OBJECTIVE: We conducted a systematic review to evaluate all available clinical evidence on trimetazidine in HF. We searched Medline/PubMed, Embase, Cochrane CENTRAL and ClinicalTrials.gov to identify relevant studies.
METHODS: Out of 213 records, we included 28 studies in the meta-analysis (containing 2552 unique patients), which almost exclusively randomised patients with HF with reduced ejection fraction (HFrEF). The studies were relatively small (median study size: N=58) and of short duration (mean follow-up: 6 months), with the majority (68%) being open label.
RESULTS: Trimetazidine in HFrEF was found to significantly reduce cardiovascular mortality (OR 0.33, 95% CI 0.21 to 0.53) and HF hospitalisations (OR 0.42, 95% CI 0.29 to 0.60). In addition, trimetazidine improved (New York Heart Association) functional class (mean difference: -0.44 (95% CI -0.49 to -0.39), 6 min walk distance (mean difference: +109 m (95% CI 105 to 114 m) and quality of life (standardised mean difference: +0.52 (95% CI 0.32 to 0.71). A similar pattern of effects was observed for both ischaemic and non-ischaemic cardiomyopathy.
CONCLUSIONS: Current evidence supports the potential role of trimetazidine in HFrEF, but this is based on multiple smaller trials of varying quality in study design. We recommend a large pragmatic randomised clinical trial to establish the definitive role of trimetazidine in the management of HFrEF.
目的:我们进行了系统评价,以评估曲美他嗪治疗HF的所有可用临床证据。我们搜索了Medline/PubMed,Embase,CochraneCENTRAL和ClinicalTrials.gov确定相关研究。
方法:在213条记录中,我们在荟萃分析中纳入了28项研究(包含2552名独特患者),几乎完全随机分配了射血分数降低(HFrEF)的HF患者。研究相对较小(中位研究规模:N=58),持续时间短(平均随访:6个月),大多数(68%)是开放标签。
结果:发现曲美他嗪在HFrEF中可显著降低心血管死亡率(OR0.33,95%CI0.21至0.53)和HF住院率(OR0.42,95%CI0.29至0.60)。此外,曲美他嗪改善(纽约心脏协会)功能等级(平均差异:-0.44(95%CI-0.49至-0.39),6分钟步行距离(平均差:+109m(95%CI105-114m)和生活质量(标准化平均差:+0.52(95%CI0.32-0.71))。对于缺血性和非缺血性心肌病均观察到相似的作用模式。
结论:目前的证据支持曲美他嗪在HFrEF中的潜在作用,但这是基于多项较小的试验,这些试验的质量各不相同。我们建议进行一项大型实用随机临床试验,以确定曲美他嗪在HFrEF治疗中的明确作用。