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

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%,

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.

Informations de copyright

© 2023 Banach, Lewek, Pol, Rabczenko, Balanescu, Blaha, Ceska, Jankowski, Surma, Kolovou, Liberopoulos, Mitu, Mitu, Naji, Paragh, Popławska, Vrablik and Pella.

Déclaration de conflit d'intérêts

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.