Background and aims: ODYSSEY APPRISE trial evaluated efficacy and safety of alirocu-mab 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 Ital-ian 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 hypercholesterole-mia (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 pa-tients 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 naso-pharyngitis. 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 pa-tients 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.Clinicaltrials.gov identifier: NCT02476006.(c) 2022 The Author(s). Published by Elsevier B.V. on behalf of The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort
Luigina Guasti;
2022-01-01
Abstract
Background and aims: ODYSSEY APPRISE trial evaluated efficacy and safety of alirocu-mab 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 Ital-ian 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 hypercholesterole-mia (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 pa-tients 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 naso-pharyngitis. 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 pa-tients 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.Clinicaltrials.gov identifier: NCT02476006.(c) 2022 The Author(s). Published by Elsevier B.V. on behalf of The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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