scholarly journals Safety and Efficacy of Roxadustat for Anemia in Patients With Chronic Kidney Disease: A Meta-Analysis and Trial Sequential Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Chao Liu ◽  
Zhangning Fu ◽  
Jiawei Jiang ◽  
Kun Chi ◽  
Xiaodong Geng ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Iron Metabolism ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Hypoxia Inducible Factor ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Safety And Efficacy

Background: Roxadustat, a hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI), has been used to treat anemia in patients with chronic kidney disease (CKD). However, its safety and efficacy remain controversial.Methods: The PubMed, EMBASE, Science Citation Index, Cochrane Central Register of Controlled Trials, and Clinical Trial Registries databases were searched for relevant studies published up to April 2021. We identified randomized controlled trials (RCTs) comparing roxadustat with placebo or erythropoiesis-stimulating agents (ESAs) in anemia patients with CKD with or without dialysis.Results: Eleven studies including 6,631 patients met the inclusion criteria. In non-dialysis-dependent (NDD-) and dialysis-dependent (DD-) CKD patients, the total adverse events were not significantly different between the roxadustat and control (placebo for NDD-CKD patients and ESA for DD-CKD patients) groups [relative risk (RR) = 1.02, 95% confidence interval (CI) = 1.00, 1.04, P = 0.08, and RR = 1.22, 95% CI = 0.91, 1.64, P = 0.18, respectively], and the trial sequential analysis (TSA) confirmed the result in the NDD-CKD groups. No significant differences in hyperkalemia and infection incidences were found between roxadustat and placebo in the DD-CKD groups. The pooled results showed that roxadustat significantly increased the hemoglobin response rate compared with placebo in the NDD-CKD group and had an effect similar to that of ESA in the DD-CKD group. However, iron metabolism parameters did not seem to be obviously optimized by roxadustat.Conclusion: Roxadustat can be safely used in CKD patients. Oral roxadustat was more effective than placebo as a therapy for anemia in NDD-CKD patients and non-inferior to ESA in correcting anemia in DD-CKD patients. However, additional clinical trials are still needed to further prove whether roxadustat can optimize iron metabolism.

scholarly journals Traction Therapy for Cervical Radicular Syndrome is Statistically Significant but not Clinically Relevant for Pain Relief. A Systematic Literature Review with Meta-Analysis and Trial Sequential Analysis

2020 ◽  
Vol 9 (11) ◽  
pp. 3389
Author(s):  
Claudio Colombo ◽  
Stefano Salvioli ◽  
Silvia Gianola ◽  
Greta Castellini ◽  
Marco Testa
Keyword(s):  
Sequential Analysis ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Treatment Modalities ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Quality Of Evidence ◽  
Radicular Syndrome

Aim: We aimed to investigate the effectiveness of traction therapy in reducing pain by performing a systematic review with meta-analysis. We also explore the best modality for administering traction to patients with cervical radicular syndrome (CRS). Methods: We searched the Medline, Physiotherapy Evidence Database (PEDro), Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) electronic databases. Two reviewers independently selected randomized controlled trials (RCTs) that compared traction in addition to other treatments versus the effectiveness of other treatments alone for pain outcome. We calculated the mean differences (MDs) and 95% confidence intervals (CIs). We used Cochrane’s tool to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate the quality of evidence and summarize the study conclusions. Results: A total of seven studies (589 patients), one with low risk of bias, were evaluated. An overall estimate of treatment modalities showed low evidence that adding traction to other treatments is statistically significant (MD −5.93 [95% CI, −11.81 to −0.04] P = 0.05 and I2 = 57%) compared to other treatments alone. The subgroup analyses were still statistically significant only for mechanical and continuous modalities. Conclusions: Overall analysis showed that, compared to controls, reduction in pain intensity after traction therapy was achieved in patients with cervical radiculopathy. However, the quality of evidence was generally low and none of these effects were clinically meaningful.

