Vol 4, No 4 (2000)
Original paper
Published online: 2000-10-30
MODIL — Multicenter Randomised Study of Moexipril and Diltiazem in Monotherapy and Combination Treatment of Essential Hypertension
Nadciśnienie tętnicze 2000;4(4):253-261.
Abstract
Background The aim of the study was to compare efficacy of moexipril or diltiazem in monotherapy and in combination antihypertensive therapy.
Materials and methods 182 patients aged 30 do 70 years with mild to moderate essential hypertension were studied. If blood pressure was between 90 and 110 mm Hg for diastolic and between 140 and 190 mm Hg for systolic after 1 week run-in placebo phase, patients were randomized to receive moexipril in dose 7,5 mg/d or diltiazem in dose 120 mg/d, once a day. After 2 weeks, in case of poor blood pressure control patients were randomized second time to receive doubled dose of the drug in monotherapy or combination therapy with low dose of moexipril and diltiazem. Treatment was continued for next 8 weeks with blood pressure control after 4 and 8 weeks.
Results Mean basic blood pressure was 160,6 ± 11,3 / 99,7 ± ± 5,2 mm Hg in moexipril group and 159,6 ± 10,5/98,7 ± ± 5,3 mmHg in diltiazem group. After 2 weeks treatment with low dose moexipril blood pressure decreased by 17/8 mm Hg (p < 0,001) and with diltiazem by 14/5 mm Hg. Efficacy (blood pressure below 140/90 mm Hg) of low dose moexipril was 45% and of low dose diltiazem 33%. Efficacy of combination therapy was significantly higher than monotherapy with doubled dose (33% vs 8% in moexipril group and 39% vs 23% in diltiazem group. Theoretically estimated effectiveness of antihypertensive strategy from low dose of calcium chanel blocker or ACE inhibitor to combination therapy with these drugs was 54,4%, and method from low dose to increased dose of single drug was 40,4 %. Side effects (hypothension, weakness, headache, dizziness and allergic skin reaction were noted in 3 patients.
Conclusions Diltiazem SR and moexipril were proved to be effective, safe and well tolerated antihypertensive agents both in monotherapy and combination treatment. Combination therapy with low dose of calcium chanel blocker and ACE inhibitor is more effective than monotherapy with high dose of one of these drugs.
Materials and methods 182 patients aged 30 do 70 years with mild to moderate essential hypertension were studied. If blood pressure was between 90 and 110 mm Hg for diastolic and between 140 and 190 mm Hg for systolic after 1 week run-in placebo phase, patients were randomized to receive moexipril in dose 7,5 mg/d or diltiazem in dose 120 mg/d, once a day. After 2 weeks, in case of poor blood pressure control patients were randomized second time to receive doubled dose of the drug in monotherapy or combination therapy with low dose of moexipril and diltiazem. Treatment was continued for next 8 weeks with blood pressure control after 4 and 8 weeks.
Results Mean basic blood pressure was 160,6 ± 11,3 / 99,7 ± ± 5,2 mm Hg in moexipril group and 159,6 ± 10,5/98,7 ± ± 5,3 mmHg in diltiazem group. After 2 weeks treatment with low dose moexipril blood pressure decreased by 17/8 mm Hg (p < 0,001) and with diltiazem by 14/5 mm Hg. Efficacy (blood pressure below 140/90 mm Hg) of low dose moexipril was 45% and of low dose diltiazem 33%. Efficacy of combination therapy was significantly higher than monotherapy with doubled dose (33% vs 8% in moexipril group and 39% vs 23% in diltiazem group. Theoretically estimated effectiveness of antihypertensive strategy from low dose of calcium chanel blocker or ACE inhibitor to combination therapy with these drugs was 54,4%, and method from low dose to increased dose of single drug was 40,4 %. Side effects (hypothension, weakness, headache, dizziness and allergic skin reaction were noted in 3 patients.
Conclusions Diltiazem SR and moexipril were proved to be effective, safe and well tolerated antihypertensive agents both in monotherapy and combination treatment. Combination therapy with low dose of calcium chanel blocker and ACE inhibitor is more effective than monotherapy with high dose of one of these drugs.
Keywords: essential hypertensiondiltiazemmoexiprilcombination antihypertensive therapy