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American Journal of Kidney Diseases :... Apr 2024The standard of care (SoC) group of randomized controlled trials (RCTs) is a useful setting to explore the secular trends in kidney disease progression because... (Meta-Analysis)
Meta-Analysis
RATIONALE & OBJECTIVE
The standard of care (SoC) group of randomized controlled trials (RCTs) is a useful setting to explore the secular trends in kidney disease progression because implementation of best clinical practices is pursued for all patients enrolled in trials. This meta-analysis evaluated the secular trend in the change of glomerular filtration rate (GFR) decline in the SoC arm of RCTs in chronic kidney disease (CKD) published in the last 30 years.
STUDY DESIGN
Systematic review and meta-analysis of the SoC arms of RCTs analyzed as an observational study.
SETTING & STUDY POPULATIONS
Adult patients with CKD enrolled in the SoC arm of RCTs.
SELECTION CRITERIA FOR STUDIES
Phase 3 RCTs evaluating GFR decline as an outcome in SoC arms.
DATA EXTRACTION
Two independent reviewers evaluated RCTs for eligibility and extracted relevant data.
ANALYTICAL APPROACH
The mean of GFR declines extracted in the SoC arm of selected RCTs were pooled by using a random effects model. Meta-regression analyses were performed to identify factors that may explain heterogeneity.
RESULTS
The SoC arms from 92 RCTs were included in the meta-analysis with a total of 32,202 patients. The overall mean GFR decline was-4.00 (95% CI, -4.55 to-3.44) mL/min/1.73m per year in the SoC arms with a high level of heterogeneity (I, 98.4% [95% CI, 98.2-98.5], P<0.001). Meta-regression analysis showed an association between publication year (β estimate, 0.09 [95% CI, 0.032-0.148], P=0.003) and reduction in GFR over time. When evaluating publication decade categorically, GFR decline was-5.44 (95% CI, -7.15 to-3.73), -3.92 (95% CI, -4.82 to-3.02), and -3.20 (95% CI, -3.75 to -2.64) mL/min/1.73m per year during 1991-2000, 2001-2010, and 2011-2023, respectively. Using meta-regression, the heterogeneity of GFR decline was mainly explained by age and proteinuria.
LIMITATIONS
Different methods assessing GFR in selected trials and observational design of the study.
CONCLUSIONS
In the last 3 decades, GFR decline has decreased over time in patients enrolled in RCTs who received the standard of care.
TRIAL REGISTRATION
Registered at PROSPERO with record number CRD42022357704.
PLAIN-LANGUAGE SUMMARY
This study evaluated the secular trend in the change in glomerular filtration rate (GFR) decline in the placebo arms of randomized controlled trials (RCTs) that were studying approaches to protect the kidneys in the setting of chronic kidney disease. The placebo groups of RCTs are useful for examining whether the rate of progression of kidney disease has changed over time. We found an improvement in the slope of change in GFR over time. These findings suggest that adherence to standards of kidney care as implemented in clinical trials may be associated with improved clinical outcomes, and these data may inform the design of future RCTs in nephrology.
Topics: Adult; Humans; Glomerular Filtration Rate; Standard of Care; Renal Insufficiency, Chronic; Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 37956953
DOI: 10.1053/j.ajkd.2023.09.014 -
Frontiers in Endocrinology 2024[This corrects the article DOI: 10.3389/fendo.2023.1168648.].
[This corrects the article DOI: 10.3389/fendo.2023.1168648.].
PubMed: 38318297
DOI: 10.3389/fendo.2024.1357219 -
International Health Jan 2024Pre-eclampsia (PE) is a pregnancy-related disorder characterized by hypertension and proteinuria occurring after 20 weeks of gestation. Several studies have been... (Meta-Analysis)
Meta-Analysis
Pre-eclampsia (PE) is a pregnancy-related disorder characterized by hypertension and proteinuria occurring after 20 weeks of gestation. Several studies have been performed to determine the serum magnesium (Mg) level in PE, but most report inconclusive results. Consequently, this study was designed to resolve this controversy among African women. PubMed, Hinari, Google Scholar and African Journals Online electronic databases were searched for studies published in English. The qualities of included articles were appraised using the Newcastle-Ottawa quality assessment tool. Stata 14 software was utilized for analysis and serum Mg levels in cases and normotensive controls were compared through mean and standardized mean difference (SMD) at the 95% confidence interval (CI). In this review, we found that the mean serum Mg level was significantly reduced in cases (0.910±0.762 mmol/L) vs controls (1.167±1.060 mmol/L). The pooled SMD of serum Mg was significantly lower in cases (-1.20 [95% CI -1.64 to -0.75]). Therefore, since serum Mg is reduced in cases vs controls, we propose that Mg is involved in the pathophysiology of PE. Nevertheless, to know the exact mechanisms of Mg in PE development will require large-scale prospective studies.
Topics: Female; Pregnancy; Humans; Pre-Eclampsia; Pregnant Women; Magnesium; Prospective Studies; Pregnancy Complications
PubMed: 37026449
DOI: 10.1093/inthealth/ihad026