Placebo-controlled comparison of the efficacy and tolerability of once-daily moxonidine and enalapril in mild to moderate essential hypertension

Abstract

Objectives: To compare the antihypertensive efficacy and tolerability of the imidazoline I1-receptor agonist moxonidine, administered as a single daily dose of 0.6 mg, with the angiotensin-converting enzyme inhibitor enalapril (20 mg o.d.) in patients with mild to moderate essential hypertension. Methods: A total of 154 patients were enrolled and randomized to placebo (n = 50), moxonidine (0.2 mg o.d.; n = 51) or enalapril (5 mg o.d.; n = 53) for 2 weeks. Dosages were then increased to moxonidine 0.6 mg o.d. or enalapril 20 mg o.d. for a further 6 weeks. Blood pressure responses to therapy were measured using conventional office techniques and by 24-h ambulatory blood pressure monitoring. Results: The average reduction in sitting blood pressure with moxonidine was similar to that achieved with enalapril (24.9 ± 20.7/13.2 ± 8.4 mmHg vs 21.9 ± 17.1/11.9 ± 7.5 mmHg, respectively) and significantly superior to that seen with placebo (1.2 ± 14.4/2.3 ± 7.0 mmHg; p < 0.001). Reductions in blood pressure after 8 weeks of treatment were as follows: moxonidine, from 166.2 ± 15.5/101.3 ± 4.0 to 141.2 ± 15.7/88.1 ± 7.7 mmHg; enalapril, from 165.4 ± 14.3/101.1 ± 4.4 to 143.5 ± 12.7/89.2 ± 7.4 mmHg; and placebo, from 162.5 ± 14.4/99.9 ± 3.9 to 161.3 ± 17.9/97.6 ± 6.6 mmHg. Both moxonidine and enalapril produced sustained reductions in blood pressure during 24-h recording (p ≤ 0.01 for overall effect of either drug vs placebo). Average 24-h blood pressure was reduced from 149.8 ± 14.3/92.2 ± 7.0 to 134.0 ± 13.1/82.3 ± 8.9 mmHg with moxonidine and from 146.5 ± 13.0/ 92.5 ± 7.2 to 131.1 ± 11.0/82.1 ± 8.8 mmHg with enalapril; the change with placebo was small (from 147.3 ± 13.3/90.0 ± 6.2 to 144.8 ± 12.9/89.5 ± 8.0 mmHg). Both drugs were generally well tolerated. No patients withdrew from the study because of drug-attributed adverse events. Conclusion: Moxonidine 0.6 mg o.d. and enalapril 20 mg o.d. have similar antihypertensive efficacy.