1.Clinical trial of empagliflozin combined with benazepril in treatment of patients with type 2 diabetic kidney disease
Hua-sang HUANG ; Jia-ying CAI ; Ya-ling CHEN ; Jian-fu ZHANG ; Shi-zhong SHEN
The Chinese Journal of Clinical Pharmacology 2024;40(23):3380-3384
Objective To observe the role of empagliflozin tablets combined with benazepril hydrochloride tablets on clinical efficacy and renal outcomes in treating type 2 diabetic kidney disease(DKD).Methods Patients with type 2 DKD were divided into treatment group and control group by means of the random number table method.The control group was treated with benazepril hydrochloride tablets(10 mg,qd)and the treatment group was treated with empagliflozin tablets on the basis of the control group.The initial dose was 10 mg,qd,adjusted to 25 mg after tolerance,qd.Two groups were treated for 3 months.The clinical efficacy,blood glucose indexes[fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1 c)],renal function indexes[serum creatinine(SCr),glomerular filtration rate(eGFR)],oxidative stress indexes[superoxide dismutase(SOD),malondialdehyde(MDA)],renal outcomes and safety were compared between the two groups before and after treatment.Results In the treatment group,63 cases were enrolled,2 cases were lost,and 61 cases were finally included in the statistical analysis.In the control group,63 cases were enrolled,2 cases were lost,and finally 61 cases were included in the statistical analysis.After treatment,the total effective rates in treatment group and control group were 88.52%(54 cases/61 cases)and 73.77%(45 cases/61 cases),respectively(P<0.05).After treatment,the peripheral blood FPB levels in treatment group and control group were(5.64±0.58)and(6.31±0.79)mmol·L-1;HbA1c levels were(6.09±0.75)%and(6.94±0.96)%;SCr levels were(111.88±11.45)and(119.41±8.31)μmol·L-1;eGFR values were(64.11±9.04)and(58.92±4.79)mL·min-1·1.73 m-2;SOD levels were(45.72±5.53)and(39.54±3.97)U·mL-1;MDA levels were(26.18±3.22)and(30.31±3.65)nmol·mL-1;the incidence rates of adverse renal outcomes were 6.56%(4 cases/61 cases)and 19.67%(12 cases/61 cases),respectively,with statistical differences(all P<0.05).The adverse drug reactions in treatment group were mainly urinary tract infection,hypoglycemia and headache,and those in control group were mainly hypotension and headache.The incidence rates of adverse drug reactions were 9.84%(6 cases/61 cases)and 6.56%(4 cases/61 cases),respectively(P>0.05).Conclusion The clinical efficacy of empagliflozin tablets combined with benazepril hydrochloride tablets in the treatment of type 2 DKD is better,which can reduce the incidence of adverse renal outcomes without increasing adverse drug reactions.
2.Clinical trial of empagliflozin combined with benazepril in treatment of patients with type 2 diabetic kidney disease
Hua-sang HUANG ; Jia-ying CAI ; Ya-ling CHEN ; Jian-fu ZHANG ; Shi-zhong SHEN
The Chinese Journal of Clinical Pharmacology 2024;40(23):3380-3384
Objective To observe the role of empagliflozin tablets combined with benazepril hydrochloride tablets on clinical efficacy and renal outcomes in treating type 2 diabetic kidney disease(DKD).Methods Patients with type 2 DKD were divided into treatment group and control group by means of the random number table method.The control group was treated with benazepril hydrochloride tablets(10 mg,qd)and the treatment group was treated with empagliflozin tablets on the basis of the control group.The initial dose was 10 mg,qd,adjusted to 25 mg after tolerance,qd.Two groups were treated for 3 months.The clinical efficacy,blood glucose indexes[fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1 c)],renal function indexes[serum creatinine(SCr),glomerular filtration rate(eGFR)],oxidative stress indexes[superoxide dismutase(SOD),malondialdehyde(MDA)],renal outcomes and safety were compared between the two groups before and after treatment.Results In the treatment group,63 cases were enrolled,2 cases were lost,and 61 cases were finally included in the statistical analysis.In the control group,63 cases were enrolled,2 cases were lost,and finally 61 cases were included in the statistical analysis.After treatment,the total effective rates in treatment group and control group were 88.52%(54 cases/61 cases)and 73.77%(45 cases/61 cases),respectively(P<0.05).After treatment,the peripheral blood FPB levels in treatment group and control group were(5.64±0.58)and(6.31±0.79)mmol·L-1;HbA1c levels were(6.09±0.75)%and(6.94±0.96)%;SCr levels were(111.88±11.45)and(119.41±8.31)μmol·L-1;eGFR values were(64.11±9.04)and(58.92±4.79)mL·min-1·1.73 m-2;SOD levels were(45.72±5.53)and(39.54±3.97)U·mL-1;MDA levels were(26.18±3.22)and(30.31±3.65)nmol·mL-1;the incidence rates of adverse renal outcomes were 6.56%(4 cases/61 cases)and 19.67%(12 cases/61 cases),respectively,with statistical differences(all P<0.05).The adverse drug reactions in treatment group were mainly urinary tract infection,hypoglycemia and headache,and those in control group were mainly hypotension and headache.The incidence rates of adverse drug reactions were 9.84%(6 cases/61 cases)and 6.56%(4 cases/61 cases),respectively(P>0.05).Conclusion The clinical efficacy of empagliflozin tablets combined with benazepril hydrochloride tablets in the treatment of type 2 DKD is better,which can reduce the incidence of adverse renal outcomes without increasing adverse drug reactions.
