AIMS: The HEAR Project was initiated because of unsolicited requests from patients, caregivers, and healthcare professionals (HCPs) regarding the correct use of the alirocumab pen. This is the first example from Italy wherein patients' perspectives were considered to gain a deeper understanding of how to implement care pathways for the management of hypercholesterolaemia. METHODS AND RESULTS: Unsolicited spontaneous questions regarding alirocumab received by the Sanofi S.r.l. Medical Information Department or Device Call Centre from patients, caregivers, or HCPs from Italy between June 2019 and October 2022 were analysed. The analysis focused on insights regarding the handling/storage of alirocumab pen. In 2021, from 30,000 proprotein convertase subtilisin/kexin type 9 (PCSK9)-inhibitor users in Italy (30,176 patients: 16,921 evolocumab users and 13,255 alirocumab users), 1,165 unsolicited spontaneous questions regarding alirocumab were collected, including 297 questions (approximately 2% of total PCSK9-inhibitor alirocumab administrations) related to pen use (263 22.6%) or product storage (34 2.9%). CONCLUSIONS: Findings from the HEAR Project support exploring the perspectives of patients who have specific questions about using the device to administer alirocumab for the treatment of hypercholesterolaemia. The findings provide crucial insights for improving care pathways for patients with very-high cardiovascular risk and hypercholesterolaemia. Further analyses are warranted to generate insights with a larger sample size and a wider geographic patient population.
Barisone et al. (Wed,) studied this question.