Olympios Christoforos, Stafylas Panagiotis, Dermitzakis Alkiviadis, Efthimiadis Ioannis, Gardikiotis Alexandros, Kakouros Stavros, Lampropoulos Stylianos, Barbetseas John, Sourgounis Angelos
Cardiology Department, Thriassio General Hospital of Elefsina, 196 00 Magoula, Greece.
Healthink, Pylaia, 570 01 Thessaloniki, Greece.
J Clin Med. 2024 Mar 14;13(6):1672. doi: 10.3390/jcm13061672.
: Although ranolazine has been available for years as a second-line treatment to reduce angina attacks in patients with stable angina pectoris, real-world data on the effectiveness, tolerability, and safety of ranolazine are limited. : A non-interventional, prospective study was conducted to assess the effectiveness and safety of ranolazine. Patients eligible for enrolment had a baseline assessment between one and fourteen days after initiating ranolazine for the first time and a follow-up visit three months later. The primary endpoints comprised the weekly frequency of angina attacks, total adverse events, and ranolazine discontinuation rate. The secondary endpoints included the use of short-acting nitrates, changes on the Canadian Cardiovascular Society (CCS) angina classification score and quality of life scale score (QoL). : In total, 1101 patients were enrolled at 214 sites. Mean weekly angina attacks were reduced from 3.6 ± 2.9 to 0.4 ± 0.9 ( < 0.0001) and the mean weekly consumption of short-acting nitrates decreased by 1.7 ± 2.2 ( < 0.0001). CCS class and QoL were also improved ( < 0.0001). Adverse events were reported by 11 (1%) patients in total, while 2 of them (0.2%) were characterised as serious. Treatment was discontinued for various reasons in 23 patients (2.1%) after the follow-up period. Ranolazine treatment was equally effective in all subgroups tested, with larger benefits observed in patients with more frequent angina and CCS angina class III and IV. Up-titration of ranolazine during the study improved the outcomes. : Ranolazine was well tolerated and effectively reduced angina attacks, with simultaneous improvement of the CCS class and QoL score in patients with stable angina.
尽管雷诺嗪作为二线治疗药物用于减少稳定型心绞痛患者的心绞痛发作已有数年,但关于雷诺嗪有效性、耐受性和安全性的真实世界数据有限。
开展了一项非干预性前瞻性研究以评估雷诺嗪的有效性和安全性。符合入组条件的患者在首次开始使用雷诺嗪后的1至14天进行基线评估,并在3个月后进行随访。主要终点包括每周心绞痛发作频率、总不良事件和雷诺嗪停药率。次要终点包括短效硝酸盐的使用、加拿大心血管学会(CCS)心绞痛分级评分和生活质量量表评分(QoL)的变化。
总共在214个研究点纳入了1101例患者。每周平均心绞痛发作次数从3.6±2.9次降至0.4±0.9次(<0.0001),短效硝酸盐的每周平均使用量减少了1.7±2.2次(<0.0001)。CCS分级和QoL也得到改善(<0.0001)。总共11例(1%)患者报告了不良事件,其中2例(0.2%)为严重不良事件。随访期后,23例(2.1%)患者因各种原因停药。在所有测试的亚组中,雷诺嗪治疗效果相同,在心绞痛发作更频繁以及CCS心绞痛分级为III级和IV级的患者中观察到更大的益处。研究期间增加雷诺嗪剂量可改善结果。
雷诺嗪耐受性良好,有效减少心绞痛发作,同时改善稳定型心绞痛患者的CCS分级和QoL评分。