4CPS-037 Analysis of usage profile, effectiveness and safety of alirocumab in a tertiary hospital

• Published in: European journal of hospital pharmacy. Science and practice Vol. 25; no. Suppl 1; p. A58
• Main Authors: Garcia, C Mondelo, Bargiela, N Fernández, Olivera, C Fernández, Filgueiras, J Balea, Arufe, V Giménez, Herranz, MI Martín
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.03.2018; BMJ Group
• Subjects: Cholesterol; Clinical trials; Low density lipoprotein; Monoclonal antibodies; Section 4: Clinical pharmacy services; Statins
• ISSN: 2047-9956; 2047-9964
• DOI: 10.1136/ejhpharm-2018-eahpconf.128

BackgroundHypercholesterolaemia is a common and growing health problem, above all in developed countries, which can cause serious consequencies in patients who suffer from it. Alirocumab is a monoclonal antibody that blocks a protein called PCSK9 and prevents LDL cholesterol receptors being absorbed and degraded inside cells, increasing their number in the surface of cells to join with LDL cholesterol and remove it from blood.PurposeTo analyse the use, effectiveness and safety of alirocumab in a tertiary-level hospital.Material and methodsObservational retrospective study of all patients treated with alirocumab from 1 December 2016 to 1 October 2017. Data sources: electronic prescription program and electronic medical records. Main variables: sex, age, cause of statins’ failure, previous clinical trial, alirocumab dose, adverse effects and LDL cholesterol levels after 3 months’ treatment.ResultsFifty patients included. Mean age: 60±11.5 years’ old; 66% male. Thirty patients (60%) had to start treatment with alirocumab due to the ineffectiveness of statins and 20 patients (40%) had to start treatment with alirocumab because of statins’ intolerance (muscle pain) disappearing completely the muscle symptoms with the treatment change. Sixteen patients (32%) were previously treated with anti-PCSK9 in clinical trials. All patients included in the study were instructed in the correct use of the dispositive of alirocumab in the first visit to the hospital pharmacy. Depending on LDL cholesterol levels at the beginning of the treatment, 42 patients (84%) received alirocumab 75 mg every 14 days, five patients (10%) received alirocumab 150 mg every 14 days and three patients (6%) received alirocumab 150 mg every 28 days. Patients previously included in clinical trials with anti-PCSK9 continued with adequate levels of LDL cholesterol and all patients who started alirocumab treatment during the study period achieved adequate levels of LDL cholesterol in 3 months’ treatment: 65.1±25.9 mg/dL. Reported adverse effects were few and slight: rinitis (four patients, one of them with epistaxis), diarrhoea (two patients), cutaneous reactions (two patients) and jaw pain (one patient).ConclusionAlirocumab constitutes an effective, safe and well-tolerated alternative to decreased LDL cholesterol to adequate levels when patients are intolerant to statins or when statins are ineffective.References and/or AcknowledgementsAlirocumab product information http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/003882/WC500194521.pdfNo conflict of interest