Need a Statin Rx but Cannot Take One? New Data for Nexlotol as a 2nd Choice

Cholesterol lowering (LDL-C) through lifestyle, supplements and prescription medications is necessary in many patients with proven atherosclerosis like a prior heart attacks or a high coronary calcium score on CT imaging. Many patients cannot tolerate a statin prescription due to aching, liver enzyme rises, brain fog and other issues.

A new study gives hope that there are effective alternatives. Bempedoic acid, an ATP citrate lyase inhibitor, known by the brand name Nexlotol, was released a few years ago and reduces low-density lipoprotein (LDL) cholesterol levels.

While it is associated with a low incidence of muscle-related adverse events its effects on cardiovascular outcomes remain uncertain.

A large study was just published establishing its benefit on outcomes. 

STUDY METHODS

The researchers conducted a double-blind, randomized, placebo-controlled trial involving patients who were unable or unwilling to take statins owing to unacceptable adverse effects (“statin-intolerant” patients) and had, or were at high risk for, cardiovascular disease. The patients were assigned to receive oral bempedoic acid (Nexlotol), 180 mg daily, or placebo. The primary end point was a four-component composite of major adverse cardiovascular events, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.

STUDY RESULTS

A total of 13,970 patients underwent randomization; 6992 were assigned to the bempedoic acid group and 6978 to the placebo group. The duration of follow-up was 40.6 months.

The mean LDL cholesterol level at baseline was 139.0 mg per deciliter in both groups, and after 6 months, the reduction in the level was greater with bempedoic acid than with placebo by 29.2 mg per deciliter; the observed difference in the percent reductions was 21.1 percentage points in favor of bempedoic acid.

The incidence of a primary end-point event was significantly lower with bempedoic acid than with placebo (819 patients [11.7%] vs. 927 [13.3%].

The incidences of a composite of death from cardiovascular causes, nonfatal stroke, or nonfatal myocardial infarction (575 [8.2%] vs. 663 [9.5%]; fatal or nonfatal myocardial infarction (261 [3.7%] vs. 334 [4.8%], and coronary revascularization (435 [6.2%] vs. 529 [7.6%] all favored the bempedoic acid treatment.

Bempedoic acid had no significant effects on fatal or nonfatal stroke, death from cardiovascular causes, and death from any cause. The incidences of gout and cholelithiasis were higher with bempedoic acid than with placebo (3.1% vs. 2.1% and 2.2% vs. 1.2%, respectively), as were the incidences of small increases in serum creatinine, uric acid, and hepatic-enzyme levels.

CONCLUSIONS

Among statin-intolerant patients, and in those that refuse statins, treatment with bempedoic acid (Nexletol) was associated with a lower risk of major adverse cardiovascular events (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization). 

At the Kahn Center, we have used Nexlotol, and the combination with ezetimibe called Nexlizet, often, but have trouble getting insurance authorization at a price patients can afford as it is a name brand medication. Some patients are paying several hundreds of dollars a month.