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Singh, Ajay K.

doi:10.1681/asn.2009040444

Cited by 27 publications

(15 citation statements)

References 54 publications

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“…There are now several analyses that suggest an effect of ESA dosage on adverse clinical outcome in the treatment of CKD anemia (17)(18)(19). This issue is reviewed more extensively elsewhere (20).…”

Section: T He Trial To Reduce Cardiovascular Endpoints Withmentioning

confidence: 99%

The FDA's Perspective on the Risk for Rapid Rise in Hemoglobin in Treating CKD Anemia

Singh¹

2010

Clinical Journal of the American Society of Nephrology

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Section: T He Trial To Reduce Cardiovascular Endpoints Withmentioning

confidence: 99%

The FDA's Perspective on the Risk for Rapid Rise in Hemoglobin in Treating CKD Anemia

Singh¹

2010

Clinical Journal of the American Society of Nephrology

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“…However, recent randomized trials of complete anemia correction using erythropoiesis stimulating agents (ESAs) raised major concerns about safety [7,8] . Whether the higher risk is secondary to detrimental CV effect of higher hemoglobin (Hb) concentrations or to dose-dependent non-erythropoietic effects of ESAs remains a matter of debate [9][10][11][12] . In particular, the latter hypothesis is substantiated by several studies evidencing the presence of receptors for ESAs in a variety of tissues outside the hematopoietic system, including vascular smooth muscle and endothelium, whose activation may lead to cell proliferation, increased release of vasoconstrictive substances and gene expression of prothrombotic factors [13][14][15][16][17] .…”

Section: Introductionmentioning

confidence: 99%

Conversion of Darbepoetin to Low Doses of CERA Maintains Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Patients

et al. 2010

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Background/Aims: Finding the lowest effective dose of erythropoietin-stimulating agents is critical in the management of renal anemia. We evaluated the efficacy of converting darbepoetin to CERA at doses lower than those usually recommended. Methods: We selected consecutive non-dialysis chronic kidney disease patients treated with darbepoetin doses ≤40 µg/week in absence of iron deficiency, recent blood transfusion, bleeding, neoplasia, myocardial infarction/stroke in the last 3 months. Darbepoetin ≤20 µg/week was shifted to CERA 75 µg/month, while darbepoetin 21–40 µg/week to CERA 100 µg/month. Primary endpoint was the change in hemoglobin (Hb goal, 11–13 g/dl) at month 3, 6, 9 and 12. Results: Studied patients (n = 37) were aged 70 ± 13 years and GFR was 30 ± 12 ml/min/1.73 m²; prevalence of males, diabetes and prior cardiovascular disease was 43, 45 and 40%, respectively. Before switching, efficacy population received darbepoetin 18 ± 10 µg/week with 28 patients receiving ≤20 µg/week. Prevalence of Hb goal at baseline was 75.7% and did not change at months 3 (70.3%), 6 (70.3%), 9 (72.2%), and 12 (80.0%). CERA dose remained unchanged during the study (81 ± 11, 82 ± 16, 91 ± 30, 90 ± 54 and 88 ± 61 µg/month). Out of the 438 visits performed, CERA dose was increased in 52 (11.9%) and reduced in 36 (8.2%) visits. Blood pressure, Hb, GFR, transferrin saturation and ferritin did not change. Conclusions: In chronic kidney disease patients treated with darbepoetin doses ≤40 µg/week, CERA can be efficaciously used at doses lower than those recommended.

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“…20 Confounding by indication and dosage-targeting bias have been raised as limitations in these analyses. 21,22 Furthermore, not all studies implicate ESA exposure in explaining risk; a recent study using marginal structural modeling failed to report an association between high ESA dosage and adverse outcome.…”

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confidence: 99%