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  • Storey, Robert F.Univ Sheffield, Dept Infect Immun & Cardiovasc Dis, Sheffield, S Yorkshire, England. (author)

Pharmacodynamics, pharmacokinetics, and safety of single-dose subcutaneous administration of selatogrel, a novel P2Y12 receptor antagonist, in patients with chronic coronary syndromes

  • Article/chapterEnglish2020

Publisher, publication year, extent ...

  • 2019-11-14
  • Oxford University Press (OUP),2020
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:uu-424548
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-424548URI
  • https://doi.org/10.1093/eurheartj/ehz807DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Gurbel, Paul A.Inova Heart & Vasc Inst, Falls Church, VA USA. (author)
  • ten Berg, JurrienSt Antonius Hosp, Dept Cardiol, Nieuwegein, Netherlands. (author)
  • Bernaud, CorineIdorsia Pharmaceut Ltd, Allschwil, Switzerland. (author)
  • Dangas, George D.Mt Sinai Hosp, Div Cardiol, New York, NY USA. (author)
  • Frenoux, Jean-MarieIdorsia Pharmaceut Ltd, Allschwil, Switzerland. (author)
  • Gorog, Diana A.Univ Hertfordshire, Hatfield, Herts, England.;Imperial Coll, Natl Heart & Lung Inst, London, England. (author)
  • Hmissi, AbdelIdorsia Pharmaceut Ltd, Allschwil, Switzerland. (author)
  • Kunadian, VijayNewcastle 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. (author)
  • James, Stefan,1964-Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367 (author)
  • Tanguay, Jean-FrancoisUniv Montreal, Inst Cardiol Montreal, Dept Med, Montreal, PQ, Canada. (author)
  • Tran, HenryInova Heart & Vasc Inst, Falls Church, VA USA. (author)
  • Trenk, DietmarUniv Heart Ctr Freiburg Bad Krozingen, Dept Cardiol & Angiol 2, Bad Krozingen, Germany. (author)
  • Ufer, MikeIdorsia Pharmaceut Ltd, Allschwil, Switzerland. (author)
  • Van der Harst, PimUniv Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands. (author)
  • Van't Hof, Arnoud W. J.Maastricht Univ Med Ctr MUMC, Dept Cardiol, Maastricht, Netherlands.;Zuyderland Med Ctr ZMC, Dept Cardiol, Heerlen, Netherlands.;Isala Hosp, Dept Cardiol, Zwolle, Netherlands. (author)
  • Angiolillo, Dominick J.Univ Florida, Div Cardiol, Coll Med, Jacksonville, FL USA. (author)
  • Univ Sheffield, Dept Infect Immun & Cardiovasc Dis, Sheffield, S Yorkshire, England.Inova Heart & Vasc Inst, Falls Church, VA USA. (creator_code:org_t)

Related titles

  • In:European Heart Journal: Oxford University Press (OUP)41:33, s. 3132-31400195-668X1522-9645

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