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In a 10-week double-blind randomised placebo-controlled trial, the efficacy, safety and effect on renal function of a single dose of fosinopril 20mg once daily were studied in 23 patients with mild to moderate essential hypertension. After discontinuation of previous antihypertensive treatment and a 4-week washout period, all patients received placebo for the next 2 weeks. Patients were then randomly assigned, in a double-blind fashion, to 1 of 2 groups: the first group (group F) was made up of 12 patients who received fosinopril 20mg once daily; the second group (group PL) was made up of 11 patients who received one matching placebo tablet once daily. The duration of treatment was 4 weeks. At the end of the placebo period and after 4 weeks’ treatment, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate were measured, routine blood and urine investigations performed, and plasma renin activity (PRA), plasma aldosterone and renal haemodynamics determined. A statistically significant reduction in both SBP (p < 0.001) and DBP (p < 0.001) was observed only in group F, 4 weeks after initiation of treatment. Heart rate remained unchanged and there were no adverse events in either group. In group F, PRA increased significantly (p < 0.05) and glomerular filtration rate remained unchanged; renal blood flow was significantly reduced (p < 0.01), although it remained within the normal limits. In conclusion, fosinopril demonstrated an adequate antihypertensive effect and was well tolerated, without any significant changes in renal haemodynamics. |
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