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Abstract

The aim was to compare the effects of the monotherapy with angiotenzin II receptor antagonist irbesartan (IRB) and calcium channel antagonist lacidipine (LAC) vs. combination therapy with these drugs in hypertensive Type II diabetic patients (DM2). Totaly 72 patients with moderate hypertension (sitting DBP>100, <110mmHg), and DM2 (well - controlled with metformin) urinary albumin excretion (UAE) of>30 to<300 mg/24h and plasma creatinine levels <1,4 mg/dl were randomized to receive 300 mg IRB (n=24),6mg LAC (n=24)or drug combination (IRB 150mg, LAC 4mg n=24) once daily for 12 months. At baseline and every 3 month during treatment blood pressure (BP) and heart rate (HR), office BP data and ABPM were assessed; body weight, creatinine and glucose levels, electrolytes, uric acid and UAE were measured. Both IRB and LAC as monotherapy significantly reduced office through BP, but the combination therapy was most effective. SBP reduced - 24.2 with combination; 18.6 with LAC and 16,2 with IRB and DBP reduced-18.4 with combination; 15,6 with LAC and 13,1 with IRB after 3 month treatment. (p<0.001 for all treatment groups vs. baselines). UAE decreased with IRB and combination therapy from 3-rd (p<0.05 vs BS) to 12-th. month (p<0.01), while only from 6-th. (p<0.05 vs. BS) to 12-th. month (p<0.01) with LAC. UAE changes were statistically significant between 3 groups only at 3rd month (p<0.05). 1) Both drugs and combination significantly decreased BP (mean, daytime, noctural) after 3 months of treatment without altering 24-hour BP and HR cyrcadian rhythm. Only combination caused a marked reduction of early morning rise of BP. 2) UAE was reduced after 3-month treatment with IRB and combination, and after 6- month treatment with LAC. 3) The combination therapy with lower doses of IRB and LAC was more effective in controling hypertension and reducing UAE in hypertensive DM2 patients with microalbuminuria, then monotherapy with high doses of these drugs.

Hypertension, Diabetes, Ambulatory Blood Pressure Monitoring
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© American Journal of Hypertension, Ltd. 2001
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