Recombinant human erythropoietin for chronic renal failure anaemia in pre-dialysis patients

Cody, June D; Daly, Conal; Campbell, Marion K; Donaldson, Cameron; Grant, Adrian; Khan, Izhar; Pennington, Susan; Vale, Luke; Wallace, S; MacLeod, Alison Murray

doi:10.1002/14651858.cd003266.pub2

Cited by 68 publications

(46 citation statements)

References 78 publications

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“…There are several randomized controlled trials (RCTs) or meta-analyses that studied whether targeting higher Hb levels might retard the progression of CKD [4,5,6,7,8,9,10,11] A pioneering study by Kuriyama et al [4] demonstrated that correction of anemia by ESA can retard the progression of renal failure especially in the non-diabetic patients. A recent report by Tsubakihara et al [5] showed that maintaining higher Hb (11.0≤ Hb ≤13.0 g/dl) with darbepoetin alfa tended to preserve renal function better in patients with CKD not on dialysis, while obviously underpowered to evaluate renal outcomes.…”

Section: Contentmentioning

confidence: 99%

“…They concluded that early initiation of Epo in pre-dialysis CKD patients with non-severe anemia significantly slows the progression of CKD and delays the initiation of renal replacement therapy. Cody et al [7] performed a meta-analysis of 15 trials (461 participants) and concluded that treatments with ESA in pre-dialysis patients corrects anemia, avoids the requirement for blood transfusions and improves QOL and exercise capacity. On the other hand, Palmer et al [8] performed a meta-analysis of 27 RCTs (10,452 patients) examined since 2004 and concluded that corrections of Hb using ESA was not significantly useful in retardation of progression of CKD.…”

Section: Contentmentioning

confidence: 99%

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How the Target Hemoglobin of Renal Anemia Should Be?

Mimura

Tanaka

Nangaku³

2015

Nephron

293

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Renal anemia is caused by the deficiency of endogenous erythropoietin (Epo) due to renal dysfunction. We think that it is possible to slow the progression of chronic kidney disease (CKD) in case we initiate Epo early in pre-dialysis patients, especially in the non-diabetic population. Erythropoiesis stimulating agent (ESA) treatments targeting mild anemia (10-12 g/dl) can decrease the risk of occurrence of cardiovascular disease (CVD) in patients with hypertension, diabetes mellitus and congestive heart failure. As the large randomized controlled trials such as Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta, Correction of Hemoglobin and Outcomes in Renal Insufficiency and Trial to Reduce Cardiovascular Events with Aranesp Thearpy in the Western countries suggested, we do not recommend high doses of ESA to achieve the target hemoglobin (Hb) level. The target Hb of >13 g/dl might lead to increase in the risk of CVD although maintaining a high Hb of >12 g/dl without ESA is not harmful for CKD patients. It is desirable to determine the target Hb in dialysis patients depending on their ages. Renal anemia should be monitored constantly to start ESA and iron replacement therapy at an appropriate time, while avoiding their excess in order to minimize the occurrence of CVD and other complications. Taken all the international guidelines and our clinical experiences together, we should consider administration of ESA when the Hb level becomes <11 g/dl in pre-dialysis patients and <10 g/dl in dialysis patients.

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Section: Contentmentioning

confidence: 99%

Section: Contentmentioning

confidence: 99%

How the Target Hemoglobin of Renal Anemia Should Be?

Mimura

Tanaka

Nangaku³

2015

Nephron

293

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“…The first comparison should be done with two early systematic reviews [40,41], published in 2004, although the evidence was quite limited, 4 trials including 77 patients in one meta-analysis and 5 trials with 207 patients in the second. Nevertheless, both meta-analyses showed no difference between Hb groups regarding the renal progression outcome.…”

