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    依帕列凈治療心衰患者可有效改善心血管和腎功能預后

    發布日期:2020年09月09日瀏覽量:文章來源:小柯機器人

      美國貝勒心臟和血管研究所Milton Packer團隊研究了依帕列凈治療心衰患者對心血管和腎功能預后的影響。2020年8月29日,該研究發表在《新英格蘭醫學雜志》上。

        鈉-葡萄糖共轉運蛋白2(SGLT2)抑制劑可降低患者因心力衰竭而住院的風險,無論其是否存在糖尿病。但該藥用于治療包括射血分數明顯降低的廣泛心力衰竭患者,療效尚不明確。

        在這項雙盲試驗中,研究組招募了3730名II、III或IV級心力衰竭且射血分數不超過40%的患者,將其按1:1隨機分配,除了推薦的治療方法外,1863名接受依帕列凈治療,1867名接受安慰劑治療。主要結局是心血管死亡或因心力衰竭加重而住院治療的綜合結果。

        中位隨訪16個月后,依帕列凈組有361名患者(19.4%)發生主要結局,顯著低于安慰劑組(462名,24.7%)。無論患者是否存在糖尿病,依帕列凈對主要結局的影響是一致的。依帕列凈組因心衰而住院的總患者數顯著低于安慰劑組。

        依帕列凈組中估計腎小球濾過率的年下降速率顯著慢于安慰劑組,發生嚴重腎結局的風險亦顯著低于安慰劑組。依帕列凈組中單純生殖道感染的風險顯著高于安慰劑組。

        總之,在接受推薦治療的心衰患者中使用依帕列凈可顯著改善預后,無論是否存在糖尿病。

        附:英文原文

        Title: Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure | NEJM

        Author: Milton Packer, M.D.,, Stefan D. Anker, M.D., Ph.D.,, Javed Butler, M.D.,, Gerasimos Filippatos, M.D.,, Stuart J. Pocock, Ph.D.,, Peter Carson, M.D.,, James Januzzi, M.D.,, Subodh Verma, M.D., Ph.D.,, Hiroyuki Tsutsui, M.D.,, Martina Brueckmann, M.D.,, Waheed Jamal, M.D.,, Karen Kimura, Ph.D.,, Janet Schnee, M.D.,, Cordula Zeller, Dipl.Math.,, Daniel Cotton, M.S.,, Edimar Bocchi, M.D.,, Michael Bhm, M.D., Ph.D.,, Dong-Ju Choi, M.D.,, Vijay Chopra, M.D.,, Eduardo Chuquiure, M.D.,, Nadia Giannetti, M.D.,, Stefan Janssens, M.D., Ph.D.,, Jian Zhang, M.D., Ph.D.,, Jose R. Gonzalez Juanatey, M.D.,, Sanjay Kaul, M.D.,, Hans-Peter Brunner-La Rocca, M.D.,, Bela Merkely, M.D.,, Stephen J. Nicholls, M.D.,, Sergio Perrone, M.D.,, Ileana Pina, M.D.,, Piotr Ponikowski, M.D.,, Naveed Sattar, M.D.,, Michele Senni, M.D.,, Marie-France Seronde, M.D.,, Jindrich Spinar, M.D.,, Iain Squire, M.D.,, Stefano Taddei, M.D.,, Christoph Wanner, M.D.,, and Faiez Zannad, M.D., Ph.D.

        Issue&Volume: 2020-08-29

        Abstract: 

        Background

        Sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.

        Methods

        In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.

        Results

        During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (–0.55 vs. –2.28 ml per minute per 1.73 m2 of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes. Uncomplicated genital tract infection was reported more frequently with empagliflozin.

        Conclusions

        Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes.

        DOI: 10.1056/NEJMoa2022190

        Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2022190


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