scholarly journals Comprehensive Analysis of Adverse Events Associated With SGLT2is: A Meta-Analysis Involving Nine Large Randomized Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Mei Qiu ◽  
Li-Min Zhao ◽  
Ze-Lin Zhan

Recently, Lin and colleagues assessed the safety of sodium-glucose cotransporter 2 inhibitors (SGLT2is) by a meta-analysis [1], in which the authors assessed 16 kinds of adverse events (AE) reported in the published articles based on 10 randomized controlled trials. We conducted a further meta-analysis and targeted the association between use of SGLT2is and occurrences of various kinds of serious AE published in the Clinical Trials website (clinicaltrials.gov). Our meta-analysis revealed that use of SGLT2is was not significantly associated with occurrences of 980 kinds of serious AE but was significantly associated with lower risks of 29 kinds of serious AE, especially including several important respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease, sleep apnoea syndrome, and pneumonia). These findings may cause more studies to evaluate the possibilities of gliflozins being used for prevention of these specific diseases.

2021 ◽  
Vol 12 ◽  
Author(s):  
Dao-Gen Yin ◽  
Mei Qiu ◽  
Xue-Yan Duan

The association between sodium-glucose cotransporter 2 inhibitors (SGLT2is) and various cardiovascular and respiratory diseases is unestablished. This meta-analysis aimed to explore whether use of SGLT2is is significantly associated with the occurrences of 80 types of cardiovascular diseases and 55 types of respiratory diseases. Large randomized trials of SGLT2is were included in analysis. Meta-analysis was conducted to synthesize risk ratio (RR) and 95% confidence interval (CI). Nine large trials were included in analysis. Compared to placebo, SGLT2is were associated with the reduced risks of 9 types of cardiovascular diseases (e.g., atrial fibrillation [RR 0.78, 95% CI 0.67-0.91], bradycardia [RR 0.60, 95% CI 0.40-0.89], and hypertensive emergency [RR 0.29, 95% CI 0.12-0.72]) and 11 types of respiratory diseases (e.g., chronic obstructive pulmonary disease [RR 0.77, 95% CI 0.61-0.97], asthma [RR 0.57, 95% CI 0.35-0.95], and sleep apnoea syndrome [RR 0.36, 95% CI 0.15-0.87]). The results of random-effects meta-analysis were similar with those of fixed-effects meta-analysis. No heterogeneity or only little heterogeneity was found in most meta-analyses. No publication bias was observed in most of the meta-analyses conducted in this study. SGLT2is were not significantly associated with the other 115 cardiovascular and respiratory diseases. SGLT2is are associated with the reduced risks of 9 types of cardiovascular diseases (e.g., atrial fibrillation, bradycardia, and hypertensive emergency) and 11 types of respiratory diseases (e.g., chronic obstructive pulmonary disease, asthma, and sleep apnoea syndrome). This proposes the potential of SGLT2is to be used for prevention of these cardiovascular and respiratory diseases.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal

AbstractDiabetes is a serious threat to global health and among the top 10 causes of death, with nearly half a billion people living with it worldwide. Treating patients with diabetes tend to become more challenging due to the progressive nature of the disease. The role and benefits of combination therapies for the management of type 2 diabetes are well-documented, while the comparative safety and efficacy among the different combination options have not been elucidated. We aimed to systematically synthesize the evidence on the comparative cardiovascular safety and efficacy of combination therapy with metformin-sodium-glucose cotransporter-2 inhibitors versus metformin-sulfonylureas in patients with type 2 diabetes. We searched MEDLINE-PubMed, Embase, Cochrane Library, and ClinicalTrials.gov up to 15 August 2019 without restriction in the year of publication. We included randomized controlled trials of patients with type 2 diabetes who were on metformin-sodium-glucose cotransporter-2 inhibitors or metformin-sulphonylureas combination therapy at least for a year. The primary endpoints were all-cause mortality and serious adverse events, and the secondary endpoints were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and changes in glycated hemoglobin A1c (HbA1c), body weight, fasting plasma glucose, blood pressure, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. We used a random-effects meta-analysis model to estimate mean differences for continuous outcomes and risk ratio for dichotomous outcomes. We followed PICOS description model for defining eligibility and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for reporting results. Of 3,190 citations, we included nine trials involving 10,974 participants. The pooled analysis showed no significant difference in all-cause mortality (risk ration [RR] = 0.93, 95% CI [0.52, 1.67]), serious adverse events (RR = 0.96, 95% CI [0.79, 1.17]) and adverse events (RR = 1.00, 95% CI [0.99, 1.02]) between the two, but in hypoglycemia (RR = 0.13, 95% CI [0.10, 0.17], P < 0.001). Participants taking metformin-sodium glucose cotransporter-2 inhibitors showed a significantly greater reduction in HbA1c (mean difference [MD] = − 0.10%, 95% CI [− 0.17, − 0.03], body weight (MD = − 4.57 kg, 95% CI [− 4.74, − 4.39], systolic blood pressure (MD = − 4.77 mmHg, 95% CI [− 5.39, − 4.16]), diastolic blood pressure (MD = − 2.07 mmHg, 95% CI [− 2.74, − 1.40], and fasting plasma glucose (MD = − 0.55 mmol/L, 95% CI [− 0.69, − 0.41]), p < 0.001. Combination therapy of metformin and sodium-glucose cotransporter-2 inhibitors is a safe and efficacious alternative to combination therapy of metformin and sulphonylureas for patients with type 2 diabetes who are at risk of cardiovascular comorbidity. However, there remains a need for additional long-term randomized controlled trials as available studies are very limited and heterogeneous.


