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. 2022 Jan 3;29(2):161–166. doi: 10.1097/MED.0000000000000706

Table 1.

Effect of bempedoic acid on low-density lipoprotein cholesterol and CRP levels in phase 2 and phase 3 trials in statin intolerant patients

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.