Abstract 17086: Alirocumab LDL-C-Lowering Efficacy in Patients With Moderate CKD

• Published in: Circulation (New York, N.Y.) Vol. 132; no. Suppl_3 Suppl 3; p. A17086
• Main Authors: Toth, Peter P, Cannon, Christopher P, Kastelein, John J, Colhoun, Helen M, Koren, Andrew, Louie, Michael J, Asset, Gaëlle, Rader, Daniel J
• Format: Journal Article
• Language: English
• Published: by the American College of Cardiology Foundation and the American Heart Association, Inc 10.11.2015
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/circ.132.suppl_3.17086

BackgroundPatients with chronic kidney disease (CKD) are at increased risk of premature cardiovascular disease. Many of these patients require adjuvant lipid-lowering therapy because of dosing restrictions of some statins in patients with CKD.ObjectiveTo determine LDL-C lowering efficacy and safety of the PCSK9 inhibitor alirocumab (ALI) in patients with hypercholesterolemia and with or without moderate CKD.MethodsThis analysis included data from 10 ODYSSEY Phase 3 trials. Moderate CKD was defined as glomerular filtration rate 30-59 mL/min/1.73m. LONG TERM and HIGH FH (n=2448) compared ALI 150 mg every two wks (Q2W) vs placebo. The remaining 6 trials (n=2535) evaluated ALI 75 mg Q2W vs placebo/ezetimibe, with increase to ALI 150 mg Q2W at wk 12 if LDL-C was ≥70 or ≥100 mg/dL at wk 8 depending on CV risk. Patients received stable background statin ± other LLT, except in ALTERNATIVE and MONO (no statin) and COMBO II (statin but no other LLT).ResultsModerate CKD at baseline was present in 481/4983 (9.7%) of patients. Mean baseline LDL-C levels of patients with and without moderate CKD were 109.6 and 127.8 mg/dL, respectively, and 96.9% and 92.7% were receiving a statin. Overall, having moderate CKD did not impact the LDL-C lowering efficacy of ALI (Figure). The smaller LDL-C reduction (vs other studies) seen in alirocumab-treated patients with moderate CKD in the ALTERNATIVE study may be related to low patient number. Adverse events (AEs) were reported by 79.0% ALI vs 81.1% control patients with moderate CKD and 74.7% ALI vs 74.5% control patients without. AEs led to discontinuation in 10.0% ALI vs 8.2% control patients with moderate CKD and 6.0% ALI and 6.6% control patients without.ConclusionsALI consistently lowered LDL-C levels vs control regardless of baseline moderate CKD status. There was no significant difference in % AEs between patients with and without moderate CKD and a numerically higher rate of discontinuations due to AEs in patients with moderate CKD.