C. Zamboulis et al., EFFECTS OF FOSINOPRIL ON RENAL-FUNCTION IN PATIENTS WITH MILD-TO-MODERATE ESSENTIAL-HYPERTENSION, Clinical drug investigation, 12(5), 1996, pp. 251-258
In a 10-week double-blind randomised placebo-controlled trial, the eff
icacy, safety and effect on renal function of a single dose of fosinop
ril 20mg once daily were studied in 23 patients with mild to moderate
essential hypertension. After discontinuation of previous antihyperten
sive treatment and a 4-week washout period, all patients received plac
ebo for the next 2 weeks. Patients were then randomly assigned, in a d
ouble-blind fashion, to 1 of 2 groups: the first group (group F) was m
ade up of 12 patients who received fosinopril 20mg once daily; the sec
ond group (group PL) was made up of 11 patients who received one match
ing placebo tablet once daily. The duration of treatment was 4 weeks.
At the end of the placebo period and after 4 weeks' treatment, systoli
c blood pressure (SBP), diastolic blood pressure (DBP) and heart rate
were measured, routine blood and urine investigations performed, and p
lasma 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 i
nitiation of treatment. Heart rate remained unchanged and there were n
o adverse events in either group. In group F, PRA increased significan
tly (p < 0.05) and glomerular filtration rate remained unchanged; rena
l blood flow was significantly reduced (p < 0.01), although it remaine
d within the normal limits. In conclusion, fosinopril demonstrated an
adequate antihypertensive effect and was well tolerated, without any s
ignificant changes in renal haemodynamics.