Cilostazol in peripheral artery disease: Cardiovascular and bleeding events in real-use conditions

Abstract

e122 Volume 37 Number 8S CiloSTazol iN peripheral arTery diSeaSe: CardioVaSCular aNd bleediNg eVeNTS iN real-uSe CoNdiTioNS J. Real; M. Giner-Soriano; R. Morros; G. Pera; and R. Fores IDIAP Jordi Gol, USR Lleida, Spain; IDIAP Jordi Gol, Barcelona, Spain; Universitat Autonoma de Barcelona, Barcelona, Spain; IDIAP Jordi Gol, USR Metropolitana Nord, Spain; and Institut Catala de la Salut, Catalunya, Spain Background: On 2013, the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) recommended that the use of cilostazol should be restricted. The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a review following reports of serious suspected side effects such as coronary heart disease (CHD), arrhythmias and haemorrhages. Objectives: To estimate the risk for ischemic events, arrhythmias and haemorrhages in patients with peripheral artery disease treated with cilostazol vs pentoxifylline. Material and Methods: Design: retrospective observational cohort study. Population: ≥ 40 years-old individuals initiating cilostazol or pentoxifylline for peripheral artery disease between 01/04/2009-30/09/2011, not previously treated. End of follow-up: 31/12/2013. Data Sources: SIDIAP database; contains anonymized clinical information from electronic clinical records in Primary Care of 5.8 million people from Catalonia on sociodemographic data, comorbidities, medical procedures, clinical parameters, laboratory data and pharmacy invoicing data. Diagnoses of CHD events, arrhythmias and haemorrhages were linked from hospital discharge database. Statistical Analysis: Two cohorts (cilostazol and pentoxifylline) were matched 1:1 using propensity-score methods to ensure comparability among groups and then followed-up from treatment initiation until event, end of follow-up or death. Survival analysis was performed and cumulative incidence rates of events were obtained for each cohort. Cox proportional-hazards regression models were performed to estimate hazard ratios and 95% confidence intervals (HR; 95% CI). Results: We included 2,953 patients per cohort. They were 68.9 years-old, 76.1% were men. Median follow-up were 1217 days. Preliminary analysis showed no statistically significant differences in the cumulative incidence rates between cohorts: 10.5% vs 11.0% CHD events with cilostazol and pentoxifylline respectively (HR= 0.97; 95% CI: 0.83–1.13), 7.1% vs 8.1% arrhythmias (HR= 0.88; 95% CI: 0.73–1.06), 0.7% cerebral haemorrhages in both cohorts (HR= 1.1; 95% CI: 0.63–2.15) and 3.6% vs 3.4% digestive haemorrhages (HR= 1.07; 95% CI: 0.81–1.40). Conclusions: We found no differences between our cilostazol and pentoxifylline patients in CHD, arrhythmias and bleeding events.