Treatment of hypertensive patients with a fixed-dose combination of bisoprolol and amlodipine – results of cohort study with more than 10 000 patients Commentary

Abstract

Introduction: Many patients need more than one antihypertensive agent for effective blood pressure (BP) control. Prescription of a fixed-dose combination (FDC) of bisoprolol and amlodipine in one tablet has been shown to significantly improve patient adherence.

Purpose: This non-interventional study investigated the effects on adherence and BP control of switching from a free-dose combination of the two antihypertensive substances to a FDC in a larger patient population.

Methods: Patients aged ≥ 18 years with essential hypertension, after at least 4 weeks of therapy with a FDC of bisoprolol and amlodipine prior to study initiation, were recruited for the 6-month study. Dosage adjustment was implemented only if medically indicated. Adherence was assessed on the basis of the ratio of pills used to pills dispensed (%) at each visit (pill count). BP and adherence were determined at baseline, 3 and 6 months.

Results: 10,532 patients (average age: 59 years; 48% female) were recruited between 2013 and 2014; 22% of patients had type 2 diabetes and 38% had cardiovascular disease. The mean daily doses prescribed in the FDC were 5.8 mg bisoprolol and 6.4 mg amlodipine. Pill counts at 6 months revealed a good to excellent adherence in > 95% of the patients. Comparison of BP at baseline and at 6 months showed substantial changes after switching to the FDC (mean systolic BP: 147.3 mmHg vs. 130.9 mmHg; mean diastolic BP: 87.9 mmHg vs. 79.1 mmHg). Clinically relevant improvement in systolic BP was established for 82% of patients. In patients with comorbidities therapy with the FDC produced a substantial improvement in BP. In addition, prescription of a FDC of bisoprolol and amlodipine resulted in heart rate reduction of 6,4 beats per minute after 6-month therapy in comparison to the baseline. A total of 89 (0.7%) adverse events (AEs were reported, including edema, headache, dizziness, bradycardia, nausea, and skin reactions. Only three AEs were classified as serious.

Conclusions: These data from a non-interventional study in a large patient population demonstrate the benefits of prescribing a FDC of bisoprolol-amlodipine in terms of an excellent adherence and an associated improvement in control of previously elevated BP and reduction in heart rate, which may be relevant in real-life practice.

Funding: Merck KGaA.