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The Use of EPO-Stimulating Agents in Heart Failure Nora Sharaya, PharmD PGY2 Pharmacotherapy Resident Butler University & Community Health Network This.

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Presentation on theme: "The Use of EPO-Stimulating Agents in Heart Failure Nora Sharaya, PharmD PGY2 Pharmacotherapy Resident Butler University & Community Health Network This."— Presentation transcript:

1 The Use of EPO-Stimulating Agents in Heart Failure Nora Sharaya, PharmD PGY2 Pharmacotherapy Resident Butler University & Community Health Network This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation

2 The Link Between Anemia and Heart Failure Anemia Hemodilution Functional Iron Deficiency Activation of the Inflammatory Cascade Impaired EPO Production Concomitant CKD ISRN Hematol 2012; 2012:

3 HF with preserved EF HF with unpreserved EF Anemia The Link Between Anemia and Heart Failure ISRN Hematol 2012; 2012:

4 A meta-analysis published in 2008 examined 153,180 patients with chronic heart failure  Of those patients, 37.2% were anemic After a minimum of six months follow up, 46.8% of patients with anemia died compared to 29.5% of the patients without anemia  Based on these results, in patients without an identifiable cause for their anemia, using erythropoietin-stimulating agents has been considered Mortality J Am Coll Cardiol. 2008;52:818–2.

5 Increased Risk of Mortality Reduced Exercise Capacity Impaired Quality of Life Increased Risk of Hospitalization Complications J Am Coll Cardiol 2008;52:818–2

6 Acknowledge the link between anemia and heart failure Discuss associated complications No cited recommendation on use of EPO stimulating agents for treatment Lack of definitive evidence ACCF/AHA Guidelines Circulation. 2013; 128: e240-e327.

7 US Boxed Warning: “Erythropoiesis-stimulating agents (ESAs) increased the risk of serious cardiovascular events, thromboembolic events, stroke, and mortality in clinical studies when administered to target hemoglobin levels >11 g/dL.” Concerns with EPO Stimulating Agents Darbepoetin (Package Insert)

8 van Veldhuisen DJ, et al. Study DesignResultsApplicability Randomized, multinational, double-blind, placebo-controlled Randomized to Wt- based dose of SQ darbepoetin alfa, a fixed dose, or placebo Q2W X25W targeting Hgb 14.0 PO iron supplement n=162 patients Darbepoetin vs. placebo trended towards : o  six-minute walk distance o Improvement in NYHA class o Improvement in health-care associated QOL In treated patients, there were trends towards improvement in: Walking distance NYHA class Health-care associated QOL Eur Heart J. 2007;28:2208–16.

9 Ghali JK, et al. Study DesignResultsApplicability Randomized, multicenter, double blind, placebo-controlled Randomized to darbepoetin alfa (starting dose, 0.75 ug/kg) or placebo subcutaneously Q2W for 52 weeks n=162 (treatment) n=157 (placebo) Mostly white males with NHYA Class III HF Well-tolerated, but no increase in exercise tolerance A trend towards ↓ mortality and hospitalization Darbepoetin is well tolerated and showed trends towards improvement: Exercise tolerance Mortality Hospitalization rate Circulation. 2008;117:526–35.

10 Study DesignResultsApplicability Randomized, double-blind, multinational, placebo-controlled Randomized to darbepoetin alfa 0.75 ug/kg (titrate to Hg>13.0) or placebo SQ Q2W Iron therapy given if TSAT <20% n=1136 (treatment) n=1142 (placebo) Primary composite outcome: o Treatment: 576 (50.7%) o Placebo: 565 (49.5%) Increased embolic and thrombotic events in the treatment group Do not support the use of darbepoetin to reduce the rate of hospitalization or death from any cause. A low hemoglobin value may be a marker of poor prognosis versus a treatment target Swedberg K, et al. N Engl J Med. 2013;368:1210–19.

11 Conclusions Treatment Target Poor Prognostic Sign

12 The Use of EPO-Stimulating Agents in Heart Failure Nora Sharaya, PharmD PGY2 Pharmacotherapy Resident Butler University & Community Health Network


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