Effect of alirocumab on cataracts in patients with acute coronary syndromes

BMC Ophthalmology

Research

Shaun G. Goodman¹  J. Wouter Jukema²  Gregory G. Schwartz³  Michael Szarek⁴  Yann Poulouin⁵  Garen Manvelian⁶  Robert Pordy⁶  Michel Scemama⁷  Gaspard Suc⁸  Ph. Gabriel Steg⁹ 

[1] Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada;St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada;Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands;Netherlands Heart Institute, Utrecht, the Netherlands;Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA;Downstate School of Public Health, State University of New York, Brooklyn, NY, USA;CPC Clinical Research and Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA;IT&M Stats, Neuilly-sur-Seine, France;Regeneron Pharmaceuticals, Tarrytown, NY, USA;Sanofi, Chilly-Mazarin, France;Université Paris-Cité, INSERM_U1148/LVTS, Paris, France;Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France;Université Paris-Cité, INSERM_U1148/LVTS, Paris, France;Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France;Institut Universitaire de France, Paris, France;FACT (French Alliance for Cardiovascular Trials), INSERM U-1148, Paris, France;Département de Cardiologie, AP-HP Hôpital Bichat, 46 Rue Henri Huchard, 75018, Paris, France;

关键词: Acute coronary syndrome;    Cataracts;    Alirocumab;    PCSK9 inhibitor;   

DOI  :  10.1186/s12886-023-03012-1

 received in 2022-08-25, accepted in 2023-06-02,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSome data suggest that low levels of low-density lipoprotein cholesterol (LDL-C) are associated with risk of cataracts. Proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitors reduce LDL-C below levels achieved with statins alone. We determined whether the incidence of cataracts was influenced by treatment with the PCSK9 inhibitor alirocumab versus placebo, and whether that incidence was affected by achieved LDL-C levels.MethodsThe ODYSSEY OUTCOMES trial (NCT01663402) compared alirocumab with placebo in 18,924 patients with recent acute coronary syndrome receiving high-intensity or maximum-tolerated statin. Incident cataracts were pre-specified events of interest. In multivariable analysis using propensity score-matching on characteristics including cataract risk factors, incident cataracts were compared in the alirocumab and placebo groups according to LDL-C levels achieved with alirocumab.ResultsOver median follow-up of 2.8 years (interquartile range 2.3 − 3.4), the incidence of cataracts was similar with alirocumab (127/9462 [1.3%]) versus placebo (134/9462 [1.4%]); hazard ratio [HR] 0.94, 95% confidence interval [CI] 0.74 − 1.20). In patients treated with alirocumab with ≥ 2 LDL-C values < 25 mg/dL (0.65 mmol/L), the incidence of cataracts was 71/4305 (1.6%), versus 60/4305 (1.4%) in propensity score-matched patients from the placebo group (HR 1.10, CI 95% 0.78 − 1.55). In patients treated with alirocumab with ≥ 2 LDL-C values < 15 mg/dL (0.39 mmol/L), the incidence of cataracts was 13/782 (1.7%), versus 36/2346 (1.5%) in matched patients from the placebo group (HR 1.03, CI 95% 0.54 − 1.94).ConclusionTreatment with alirocumab versus placebo, added to statin, did not influence the incidence of cataracts, even when achieved LDL-C levels on alirocumab were very low. Longer follow-up studies might be necessary to exclude the long-term effects on the incidence or progression of cataracts.Trial registrationClinicalTrials.gov Identifier: NCT01663402.

【 授权许可】

CC BY   
© The Author(s) 2023

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