The authors randomized parallel double multicenter study concluded that low doses of the bound-combined bisoprolol fumarate / hydrochlorothiazide (HCTZ) ( Ziac) are as safe and effective as standard monotherapy with amlodipine (Norvasc) or enalapril (Vazotek).
The survey involved 218 adults with mild to moderate idiopathic hypertension (average diastolic blood pressure (BP) 95-114 mmHg. Cent.). In the beginning, and at regular intervals during the test, the researchers completed a medical history, which reflected the results of physical examination, study participants filled out a special questionnaire, questionnaires concerning their quality of life.
Patients after randomization, received one of the following drugs: Ziac Bisoprolol / HCTZ 2,5 / 6,25 mg / day), enalapril (5 mg / day) or amlodipine (2.5 mg). Every 2 weeks individual dose could be increased so that the diastolic BP decreased to 90 mm Hg. Art or less. If it becomes necessary, the dose of bisoprolol / HCTZ could be increased to 5 / 6, 25 or 10 / 6,25 mg, enalapril 10 mg or 20 mg and amlodipine 5 or 10 mg.
Reaction to taking Ziac Bisoprolol / HCTZ and amlodipine was significantly better than receiving enalapril. Positive response (diastolic blood pressure below 90 mm Hg. Art. Or decreased by more than 10 mm Hg. Art. Compared to basal) was observed in 71% of patients treated with bisoprolol / HCTZ, 69% of patients treated with amlodipine, and 45% of patients treated with enalapril.
Severity of changes in both systolic and diastolic blood pressure was significantly greater in groups, we chavshih Ziac Bisoprolol / HCTZ and amlodipine than in the group treated with enalapril.
In the group treated with bisoprolol / HCTZ fewer patients (31%) required the highest dose to achieve target levels of diastolic blood pressure (in groups of amlodipine and enalapril, the rate was respectively 43 and 49%).
Self-assessment of quality of life (maximum 110 points), slightly improved in the groups treated with bisoprolol / HCTZ and amlodipine (respectively 0.9 and 0.5 points) and worsened in the group treated with enalapril (- 2,3). The difference between the combination therapy group and the group treated with enalapril was, in our opinion, “very large”.
The frequency of side effects associated with medication was comparable in all groups. The most common side effects were headache and fatigue that are often observed in patients treated with amlodipine and enalapril (42 and 47%) than in the group treated with Ziac bisoprolol / HCTZ (29%).
