- 學位論文
薈萃分析：SGLT2 抑製劑治療心衰竭的大型隨機對照試驗 臨床試驗計劃書：SGLT2 抑製劑對急性冠心症患者出院時的主要心血管不良事件的影響
Meta-analysis: Large randomized controlled trials of SGLT2 inhibitors in heart failure Clinical Trial Protocol: Effects of SGLT2 inhibitor on Major Adverse Cardiovascular Events at discharge of Acute Coronary Syndrome
摘要
簡介 DAPA-HF、EMPEROR-Reduced 和 EMPEROR-Preserved 臨床試驗表明，SGLT2 抑製劑可降低不同型心臟衰竭患者的心血管死亡或因心衰竭住院的複合終點。 然而，沒有一個單一臨床試驗有足夠的統計強度(power)來評估單一終點的療效，例如心血管死亡、全因死亡或是亞組分析。 我們試圖評估 SGLT2 抑製劑對射血分率降低或保留的心衰竭患者的心血管療效。 方法 薈萃分析使用了 DAPA-HF、EMPEROR-Reduced 和 EMPEROR-Preserved。 我們的主要終點是全因死亡，次要終點包括心血管死亡和心血管死亡或心衰竭住院的複合終點。 此外，我們評估了亞組分析的療效。 亞組分析包含了第二型糖尿病、性別、心衰竭史、eGFR、心衰竭原因和 NYHA 功能分級狀態。 我們使用來自 Cox proportional hazard models的 Hazard Ratio，並使用 I2 來評估統計異質性。 結果 在包括 14462 名患者在內的所有三項試驗中，SGLT2 抑製劑治療的全因死亡減少 9%（HR 0.91，95%CI 0.82~1.02；p=0.11）和心血管死亡減少 13%（0.87，0.78~ 0·97；p=0.01)。 此外，心血管死亡或首次心衰竭住院的複合事件相對減少了 29%（0.71，0.64~0·78；p<0.00001）。 在糖尿病、性別、心衰竭住院史、eGFR和心衰竭原因等亞組分析中，治療效果是一致的。 然而，NYHA 功能類別的亞組存在異質性。 解析 在不同試驗和不同亞組中，SGLT2 抑製劑對心血管死亡或心衰竭住院複合事件的影響是一致的。 然而，NYHA 功能類別的亞組分析中存在異質性。
並列摘要
Introduction DAPA-HF, EMPEROR-Reduced, and EMPEROR-Preserved trials showed that SGLT2 inhibitors reduced the composite endpoint of cardiovascular death or hospitalization for heart failure in patients with different subtypes of heart failure. However, no single trial has enough power to assess efficacy on any single endpoint, such as cardiovascular death, all-cause death, and efficacy in subgroups. We try to evaluate the efficacy of SGLT2 inhibitors on cardiovascular outcomes in heart failure patients with either a reduced or preserved ejection fraction. Methods DAPA-HF, EMPEROR-Reduced, and EMPEROR-Preserved trials were used for this meta-analysis. Our primary outcome was the time to all-cause death and secondary outcomes included cardiovascular death and the composite endpoint of cardiovascular death or hospitalization for heart failure. Also, we evaluated the efficacy in subgroups. The subgroups were type 2 diabetes status, sex, history of heart failure, eGFR, cause of heart failure, and NYHA functional class status. We used HRs from Cox proportional hazard models and I2 was used to evaluate the statistical heterogeneity. Result In all three trials including 14462 patients, treatment with SGLT2 inhibitors resulted in a 9% reduction in all-cause death (HR 0.91, 95%CI 0.82~1.02; p=0.11) and 13% reduction in cardiovascular death (0.87, 0.78~0·97; p=0.01). Furthermore, there is 29% relative reduction in the composite of cardiovascular death or first hospitalization for heart failure (0.71, 0.64~0·78; p<0.00001). The treatment effects were consistent in subgroups of diabetes, sex, history of hospitalization for heart failure, eGFR, and cause of heart failure. However, there is heterogeneity in the subgroup of NYHA functional class. Interpretation The effects of SGLT2 inhibitors on the composite of cardiovascular death or hospitalization for heart failure were consistent in independent trials and in different subgroups. However, there is heterogeneity in the subgroup of NYHA functional class.
參考文獻
延伸閱讀
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