Low-dose clonidine administration in the treatment of mild or moderate essential hypertension: results from a double-blind placebo-controlled study (Clobass)

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Abstract
Five hundred and fifty-nine hypertensive outpatients with diastolic blood pressure between 95 and 110mmHg participated in this double-blind, placebo-controlled, multicenter study. Eligible subjects were randomly allocated to receive either clonidine (75 µg twice daily) or a placebo. After 4 weeks, 'responders' to treatment (diastolic blood pressure reduced to ≤ 90mmHg or by ≥10mmHg) were kept on monotherapy and checked at 4-weekly intervals for another 3 months. Non-responders were given 15 mg chlorthalidone and were also checked for a further 3 months. At the end of the first month, 54.2% of the subjects were responders to clonidine and 41.5% were responders to the placebo (P < 0.05 for both groups). Of the remaining patients, 69.0% became responders to clonidine plus chlorthalidone, whereas only 34.7% were responders to placebo plus chlorthalidone (P < 0.01 for both groups). Withdrawals from the study because of excessive diastolic blood pressure levels were about eight times less frequent among the subjects treated with clonidine, either alone or with chlorthalidone. Dry mouth was twice as frequent in the clonidine-treated patients, but there was no significant difference in the incidence of all side effects or the number of withdrawals from the study because of side effects between the two groups. We conclude that low-dose clonidine is effective in the treatment of mild or moderate hypertension. Clonidine-related side effects are still evident, but the overall tolerance profile for this reduced dosage of the drug appears to be favorable

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