Main Article Content
This non-investigational study with the primary goal to assess patient adherence to the fixed dose combination (FDC) of bisoprolol and amlodipine in daily practice was carried out in six countries in Eastern Europe, in Czech Republic, Hungary, Poland, Romania, Serbia and Slovakia. In this paper, the results of 740 patients recruited in Czech Republic are presented. Secondary objectives included the assessment of blood pressure, pulse pressure values and heart rate.
Material and Methods
Patients eligible for recruitment were over 18 years of age, had essential hypertension, had already been switched from a free combination of bisoprolol 5–10mg/d and amlodipine 5–10mg/d to the FDC at least 4 weeks prior to recruitment, and gave informed consent. Women in childbearing age were under reliable contraception.
Exclusion criteria included pregnancy, lactation, any contraindication to the FDC according to the local label and any other antihypertensive medication.
The primary target parameter was patient adherence under the FDC. Adherence was measured by tablet count (tablets taken divided by tablets prescribed, times 100). The definition was as follows: excellent >90%, good 76-90%, moderate 51-75%, bad <50%. The study hypothesis was that at least 90% of the patients showed good to excellent adherence.
All other patient data, clinical findings and laboratory values were recorded upon availability at study start and after 6 months.
There were more male (383, 52%) than female (357, 48%) patients. The mean age was 58.8 years with a Q1 – Q3 interval of 51 to 68 years. The youngest patient was 23 years and the oldest 95 years old. All patients had been pretreated once daily with a free combination of bisoprolol (mean 5.8mg) and amlodipine (mean 5.9mg). In most patients, the doses were not changed at the switch to the FDC or later during the study, resulting in a mean of 6.2mg for bisoprolol and 5.9mg for amlodipine.
Over the 6 months of treatment, the adherence of 98% of the patients was good to excellent. Thus, the study expectation was more than met.
Potentially due to the excellent adherence, there was a 12.1mmHg reduction in mean systolic and a 6.9mmHg reduction in mean diastolic blood pressure after 6 months compared to study start. The benefits of patient adherence on blood pressure control are confirmed by the improvement of the pulse pressure by an average of 59.1mmHg±13 at study start versus 54.1mmHg±10 after 6 month of treatment. Heart rate decreased by a mean of 5.6bpm.
Only in 2 patients (0.3%), two adverse drug reactions probably related to the study medication were documented after 6 months: one case of hypotension and one case of edema. None of the adverse drug reactions (ADR) was considered serious and both patients fully recovered. Overall, the FDC of bisoprolol and amlodipine was well tolerated.
The study results clearly show that the high adherence under the FDC of bisoprolol and amlodipine may contribute to better blood pressure control and, thus, to a better risk reduction for cardiovascular events.
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