scholarly journals The safety and efficacy of SDLT-2 (Sodium-glucose co-transporter 2) inhibitor versus placebo in the treatment of heart failure in patients with or without T2DM (Type 2 diabetes mellitus): A Systemic Review and Meta-analysis.

2020 ◽  
Author(s):  
Qian Zhang ◽  
Xiaofei Wang ◽  
Peipei Ge ◽  
Aizhen Hu ◽  
Xuexun Li

Abstract Background Sodium-glucose co-transporter 2 (SGLT2) inhibitor which is a type of drug used for the treatment of diabetes mellitus, has been reported by many trials that it could be beneficial for patients with established heart failure. A meta-analysis on this subject could obtain more reliable estimates of the efficacy and safety outcomes. Methods A systematic review and meta-analysis of randomized, placebo-controlled trials of SGLT2 inhibitor in patients with heart failure was conducted. We searched PubMed, Cochrane Library, and Web of Science for trials published from inception to March, 2018. PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was used to conduct the review. For quality assessment of included studies. The methodological quality of the included trials was assessed using the Cochrane tool for assessing randomized clinical trials (RCT). Efficacy outcomes included hospitalization for heart failure and all-cause death. Safety outcomes consisted of serious adverse event (SAE) and volume depletion. Results We included data from 5 identified studies and 8775 patients (aged 64.9, female 29.8%). A total of 3930 (44.8%) patients were known to have diabetes mellitus. Compared with placebo, SGLT2 inhibitor decrease the incidence of hospitalization for heart failure (RR 0.692; 95%CI, 0.611-0.784 P<0.001), and all-cause death (RR 0.824; 95%CI, 0.736-0.922 P=0.001). The incidence of SAE in patients with a treatment of SGLT2 inhibitor was low (RR 0.869; 95%CI, 0.779-0.970 P=0.012). SGLT2 inhibitor didn’t increase the incidence of volume depletion (RR1.165, 95%CI, 0.977-1.390 P=0.089). Conclusion Our results confirm that SGLT2 inhibitor is effective and safe for patients with heart failure regardless of presence of diabetes mellitus.

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Zhe Wang

Abstract Background and Aims Dapagliflozin is an inhibitor of sodium-dependent glucose transporters 2, which is a new drug for diabetes mellitus. Recent researches indicated that among patients with heart failure, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than those who received placebo, regardless of the presence or absence of diabetes. This systematic review aimed to evaluate efficacy and safety of dapagliflozin for heart failure. Method According to the collaborative search strategy, MEDLINE(1966-2020.9), Embase(1974-2020.9), Chinese Wanfang database(1996-2020.9),CNKI(1979-2020.9), the clinical control test database of Cochrane Library and were searched. Only randomized controlled trials (RCT) were included in this research. Quality assessment and data extraction were conducted by two independent investigators. Meta-analysis was conducted by Stata 11.0. Results A total of 5 RCTs were identified which met the inclusion criteria, including 5998 patients. Compared with control group, dapagliflozin was associated with a lower risk of cardiovascular mortality/hospitalization for heart failure composite events (HR=0.73, 95%CI 0.64∼0.83, P&lt;0.001), cardiovascular mortality (RR=0.80, 95%CI 0.68∼0.93, P=0.005), hospitalization for heart failure (HR=0.68, 95%CI 0.58∼0.80, P&lt;0.001), and all-cause mortality (RR=0.80, 95%CI 0.70∼0.92, P=0.002). Dapagliflozin also increased the Kansas city cardiomyopathy questionnaire (KCCQ), without increasing the risk of major hypoglycemia, volume depletion, renal adverse event and amputation. Conclusion Dapagliflozin could effectively lower the risk of mortality and hospitalization for heart failure, as well as improve the quality of life among patients with heart failure.


Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Akira Sekikawa ◽  
Nobutake Hirooka ◽  
Abhishek Vishnu ◽  
Vashudha Ahuja ◽  
Emmanuel Sampene ◽  
...  

