Open-label, uncontrolled, clinical trial of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension

Abstract

Background: Barnidipine hydrochloride is a calcium channel blocker that is administered in a single daily dose. It has been shown to be effective in lowering blood pressure in Japanese patients with essential hypertension, renal parenchymal hypertension, and renovascular hypertension. Objective: The purpose of this study was to assess the antihypertensive efficacy and tolerability of barnidipine hydrochloride in Korean patients with renal parenchymal hypertension. Methods: This open-label, uncontrolled study used a dose-escalation design, with 5 to 15 mg barnidipine administered once daily for 4 to 8 weeks. Korean patients with renal parenchymal hypertension were enrolled. Results: Of the 31 patients enrolled, 30 (15 men and 15 women; mean age, 45.1 ± 10.4 years; mean body weight, 62.5 ± 10.4 kg; mean sitting systolic blood pressure [SBP], 158.0 ± 13.2 mm Hg; mean diastolic blood pressure [DBP], 101.8 ± 7.1 mm Hg) completed the entire schedule of drug administration. One patient discontinued hospital visits at 2 weeks. In 3 patients treated with barnidipine 5 mg/d for 4 weeks, mean SBP and DBP were 131.7 ± 16.1 mm Hg and 85.0 ± 5.0 mm Hg, respectively, after 4 weeks of treatment compared with 160.0 ± 34.6 mm Hg and 105.0 ± 13.2 mm Hg at baseline. In 15 patients treated with barnidipine 5 mg/d for 2 weeks and 10 mg/d for 4 weeks, mean SBP and DBP were 138.3 ± 7.9 mm Hg and 84.3 ± 8.0 mm Hg, respectively, 6 weeks after treatment compared with 160.7 ± 13.7 mm Hg and 102.7 ± 9.0 mm Hg at baseline ( P < 0.05). In 12 patients treated with barnidipine 5 mg/d for 2 weeks, 10 mg/d for 2 weeks, and 15 mg/d for 4 weeks, mean SBP and DBP were 139.6 ± 8.7 mm Hg and 85.8 ± 8.7 mm Hg, respectively, 8 weeks after treatment compared with 158.3 ± 13.7 mm Hg and 100.8 ± 6.0 mm Hg at baseline ( P < 0.05). Mean sitting SBP after 4 to 8 weeks of treatment with barnidipine was 139.9 ± 8.5 mm Hg (mean reduction, 18.1 mm Hg [11.4%]) and mean sitting DBP was 85.5 ± 7.5 mm Hg (mean reduction, 16.3 mm Hg [16%]). Sitting heart rate did not change after treatment with barnidipine. Barnidipine was well tolerated; mild adverse events occurred in 5 of 30 patients (17%) and included facial flushing (13%), tachycardia (13%), and headache (7%). Conclusions: The results suggest that barnidipine is effective in reducing systemic hypertension and is well tolerated in this sample of Korean patients with renal parenchymal hypertension.