A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort
Angelo B Cefalù, Raffaella Garbelotto, Giuliana Mombelli, Matteo Pirro, Paolo Rubba, Marcello Arca, Claudio Borghi, Katia Bonomo, Stefano Gonnelli, Katia Massaroni, Giampaolo Tirone, Maurizio Averna, ODYSSEY APPRISE Study Italian Investigators, Francesco Angelico, Francesco Cipollone, Enzo Corghi, Pompilio Faggiano, Cesare Greco, Luigina Guasti, Tiziano Lucchi, Carlo Sabba, Riccardo Sarzani, Pierfranco Terrosu, Alberto Zambon, Angelo B Cefalù, Raffaella Garbelotto, Giuliana Mombelli, Matteo Pirro, Paolo Rubba, Marcello Arca, Claudio Borghi, Katia Bonomo, Stefano Gonnelli, Katia Massaroni, Giampaolo Tirone, Maurizio Averna, ODYSSEY APPRISE Study Italian Investigators, Francesco Angelico, Francesco Cipollone, Enzo Corghi, Pompilio Faggiano, Cesare Greco, Luigina Guasti, Tiziano Lucchi, Carlo Sabba, Riccardo Sarzani, Pierfranco Terrosu, Alberto Zambon
Abstract
Background and aims: ODYSSEY APPRISE trial evaluated efficacy and safety of alirocumab in 994 patients with hypercholesterolemia and high CV risk in a real-life setting. The aim of the present report is to detail on the Italian cohort enrolled and treated in the trial.
Methods and results: The methodology of the of the multinational, single-arm, Phase 3b open-label ODYSSEY APPRISE (Clinicaltrials.gov: NCT02476006) has been previously reported. 255 Italian patients were enrolled and treated according to the trial protocol. Overall mean exposure to alirocumab was 83.3 ± 27.7 weeks. At week 12, LDL-C decreased by 51.3 ± 23.1% and this reduction was overall maintained for the duration of the study. A similar reduction was observed in patients with and without heterozygous familial hypercholesterolemia (HeFH 50.7% ± 23.9 vs. non-FH, 53.6% ± 19.6). LDL-C was reduced below 1.8 mmol/L and/or by ≥ 50% reduction from baseline in 62% of patients overall (61% in HeFH and 67% in non-FH). Alirocumab was similarly well tolerated in the Italian cohort as in the entire study population and the more common treatment emergent adverse events (TEAEs) were influenza, myalgia and nasopharyngitis. The incidence LDL-C levels <25 mg/dl and <15 mg/dl, was 8.2% and 2.9% respectively.
Conclusion: The efficacy and safety of alirocumab in a real-life setting, in the Italian subgroup of patients are consistent with findings in the entire study population and confirm that alirocumab is a beneficial approach to further reduce LDL-C levels in patients at high CV risk on maximally tolerated conventional lipid lowering treatment.
Gov identifier: NCT02476006.
Keywords: Alirocumab; Heterozygous familial hypercholesterolemia; High cardiovascular risk; Italy; LDL-C.
Conflict of interest statement
Declaration of competing interest A.B.C. received a consultancy fee for writing the article that examines the Italian data of the ODYSSEY APPRISE study; has received grants and personal honoraria for consultancy and lecturing from Aegerion, Akcea, Alfasigma, Amryt Pharmaceuticals, Inc., and Sanofi. M.Av. has received grants and personal honoraria for consultancy from Aegerion, Akcea, Ionis, Alfasigma, Amgen, Amryt, Pfizer, Sanofi. KG and GT, Sanofi employee, may hold shares and/or stock options in the company. M.Ar. has received grants and personal honoraria for consultancy from Amgen, Sanofi. S.N., K.B., R.G., C.B., P.R., S.G., G.M., and M.P. have nothing to disclose.
Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.
Source: PubMed