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

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 doseescalation 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 25 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 nun Hg and 85.8 ± 8.7 mm Hg, respectively, g weeks after treatment compared with 158.3 ± 13.7 nun 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 nun 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. Barnidipine hydrochloride, calcium channel blocker, renal parenchymal hypertension, blood pressure.