Abstract
Introduction: In patients with hypertensive intracerebral hemorrhage (ICH), intravenous (i.v.) Nicardipine is often used to lower the blood pressure. However, reflex tachycardia is a well-known side effect. Bisoprolol transdermal patch, a beta-blocker to be percutaneously absorbed, recently became commercially available in Japan. It can be used for patients with acute ICH with vomiting or dysphagia. The aim of this study is to evaluate suppressing effect of tachycardia and cost effectiveness of adding Bisoprolol transdermal patch to i.v. Nicardipine in patients with hypertensive ICH. Methods: We randomly assigned patients who were admitted to our department from January 2015 through April 2017 because of acute ICH to single antihypertensive treatment group (i.v. Nicardipine only) or combination treatment group (Bisoprolol transdermal patch and i.v. Nicardipine). The primary outcome was heart rate during 24 hours after admission. Key secondary outcomes were dose of Nicardipine (drug costs), neurological prognosis as defined by modified Rankin scale 0 to 2, and adverse drug reactions. Results: A total of 59 patients were randomized into two groups; 35 patients were assigned to single antihypertensive treatment group and 24 patients were assigned to combination treatment group. There were no significant differences between two groups in baseline characteristics on admission (age, body weight, hematoma volume, NIHSS, systolic blood pressure, heart rate). Mean heart rate during 24 hours after admission were significantly lower in combination treatment group (78.10±11.43 vs. 86.13±12.46, P=0.021). Hourly heart rate of combination treatment group was significantly lower in 5 to 24 hours later from start of treatment. Dose of Nicardipine was tended to be lower in combination treatment group (80.54±65.93 vs. 119.7±96.80mg, P=0.10), and costs of antihypertensive drug was tended to be lower in combination treatment group (5708±4569 vs. 8292±6708 yen, P=0.13). Neurological prognosis showed no difference (P=0.72), and bradycardia occurred in three patients of combination treatment group. Conclusions: Adding Bisoprolol transdermal patch to Nicardipine can decrease heart rate and may reduce drug costs in antihypertensive treatment for acute ICH.
Published Version
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