The Use of EPO-Stimulating Agents in Heart Failure
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Transcript of The Use of EPO-Stimulating Agents in Heart Failure
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The Use of EPO-Stimulating Agents in Heart Failure
Nora Sharaya, PharmDPGY2 Pharmacotherapy ResidentButler University & Community Health Network
This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation
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The Link Between Anemia and Heart Failure
AnemiaHemodilution
Functional Iron
Deficiency
Activation of the
Inflammatory Cascade
Impaired EPO Production
Concomitant CKD
ISRN Hematol 2012; 2012: 246915
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HF with preserved EF
HF with unpreserved
EF
Anemia
The Link Between Anemia and Heart Failure
ISRN Hematol 2012; 2012: 246915
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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.
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Increased Risk of Mortality
Reduced Exercise Capacity
Impaired Quality of Life
Increased Risk of Hospitalization
Complications
J Am Coll Cardiol 2008;52:818–2
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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.
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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)
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van Veldhuisen DJ, et al.
Study Design Results Applicability
• 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 distanceo Improvement
in NYHA classo 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.
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Ghali JK, et al.
Study Design Results Applicability
• 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.
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Study Design Results Applicability • 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.
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Conclusions
Treatment Target
Poor Prognostic Sign
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The Use of EPO-Stimulating Agents in Heart Failure
Nora Sharaya, PharmDPGY2 Pharmacotherapy ResidentButler University & Community Health NetworkEmail: [email protected]