Abstract
Objective: We comparatively studied the combined effects of 2 types of calcium channel blocker (CCB) (Azelnidipine tablet: AZL, Nifedipine CR tablet: NCR) in hypertensive patients with diabetes who have failed to achieve target blood pressure levels by usual dose of angiotensin II receptor antagonist (ARB). Methods: AZL 8-16 mg/day or NCR 10-40 mg/day was randomly allocated to 58 hypertensive patients with type 2 diabetes combined with valsartan 80 mg once after breakfast, and the dose was increased until they achieved their target blood pressure <130/80 mmHg (JSH2009). During the study, measurement of blood pressure/heart rate and hematology/urinalysis were performed for 6 months. Results: The doses of CCB were 17.1±9.4 mg/day in the AZL group and 13.2±3.9 mg/day in the NCR group (mean±SD). No significant difference was observed in the patients characteristics between the two groups. Twenty-two patients were with eGFR <60, and 46 patients with normal albuminuria. Although 65% or higher patients achieved target blood pressure level in month 6 in both groups, the blood pressure was significantly lower in the NCR group than the AZL group after month 2, and the rate of target attainment was significantly higher in the NCR group in month 4. The heart rate was decreased significantly in the NCR group. No changes were observed in the blood glucose, HbA1c, and urinary Alb/Cr in both groups, and eGFR was maintained favorably. No significant difference was observed in the changes in blood pressure and renal function in 22 patients with eGFR <60 at the study initiation in both groups. Conclusions: In type 2 diabetes patients with the stage 1-2 nephropathy, both high dose AZL and low dose NCR combined with ARB achieved target blood pressure levels, and could maintain the renal function favorably. It was confirmed that NCR has superior early antihypertensive effect and cost-effectiveness than AZL.
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