Section: Discussionmentioning

confidence: 99%

Erythropoiesis-Stimulating Agents (ESA) for Preventing the Progression of Chronic Kidney Disease: A Meta-Analysis of 19 Studies

et al. 2014

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Background: The effect of anemia correction on kidney function in chronic kidney disease (CKD) patients remains unclear. As 19-40% of patients with CKD receive an erythropoiesis-stimulating agent (ESA), this is a potentially important consideration. Summary: We conducted a systematic review and meta-analysis of randomized trials to January 1, 2014 in adult patients with CKD stages 1 to 4. Selection criteria for studies: randomized controlled trials of at least 2 months duration. Patients were allocated to ESA versus placebo, no treatment, or different ESA doses with the purpose of achieving a higher versus a lower hemoglobin target. The analyzed outcomes were the need for renal replacement therapy, doubling of serum creatinine, change in GFR (ml/min), mortality and withdrawal of treatment due to adverse events. A total of 19 trials (n = 8,129 participants with CKD stage 1-4) were reviewed. There was no difference in the risk of end-stage kidney disease (RR, 0.97 [CI 0.83-1.20], 17 trials, 8,104 participants), change in GFR (Mean Difference [MD] -0.45 [-2.21, 1.31], 9 trials, 1,848 participants) or withdrawal of treatment due to adverse events (RR, 1.18 [CI 0.77-1.81], 10 trials, n = 1,958 participants) for patients at higher hemoglobin (Hb) targets. Furthermore, no statistically significant differences in mortality (Risk Ratio [RR] 1.10 [CI 0.90-1.35], 16 trials, n = 8,082 participants) were observed. Key Messages: There is no evidence that ESA treatment affects renal function in patients with CKD. Use of these agents should not therefore be influenced by considerations about influencing CKD progression.

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“…2) [25]. Without definitive clinical outcome data, there has been an extrapolation of perceived benefits, particularly regarding quality of life assessments to the much larger patient population, those with less severe CKD not requiring dialysis [26]. The strong associations of CKD with higher rates of cardiovascular death, myocardial infarction, stroke and heart failure that were even more adversely impacted in patients with concomitant anemia provided a strong rationale for the use of ESAs in these patients.…”

Section: Dialysismentioning

confidence: 99%

Anemia treatment in chronic kidney disease: shifting uncertainty

Pfeffer

2008

Heart Fail Rev

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Epidemiologic observations showing associations between higher levels of some biologic markers such as blood pressure and serum cholesterol with heightened risk of death and non-fatal cardiovascular events have provided important data to develop hypotheses regarding pharmacologic therapies to modify these markers to improve prognosis. Randomized controlled trials have shown that strategies to reduce blood pressure with a variety of antihypertensive agents and LDL cholesterol with statins do, indeed, result in important improvements in clinical outcomes. However, there are several instances where a hypothesis based on strong observational data has been rejected based on surprising counterintuitive evidence generated from randomized controlled clinical trials. Use of inotropic therapies for patients with reduced left ventricular ejection fraction heart failure, administration of class I antiarrhythmic agents to suppress ventricular arrhythmias in high-risk patients, and use of hormone replacement therapy for postmenopausal women have each shown that therapies presumed to be of benefit may actually be producing unfavorable clinical results. Use of erythropoietic stimulating agents (ESA) in chronic kidney disease patients with anemia is similarly based on strong observational data indicating that the degree of anemia is independently associated with higher risk for cardiovascular morbidity and mortality. In non-dialysis patients with mild to moderate anemia, current clinical outcome studies have only addressed arbitrary hemoglobin targets for ESA therapy and have shown that targeting the higher hemoglobin levels was not associated with the benefit and may even result in harm. This review will outline the importance of having a placebo-controlled trial in this patient population to better assess the risk benefit profile of this therapy.

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Recombinant human erythropoietin for chronic renal failure anaemia in pre-dialysis patients

Cited by 68 publications

References 78 publications

How the Target Hemoglobin of Renal Anemia Should Be?

How the Target Hemoglobin of Renal Anemia Should Be?

Erythropoiesis-Stimulating Agents (ESA) for Preventing the Progression of Chronic Kidney Disease: A Meta-Analysis of 19 Studies

Anemia treatment in chronic kidney disease: shifting uncertainty

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