Effect of Extracorporeal Blood Purification on Mortality in Sepsis: A Meta-Analysis and Trial Sequential Analysis

2020 ◽  
pp. 1-11
Author(s):  
Timothy A.C. Snow ◽  
Shona Littlewood ◽  
Carlos Corredor ◽  
Mervyn Singer ◽  
Nishkantha Arulkumaran
Keyword(s):  
Sequential Analysis ◽  
Meta Analysis ◽  
Blood Purification ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Mortality Benefit ◽  
Nonspecific Adsorption ◽  
Extracorporeal Blood ◽  
Extracorporeal Blood Purification

<b><i>Objective:</i></b> The objective of this study was to conduct a meta-analysis and trial sequential analysis (TSA) of published randomized controlled trials (RCTs) to determine whether mortality benefit exists for extracorporeal blood purification techniques in sepsis. <b><i>Data Sources:</i></b> A systematic search on MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs was performed. <b><i>Study Selection:</i></b> RCTs investigating the effect of extracorporeal blood purification device use on mortality among critically ill septic patients were selected. <b><i>Data Extraction:</i></b> Mortality was assessed using Mantel-Haenszel models, and <i>I</i><sup>2</sup> was used for heterogeneity. Data are presented as odds ratios (OR); 95% confidence intervals (CIs); <i>p</i> values; <i>I</i><sup>2</sup>. Using the control event mortality proportion, we performed a TSA and calculated the required information size using an anticipated intervention effect of a 14% relative reduction in mortality. <b><i>Data Synthesis:</i></b> Thirty-nine RCTs were identified, with 2,729 patients. Fourteen studies used hemofiltration (<i>n</i> = 789), 17 used endotoxin adsorption devices (<i>n</i> = 1,363), 3 used nonspecific adsorption (<i>n</i> = 110), 2 were cytokine removal devices (<i>n</i> = 117), 2 used coupled plasma filtration adsorption (CPFA) (<i>n</i> = 207), 2 combined hemofiltration and perfusion (<i>n</i> = 40), and 1 used plasma exchange (<i>n</i> = 106). On conventional meta-analysis, hemofiltration (OR 0.56 [0.40–0.79]; <i>p</i> &#x3c; 0.001; <i>I</i><sup>2</sup> = 0%), endotoxin removal devices (OR 0.40 [0.23–0.67], <i>p</i> &#x3c; 0.001; <i>I</i><sup>2</sup> = 71%), and nonspecific adsorption devices (OR 0.32 [0.13–0.82]; <i>p</i> = 0.02; <i>I</i><sup>2</sup> = 23%) were associated with mortality benefit, but not cytokine removal (OR 0.99 [0.07–13.42], <i>p</i> = 0.99; <i>I</i><sup>2</sup> = 64%), CPFA (OR 0.50 [0.10–2.47]; <i>p</i> = 0.40; <i>I</i><sup>2</sup> = 64%), or combined hemofiltration and adsorption (OR 0.71 [0.13–3.79]; <i>p</i> = 0.69; <i>I</i><sup>2</sup> = 0%). TSA however revealed that based on the number of existing patients recruited for RCTs, neither hemofiltration (TSA-adjusted CI 0.29–1.10), endotoxin removal devices (CI 0.05–3.40), nor nonspecific adsorption devices (CI 0.01–14.31) were associated with mortality benefit. <b><i>Conclusion:</i></b> There are inadequate data at present to conclude that the use of extracorporeal blood purification techniques in sepsis is beneficial. Further adequately powered RCTs are required to confirm any potential mortality benefit, which may be most evident in patients at greatest risk of death.

scholarly journals Ganglioside-monosialic acid (GM1) for prevention of chemotherapy-induced peripheral neuropathy: a meta-analysis with trial sequential analysis

2021 ◽  
Author(s):  
Shaoyong Wu ◽  
Xiaohui Bai ◽  
Caixia Guo ◽  
Zhimei Huang ◽  
Handong Ouyang ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Random Errors ◽  
Clinical Issue ◽  
Response To Chemotherapy

