Rittinghausen R
Boehringer Mannheim GmbH, Federal Republic of Germany.
Drugs. 1988;36 Suppl 6:92-101. doi: 10.2165/00003495-198800366-00016.
The aim of this multicentre, double-blind, randomised, controlled study was to evaluate the antihypertensive effect and to determine the response rates, safety and tolerability of 3 doses of carvedilol (25, 50 and 100 mg) compared with those of pindolol 15 mg, in ambulatory patients with mild to moderate uncomplicated essential hypertension. Mean supine diastolic blood pressure was the primary efficacy variable. 205 subjects between 23 and 70 years of age were randomly assigned to receive an oral dose of carvedilol or pindolol once daily for 13 weeks after a placebo run-in period of up to 4 weeks. Before administration of the study medication, blood pressure was recorded at each visit by use of the cuff method, and heart rate was counted. The results showed similar reductions in mean supine diastolic blood pressure among all 4 treatments after 13 weeks. Carvedilol showed a good and similar response rate of approximately 84% at all doses. Heart rate was not significantly changed. The number of patients having adverse experiences possibly related to drug therapy was 4, 16 and 15 with 25, 50 and 100 mg carvediolol, respectively, and 9 with pindolol 15 mg. Dizziness was the most common side effect reported for all medications. In conclusion, carvedilol 25 mg appeared to be the optimum dose in the present study, displaying a high antihypertensive potency with few side effects.
这项多中心、双盲、随机对照研究的目的是评估3种剂量(25毫克、50毫克和100毫克)的卡维地洛与15毫克吲哚洛尔相比,对轻至中度无并发症原发性高血压门诊患者的降压效果,并确定其有效率、安全性和耐受性。平均仰卧位舒张压是主要疗效变量。205名年龄在23至70岁之间的受试者在长达4周的安慰剂导入期后,被随机分配接受每日一次口服剂量的卡维地洛或吲哚洛尔,为期13周。在服用研究药物之前,每次就诊时使用袖带法记录血压,并计算心率。结果显示,13周后,所有4种治疗方法的平均仰卧位舒张压均有相似程度的降低。卡维地洛在所有剂量下的有效率均良好且相似,约为84%。心率无显著变化。可能与药物治疗相关的不良经历患者数量,服用25毫克、50毫克和100毫克卡维地洛的分别为4例、16例和15例,服用15毫克吲哚洛尔的为9例。头晕是所有药物报告中最常见的副作用。总之,在本研究中,25毫克卡维地洛似乎是最佳剂量,显示出高降压效力且副作用较少。