1.
A systematic review assessing the under-representation of cancer patients in COVID-19 trials
Buchrits S, Fredman D, Ben Tikva Kagan K, Gafter-Gvili A
Acta haematologica. 2022
Abstract
Background - The new severe acute respiratory syndrome coronavirus 2 have emerged as a global pandemic that threatens thousands around the world. Observational cohort studies have demonstrated that cancer patients have inferior outcomes due to underlying malignancy, treatment-related immunosuppression, or increased comorbidities. We aimed to examine the representation of cancer patients (hematological malignancies and solid tumors) in COVID-19 therapeutic and prophylactic interventional trials. Methods- In this review, all randomized controlled trials (RCTs) published between December 2019 and August 2021 were included. We included only trials evaluating medications that were recommended by NIH guidelines: steroids, Tocilizumab, Remdesivir and REGN-COV2. Results- The search yielded 540 potentially relevant RCTs, 22 of which were considered suitable. All trials included patients with solid cancer and hematological malignancies in the formal reported inclusion criteria. However, only two trials reported the accurate number of cancer patients included. Ten trials excluded neutropenic patients and seven trials excluded thrombocytopenic patients. Eleven trials excluded patients that were treated with any immunosuppression treatment. None of the two trials that included cancer patients reported separate outcomes for this population. Conclusion- Our systematic review shows that cancer patients are under-represented in COVID-19 interventional therapeutic trials, and evidence regarding outcomes are lacking.
2.
Iron supplementation for restless legs syndrome - A systematic review and meta-analysis
Avni T, Reich S, Lev N, Gafter-Gvili A
European journal of internal medicine. 2019
Abstract
BACKGROUND Iron supplementation, is recommended for the treatment of restless legs syndrome (RLS). We gathered evidence for the efficacy and safety of iron supplementation for RLS. METHODS A systematic review and meta-analysis of randomized controlled trials that compared iron supplementation versus no iron for patients with RLS was performed. Multiple databases were searched. The primary outcome was the effect of iron on the International Restless Legs Syndrome score (IRLSS) at 4weeks after treatment. For dichotomous data, risk ratios (RR) with 95% confidence intervals (CIs) were estimated and pooled. For continuous data, weighted mean differences (WMD) were calculated. RESULTS Ten trials fulfilled the inclusion criteria. Iron therapy was associated with a significant decrease of the IRLSS of -3.55 [95% CI (-5.41) - (-1.68)] points and an increase in the percentage of patients with improvement of the IRLSS score, RR of 2.16 [95% CI 1.56-2.98]. IV FCM was associated with improvement in both the IRLSS (WMD of -2.79 (95% CI (-4.62) - (-0.96), 4 trials, I(2)=0%) and on the RLS-QOL by WMD of 8.67 (95% CI 1.68-15). Iron was associated with an increased rate of adverse events RR 2.04 (95% CI 1.46-2.85), which were not severe and not associated with increased rate of treatment discontinuation. CONCLUSION Iron supplementation is associated with improvement of the IRLSS score. Our meta-analysis supports the use of iron, oral or IV, as effective therapy for patients with RLS. Further studies should assess subgroups of patients most likely to benefit from iron supplementation.
3.
Intravenous versus oral iron supplementation for the treatment of anemia in CKD: an updated systematic review and meta-analysis
Shepshelovich D, Rozen-Zvi B, Avni T, Gafter U, Gafter-Gvili A
American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation. 2016;68((5):):677-690
Abstract
BACKGROUND Iron supplementation is crucial for the treatment of anemia of chronic kidney disease (CKD). Although intravenous (IV) iron is preferred for patients with CKD receiving dialysis (CKD stage 5D), the method of iron replacement for patients with CKD stages 3 to 5 is controversial. STUDY DESIGN Systematic review and meta-analysis. A search was performed until October 2015 of MEDLINE, Cochrane Library, conference proceedings in nephrology, and reference lists of included trials. SETTING & POPULATION Patients with CKD stages 3 to 5 or 5D. SELECTION CRITERIA FOR STUDIES All randomized controlled trials, regardless of publication status or language. INTERVENTION IV versus oral iron supplementation. OUTCOMES The primary outcome was defined as percentage of patients reaching an elevation in hemoglobin (Hb) concentration > 1g/dL. Secondary end points included percentage of patients who reached Hb levels > 11g/dL, absolute Hb concentration, change in Hb concentration, transferrin saturation, ferritin levels, erythropoiesis-stimulating agents and blood transfusion requirement, and quality of life. Safety analysis included all-cause mortality and serious and all adverse events. RESULTS 24 trials were identified, 13 including 2,369 patients with CKD stages 3 to 5 and 11 including 818 patients with CKD stage 5D. Patients treated with IV iron were more likely to reach an Hb response > 1g/dL (risk ratios [RRs] of 1.61 [95% CI, 1.39-1.87] for CKD stages 3-5 and 2.14 [95% CI, 1.68-2.72] for CKD stage 5D). Safety analysis showed similar rates of mortality and serious and any adverse effects. IV iron replacement was associated with higher risk for hypotension (RR, 3.71; 95% CI, 1.74-7.94) and fewer gastrointestinal adverse events (RR, 0.43; 95% CI, 0.28-0.67). LIMITATIONS Significant heterogeneity between trials; follow-up was usually limited to 3 months. CONCLUSIONS Our results agree with current recommendations for IV iron replacement for patients with CKD stage 5D and support increased use of IV iron for patients with CKD stages 3 to 5.
4.
Intravenous versus oral iron supplementation for the treatment of anemia in CKD: systematic review and meta-analysis
Rozen-Zvi B, Gafter-Gvili A, Paul M, Leibovici L, Shpilberg O, Gafter U
American Journal of Kidney Diseases. 2008;52((5):):897-906.
Abstract
BACKGROUND Iron supplementation is essential for the treatment of patients with anemia of chronic kidney disease (CKD). It is not clear which is the best method of iron administration. STUDY DESIGN Systematic review and meta-analysis. A search was performed until January 2008 of MEDLINE, Cochrane Central Register of Controlled Trials, conference proceedings in nephrology, and reference lists of included trials. SETTING & POPULATION Patients with CKD (stages III to V). We included dialysis patients and patients with CKD not on dialysis therapy (hereafter referred to as patients with CKD). SELECTION CRITERIA FOR STUDIES We included all randomized controlled trials regardless of publication status or language. INTERVENTION Intravenous (IV) versus oral iron supplementation. OUTCOMES MEASURES Primary outcomes assessed: absolute hemoglobin (Hb) level or change in Hb level from baseline. We also assessed all-cause mortality, erythropoiesis-stimulating agent requirement, adverse events, ferritin level, and need for renal replacement therapy in patients with CKD. RESULTS 13 trials were identified, 6 including patients with CKD and 7 including dialysis patients. Compared with oral iron, there was a significantly greater Hb level in dialysis patients treated with IV iron (weighted mean difference, 0.83 g/dL; 95% confidence interval, 0.09 to 1.57). Meta-regression showed a positive association between Hb level increase and IV iron dose administered and a negative association with baseline Hb level. For patients with CKD, there was a small but significant difference in Hb level favoring the IV iron group (weighted mean difference, 0. 31 g/dL; 95% confidence interval, 0.09 to 0. 53). Data for all-cause mortality were sparse, and there was no difference in adverse events between the IV- and oral-treated patients. LIMITATIONS There was significant heterogeneity between trials. Follow-up was limited to 2 to 3 months. CONCLUSIONS Our review shows that patients on hemodialysis therapy have better Hb level response when treated with IV iron. For patients with CKD, this effect is small.