Optimized Treatment of Refractory Hypercholesterolemia in Patients With Atherosclerotic Cardiovascular Disease or Heterozygous Familial Hypercholesterolemia With Alirocumab (OPTIMIZE).

Background

Low-density lipoprotein cholesterol (LDL-C) is a major risk factor for atherosclerotic cardiovascular disease (ASCVD). In confirmatory trials, proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab substantially lowered LDL-C and reduced cardiovascular morbidity and mortality. However, the routine clinical use of alirocumab in Switzerland has not yet been studied.

Methods

In this prospective nation-wide cohort study, we aimed to investigate the patient profile and routine clinical efficacy and safety of alirocumab in 207 patients with ASCVD or heterozygous familial hypercholesterolemia and increased LDL-C despite maximally tolerated statin therapy. LDL-C was measured at baseline and after 3-months follow-up.

Results

Overall, mean age was 63 ± 11 years, 138 (67%) were men, and 168 (81%) had statin intolerance (SI). Patients with SI had a higher baseline LDL-C (4.3 ± 1.4 vs. 3.3 ± 1.4 mmol/l;

Conclusions

In routine clinical practice, alirocumab was predominantly used in patients with SI suggesting that the great majority of patients with insufficient LDL-C control who would be candidates for alirocumab are not receiving this therapeutic option in Switzerland. LDL-C lowering was potent and similar in patients with and without SI, replicating the favorable efficacy-safety profile of alirocumab from randomized trials.

Informations de copyright

Copyright © 2022 Sudano, Mach, Moccetti, Burkard, Fahe, Delabays, Rickli, Keller, Dopheide, Bodenmann, Fiolka, Ehret and Spirk.

Déclaration de conflit d'intérêts

IS received speaker fee and research support by Sanofi as well as travel and personal fees by Amgen, Astra Zeneca, Daiichi Sankyo, Menarini, MSD, Recordati, and Servier. TB received research funding to institution by CSEM, Collabree, Medtronic, Roche Diagnostics, and Sanofi as well as travel, speaker, or advisory board fees by Boehringer Ingelheim, Daiichi Sankyo, Novartis, Sanofi, and Servier. SB, TF, and DS are employees of Sanofi, Vernier, Switzerland, and may hold shares and/or stock options in Sanofi. GE received grants or consulting fees to institution from Amgen, Novartis, Sanofi, and Servier, and personal royalties or licenses from UpToDate. No other conflict of interest was reported from the authors regarding the content of this manuscript.