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting side effect that largely remains an unresolved clinical issue, leading to long-term morbidity. This meta-analysis aimed to evaluate the efficacy and safety of Ganglioside-monosialic acid (GM1) in preventing CIPN.Methods: Systematic literature searches of Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were performed to identify randomized controlled trials and cohort studies that evaluated the efficacy of GM1 for preventing CIPN. Ameta-analysis was conducted to calculate odds ratios (ORs) and 95% confidential intervals (CIs) using a random-effects model. Trial sequential analyses (TSA) also were conducted to control for random errors. Results: A total of five studies involving 868 participants were included. The results showed that GM1 did not reduce the overall incidence of grade ≥2 CIPN when the common terminology criteria for adverse events (CTCAE) was used (OR 0.34, 95% CI 0.34-1.11). Subgroup analyses showed that GM1 could not reduce the risk of CTCAE grade ≥2 CIPN (OR 0.63, 95% CI 0.35-1.13) and neurotoxicity criteria of Debiopharm (DEB-NTC) grade ≥2 CIPN (OR 0.25, 95% CI 0.01-7.10) in oxaliplatin-treated patients, although GM1 might reduce the risk of CTCAE grade≥2 CIPN in the taxane subgroup in one study (OR 0.003, 95% CI 0.00-0.05). Besides, TSA suggested that the results in the taxane subgroup were robust, while that of the oxaliplatin subgroup were inconclusive. Furthermore, GM1 did not influence the rate of response to chemotherapy and CTCAE grade ≥2 adverse events such as fatigue, nausea, diarrhea, and rash.Conclusions: GM1 was not associated with a lower risk of oxaliplatin-induced peripheral neuropathy nor could improve the response or safety to chemotherapy; however, it might be able to prevent taxane-induced peripheral neuropathy. Higher-quality trials are required to clarify the preventive effect of GM1 in oxaliplatin-treated patients.

scholarly journals Outcomes of coronavirus 2019 infection in patients with chronic kidney disease: a systematic review and meta-analysis

2021 ◽  
Vol 12 ◽  
pp. 204062232199886
Author(s):  
Yi-Chih Lin ◽  
Tai-Shuan Lai ◽  
Shuei-Liong Lin ◽  
Yung-Ming Chen ◽  
Tzong-Shinn Chu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Case Series ◽  
Pooled Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
All Cause Mortality

Background: Information on coronavirus disease 2019 (COVID-19) infection in patients with chronic kidney disease (CKD) remains limited. To understand the influence of COVID-19 infection in patients with pre-existing CKD, we conducted a systematic review and meta-analysis to evaluate and compare the risks of all-cause mortality, hospitalization, and critical progression between patients with and without CKD. Methods: We selected randomized controlled trials (RCTs), prospective or retrospective observational, case-control, cross-sectional, and case-series studies analyzing outcomes of COVID-19 infection in patients with pre-existing CKD from the PubMed, Embase, and Cochrane Central Register of Controlled Trials databases published on the Internet before 16 July 2020. Results: A total of 27 studies comprising 77,856 patients with COVID-19 infection was identified; 3922 patients with pre-existing CKD were assigned CKD group, and 73,934 patients were assigned to the non-CKD group. The pooled analysis showed that patients with CKD had a significantly higher risk of all-cause mortality and hospitalization than those without CKD [odds ratio (OR) 2.25, 95% confidence interval (CI) 1.91–2.66, p < 0.001; OR 4.29, 95% CI 2.93–6.28, p < 0.001; respectively]. Patients with CKD had a higher risk of critically ill conditions than those without CKD in the pooled analysis of studies with multivariable adjustment (adjusted OR 2.12, 95% CI 0.95–4.77, p = 0.07) and in the analysis of all included studies (OR 1.27, 95% CI 0.71–2.26, p = 0.41), but both analyses did not attain statistical significance. Conclusion: COVID-19 infected patients with CKD had significantly increased risks of all-cause mortality and hospitalization compared with those without CKD.

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