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  • Sitbon, OlivierUniversite Paris-Saclay, Le Kremlin-Bicetre, France (författare)

Selexipag for the Treatment of Pulmonary Arterial Hypertension

  • Artikel/kapitelEngelska2015

Förlag, utgivningsår, omfång ...

  • 2015
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:liu-124279
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-124279URI
  • https://doi.org/10.1056/NEJMoa1503184DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Laila Hübbert vid avdelningen för kardiovaskulär medicin samt Kardiologiska kliniken US, tillhör "GRIPHON Investigators".
  • BACKGROUND: In a phase 2 trial, selexipag, an oral selective IP prostacyclin-receptor agonist, was shown to be beneficial in the treatment of pulmonary arterial hypertension.METHODS: In this event-driven, phase 3, randomized, double-blind, placebo-controlled trial, we randomly assigned 1156 patients with pulmonary arterial hypertension to receive placebo or selexipag in individualized doses (maximum dose, 1600 μg twice daily). Patients were eligible for enrollment if they were not receiving treatment for pulmonary arterial hypertension or if they were receiving a stable dose of an endothelin-receptor antagonist, a phosphodiesterase type 5 inhibitor, or both. The primary end point was a composite of death from any cause or a complication related to pulmonary arterial hypertension up to the end of the treatment period (defined for each patient as 7 days after the date of the last intake of selexipag or placebo).RESULTS: A primary end-point event occurred in 397 patients--41.6% of those in the placebo group and 27.0% of those in the selexipag group (hazard ratio in the selexipag group as compared with the placebo group, 0.60; 99% confidence interval, 0.46 to 0.78; P<0.001). Disease progression and hospitalization accounted for 81.9% of the events. The effect of selexipag with respect to the primary end point was similar in the subgroup of patients who were not receiving treatment for the disease at baseline and in the subgroup of patients who were already receiving treatment at baseline (including those who were receiving a combination of two therapies). By the end of the study, 105 patients in the placebo group and 100 patients in the selexipag group had died from any cause. Overall, 7.1% of patients in the placebo group and 14.3% of patients in the selexipag group discontinued their assigned regimen prematurely because of adverse events. The most common adverse events in the selexipag group were consistent with the known side effects of prostacyclin, including headache, diarrhea, nausea, and jaw pain.CONCLUSIONS: Among patients with pulmonary arterial hypertension, the risk of the primary composite end point of death or a complication related to pulmonary arterial hypertension was significantly lower with selexipag than with placebo. There was no significant difference in mortality between the two study groups. (Funded by Actelion Pharmaceuticals; GRIPHON ClinicalTrials.gov number, NCT01106014.).

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Channick, RichardMassachusetts General Hospital, Boston, USA (författare)
  • Chin, Kelly MSouthwestern Medical Center, Dallas, USA (författare)
  • Frey, AlineActelion Pharmaceuticals, Allschwil, Switzerland (författare)
  • Gaine, SeanNational Pulmonary Hypertension Unit, Mater University Hospital, Dublin, Ireland (författare)
  • Galiè, NazzarenoUniversity of Bologna, Bologna, Italy (författare)
  • Ghofrani, Hossein-ArdeschirUniversity of Giessen andMarbury Lung Center, GermanCenter of Lund Research, Giessen, Germany (författare)
  • Hoeper, Marius MHannover Medical School and German Center of Lung Research, Hannover, Germany (författare)
  • Lang, Irene MDivision of Cardiology, Allgemeines Kramkenhasu, Vienna (författare)
  • Preiss, RalphActelion Pharmaceuticals, Allschwil, Switzerland (författare)
  • Rubin, Lewis JUniversity of Calfornia, San Diego, USA (författare)
  • Di Scala, LillaActelion Pharmaceuticals, Allschwil, Switzerland (författare)
  • Tapson, VictorSinai Medical Centre, Los Angeles, USA (författare)
  • Adzerikho, IgorMinskRegional Clinical Hospital, Minsk, Belarus (författare)
  • Liu, JinmingShanghai Pulmonary Hospital, Shanghai, China (författare)
  • Moiseeva, OlgaFederal Almazow North-West Medical Research Center, St Petersburg, Russia (författare)
  • Zeng, XiaofengPeking Union Medical College Hospital, Beijing, China (författare)
  • Simonneau, GéraldUniversity Paris-Saclay, Le Kremlin-Bicetre, France (författare)
  • McLaughlin, Vallerie VUniversity of Michigan Health System, Ann Arbor, USA (författare)
  • Universite Paris-Saclay, Le Kremlin-Bicetre, FranceMassachusetts General Hospital, Boston, USA (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:New England Journal of Medicine373:260028-47931533-4406

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