Author(s):  
Ke Wang ◽  
Shijie Liu ◽  
Zhaowei Kong ◽  
Yanjie Zhang ◽  
Jing Liu

Objective: This study is the first meta-analysis investigating the rehabilitative effects of Wuqinxi for patients with chronic obstructive pulmonary disease (COPD). Methods: Five electronic databases (PubMed, Web of Science, Scopus, CNKI, and Wanfang) from inception until early November 2018 were searched. All randomized controlled trials (RCT) using Wuqinxi as the main intervention component were included for meta-analysis. The pooled effect sizes (Standardized mean difference, SMD) were calculated to determine the magnitude of the Wuqinxi intervention effect. Moderator analysis was only conducted for total training time. Results: Overall results of the meta-analysis indicated that Wuqinxi exercise significantly improved exercise capability (SMD = 1.18, 95% CI 0.53 to 1.84, e < 0.001, I2 = 84.97%), FEV1 (SMD = 0.44, 95% CI 0.12 to 0.77, e < 0.001, I2 = 33.77%), FEV1% (SMD = 0.59, 95% CI 0.24 to 0.93, e < 0.001, I2 = 63.79%), FEV1/FVC (SMD = 0.65, 95% CI 0.37 to 0.93, e = 0.006, I2 = 44.32%) and CCQ (SMD = 1.23, 95% CI 0.31 to 2.14, e = 0.01, I2 = 93.32%). Conclusions: With no occurrence of adverse event, clinicians could try to incorporate Wuqinxi exercise into their first-line rehabilitation regime for COPD patients.


2019 ◽  
Vol 33 (12) ◽  
pp. 1847-1862 ◽  
Author(s):  
Holger Cramer ◽  
Heidemarie Haller ◽  
Petra Klose ◽  
Lesley Ward ◽  
Vincent CH Chung ◽  
...  

Objectives: To determine the effectiveness and safety of yoga interventions on disease symptoms, quality of life and function in patients diagnosed with chronic obstructive pulmonary disease (COPD). Data sources: Medline/PubMed, Scopus, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through 6 June 2019. Review methods: Randomized controlled trials assessing the effects of yoga on quality of life, dyspnea, exercise capacity, and pulmonary function (FEV1) in patients with COPD were included. Safety was defined as secondary outcome. Mean differences (MD) and standardized mean differences (SMD) with 95% confidence intervals (CIs) were computed. Risk of bias was assessed using the Cochrane tool. Results: Eleven randomized controlled trials with a total of 586 patients were included. Meta-analysis revealed evidence for effects of yoga compared to no treatment on quality of life on the COPD Assessment Test (MD = 3.81; 95% CI = 0.97 to 6.65; P = 0.009, I2 = 70%), exercise capacity assessed by the 6-minute walk test (MD = 25.53 m; 95% CI = 12.16 m to 38.90 m; P = 0.001, I2 = 0%), and pulmonary function assessed by FEV1 predicted (MD  = 3.95%; 95% CI = 2.74% to 5.17%; P < 0.001, I2 = 0%). Only the effects on exercise capacity and pulmonary function were robust against methodological bias. Effects were only present in breathing-focused yoga interventions but not in interventions including yoga postures. Adverse events were reported infrequently. Conclusion: This meta-analysis found robust effects of yoga on exercise capacity and pulmonary function in patients with COPD. Yoga, specifically yoga breathing techniques, can be an effective adjunct intervention for patients with COPD. Yoga’s safety needs to be assessed in more depth in future studies.


Author(s):  
Professor Ann B Millar ◽  
Dr Richard Leach ◽  
Dr Rebecca Preston ◽  
Dr Richard Leach ◽  
Dr Richard Leach ◽  
...  

Chapter 5 covers respiratory diseases and respiratory failure, including clinical presentations of respiratory disease, assessment of diffuse lung disease, hypoxaemia, respiratory failure, and oxygen therapy, pneumonia, mycobacterial infection, asthma, chronic obstructive pulmonary disease (COPD), lung cancer, mediastinal lesions, pneumothorax, pleural disease, asbestos-related lung disease, diffuse parenchymal (interstitial) lung disease, sarcoidosis, pulmonary hypertension, acute respiratory distress syndrome, bronchiectasis and cystic fibrosis, bronchiolitis, eosinophilic lung disease, airways obstruction, aspiration syndromes, and near-drowning, pulmonary vasculitis, the immunocompromised host, sleep apnoea, and rare pulmonary diseases.


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