JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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Blood pressure control and response rates with zofenopril compared with amlodipine in hypertensive patients.

Angiotensin-converting enzyme inhibitors (ACEIs) and calcium antagonists are today extensively used as first-line monotherapy as well as appropriate combination therapy in mild to moderate hypertension. In a parallel-group study, using clinically recommended doses, the ACEI zofenopril was compared with the calcium antagonist amlodipine in respect of their antihypertensive properties. In the study, 303 hypertensive patients, aged 18-75 years, were compared in terms of antihypertensive response and adverse effects after treatment with zofenopril, 30-60 mg once daily or amlodipine 5-10 mg od. After receiving the lower starting dose, up-titration was optional at 4 weeks to the higher dose if diastolic pressure (DBP) was 90 mmHg or more or if a decrease from base line of < 10 mmHg was present. After 4 weeks and appropriate up-titration of dose in non-responder patients, there were significant and similar reductions of sitting DBP by -10.0 and -9.9 mmHg and systolic blood pressure (SBP) by -13.0 and -13.2 mmHg the in the zofenopril and amlodipine groups, respectively. After 12 weeks of therapy, there were further reductions in blood pressure (BP) by the respective therapies. Thus, the higher zofenopril dose lowered SBP/DBP by 15.7/12.0 mmHg and the higher amlodipine dose by 17.1/ 12.2 mmHg (ns). Also, at the end of the study, the percentage of patients controlled (with sitting DBP < 90 mmHg) was 61.4% in the amlodipine and 62.2% in the zofenopril group and the percentage controlled (with sitting DBP < 90 mmHg and/or a decrease of at least 10 mmHg) was 76.4 in the amlodipine and 70.1 in the zofenopril groups (both ns). We conclude that SBP as well as DBP were substantially reduced in mild to moderate hypertensive patients over 12 weeks treatment with zofenopril or amlodipine in monotherapy. Thus, given the size of the BP reduction, such treatments are likely to produce beneficial cardiovascular outcome effects in patients with mild to moderate hypertension.

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