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Eligibility for sac...
Eligibility for sacubitril/valsartan in heart failure across the ejection fraction spectrum: real-world data from the Swedish Heart Failure Registry
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- Savarese, G. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden
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- Hage, C. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden
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- Benson, L. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden
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- Schrage, B. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden; Univ Heart & Vasc Ctr Hamburg, Germany
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- Thorvaldsen, T. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden
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- Lundberg, A. (författare)
- Novartis Sverige, Sweden
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- Fudim, M. (författare)
- Duke Univ, NC USA
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- Linde, C. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden
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- Dahlström, Ulf (författare)
- Linköpings universitet,Avdelningen för diagnostik och specialistmedicin,Medicinska fakulteten,Region Östergötland, Kardiologiska kliniken US
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- Rosano, G. M. C. (författare)
- IRCCS San Raffaele, Italy; St Georges Hosp NHS Trust Univ London, England
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- Lund, L. H. (författare)
- Karolinska Institutet,Karolinska Inst, Sweden
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(creator_code:org_t)
- 2020-09
- 2021
- Engelska.
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Ingår i: Journal of Internal Medicine. - : WILEY. - 0954-6820 .- 1365-2796. ; 289:3, s. 369-384
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Abstract
Ämnesord
Stäng
- Background Randomized controlled trials (RCT) generalizability may be limited due to strict patient selection. Objective In a real-world heart failure (HF) population, we assessed eligibility for sacubitril/valsartan based on PARADIGM-HF (sacubitril/valsartan effective)/PARAGON-HF [sacubitril/valsartan effective in mildly reduced ejection fraction (EF)]. Methods Outpatients from the Swedish HF Registry (SwedeHF) were analysed. In SwedeHF, EF is recorded as <30, 30-39, 40-49 and >= 50%. In PARAGON-HF, sacubitril/valsartan was effective with EF <= 57% (i.e. median). We defined reduced EF/PARADIGM-HF as EF < 40%, mildly reduced EF/PARAGON-HF <= median as EF 40-49%, and normal EF/PARAGON-HF > median as EF >= 50%. We assessed 2 scenarios: (i) criteria likely to influence treatment decisions (pragmatic scenario); (ii) all criteria (literal scenario). Results Of 37 790 outpatients, 57% had EF < 40%, 24% EF 40-49% and 19% EF >= 50%. In the pragmatic scenario, 63% were eligible in EF < 50% (67% for EF < 40% and 52% for 40-49%) and 52% in EF >= 40% (52% for EF >= 50%). For the literal scenario, 32% were eligible in EF < 50% (38% of EF < 40%, 20% of EF 40-49%) and 22% in EF >= 40% (25% for EF >= 50%). Eligible vs. noneligible patients had more severe HF, more comorbidities and overall worse outcomes. Conclusion In a real-world HF outpatient cohort, 81% of patients had EF < 50%, with 63% eligible for sacubitril/valsartan based on pragmatic criteria and 32% eligible based on literal trial criteria. Similar eligibility was observed for EF 40-49% and >= 50%, suggesting that our estimates for EF < 50% may be reproduced whether or not a higher cut-off for EF is considered.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- eligibility; PARADIGM-HF; PARAGON-HF; sacubitril; valsartan; trial
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Savarese, G.
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Hage, C.
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Benson, L.
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Schrage, B.
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Thorvaldsen, T.
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Lundberg, A.
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Fudim, M.
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Linde, C.
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Dahlström, Ulf
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Rosano, G. M. C.
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Lund, L. H.
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kardiologi
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Journal of Inter ...
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Linköpings universitet
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Karolinska Institutet