Regional differences in physicians' behavior and factors influencing the intensity of PCSK9 inhibitor therapy with alirocumab: a subanalysis of the ODYSSEY APPRISE study.

Autor:	Banach M; Department of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland.; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland.; Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland.; Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, United States., Lewek J; Department of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland.; Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland., Pol K; Sanofi, Bridgewater, NJ, United States., Rabczenko D; Department of Population Health Monitoring and Analysis, National Institute of Public Health NIH-National Research Institute, Warsaw, Poland., Balanescu SM; Department of Cardiology, Elias Emergency University Hospital, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania., Blaha V; The 3rd Department of Internal Medicine-Metabolic Care and Gerontology, Charles University and University Hospital in Hradec Králové, Hradec Králové, Czechia., Ceska R; 3rd Department of Medicine-Department of Endocrinology and Metabolism of the First Faculty of Medicine, Charles University and General University Hospital, Prague, Czechia., Jankowski P; Department of Internal Medicine and Geriatric Cardiology, Center of Postgraduate Medical Education, Warsaw, Poland.; Department of Epidemiology and Health Promotion, School of Public Health, Center of Postgraduate Medical Education, Warsaw, Poland., Surma S; Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland., Kolovou G; Cardiometabolic Center, Metropolitan Hospital, Piraeus, Greece., Liberopoulos E; First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital, Athens, Greece., Mitu F; Department of Medical Specialties I, 'Grigore T. Popa', University of Medicine and Pharmacy, Iasi, Romania., Mitu M; Cardiovascular Rehabilitation Clinic, Clinical Rehabilitation Hospital, Iasi, Romania., Naji FH; University Clinical Center Maribor, Maribor, Slovenia., Paragh G; Division of Metabolism, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary., Popławska M; Sanofi, Warsaw, Poland., Vrablik M; 3rd Department of Medicine-Department of Endocrinology and Metabolism of the First Faculty of Medicine, Charles University and General University Hospital, Prague, Czechia., Pella D; 2nd Department of Cardiology of the East Slovak Institute of Cardiovascular Disease and Faculty of Medicine, PJ Safarik University, Kosice, Slovakia.
Jazyk:	angličtina
Zdroj:	Frontiers in cardiovascular medicine [Front Cardiovasc Med] 2023 Jun 19; Vol. 10, pp. 1206551. Date of Electronic Publication: 2023 Jun 19 (Print Publication: 2023).
DOI:	10.3389/fcvm.2023.1206551
Abstrakt:	Background: Despite better accessibility of the effective lipid-lowering therapies, only about 20% of patients at very high cardiovascular risk achieve the low-density lipoprotein cholesterol (LDL-C) goals. There is a large disparity between European countries with worse results observed for the Central and Eastern Europe (CEE) patients. One of the main reasons for this ineffectiveness is therapeutic inertia related to the limited access to appropriate therapy and suitable dosage intensity. Thus, we aimed to compare the differences in physicians' therapeutic decisions on alirocumab dose selection, and factors affecting these in CEE countries vs. other countries included in the ODYSSEY APPRISE study. Methods: ODYSSEY APPRISE was a prospective, single-arm, phase 3b open-label (≥12 weeks to ≤30 months) study with alirocumab. Patients received 75 or 150 mg of alirocumab every 2 weeks, with dose adjustment during the study based on physician's judgment. The CEE group in the study included Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia, which we compared with the other nine European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Spain, and Switzerland) plus Canada. Results: A total of 921 patients on alirocumab were involved [modified intention-to-treat (mITT) analysis], including 114 (12.4%) subjects from CEE countries. Therapy in CEE vs. other countries was numerically more frequently started with lower alirocumab dose (75 mg) at the first visit (74.6 vs. 68%, p  = 0.16). Since week 36, the higher dose was predominantly used in CEE patients (150 mg dose in 51.6% patients), which was maintained by the end of the study. Altogether, alirocumab dose was significantly more often increased by CEE physicians (54.1 vs. 39.9%, p  = 0.013). Therefore, more patients achieved LDL-C goal at the end of the study (<55 mg/dl/1.4 mmol/L and 50% reduction of LDL-C: 32.5% vs. 28.8%). The only factor significantly influencing the decision on dose of alirocumab was LDL-C level for both countries' groups (CEE: 199.2 vs. 175.3 mg/dl; p  = 0.019; other: 205.9 vs. 171.6 mg/dl; p  < 0.001, for 150 and 75 mg of alirocumab, respectively) which was also confirmed in multivariable analysis (OR = 1.10; 95% CI: 1.07-1.13). Conclusions: Despite larger unmet needs and regional disparities in LDL-C targets achievement in CEE countries, more physicians in this region tend to use the higher dose of alirocumab, they are more prone to increase the dose, which is associated with a higher proportion of patients reaching LDL-C goals. The only factor that significantly influences decision whether to increase or decrease the dose of alirocumab is LDL-C level. Competing Interests: MB: speakers bureau: Amgen, Daiichi Sankyo, KRKA, Polpharma, Mylan/Viatris, Novartis, Novo-Nordisk, Pfizer, Sanofi-Aventis, Teva, and Zentiva; consultant to Adamed, Amgen, Daiichi Sankyo, Esperion, NewAmsterdam, Novartis, Novo-Nordisk, and Sanofi-Aventis; Grants from Amgen, Daiichi Sankyo, Mylan/Viatris, Sanofi, and Valeant; CMDO at Longevity Group (Luxemburg). PJ: speakers bureau, grants, and participation in trials sponsored by Amgen, Polpharma, Novartis, Novo-Nordisk, Pfizer, Sanofi-Aventis, Servier, and Zentiva. GK has given talks, attended conferences, received consultancy fees, and participated in trials sponsored by Amgen, Novartis, Sanofi, Servier, Viatris, and Amryt. EL reports grants from Hellenic Atherosclerosis Society; personal fees and non-financial support from AMGEN, personal fees from SANOFI, personal fees from LILLY, personal fees from BAYER, personal fees from NOVO-NORDISK, grants and personal fees from ASTRA-ZENECA, personal fees from BOEHRINGER INGELHEIM, personal fees from NOVARTIS, personal fees from SERVIER, and grants and personal fees from VIATRIS, outside the submitted work. FM attended conferences, symposia, has given talks, participated in trials, and received consultancy fees sponsored by Amgen, Astra-Zeneca, Bayer, Boehringer Ingelheim, Novartis, Sanofi, Servier, Zentiva, and Pfizer. GP: speakers bureau: Gedeon Richter and Novartis; MV has given talks, attended conferences, received consultancy fees, and participated in trials sponsored by Amgen, Astra-Zeneca, Bayer, Boehringer Ingelheim, KRKA, MSD, Novartis, Novo-Nordisk, Pfizer, Sanofi, Servier, Viatris, and Zentiva. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (© 2023 Banach, Lewek, Pol, Rabczenko, Balanescu, Blaha, Ceska, Jankowski, Surma, Kolovou, Liberopoulos, Mitu, Mitu, Naji, Paragh, Popławska, Vrablik and Pella.)
Databáze:	MEDLINE
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