Introduction: Although marine n-3 fatty acids are believed to be cardioprotective through their anti-arrhythmic, anti-thrombotic, anti-atherogenic and other effects, results from recent meta-analyses of marine n-3 fatty acids on cardiovascular disease (CVD) are controversial. We performed a meta-analysis of marine n-3 fatty acids on CVD outcomes in randomized clinical trials (RCTs) to test the hypothesis that marine n-3 fatty acids are anti-atherogenic. We also tested the hypothesis that such benefit is dose-dependent. Methods: A systematic review of English language articles using PubMed, EMBASE and Cochrane Library through Aug 2012 was performed selecting RCTs evaluating the effect of marine n-3 fatty acids intake for 2 years or more on cardiovascular diseases, coronary disease, arteriosclerosis, cardiac imaging techniques, and carotid artery ultrasound. Descriptive and quantitative information was extracted. Odds ratios were calculated for cardiac event outcome. Correlation coefficients were obtained from studies of which outcome is intima-media thickness (IMT) and coronary lumen diameter (CD). We converted the estimates into a single effect size; the log odds ratio and its corresponding standard error. Results: Of 14,236 citations retrieved, 13 studies were selected, including studies reporting IMT (n=3) and CD (n=2) and major CVD events (n=8). Overall, marine n-3 fatty acids significantly reduced atherosclerotic CVD (RR 0.94: 95%CI 0.90 to 0.99, p<0.05). There was no evidence of heterogeneity (p=0.65) or publication bias (p=0.37, Begg’s test). A sub-analysis among 8 studies of major CVD events showed the similar results (RR 0.94: 95% CI 0.89 to 0.99, p<0.05). Another sub-analysis among 4 studies excluding sudden cardiac death as an outcome showed RR of 0.91 (95% CI 0.82 to 1.02, p=0.097). A meta-regression analysis shows that dose of marine n-3 fatty acids was inversely associated with CVD outcome, although the association was not statistically significant (p=0.06). Conclusions: The result of our meta-analysis supports a modest anti-atherogenic effect of marine n-3 fatty acids. This benefit may be proportional to the amount of marine n-3 fatty acids consumed.


2020 ◽  
Author(s):  
Yanbo Yang ◽  
Mingjia Chen ◽  
Zilan Wang ◽  
Yue Sun ◽  
Fan Jiang ◽  
...  

Abstract Background Erenumab is a novel monoclonal calcitonin gene–related peptide receptor antibody that is used for the preventive treatment of migraine.Objectives To evaluate overall safety and efficacy and dose-response relationship of erenumab in patients with episodic migraine and patients with prior migraine treatment failures.Methods We searched randomized clinical trials on PUBMED, EMBASE database, and Cochrane Library database. A pair-wise meta-analysis and Bayesian network analysis were performed.Results For efficacy outcomes, the network meta-analysis suggests that compared with erenumab 70 mg, participants received erenumab 140 mg reported significantly decreased MSMD and increased 50% response rate, and erenumab was most likely to be ranked first for MMD, MSMD and 50% response rate. For safety outcomes, the network meta-analysis has found no significant difference between the 70 mg group and the 140 mg group measured by AE and SAE. For patients with ≥2 treatment failures, 140mg erenumab group, patients with ≥2 treatment failures reported significantly reduced MMD and MSMD, increased 50%, and 75% response rate, compared with placebo. For safety outcomes, no significant difference was found between 140 mg erenumab group and the placebo group.Conclusion Erenumab was effective in patients with episodic migraine. 140 mg erenumab was associated with better efficacy outcomes without increased risk for developing adverse events compared with 70 mg erenumab, and 140 mg erenumab was effective in patients with prior migraine treatment failures.Registration number: CRD42020198985


2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Yuan-long Sun ◽  
Yi-ping Li ◽  
Ting-ting Qiang ◽  
Xiao-fen Ruan ◽  
Xiao-long Wang

