients, adding bempedoic acid to a regimen that includes monotherapy ezetimibe or also in combination with statins could offer them a “new hope that they currently don’t have.”
The study, “Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol,” was published online in the New England Journal of Medicine.