Treatment with apabetalone – the first in class bromodomain and extra-terminal (BET) inhibitor – in patients who had acute coronary syndrome (ACS) with type 2 diabetes and low HDL-C "shows promise," according to results of the BETonMACE trial presented Nov. 16 during AHA 2019 in Philadelphia, PA.

Kausik K. Ray, MD, FACC, et al., looked at 2,425 patients at 195 sites in 13 countries following ACS, who have type 2 diabetes and low HDL-C: ≤40 mg/dl for men and ≤45 mg/dl for women, for a median follow-up of 26 months. Patients were randomized to receive 100 mg of apabetalone orally twice daily vs. placebo on top of guideline-recommended standard of care "including intensive or maximum-tolerated treatment with atorvastatin or rosuvastatin."

Results showed that the primary endpoint – time to the first occurrence of cardiovascular death, non-fatal myocardial infarction, or stroke – was 10.3 percent in the apabetalone group vs. 12.4 percent in the placebo group. Further, key secondary endpoints of first occurrence of primary end point or hospitalization for unstable angina or urgent or emergency revascularization procedure was 11.9 percent in the apabetalone group vs. 13.8 percent in the placebo group.

In general, Ray and colleagues observed that "apabetalone was generally well tolerated with an overall incidence of adverse events similar to that in the placebo group. However, discontinuation of treatment due to elevated liver function tests was more frequent with apabetalone." They also noted that apabetalone "did not have a significant effect on incidence of the primary endpoint," with the observed rate in the placebo group somewhat lower than anticipated (9.7 percent vs. 10.5 percent) at 18 months. Additionally "the study was powered on a 30 percent reduction in risk of primary endpoint, and was underpowered to detect a smaller difference in events," they said.

Looking ahead, Ray, et al., recommend further studies on the approach.

Keywords: AHA19, AHA Annual Scientific Sessions, Acute Coronary Syndrome, Metabolic Syndrome, Dyslipidemias

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