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.

1st Department of Propaedeutic Internal Medicine Medical School National and Kapodistrian University of Athens Laiko General Hospital Athens Greece

2nd Department of Cardiology of the East Slovak Institute of Cardiovascular Disease and Faculty of Medicine PJ Safarik University Kosice Slovakia

3rd Department of Medicine Department of Endocrinology and Metabolism of the 1st Faculty of Medicine Charles University and General University Hospital Prague Czechia

Cardiometabolic Center Metropolitan Hospital Piraeus Greece

Cardiovascular Rehabilitation Clinic Clinical Rehabilitation Hospital Iasi Romania

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

Department of Cardiology and Congenital Diseases of Adults Polish Mother's Memorial Hospital Research Institute Lodz Poland

Department of Cardiology Elias Emergency University Hospital Carol Davila University of Medicine and Pharmacy Bucharest Romania

Department of Epidemiology and Health Promotion School of Public Health Center of Postgraduate Medical Education Warsaw Poland

Department of Internal Medicine and Geriatric Cardiology Center of Postgraduate Medical Education Warsaw Poland

Department of Medical Specialties 1 Grigore T Popa University of Medicine and Pharmacy Iasi Romania

Department of Population Health Monitoring and Analysis National Institute of Public Health NIH National Research Institute Warsaw Poland

Department of Preventive Cardiology and Lipidology Medical University of Lodz Lodz Poland

Division of Metabolism Department of Internal Medicine Faculty of Medicine University of Debrecen Debrecen Hungary

Faculty of Medical Sciences in Katowice Medical University of Silesia Katowice Poland

Sanofi Bridgewater NJ United States

Sanofi Warsaw Poland

The 3rd Department of Internal Medicine Metabolic Care and Gerontology Charles University and University Hospital in Hradec Králové Hradec Králové Czechia

University Clinical Center Maribor Maribor Slovenia

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