Table 1.
Study | Study design | Inclusion criteria | Primary outcomes | Treatment duration | Study groups | N patients | Percent change in LDL-C from baseline | Percent change in CRP from baseline |
Thompson, 2015 Phase 2 | Randomized double-blind placebo-controlled | Statin-intolerant LDL-C 100–220 mg/dl | Percent change in LDL-C | 8 weeks | Increasing doses of BA Placebo | 37 19 | −32% −3.3% | −42% 0 |
Thompson, 2016 Phase 2b | Randomized Double-blind Placebo-controlled | 18–80y LDL-C ≥ 130–220 mg/dl | Percent change in LDL-C | 12 weeks | BA 120 mg BA 180 mg BA 120 mg + Eze 10 mg BA 180 mg + Eze 10 mg Eze 10 mg | 99 97 22 24 98 | −27.5% −30.1% −43.1% −47.7% −21.2% | −30.1% −40.2% −38.1% −25.6% −10.5% |
Laufs, 2019 Phase 3 | Randomized Double-blind Placebo-controlled Parallel group | Statin intolerant LDL-C at least 130 mg/dl (primary prevention) or LDL-C at least 100 mg/dl (secondary prevention or HeFH) | Percent change in LDL-C | 24 weeks | BA 180 mg Placebo | 234 111 | −23.6% −1.3% | −25.4% +2.7% |
Ballantyne, 2018 Phase 3 | Randomized Double-blind Placebo-controlled Parallel group | Statin intolerant LDL-C at least 100 mg/dl | Percent change in LDL-C | 4-week run-in with Eze 10 mg 12 weeks | BA 180 mg Placebo | 181 88 | −23.5% +5.0% | −32.5% +2.1% |
BA, bempedoic acid; Eze: ezetimibe; CRP, high sensitivity C-reactive protein; LDL-C, low density lipoprotein cholesterol.