Weigmann I, Terhaag B, Wierich W, Herrmann W M
Arzneimittelwerk Dresden GmbH, Abteilung Medizinische Forschung, Radebeul, Berlin.
Arzneimittelforschung. 1998 Mar;48(3):240-4.
The dose dependence of the antihypertensive effect of the beta 1 selective blocker talinolol (CAS 57460-41-0, Cordanum) was investigated in 97 essential hypertensive patients (mild to moderate) using the ambulatory blood pressure monitoring (ABPM) in a single-centre, double-blind, randomized parallel-group study. After 4 weeks of treatment a comparison was made between the once daily administered doses of 50, 100 and 200 mg as well as with placebo. The primary parameter was the mean diastolic blood pressure between 8.00 and 22.00 (dTMW). Furthermore, the duration of action of the once daily administration of 200 mg talinolol was compared with the twice daily application of 100 mg each. With regard to dTMW an increasing antihypertensive effect was determined for the dosage step from 50 mg to 100 mg talinolol/d. No further increase in the blood pressure lowering effect was observed with 200 mg talinolol/d. The highest frequency of therapy responders was found in the 100 mg group with 72.2%. Moreover it could be demonstrated, that within the dosage range of 1 x 100-200 mg Talinolol/d a significant and 24 h lasting reduction of blood pressure and pulse rate was achieved, including the early morning period. There were no differences between the blood pressure profile of the 200 mg group and the 2 x 100 mg group at the end of the 4 weeks treatment. All talinolol dosages investigated in this study were proved to be safe and well tolerated. The observed complaints classified as adverse drug reactions represented typical side effects of beta-blockers of mild to moderate intensity. It can be concluded from the results that the once daily intake of talinolol in the dosage range of 100-200 mg/d shows a reliable efficacy in the treatment of essential hypertension accompanied by a noncritical safety profile.
在一项单中心、双盲、随机平行组研究中,采用动态血压监测(ABPM)对97例轻度至中度原发性高血压患者,研究了β1选择性阻滞剂他林洛尔(CAS 57460 - 41 - 0,Cordanum)降压作用的剂量依赖性。治疗4周后,对每日一次服用的50、100和200 mg剂量以及安慰剂进行了比较。主要参数是8:00至22:00之间的平均舒张压(dTMW)。此外,还比较了每日一次服用200 mg他林洛尔与每日两次各服用100 mg的作用持续时间。就dTMW而言,他林洛尔剂量从50 mg/d增加到100 mg/d时,降压作用增强。200 mg/d的他林洛尔未观察到血压降低效果进一步增加。100 mg组治疗反应者频率最高,为72.2%。此外,可以证明,在1×100 - 200 mg他林洛尔/d的剂量范围内,包括清晨时段,血压和脉搏率可实现显著且持续24小时的降低。4周治疗结束时,200 mg组和2×100 mg组的血压曲线无差异。本研究中所研究的所有他林洛尔剂量均被证明是安全且耐受性良好的。观察到的被归类为药物不良反应的主诉代表了轻度至中度强度β受体阻滞剂的典型副作用。从结果可以得出结论,每日一次摄入100 - 200 mg/d剂量的他林洛尔在治疗原发性高血压方面显示出可靠的疗效,且安全性良好。