Cholesterol-Lowering Drug Decreases Risk of Heart Disease Death in Patients With Diabetes

Patients with risk factors for coronary artery disease who have high cholesterol, particularly those with diabetes, should be treated with a nonstatin cholesterol-lowering drug, according to a study presented as a poster at the 83rd Scientific Sessions of the American Diabetes Association in San Diego, California. It was also simultaneously published in JAMA.

Statins are a commonly used cholesterol-lowering medicine that can help reduce the amount of low-density lipoprotein (LDL-C), or “bad cholesterol,” in the blood. However, data show that approximately 1 in every 10 to 12 patients have a statin intolerance (SI). SI is linked with diabetes because statins increase blood sugar due to the medicine preventing insulin from processing blood sugar properly. As a result, the investigators noted, SI can put people at higher risk of developing type 2 diabetes.

Researchers aimed to assess the effects of bempedoic acid, a novel, nonstatin drug used to lower LDL-C, on cardiovascular outcomes in statin-intolerant patients. The masked, randomized CLEAR Outcomes trial comprised 13,970 statin-intolerant patients, including 4206 patients (mean age, 68 years; 67% with diabetes; 59% female) with risk factors of heart disease but without a prior health-related event. The primary efficacy outcome of interest was defined as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.

A Critical Early Prevention Measure

The study showed a 22% reduction in LDL-C associated with bempedoic acid use. Using the treatment over the duration of 40 months was correlated with a significant risk reduction for the primary endpoint (5.3% vs 7.6%, equating to an adjusted hazard ratio of 0.70; 95% CI, 0.55-0.89; P=.002). The results represent a 30% reduction in major heart-related events. A 39% reduction in the risk of death from heart disease was also observed.

“We know early prevention measures are critical to slowing the progression of heart disease, especially for people with comorbidities like diabetes,” said lead author Steven E. Nissen, MD, chief academic officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, in a press release. “Unfortunately, less than half of patients in the United States similar to the study patient population are being treated with cholesterol-lowering drugs—leaving them at risk. The results presented today are a wake-up call for the clinical community that patients with risk factors for coronary disease and high cholesterol, particularly those with diabetes, should be treated with a cholesterol-lowering drug.”