Incidence of most common AEs generally comparable to placebo1
Based on a pooled analysis of 2 clinical studies of up to 52 weeks in duration.1
AEs occurring in ≥2% of patients WITH ASCVD and HeFH using NEXLETOL (and more frequently than placebo)1
|Adverse reaction||NEXLETOL* (n=2,009)||Placebo (n=999)|
|Upper respiratory tract infection||4.5%||4.0%|
|Abdominal pain or discomfort‡||3.1%||2.2%|
|Pain in extremity||3.0%||1.7%|
|Elevated liver enzymes§||2.1%||0.8%|
*Patients received NEXLETOL 180 mg orally once daily plus maximally tolerated statin therapy alone or in combination with other lipid-lowering therapies.
†Included patients with hyperuricemia and patients with increased blood uric acid.
‡Included patients with abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort.
§Included patients with increased AST, increased ALT, increased hepatic enzyme, and increased liver function test.
Discontinuation rates due to AEs1: NEXLETOL 11%; placebo 8%
Incidence of skeletal muscle AEs comparable to placebo1
Muscle spasms: NEXLETOL 3.6%; placebo 2.3%
AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; AST=aspartate aminotransferase; ALT=alanine aminotransferase.
Reference: 1. NEXLETOL. Prescribing information. ESPERION Therapeutics, Inc.; 2020.