Efficacy of and Adherence to a Fixed-dose Combination of Bisoprolol and Amlodipine in Hypertensive Patients with and without Type 2 Diabetes Mellitus or Coronary Artery Disease

Study objective: The data from a non-interventional study in more than 10,000 patients were assessed to analyse relationships between hypertension and diabetes or cardiovascular diseases. A further aim was to investigate the effect exerted by treatment with a fixed-dose combination (FDC) of bisoprolol and amlodipine in respect of patient adherence and blood pressure control. Material and methods: The data from the baseline findings of patients receiving treatment with bisoprolol and amlodipine were recorded in case report forms and compared with the data from the findings following 6months of treatment with the corresponding FDC. Only minor changes to the original daily dose of both active substances were made for the switch. Four groups were formed: 1. Without comorbidities, 2. diabetespositive, 3. cardiovascular disease-positive, 4. diabetes- and cardiovascular disease-positive. Type 2 diabetes mellitus was diagnosed following the American Diabetes Association (ADA) criteria: fasting plasma glucose (FPG) >125 mg/ dl (>6.9 mmol/l), and/or a 2-h plasma glucose (2-h PG) value after a 75-g oral glucose tolerance test (OGTT) >199 mg/dl (>11.0 mmol/l) and/or an HbA1C >6.4%. Adherence was determined on the basis of the consumption of the prescribed tablets: excellent >90%, good: 76-90%, moderate: 51-75%, poor ≤ 50%. The effect was assessed on the basis of the reduction in blood pressure and pulse pressure values and by calculating the proportion of patients with a target blood pressure value <140/90 mmHg. Results: The data from a total of 10,430 patients were used for the comparative evaluations. Group 1 included 53% of the patients at baseline with a mean blood pressure of 145.5/88.3 mmHg. The proportion of patients >140/90 mmHg was 28%. The following data were obtained for the groups with comorbidities: Group 2 (8%): mean blood pressure: 149.3/89.2; 33% >140/90 mmHg Group 3 (25%): mean blood pressure: 148.5/88.3; 31% >140/90 mmHg Group 4 (14%): mean blood pressure: 151.5/90.1; 38% >140/90 mmHg. The mean dose of the fixed-dose combination in group 1 was 5.7 ± 2 mg/day for bisoprolol and 6.3 ± 2 mg/day for amlodipine. The highest dose was prescribed to patients in group 4:6.0 ± 2/6.6 ± 2 mg/day. After 6 months, good to excellent adherence was recorded for 95% of patients in all groups. The mean systolic blood pressure values were: Group 1: 130 ± 9, Group 2: 131.7 ± 11, Group 3: 131.3 ± 10, Group 4: 132.3 ± 10 mmHg. Pulse pressure decreased similarly with an effect strength d >0.5 in all groups. Conclusion: The switch from a free to a fixed-dose combination of the antihypertensive agents bisoprolol and amlodipine results in good to very good adherence in patients. This is accompanied by a significant reduction in previously increased blood pressure values in most cases to below the target value of 140/90 mmHg, irrespective of any existing comorbidities such as diabetes and cardiovascular diseases, indicating a reduction in the risk of fatal events.