3.Current use of oral anticoagulation therapy and influencing factors among coronary artery disease patients with nonvalvular atrial fibrillation in China.
Yan QIAO ; Yue WANG ; Song Nan LI ; Chen Xi JIANG ; Cai Hua SANG ; Ri Bo TANG ; De Yong LONG ; Jia Hui WU ; Liu HE ; Xin DU ; Jian Zeng DONG ; Chang Sheng MA
Chinese Journal of Cardiology 2023;51(5):504-512
Objective: To investigate current use of oral anticoagulant (OAC) therapy and influencing factors among coronary artery disease (CAD) patients with nonvalvular atrial fibrillation (NVAF) in China. Methods: Results of this study derived from "China Atrial Fibrillation Registry Study", the study prospectively enrolled atrial fibrillation (AF) patients from 31 hospitals, and patients with valvular AF or treated with catheter ablation were excluded. Baseline data such as age, sex and type of atrial fibrillation were collected, and drug history, history of concomitant diseases, laboratory results and echocardiography results were recorded. CHA2DS2-VASc score and HAS-BLED score were calculated. The patients were followed up at the 3rd and 6th months after enrollment and every 6 months thereafter. Patients were divided according to whether they had coronary artery disease and whether they took OAC. Results: 11 067 NVAF patients fulfilling guideline criteria for OAC treatment were included in this study, including 1 837 patients with CAD. 95.4% of NVAF patients with CAD had CHA2DS2-VASc score≥2, and 59.7% of patients had HAS-BLED≥3, which was significantly higher than NVAF patients without CAD (P<0.001). Only 34.6% of NVAF patients with CAD were treated with OAC at enrollment. The proportion of HAS-BLED≥3 in the OAC group was significantly lower than in the no-OAC group (36.7% vs. 71.8%, P<0.001). After adjustment with multivariable logistic regression analysis, thromboembolism(OR=2.48,95%CI 1.50-4.10,P<0.001), left atrial diameter≥40 mm(OR=1.89,95%CI 1.23-2.91,P=0.004), stain use (OR=1.83,95%CI 1.01-3.03, P=0.020) and β blocker use (OR=1.74,95%CI 1.13-2.68,P=0.012)were influence factors of OAC treatment. However, the influence factors of no-OAC use were female(OR=0.54,95%CI 0.34-0.86,P=0.001), HAS-BLED≥3 (OR=0.33,95%CI 0.19-0.57,P<0.001), and antiplatelet drug(OR=0.04,95%CI 0.03-0.07,P<0.001). Conclusion: The rate of OAC treatment in NVAF patients with CAD is still low and needs to be further improved. The training and assessment of medical personnel should be strengthened to improve the utilization rate of OAC in these patients.
Humans
;
Female
;
Male
;
Atrial Fibrillation/drug therapy*
;
Coronary Artery Disease/complications*
;
Anticoagulants/therapeutic use*
;
Platelet Aggregation Inhibitors/therapeutic use*
;
Risk Factors
;
China
;
Administration, Oral
;
Stroke
4.Catheter ablation versus medical therapy for atrial fibrillation with prior stroke history: a prospective propensity score-matched cohort study.
Wen-Li DAI ; Zi-Xu ZHAO ; Chao JIANG ; Liu HE ; Ke-Xin YAO ; Yu-Feng WANG ; Ming-Yang GAO ; Yi-Wei LAI ; Jing-Rui ZHANG ; Ming-Xiao LI ; Song ZUO ; Xue-Yuan GUO ; Ri-Bo TANG ; Song-Nan LI ; Chen-Xi JIANG ; Nian LIU ; De-Yong LONG ; Xin DU ; Cai-Hua SANG ; Jian-Zeng DONG ; Chang-Sheng MA
Journal of Geriatric Cardiology 2023;20(10):707-715
BACKGROUND:
Patients with atrial fibrillation (AF) and prior stroke history have a high risk of cardiovascular events despite anticoagulation therapy. It is unclear whether catheter ablation (CA) has further benefits in these patients.
METHODS:
AF patients with a previous history of stroke or systemic embolism (SE) from the prospective Chinese Atrial Fibrillation Registry study between August 2011 and December 2020 were included in the analysis. Patients were matched in a 1:1 ratio to CA or medical treatment (MT) based on propensity score. The primary outcome was a composite of all-cause death or ischemic stroke (IS)/SE.
