Incidence of most common AEs generally comparable to placebo1
Based on a 4-arm, 12-week, randomized, double-blind, placebo-controlled, parallel group, factorial trial.2
AEs OCCURRING IN ≥3% OF PATIENTS IN THE NEXLIZET GROUP1
|Urinary tract infection||5.9%||3.4%||2.3%||2.4%|
|Upper respiratory tract infection||3.5%||1.1%||0.0%||0.0%|
|Blood creatinine increased||3.5%||1.1%||0.0%||0.0%|
|Blood uric acid increased||3.5%||1.1%||0.0%||0.0%|
Discontinuation rates due to AEs2: NEXLIZET 8%; NEXLETOL 10%; ezetimibe 12%; placebo 5%
- Most common reason for NEXLIZET treatment discontinuation was oral discomfort (NEXLIZET 2%; placebo 0%)
Incidence of AEs occurring in pivotal trials of NEXLETOL or ezetimibe that did not occur at a significant rate in the pivotal trial of NEXLIZET above2
- Pivotal trials for NEXLETOL: AEs occurring in ≥2% of patients with ASCVD and HeFH using NEXLETOL* (and more frequently than placebo) included muscle spasms (NEXLETOL 3.6%; placebo 2.3%), hyperuricemia† (3.5%; 1.1%), abdominal pain or discomfort‡ (3.1%; 2.2%), pain in extremity (3.0%; 1.7%), anemia (2.8%; 1.9%), and elevated liver enzymes§ (2.1%; 0.8%). For more information, please see NEXLETOL safety
- Pivotal trials for ezetimibe: AEs occurring in ≥2% of patients using ezetimibe (and at an incidence greater than placebo), regardless of causality, included diarrhea (ezetimibe 4.1%; placebo 3.7%), arthralgia (3.0%; 2.2%), sinusitis (2.8%; 2.2%), pain in extremity (2.7%; 2.5%), and influenza (2.0%; 1.5%)
*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.
AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; AST=aspartate aminotransferase; ALT=alanine aminotransferase.
Reference: 1. Data on file. CSR 1002-053. January 2019. 2. NEXLIZET. Prescribing information. ESPERION Therapeutics, Inc.; 2020.