Efficacy and tolerance of cicletanine, a new antihypertensive agent: overview of 1226 treated patients.

The data gathered from 1226 patients for 20 controlled therapeutic studies performed during the phase-III development of cicletanine, a new antihypertensive agent, were pooled in a computerized database. An extensive statistical analysis of these data collected over 1-2 years was performed to give a clear interpretation of long-term efficacy and tolerance of this drug. In mild to moderate hypertension, the dose-response relationship observed after one month of treatment on diastolic (DBP) and systolic (SBP) blood pressure disappeared during the third month. After a 3-month treatment in monotherapy with the recommended dosage (50-100 mg/day) we observed a mean decrease of 29.7 +/- 17.8 mmHg for SBP and 23.3 +/- 13.2 mmHg for DBP. At this stage 70.9% of patients were stabilized (SBP less than 160 mmHg and DBP less than 95 mmHg) with cicletanine. After this initial regular decrease of blood pressure values, an additional decrease of several mmHg was observed during the 24 months of treatment, thus significantly augmenting the number of stabilized patients. No significant difference in efficacy was observed in adult and elderly (65 to 95 years) patients. The clinical tolerance was very good, only a few slight and transitory side-effects have been reported. Biological tolerance was also very good. Depending on the dosage used, only a slight and transitory variation in sodium and potassium levels was observed. Glucose, creatinine and lipids either remained stable or were improved during treatment. This analysis demonstrates the beneficial effect and the good tolerance of cicletanine (50-100 mg/day) in the treatment of hypertension, which can be explained by its special mode of action.