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Background: Current guidelines support aggressive LDL-C lowering in patients with diabetes. We assessed the efficacy and safety of BA, a first-in-class ATP-citrate lyase inhibitor, by baseline glycemic status (diabetes, prediabetes, or normoglycemia) in patients with hypercholesterolemia.

Methods: Four phase 3 trials randomized 3623 patients on stable lipid-lowering therapy to receive BA 180 mg or placebo (PBO) once daily for 12 to 52 weeks. Studies were grouped into 2 pools by enrollment criteria (52-weeks in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia vs. 12-or 24-weeks in patients with statin intolerance). Primary efficacy endpoint was percent change from baseline to week 12 in LDL-C.

Results: In both pools, BA significantly lowered LDL-C compared with PBO, regardless of baseline glycemic status (all P<. 001; Table). Significant reductions with BA …