A double-blind multicentre study was performed initially to assess the effect of 4 weeks' treatment of
cicletanine in daily doses of 12.5, 25, 50 and 100 mg, for the treatment of 60 patients with mild to moderate
essential hypertension. A significant reduction in blood pressure was achieved with each dosage. Analysis of the responder rate indicated a significant dose-response relationship which was clinically relevant only for the 50 and 100 mg doses. The minimum therapeutic dosage of
cicletanine for the treatment of
essential hypertension was concluded to be 50 mg daily. A further 12-week study was performed in 40 patients with mild to moderate
essential hypertension, commencing with a daily dose of
cicletanine (50 mg) and increasing the dosage if necessary to 100 mg and 200 mg daily after 4 and 8 weeks, respectively. Blood pressure control was achieved in all patients and in the majority (70%) with a daily dosage of 100 mg
cicletanine. Treatment was continued in all patients until a total duration of 2 years had been completed.
Cicletanine was shown to be very well tolerated and a significant reduction in blood pressure was achieved at 6, 9, 12, 18 and 24 months. During the second year of treatment, all the patients were stabilized with a daily dosage of 50 mg
cicletanine. These results are consistent with a previously reported study in 25 patients with mild to moderate
essential hypertension. Twelve weeks of treatment with
cicletanine (50 mg daily) produced a significantly greater reduction in blood pressure than a combination of 5 mg
amiloride hydrochloride and 50 mg
hydrochlorothiazide daily. This reduction was more significant for the diastolic than the systolic blood pressure measurements. A diastolic blood pressure of 90 mmHg, or less, was achieved in all patients receiving treatment with
cicletanine (50 mg daily), except for two patients where the dosage was increased to 100 mg daily.