Abstract
ObjectiveThe goal of this study was to assess the therapeutic efficacy and tolerability of barnidipine hydrochloride in patients with renal parenchymal hypertension. MethodsThe study consisted of 2 phases: a 2-week observation period and a 6- to 8-week treatment period. During the observation period, 1 placebo capsule was administered orally once daily for 2 weeks. One capsule of barnidipine 5 mg was given orally once daily during the initial 2 weeks of the treatment period. If the target hypotensive effect (ie, a decrease in systolic blood pressure [SBP]>20 mm Hg or in diastolic blood pressure [DBP]>10 mm Hg) was not achieved during the initial treatment period, the daily dose of barnidipine could be increased in 5-mg increments at 2-week intervals up to a maximum daily dose of 15 mg. Patients were instructed to discontinue all medications that could affect blood pressure. ResultsThirty-seven patients with renal parenchymal hypertension were enrolled. Of these, 31 completed the study. Six patients dropped out: 2 voluntarily discontinued treatment during the observation period; 2 stopped hospital visits at 4 and 6 weeks, respectively; and 2 discontinued because of adverse events. At the end of the 2-week observation period, the median values for baseline SBP and DBP were 170 mm Hg (range, 140ȁ200 mm Hg) and 110 mm Hg (range, 95ȁ130 mm Hg), respectively. After the initial 2 weeks of treatment, the respective values were 150 mm Hg (range, 120ȁ185 mm Hg) and 100 mm Hg (range, 80ȁ130 mm Hg). After 4 weeks of treatment, median SBP was 145 mm Hg (range, 120ȁ180 mm Hg) and median DBP was 90 mm Hg (range, 80ȁ130 mm Hg). At the end of treatment, the respective SBP and DBP values were 140 mm Hg (range, 120ȁ180 mm Hg) and 90 mm Hg (range, 70ȁ130 mm Hg). All of these reductions were significant compared with baseline values (P < 0.01). Blood pressure was considered to be reduced in 25 patients (80.6%), slightly reduced in 1 (3.2%), unchanged in 4 (12.9%), and slightly elevated in 1 (3.2%). Heart rate was not significantly affected. No significant adverse events were observed during or after treatment with barnidipine. ConclusionResults of this study suggest that barnidipine may be helpful in treating patients with renal parenchymal hypertension.
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