Müller-Werdan Ursula, Stöckl Georg, Ebelt Henning, Nuding Sebastian, Höpfner Florian, Werdan Karl
Exp Gerontol. 2014 Nov;59:34-41. doi: 10.1016/j.exger.2014.09.002.
Clinical trials have proven the anti-anginal and anti-ischemic efficacy of the pacemaker current inhibitor ivabradine in combination with beta-blockers in patients with stable angina pectoris (AP). This retrospective subgroup analysis of the ADDITIONS study evaluated the effectiveness and tolerability of ivabradine combined with beta-blockers, and its effects on angina symptoms and quality of life in elderly patients ≥ 75 years in everyday practice.
In the non-interventional, multicenter, prospective, open-label ADDITIONS study 2330 patients with stable AP of different age groups were treated with a flexible dose of ivabradine twice daily in addition to beta-blockers for 4 months. Heart rate (HR), number of angina attacks, nitrate consumption, tolerance, and quality of life (QoL) were evaluated. A subgroup analysis was performed, focusing on 479 patients (21%) ≥ 75 years.
In these 479 patients ≥ 75 years ivabradine (mean dose 11.61 ± 3.18 mg per day) after 4 months of treatment reduced HR by 19.2 ± 11.6 bpm to 65.4 ± 8.3 bpm. The average number of angina attacks per week was decreased by 1.6 ± 1.8 to 0.4 ± 1.3 and the average consumption of short-acting nitrates per week was reduced by 2.2 ± 3.2 to 0.6 ± 1.8 units (both p < 0.0001). There was a marked shift in Canadian Cardiovascular Society (CCS) grade distribution with most patients (57%) now classified as CCS grade I, and 42% as CCS grades II and III. This was accompanied by an improvement in EQ-5D QoL index to 0.75 ± 0.22 (p < 0.0001). Tolerability of ivabradine treatment was rated by the physicians as “very good/good” for 72%/28% of elderly patients.
In daily clinical practice, addition of ivabradine to beta-blockers was effective in reducing HR, angina attacks and nitrate consumption in elderly patients (≥ 75 years) with stable angina pectoris. In addition, a marked improvement of CCS symptom scores and QoL was demonstrated. Treatment was generally well tolerated.
临床试验已证明,起搏器电流抑制剂伊伐布雷定与β受体阻滞剂联合应用于稳定型心绞痛(AP)患者时具有抗心绞痛和抗缺血的疗效。这项ADDITIONS研究的回顾性亚组分析评估了伊伐布雷定联合β受体阻滞剂在日常临床实践中对≥75岁老年患者的有效性、耐受性及其对心绞痛症状和生活质量的影响。
在非干预性、多中心、前瞻性、开放标签的ADDITIONS研究中,2330例不同年龄组的稳定型AP患者,在使用β受体阻滞剂的基础上,每日两次灵活剂量服用伊伐布雷定,持续4个月。评估心率(HR)、心绞痛发作次数、硝酸酯类药物消耗量、耐受性和生活质量(QoL)。进行了亚组分析,重点关注479例(21%)≥75岁的患者。
在这479例≥75岁的患者中,治疗4个月后伊伐布雷定(平均剂量为每日11.61±3.18 mg)使HR从65.4±8.3次/分钟降低了19.2±11.6次/分钟。每周心绞痛发作的平均次数从1.6±1.8次减少至0.4±1.3次,每周短效硝酸酯类药物的平均消耗量从2.2±3.2单位减少至0.6±1.8单位(均p<0.0001)。加拿大心血管学会(CCS)分级分布有明显变化,大多数患者(57%)现在被归类为CCS I级,42%为CCS II级和III级。同时,EQ-5D生活质量指数提高到0.75±0.22(p<0.0001)。医生对伊伐布雷定治疗耐受性的评价为,72%/28%的老年患者为“非常好/好”。
在日常临床实践中,伊伐布雷定联合β受体阻滞剂可有效降低≥75岁稳定型心绞痛老年患者的心率、心绞痛发作次数和硝酸酯类药物消耗量。此外,CCS症状评分和生活质量有显著改善。治疗的耐受性总体良好。