Köster Ralf, Kaehler Jan, Meinertz Thomas
University Heart Center Hamburg, Clinic for Cardiology and Angiology, Martinistrasse 52, Hamburg, Germany.
Am Heart J. 2009 Oct;158(4):e51-7. doi: 10.1016/j.ahj.2009.06.008.
The antianginal efficacy of ivabradine was studied in controlled clinical trials. Strict patient selection criteria may cause a discrepancy between the results of highly controlled clinical trials and everyday routine practice. The objective of this study was to evaluate the efficacy and safety of ivabradine in everyday routine practice.
In this multicenter study, 4,954 patients with stable angina pectoris received ivabradine in everyday routine practice and underwent follow-up for 4 months. The heart rate (HR), angina pectoris attacks, nitrate consumption, overall efficacy, and tolerance were evaluated.
Within 4 months of treatment with ivabradine, HR was reduced by 12.4 +/- 12.2 beat/min from 82.9 +/- 15.3 to 70.4 +/- 9.2 beat/min (P < .0001). Angina pectoris attacks were reduced from 2.4 +/- 3.1 to 0.4 +/- 1.5 per week (P < .0001). Consumption of short-acting nitrates was reduced from 3.3 +/- 4.4 to 0.6 +/- 1.6 U/wk (P < .0001). Seventy-eight cases of adverse drug reactions were reported. The most common adverse drug reactions were nausea (n = 11, 0.22%) and dizziness (n = 9, 0.18%). Efficacy and tolerance were graded by physicians as being "excellent/very good" for 97% and 98% of the patients treated.
Ivabradine reduces the HR and is highly effective and well tolerated in the treatment of patients with symptomatic coronary artery disease. The results confirm the findings of controlled clinical trials in a broad patient population in everyday routine practice.
在对照临床试验中研究了伊伐布雷定的抗心绞痛疗效。严格的患者选择标准可能导致高度对照临床试验的结果与日常常规实践之间存在差异。本研究的目的是评估伊伐布雷定在日常常规实践中的疗效和安全性。
在这项多中心研究中，4954例稳定型心绞痛患者在日常常规实践中接受伊伐布雷定治疗，并进行了4个月的随访。评估了心率（HR）、心绞痛发作、硝酸酯类药物用量、总体疗效和耐受性。
在接受伊伐布雷定治疗的4个月内，心率从82.9±15.3次/分钟降至70.4±9.2次/分钟，降低了12.4±12.2次/分钟（P<.0001）。心绞痛发作次数从每周2.4±3.1次降至0.4±1.5次（P<.0001）。短效硝酸酯类药物用量从每周3.3±4.4单位降至0.6±1.6单位（P<.0001）。报告了78例药物不良反应。最常见的药物不良反应是恶心（n=11，0.22%）和头晕（n=9，0.18%）。医生将97%接受治疗的患者的疗效和98%患者的耐受性评为“优秀/非常好”。
伊伐布雷定可降低心率，在治疗有症状的冠状动脉疾病患者中具有高效性和良好的耐受性。结果在日常常规实践中的广泛患者群体中证实了对照临床试验的结果。
