| Objective: To evaluate the efficacy and safety of dagliazine in elderly patients with reduced ejection fraction heart failure by observing the changes of cardiac function,activity tolerance,renal function and other indexes and adverse drug reactions after taking dagliazine.Method: Method: A total of 253 elderly patients diagnosed with reduced ejection fraction heart failure in the Department of Cardiology,Hefei Second People’s Hospital from January 2020 to June 2021 were selected.According to the inclusion criteria,200 patients were enrolled.No Sodium-glucose cotransporter-2(SGLT2)inhibitors were used in the six months prior to inclusion.According to random number table method,they were divided into control group(100 cases)and observation group(100cases).The control group was given conventional heart failure treatment drugs,and the observation group was given dagliazine 10 mg qd on the basis of conventional heart failure treatment drugs.Both groups were treated with anti-heart failure for 6months.General data of blood routine,biochemistry,blood pressure,cardiac ultrasound index and other ventricular remodeling data were collected before and after treatment.Baseline clinical data of the two groups were compared,Left ventricular ejection fractions LVEF before and after treatment,Left ventricular end-diastolic diameter LVDd),Left ventricular end-systolic diameter(LVSd),N-terminal pro-brain natriuretic peptide(N-terminal pro-brain natriuretic peptide,NT-pro BNP),estimated glomerular filtration rate(e GFR),6 minute walking distance(6MWD),and other differences.The incidence of cardiovascular adverse events(rehospitalization of worsening heart failure and cardiogenic death)within 12 months after treatment and adverse drug reactions within 6 months after treatment in 2 groups were analyzed.Results: There were no significant differences in age,sex,proportion of T2 DM,body mass index,NYHA grade,systolic blood pressure,heart rate and glycosylated hemoglobin between the two groups(P > 0.05).Before treatment,LVEF was similar between control group and observation group,with no statistical significance(P >0.05).After 6 months of treatment,LVEF in both groups was improved,and the improvement of LVEF in observation group was more significant than that in control group(43.21 ± 3.04 vs 57.03 ± 5.05,P < 0.05).LVSd and LVSd decreased before and after treatment in both groups,and LVSd in observation group(42.49 ± 2.25 vs 39.38 ±2.83,P < 0.05)and LVDd decreased significantly(55.90 ± 2.01 vs 51.07 ± 2.98).There were no significant differences in NT-pro BNP,e GFR and 6MWD between the two groups before treatment(P > 0.05).Two groups of patients after 6 months of treatment,NT-pro BNP decreased,the difference was statistically significant(P < 0.05),but the observation group NT-pro BNP decreased more significantly than the control group(1710.85 ± 319.71 vs 1205.07 ± 243.93).After 6 months of treatment,6MWD increased in both groups,with statistical significance(P < 0.05),but the increase of6 MWD in the observation group was more significant than that in the control group(427.38 ± 38.66 vs 389.25 ± 25.09).e GFR in both groups was decreased compared with that before treatment,but there was no significant difference between groups(P >0.05).During follow-up within 12 months after treatment,7 patients in the control group and 5 patients in the observation group were lost to follow-up.In the control group,31 adverse end-point events occurred,including 15 deaths.In the observation group,18 adverse endpoint events occurred,including 6 deaths.Compared with the control group,dagliazine reduced the relative risk of major adverse endpoint events by42%[HR=0.72,95%CI(0.26-0.89),P=0.027],including hospitalizations due to heart failure [HR=0.49,95%CI 0.28-0.98].P=0.044] was lower than the control group.During 6 months of treatment,patients in both groups were regularly examined,including liver function,kidney function,blood glucose,blood pressure and electrocardiogram.There were 5 cases of hypoglycemia,2 cases of urinary tract infection and 1 case of renal function impairment in the observation group,and 1 case of hypotension and 1 case of urinary tract infection in the control group.However,there was no significant difference in the incidence of adverse reactions between the two groups.Conclusion: In addition to the standard anti-heart failure treatment in patients with reduced ejection fraction,dagliazine can further improve the cardiac function in patients with heart failure,inhibit ventricular remodeling,improve the quality of life of patients,and reduce the risk of cardiovascular adverse events with few adverse reactions and good safety. |
