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Pharmacodynamics, p...
Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes
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- Storey, Robert F. (författare)
- Univ Sheffield, Dept Infect Immun & Cardiovasc Dis, Sheffield, S Yorkshire, England.
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- Gurbel, Paul A. (författare)
- Inova Heart & Vasc Inst, Falls Church, VA USA.
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- ten Berg, Jurrien (författare)
- St Antonius Hosp, Dept Cardiol, Nieuwegein, Netherlands.
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- Bernaud, Corine (författare)
- Idorsia Pharmaceut Ltd, Allschwil, Switzerland.
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- Dangas, George D. (författare)
- Mt Sinai Hosp, Div Cardiol, New York, NY USA.
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- Frenoux, Jean-Marie (författare)
- Idorsia Pharmaceut Ltd, Allschwil, Switzerland.
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- Gorog, Diana A. (författare)
- Univ Hertfordshire, Hatfield, Herts, England.;Imperial Coll, Natl Heart & Lung Inst, London, England.
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- Hmissi, Abdel (författare)
- Idorsia Pharmaceut Ltd, Allschwil, Switzerland.
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- Kunadian, Vijay (författare)
- Newcastle Univ, Fac Med Sci, Newcastle Upon Tyne, Tyne & Wear, England.;Newcastle Tyne Hosp NHS Fdn Trust, Freeman Hosp, Cardiothorac Ctr, Newcastle Upon Tyne, Tyne & Wear, England.
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- James, Stefan, 1964- (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)
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- Tanguay, Jean-Francois (författare)
- Univ Montreal, Inst Cardiol Montreal, Dept Med, Montreal, PQ, Canada.
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- Tran, Henry (författare)
- Inova Heart & Vasc Inst, Falls Church, VA USA.
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- Trenk, Dietmar (författare)
- Univ Heart Ctr Freiburg Bad Krozingen, Dept Cardiol & Angiol 2, Bad Krozingen, Germany.
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- Ufer, Mike (författare)
- Idorsia Pharmaceut Ltd, Allschwil, Switzerland.
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- Van der Harst, Pim (författare)
- Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands.
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- Van't Hof, Arnoud W. J. (författare)
- Maastricht Univ Med Ctr MUMC, Dept Cardiol, Maastricht, Netherlands.;Zuyderland Med Ctr ZMC, Dept Cardiol, Heerlen, Netherlands.;Isala Hosp, Dept Cardiol, Zwolle, Netherlands.
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- Angiolillo, Dominick J. (författare)
- Univ Florida, Div Cardiol, Coll Med, Jacksonville, FL USA.
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Univ Sheffield, Dept Infect Immun & Cardiovasc Dis, Sheffield, S Yorkshire, England Inova Heart & Vasc Inst, Falls Church, VA USA. (creator_code:org_t)
- 2019-11-14
- 2020
- Engelska.
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 41:33, s. 3132-3140
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https://uu.diva-port... (primary) (Raw object)
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Aims To study the pharmacodynamics and pharmacokinetics of selatogrel, a novel P2Y(12) receptor antagonist for subcutaneous administration, in patients with chronic coronary syndromes (CCS). Methods and results In this double-blind, randomized study of 345 patients with CCS on background oral antiplatelet therapy, subcutaneous selatogrel (8 mg, n = 114; or 16 mg, n = 115) was compared with placebo (n = 116) (ClinicalTrials.gov: NCT03384966). Platelet aggregation was assessed over 24 h (VerifyNow assay) and 8 h (light transmittance aggregometry; LTA). Pharmacodynamic responders were defined as patients having P2Y(12) reaction units (PRU) <100 at 30 min post-dose and lasting >= 3 h. At 30 min post-dose, 89% of patients were responders to selatogrel 8 mg, 90% to selatogrel 16 mg, and 16% to placebo (P < 0.0001). PRU values (mean standard deviation) were 10 +/- 25 (8 mg), 4 +/- 10 (16 mg), and 163 +/- 73 (placebo) at 15 min and remained <100 up to 8 h for both doses, returning to pre-dose or near pre-dose levels by 24 h post-dose. LTA data showed similarly rapid and potent inhibition of platelet aggregation. Selatogrel plasma concentrations peaked similar to 30 min post-dose. Selatogrel was safe and well-tolerated with transient dyspnoea occurring overall in 7% (16/229) of patients (95% confidence interval: 4-11%). Conclusions Selatogrel was rapidly absorbed following subcutaneous administration in CCS patients, providing prompt, potent, and consistent platelet P2Y(12) inhibition sustained for >= 8 h and reversible within 24 h. Further studies of subcutaneous selatogrel are warranted in clinical scenarios where rapid platelet inhibition is desirable.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- Selatogrel
- Platelet aggregation
- Coronary artery disease
- P2Y(12) receptor antagonist
- Pharmacodynamics
- Pharmacokinetics
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Storey, Robert F ...
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Gurbel, Paul A.
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ten Berg, Jurrie ...
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Bernaud, Corine
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Dangas, George D ...
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Frenoux, Jean-Ma ...
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Gorog, Diana A.
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Hmissi, Abdel
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Kunadian, Vijay
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James, Stefan, 1 ...
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Tanguay, Jean-Fr ...
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Tran, Henry
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Trenk, Dietmar
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Ufer, Mike
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Van der Harst, P ...
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Van't Hof, Arnou ...
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Angiolillo, Domi ...
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