4CPS-136 Are cardiovascular adverse events with ibrutinib well considered?. (2nd March 2018)

• Record Type: Journal Article
• Authors: Cavagna, P; Sarfati, L; Roos-Weil, D; Leblond, V; Tilleul, P; Bellanger, A
• Is Part Of: European journal of hospital pharmacy. Volume 25(2018)Supplement 1
• Page Start: A105
• Page End: A105
• Publication Date: 2018-03-02
• Subjects: Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2018-eahpconf.227
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Background: Chronic lymphocytic leukaemia and mantle cell lymphoma have a new standard of care: ibrutinib (metabolised by CYP3A4/5 and P-glycoprotein inhibitor). Cardiovascular (CV) adverse events are characterised by atrial fibrillation (AF) (5%–13.8%), bleeding event (BE) (grade 3 or 4 about 3%–4%) and hypertension. CV pre-treatment evaluation is not required in the ibrutinib summary of product characteristics. Purpose: Evaluate whether the CV risks are considered regarding the prescription of ibrutinib and measure cardiovascular adverse event occurence during treatment. Material and methods: A retrospective analyse was conducted including patients with ibrutinib initiation in our Haematology Department from May 2014 to July 2017. A demographic, clinical and biological database including adverse events, CV evaluation and potential drug interactions was constituted consulting all the medical records. The incidence of AF and BE and the CHA2 DS2 -VASc score were calculated. Results: Fifty-fivemedical records were analysed. Thirty-six patients (65%) had at least one CV risk factor and 14 patients (25%) had at least one initial cardiac examination (ECG/Holter, echocardiography, cardiology consultation). Twenty-one patients (38%) had CV monitoring during their treatment. Four patients developed AF (1 to 7 months after starting the treatment) and were treated with anti-arrhythmics and anti-coagulants (one patient with CHA2 DS2 -VASc<2). Among these, three patients had initial cardiologic examination because of their CV risk factor and one had no cardiac examination. Twenty-four patients (44%) had at least one BE, five of these were under anti-platelet medication. Three patients developed hypertension and one had myocardial infarction. Drug-drug interactions were detected in four patients who had BE and one that developed AF (implicating verapamil, irbesartan and posaconazole). Conclusion: Our results show that cardiac pre-treatment examinations are rarely performed (25%) despite our patients' CV risk factors. With 7.2% of AF, this risk is not negligible considering the limited cohort. A part of serious BE could have been prevented, as concomitant drugs, especially CYP3A4 inhibitor, seem to play a role in CV adverse event occurrence. As a result of drug interactions and CV consequences, which can lead to serious outcomes, a multidisciplinary consultation including a haematologist, cardiologist and pharmacist, should be established at the initiation and during treatment by ibrutinib. References and/or Acknowledgements: 1. Byrd JC, et al. 2014. 2. Brown JR, et al. 2017. No conflict of interest