Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance Bempedoic acid (monotherapy or combined with ezetimibe) is the most recent drug approved for adult with primary hypercholesterolaemia and mixed dyslipidaemia. It is reimbursed by the Italian National Health Service for patients who are intolerant to statins or for whom maximum tolerated doses of statins fail to achieve therapeutic goals. The annual cost per patient for this therapy can range from 4 to 15 times higher than that of statin therapy. Aim and Objectives To ensure proper use, we conducted an analysis of patients enrolled in a treatment with bempedoic acid at a Local Health Authority (LHA), with the aim of evaluating therapeutic continuity and assessing reports of adverse drug reactions (ADR) in the National Pharmacovigilance Network (NPN) for patients who discontinued therapy. Material and Methods The patient cohort included those who initiated treatment between 1/06/2023 and 30/05/2024. The population was characterised by total number, sex, pathology, type of treatment, and prescriber. Particular attention was given to patients who discontinued bempedoic acid therapy. Additionally, reports of ADR to bempedoic acid were examined in the NPN for this LHA. Results A total of 542 patients were enrolled from 1 June 2023 to 30 May 2024, 49.4% male and 50.6% female. The predominant diagnosis was mixed dyslipidaemia (62%), followed by primary non-familial hypercholesterolaemia (28.6%) and heterozygous familial hypercholesterolaemia (7.0%). 48.3% of the patients were treated with bempedoic acid alone, while 51.7% received bempedoic acid and ezetimibe. Specialised clinicians prescribed 81.5% of these treatments, whereas the remaining 18.5% were prescribed by general practitioners. Statin intolerance was the primary reason for initiating bempedoic acid therapy in 45.6% of cases, 12% of patients were intolerant to both statins and ezetimibe, 0.2% were intolerant to ezetimibe alone and 36.5% were on statins at the maximum tolerated dose. A total of 23.1% of patients discontinued bempedoic acid therapy without any clinically documented reason known to the pharmacist (likely due to intolerance, non-adherence, or lack of therapeutic efficacy). No suspected ADR were reported to the LHA. Conclusion and Relevance The findings regarding therapy discontinuation underscore the necessity of increasing healthcare professionals’ awareness of the importance of reporting ADR to better characterise the safety profile of bempedoic acid, a drug under additional pharmacovigilance monitoring. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: C Giannini, M Conti, D Paoletti, O Fabi, S Ginnasi, F Battistuz, MR Petrillo, T Gregori, A Cavaliere
Institution: Azienda Sanitaria Locale Viterbo
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408377098