LB.03.16] COMPLIANCE AND ACCEPTANCE OF FIXED-DOSE COMBINATION OF BISOPROLOL AND ASPIRIN. OPEN-LABEL MULTICENTER STUDY

Abstract

Objective: The use of fixed-dose combination (FDC) is recommended to improve both compliance and persistence to the treatment of hypertension (HTN). In the study patients’ compliance to therapy with bisoprolol (Bis) and acetylosalicylic acid (ASA) using a single-pill combination was compared with a two-pill approach. Design and method: Patients with HTN and/or coronary heart disease (CHD) treated with free combination of bisoprolol and ASA who were switched to FDC containing bisoprolol/aspirin at least 4 weeks prior to study initiation. During 3 months of observation, compliance was estimated with pill count of returned packages, patient’ diary, time of refill visits and on the last visit with self-reported Morisky's Medication Adherence Scale (MMAS). Results: Of 408 screened subjects, 356 were enrolled into the study. The mean age (±SD) was 64.3 ± 11.9 years and 56.5% were men, HTN was diagnosed in 95.2%, CHD in 65.7% and type 2 diabetes in 21.3% of them. The mean duration of treatment with free combination of Bis/ASA was 17.8 ± 26.6 months, by the end of the study 87.9% of patients were taking the dose 5/75 mg and 12.1% - 10/75 mg, Bis/ASA, respectively. Twenty two subjects had the dose of Bis up-titrated to 10 mg. During the study period, SBP was reduced from 130.9 ± 11.8 mm Hg to 126.6 ± 11.7 mm Hg (p < 0.001), DBP from 78.1 ± 9.0 mm Hg to 76.0 ± 8.3 mm Hg (p < 0.001) and heart rate from 68.7 ± 6.9 beats/min to 66.0 ± 6.8 beats/min (p < 0.001). Based on the pill count, excellent compliance (>90%) was found in 93% and good (76–90%) in 5.3% of patients. Compliance based on patients’ diaries was excellent and good in 323 subjects (90.7%) Overall MMAS score was 3.1 ± 1.0 and 78.7% of patients preferred FDC, 9.3% free combination and 10.4% disclosed no preference. Medication persistence was 98.3%. There was no adverse events that required withdrawal of the therapy or down-titration of the dose of Bis. For subjects with better compliance the trend for better BP control was observed. Conclusions: Fixed-dose bisoprolol-ASA was associated with excellent adherence, patients’ preference and improvement of blood pressure control in subjects with high cardiovascular risk.