Background. Insect drugs have great potential for treating cardiovascular diseases. Xinmailong (XML) injection, a bioactive composite extracted from Periplaneta americana (a species of cockroach), was wildly used in treating heart failure in China. This meta-analysis aimed to assess the efficacy and safety of XML injection for the improvement of cardiac function in HF. Materials and Methods. Online literature search for relevant studies was performed using databases including PubMed, EMBASE, Cochrane Library, CNKI, and Wanfang. Left ventricular ejection fraction (LVEF), six-minute walk test (6MWT), and brain natriuretic peptide (BNP) were selected as target outcomes. The analysis was performed using Stata 12.0, and sources of heterogeneity were explored by subgroup analysis and metaregression. Results. 32 studies were included in this meta-analysis after meeting the inclusion/exclusion criteria. The results demonstrated that additional use of XML improved LVEF (WMD = 5.82, 95% CI: 5.52–7.13, P < 0.00001 ) and 6MWT (WMD = 51.48, 95% CI: 35.83–67.13, P < 0.00001 ) and reduced BNP (WMD = −172.84, 95% CI: −205.79 to −139.89, P < 0.00001 ). The results of subgroup analyses and metaregression suggested that XML injection has more cardiac function improvement for middle-aged HF patients than youth, and greater LVEF and 6MWT improvement were associated with higher average age. Conclusions. XML plus conventional treatment demonstrated a significant effect in reducing cardiac dysfunction in HF patients, and age is a potential factor of higher efficacy. Given the heterogeneity and bias of the included RCTs, large, prospective, rigorous trials are still needed.


2019 ◽  
Vol 121 (8) ◽  
pp. 841-848 ◽  
Author(s):  
Shuo Zhang ◽  
Fengxiao Zhang ◽  
Meng Du ◽  
Kun Huang ◽  
Cheng Wang

AbstractFe therapy can be effective in heart failure patients both with and without anaemia. However, the role of Fe therapy in such patients is still uncertain. In this review, the aim was to evaluate the efficacy and safety of Fe therapy in adult patients with heart failure who have reduced ejection fraction (HFrEF). Multiple databases (PubMed, Medline, EMBASE, the Cochrane Library and Clinical Trials) were searched up to December 2017 and the reference lists of relevant articles obtained from the search were reviewed. Data extracted from randomised control trials (RCT) selected for the review were pooled using a fixed effects model or a random effects model, according to heterogeneity between trials. Nine RCT were included in this meta-analysis which included a total of 789 patients who received Fe therapy and who in turn were compared with 585 controls. There was significant improvement in the 6-min walk test (19·05 m, 95 % CI 10·48, 27·62) and peak VO2/kg (0·93 ml/kg per min, 95 % CI 0·16, 1·69) in the Fe supplementation arm. With Fe therapy, fewer patients were hospitalised for heart failure (OR: 0·42, 95 % CI 0·27, 0·65), but no relationship was found for total re-hospitalisation (OR: 0·70, 95 % CI 0·32, 1·51) or mortality (OR: 0·70, 95 % CI 0·38, 1·28). Fe therapy has the potential to improve exercise tolerance, reduce re-hospitalisations for patients with HFrEF having Fe deficiency. In addition, Fe supplementation was found to be safe, with no increased rate of adverse events.


Author(s):  
Paola Andrea Rivera ◽  
Milton J. M. Rodríguez-Zúñiga ◽  
José Caballero-Alvarado ◽  
Fabián Fiestas

Abstract Objective The objective of this study was to investigate whether glycated hemoglobin (HbA1c) is a valid surrogate for evaluating the effectiveness of antihyperglycemic drugs in diabetes mellitus (DM) trials. Methods We conducted a systematic review of placebo-controlled randomized clinical trials (RCTs) evaluating the effect of a treatment on HbA1c (mean difference between groups) and clinical outcomes (relative risk of mortality, myocardial infarction, stroke, heart failure, and/or kidney injury) in patients with DM. Then, we investigated the association between treatment effects on HbA1c and clinical outcomes using regression analysis at the trial level. Lastly, we interpreted the correlation coefficients (R) using the cut-off points suggested by the Institute for Quality and Efficiency in Healthcare (IQWiG). HbA1c was considered a valid surrogate if it demonstrated a strong association: lower limit of the 95 percent confidence interval (95 percent CI) of R greater than or equal to .85. Results Nineteen RCTs were identified. All studies included adults with type 2 DM. None of the associations evaluated was strong enough to validate HbA1c as a surrogate for any clinical outcome: mortality (R = .34; 95 percent CI −.14 to .69), myocardial infarction (R = .20; −.30 to .61), heart failure (R = .08; −.40 to .53), kidney injury (R = −.04; −.52 to .47), and stroke (R = .81; .54 to .93). Conclusions The evidence from multiple placebo-controlled RCTs does not support the use of HbA1c as a surrogate to measure the effectiveness of antihyperglycemic drugs in DM studies.


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