Monitoring the effectiveness and safety of the fixed dose combination of ramipril/amlodipine therapy in patients with metabolic syndrome suffering from mild or moderate hypertension despite current antihypertensive treatment.
Design and method:
Open, prospective, phase IV clinical observational study, which involved known metabolic syndrome patients (age over 18 years) with mild or moderate hypertension. Ramipril/amlodipine fixed dose combination (5/5, 5/10, 10/5 or, 10/10 mg) were administered or titrated in 3 visits, during the 6 months of trial period. The doses of the fixed combination drugs were determined individually during the visits by physicians involved in the study. The target blood pressure value was <140/90 mmHg (<140/85 mmHg in diabetic subgroup).
63% of total patient (9,052) has fulfilled the protocol during the six months of trial (5,707 patients). The age of patients was 61.3 ± 11.97 (mean ± SD) years, 2.736 (47.9%) men and 2,971 (52.1%) women. 74.0% of total metabolic patients has reached target blood pressure at the end of 6th month (primary end point). The blood pressure has decreased significantly from 158.7 ± 8.97/91.9 ± 7.30 mmHg (1. visit) to 131.6 ± 7.73/79.8 ± 12.20 (3. visit) (p < 0.0001). Patients with hypertension in metabolic syndrome have tolerated well the various fixed combination of ramipril/amlodipine.
Introducing ramipril/amlodipine fixed dose combination has a benefitial effect on reaching blood pressure in high risk patietens with metabolic syndrome.
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