Haddad Haissam, Bergeron Sebastien, Ignaszewski Andrew, Searles Gregory, Rochdi Driss, Dhage Priyanka, Bastien Natacha
Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
Department of Medicine, Centre de Recherche de l'Institut, Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Québec, Canada.
CJC Open. 2020 Apr 26;2(5):344-353. doi: 10.1016/j.cjco.2020.04.007. eCollection 2020 Sep.
To determine the effectiveness of sacubitril/valsartan 97/103 mg twice daily (b.i.d.) on tolerability, safety, and quality of life (QoL) in Canadian patients with heart failure with reduced ejection fraction in a real-life setting.
In rospective, Multicenter, Open Lbel, Post-Appovl tudy med at Characterizing the Use of CZ696 at 97 mg Sacubitril/103 mg Valsartan bid in Patients With HFrEF (PARASAIL), an open-label, prospective, phase IV, multicentre study, outpatients with heart failure with reduced ejection fraction and New York Heart Association functional class II-III were followed up for 12 months. The suggested starting dose of sacubitril/valsartan was 24/26 mg b.i.d. replacing angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, with an uptitration to 97/103 mg b.i.d. or as per clinical judgement. The primary endpoint was the proportion of patients achieving the target dose of sacubitril/valsartan 97/103 mg b.i.d. after 6 months of treatment.
For the 302 patients included, the mean age was 64.47 years, and a majority of patients (82.8%) belonged to New York Heart Association class II. Overall, 195 (64.6%) patients were on maximum dose of sacubitril/valsartan 97/103 mg b.i.d. after 6 months and 62.3% remained on this dose at month 12. Using patient global assessment, patients experienced an improvement in QoL. For Minnesota Living with Heart Failure Questionnaire scores, a significant decrease from the baseline was observed at weeks 4, 12, and 24 ( < 0.0001 for all), which indicated an improvement in QoL. The patient global assessment and Minnesota Living with Heart Failure Questionnaire results correlate with moderate but significant changes in Euro quality of life-5D visual analogue scale scores.
Results of the PARASAIL study in a real-life setting have shown that most patients were on sacubitril/valsartan 97/103 mg b.i.d. and the treatment was well tolerated. The patient-reported outcomes showed an overall improvement in patients' QoL.
在现实生活环境中，确定沙库巴曲缬沙坦97/103毫克每日两次（bid）对加拿大射血分数降低的心力衰竭患者的耐受性、安全性及生活质量（QoL）的有效性。
在一项名为“PARASAIL（射血分数降低的心力衰竭患者使用97毫克沙库巴曲/103毫克缬沙坦bid的特征研究）”的开放标签、前瞻性、IV期、多中心研究中，对射血分数降低且纽约心脏协会功能分级为II-III级的门诊心力衰竭患者进行了12个月的随访。沙库巴曲缬沙坦的建议起始剂量为24/26毫克bid，替代血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂，并根据临床判断滴定至97/103毫克bid。主要终点是治疗6个月后达到沙库巴曲缬沙坦97/103毫克bid目标剂量的患者比例。
纳入的302例患者中，平均年龄为64.47岁，大多数患者（82.8%）属于纽约心脏协会II级。总体而言，195例（64.6%）患者在6个月后达到了沙库巴曲缬沙坦97/103毫克bid的最大剂量，在第12个月时62.3%的患者仍维持该剂量。根据患者整体评估，患者的生活质量有所改善。对于明尼苏达心力衰竭生活问卷评分，在第4周、12周和24周时观察到与基线相比有显著下降（均P<0.0001），这表明生活质量有所改善。患者整体评估和明尼苏达心力衰竭生活问卷结果与欧洲五维度健康量表视觉模拟评分的中度但显著变化相关。
PARASAIL研究在现实生活环境中的结果表明，大多数患者使用沙库巴曲缬沙坦97/103毫克bid，且治疗耐受性良好。患者报告的结果显示患者的生活质量总体有所改善。