RESULTS:
During a total of 4.1 ± 2.3 years of follow-up, the primary outcome occurred in 111 patients in the CA group (3.3 per 100 person-years) and in 229 patients in the MT group (5.7 per 100 person-years). The CA group had a lower risk of the primary outcome compared to the MT group [hazard ratio (HR) = 0.59, 95% CI: 0.47-0.74, P < 0.001]. There was a significant decreasing risk of all-cause mortality (HR = 0.43, 95% CI: 0.31-0.61, P < 0.001), IS/SE (HR = 0.73, 95% CI: 0.54-0.97, P = 0.033), cardiovascular mortality (HR = 0.32, 95% CI: 0.19-0.54, P < 0.001) and AF recurrence (HR = 0.33, 95% CI: 0.30-0.37, P < 0.001) in the CA group compared to that in the MT group. Sensitivity analysis generated consistent results when adjusting for time-dependent usage of anticoagulants.
CONCLUSIONS
In AF patients with a prior stroke history, CA was associated with a lower combined risk of all-cause death or IS/SE. Further clinical trials are warranted to confirm the benefits of CA in these patients.
6.Association between atrial fibrillation reoccurrence and new-onset ischemic stroke among patients with nonvalvular atrial fibrillation.
Liu HE ; Chao JIANG ; Chen Xi JIANG ; Ri Bo TANG ; Cai Hua SANG ; De Yong LONG ; Xin DU ; Jian Zeng DONG ; Chang Sheng MA
Chinese Journal of Cardiology 2023;51(9):944-950
Objective: Explore the association between atrial fibrillation (AF) reoccurrence and new-onset ischemic stroke (IS) in patients with nonvalvular AF, and explore whether there is a high-risk period of IS after recurrent episodes of AF. Methods: A nested case-control study design was used. A total of 565 nonvalvular AF patients with new-onset IS after a follow-up of at least 2 years in the China-AF cohort were enrolled as the case group, and 1 693 nonvalvular AF patients without new-onset IS were matched as the control group at a ratio of 1∶3. Frequency and types of recurrent AF in the previous 1 or 2 years were compared between two groups, and the adjusted associations of AF reoccurrence with new onset IS were explored using conditional logistic regression analysis. The proportion of recurrent AF was compared between the case period and control period, and conditional logistic regression analysis was performed to calculate adjusted associations of case-period AF with IS. Results: The nested case-control study design results showed that the proportion of at least one record of recurrent AF in the previous 1 year was higher in the case group than in the control group (72.0% vs. 60.8%, P<0.05), and the recurrent AF was positively correlated with new-onset IS (adjusted OR=1.80, P<0.001). Similar results were also observed in the previous 2 years period. The case-crossover study design analysis showed that among 565 patients with new-onset IS, recurrent AF in the case period was positively correlated with IS (adjusted OR=1.61, P=0.003). Conclusion: Recurrent AF is associated with IS, and there may be a high-risk period of IS after recurrent episodes of AF.
Humans
;
Atrial Fibrillation/epidemiology*
;
Case-Control Studies
;
Cross-Over Studies
;
Ischemic Stroke
;
China/epidemiology*
9.Association between atrial fibrillation reoccurrence and new-onset ischemic stroke among patients with nonvalvular atrial fibrillation.
Liu HE ; Chao JIANG ; Chen Xi JIANG ; Ri Bo TANG ; Cai Hua SANG ; De Yong LONG ; Xin DU ; Jian Zeng DONG ; Chang Sheng MA
Chinese Journal of Cardiology 2023;51(9):944-950
Objective: Explore the association between atrial fibrillation (AF) reoccurrence and new-onset ischemic stroke (IS) in patients with nonvalvular AF, and explore whether there is a high-risk period of IS after recurrent episodes of AF. Methods: A nested case-control study design was used. A total of 565 nonvalvular AF patients with new-onset IS after a follow-up of at least 2 years in the China-AF cohort were enrolled as the case group, and 1 693 nonvalvular AF patients without new-onset IS were matched as the control group at a ratio of 1∶3. Frequency and types of recurrent AF in the previous 1 or 2 years were compared between two groups, and the adjusted associations of AF reoccurrence with new onset IS were explored using conditional logistic regression analysis. The proportion of recurrent AF was compared between the case period and control period, and conditional logistic regression analysis was performed to calculate adjusted associations of case-period AF with IS. Results: The nested case-control study design results showed that the proportion of at least one record of recurrent AF in the previous 1 year was higher in the case group than in the control group (72.0% vs. 60.8%, P<0.05), and the recurrent AF was positively correlated with new-onset IS (adjusted OR=1.80, P<0.001). Similar results were also observed in the previous 2 years period. The case-crossover study design analysis showed that among 565 patients with new-onset IS, recurrent AF in the case period was positively correlated with IS (adjusted OR=1.61, P=0.003). Conclusion: Recurrent AF is associated with IS, and there may be a high-risk period of IS after recurrent episodes of AF.
Humans
;
Atrial Fibrillation/epidemiology*
;
Case-Control Studies
;
Cross-Over Studies
;
Ischemic Stroke
;
China/epidemiology*

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