Safety of dapagliflozin initiation in acute decompensated heart failure patients with reduced left ventricular ejection fraction

Anastasiya E. Poskakalova, S. Nasonova, I. Zhirov, S. Tereshchenko
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Abstract

Background. Chronic heart failure (CHF) is an immediate cardiological problem. At the same time, acute decompensated heart failure (ADHF) is associated with an extremely unfavorable prognosis and low survival of patients. Aim. To evaluate the safety of sodium-glucose cotransporter-2 inhibitor dapagliflozin early administration in patients with ADHF with a reduced left ventricular ejection fraction (LVEF) regardless of type 2 diabetes mellitus (diabetes). Materials and methods. We used standard CHF therapy and intravenous diuretic therapy in combination with 10 mg dapagliflozin in 43 patients with NYHA class IIIV ADHF. The study mainly included 39 (90.7%) male patients, the mean age was 6012 years (5663), diabetes was in 14 (32.6%) patients. Dapagliflozin was prescribed by a mean of 2 days (13) from admission to the hospital. The parameters were analyzed at the time of inclusion in the study and when CHF compensation was achieved. Results. The median of the length of hospital stay was 7 days (610). LVEF significantly increased during hospitalization from 276 to 307% (p0.001) and the level of NT-proBNP decreased: from 3700 pg/ml (17455331) to 1366 pg/ml (10252878); p=0.007. A decrease in the marker was observed in 90% of patients. Hypotension (decrease in systolic blood pressure BP less than 90 mmHg) was observed in 10 (23.3%) patients. A statistically significant decrease in BP was found: systolic and diastolic BP on admission was 114 mmHg (100126) and 70 mmHg (7080), respectively, when CHF compensation was achieved 110 mmHg (98120) and 70 mmHg (6178); p=0.047 and p=0.013, respectively. The increase in hematocrit during hospitalization was also statistically significant from 43.53.6 to 46.14.9% (p0.001) and this was found in 67% of patients. A total of 4 (9.3%) patients had acute renal injury (decrease in estimated glomerular filtration rate GFR by 25% or more). At the same time, there was no decrease in GFR of less than 15 ml/min/1.73 m2. There was no statistically significant decrease in GFR and an increase in creatinine levels during hospitalization (p=0.214 and 0.173, respectively). Urinary tract infections were observed in 1 (2.3%) patient, transient hypoglycemia in 2 (4.7%) patients, which did not lead to the discontinuation of dapagliflozin. Diabetic ketoacidosis, allergic reactions, syncope, lower extremity amputations were not observed in patients taking dapagliflozin. Conclusion. It can be concluded that dapagliflozin has a favorable safety profile when used in patients with ADHF, regardless of the presence or absence of diabetes.
达格列净起始治疗急性失代偿性心力衰竭左室射血分数降低患者的安全性
背景。慢性心力衰竭(CHF)是一个直接的心脏病问题。同时,急性失代偿性心力衰竭(ADHF)患者预后极差,生存率低。的目标。评价钠-葡萄糖共转运蛋白-2抑制剂达格列净早期应用于左室射血分数(LVEF)降低的ADHF患者的安全性,不论是否患有2型糖尿病。材料和方法。我们对43例NYHA iii类ADHF患者采用标准的CHF治疗和静脉利尿剂治疗联合10mg达格列净。男性患者39例(90.7%),平均年龄6012岁(5663岁),糖尿病14例(32.6%)。达格列净的处方时间平均为入院后2天(13天)。在纳入研究时和达到CHF补偿时对参数进行分析。结果。住院时间的中位数为7天(610天)。住院期间LVEF从276显著增加到307% (p0.001), NT-proBNP水平下降:从3700 pg/ml(17455331)降至1366 pg/ml (10252878);p = 0.007。在90%的患者中观察到该标志物的下降。10例(23.3%)患者出现低血压(收缩压降低BP低于90 mmHg)。血压有统计学意义的降低:入院时收缩压和舒张压分别为114 mmHg(100126)和70 mmHg(7080),当CHF补偿达到110 mmHg(98120)和70 mmHg(6178)时;P =0.047, P =0.013。住院期间红细胞压积的增加也有统计学意义,从43.53.6增加到46.14.9% (p0.001), 67%的患者出现这种情况。共有4例(9.3%)患者出现急性肾损伤(估计肾小球滤过率GFR降低25%或更多)。同时,GFR在小于15 ml/min/1.73 m2时没有下降。住院期间GFR降低、肌酐升高无统计学意义(p值分别为0.214、0.173)。尿路感染1例(2.3%),短暂性低血糖2例(4.7%),未导致停用达格列净。服用达格列净的患者未见糖尿病酮症酸中毒、过敏反应、晕厥、下肢截肢。结论。可以得出结论,无论是否存在糖尿病,在ADHF患者中使用达格列净都具有良好的安全性。
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