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  • Galiè, NazzarenoUniversity of Bologna, Italy (author)

Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension

  • Article/chapterEnglish2015

Publisher, publication year, extent ...

  • 2015
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:liu-124285
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-124285URI
  • https://doi.org/10.1056/NEJMoa1413687DOI

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  • Language:English
  • Summary in:English

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

Notes

  • Laila Hübbert vid avdelningen för kardiovaskulär medicin samt kardiologiska kliniken US, tillhör "AMBITION Investigators"
  • BACKGROUND: Data on the effect of initial combination therapy with ambrisentan and tadalafil on long-term outcomes in patients with pulmonary arterial hypertension are scarce.METHODS: In this event-driven, double-blind study, we randomly assigned, in a 2:1:1 ratio, participants with World Health Organization functional class II or III symptoms of pulmonary arterial hypertension who had not previously received treatment to receive initial combination therapy with 10 mg of ambrisentan plus 40 mg of tadalafil (combination-therapy group), 10 mg of ambrisentan plus placebo (ambrisentan-monotherapy group), or 40 mg of tadalafil plus placebo (tadalafil-monotherapy group), all administered once daily. The primary end point in a time-to-event analysis was the first event of clinical failure, which was defined as the first occurrence of a composite of death, hospitalization for worsening pulmonary arterial hypertension, disease progression, or unsatisfactory long-term clinical response.RESULTS: The primary analysis included 500 participants; 253 were assigned to the combination-therapy group, 126 to the ambrisentan-monotherapy group, and 121 to the tadalafil-monotherapy group. A primary end-point event occurred in 18%, 34%, and 28% of the participants in these groups, respectively, and in 31% of the pooled-monotherapy group (the two monotherapy groups combined). The hazard ratio for the primary end point in the combination-therapy group versus the pooled-monotherapy group was 0.50 (95% confidence interval [CI], 0.35 to 0.72; P<0.001). At week 24, the combination-therapy group had greater reductions from baseline in N-terminal pro-brain natriuretic peptide levels than did the pooled-monotherapy group (mean change, -67.2% vs. -50.4%; P<0.001), as well as a higher percentage of patients with a satisfactory clinical response (39% vs. 29%; odds ratio, 1.56 [95% CI, 1.05 to 2.32]; P=0.03) and a greater improvement in the 6-minute walk distance (median change from baseline, 48.98 m vs. 23.80 m; P<0.001). The adverse events that occurred more frequently in the combination-therapy group than in either monotherapy group included peripheral edema, headache, nasal congestion, and anemia.CONCLUSIONS: Among participants with pulmonary arterial hypertension who had not received previous treatment, initial combination therapy with ambrisentan and tadalafil resulted in a significantly lower risk of clinical-failure events than the risk with ambrisentan or tadalafil monotherapy. (Funded by Gilead Sciences and GlaxoSmithKline; AMBITION ClinicalTrials.gov number, NCT01178073.).

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

  • Barberà, Joan AUniversity of Barcelona and Biomedical Research Networking Center on Respiratory Diseases, Madrid, Spain (author)
  • Frost, Adaani EBaylor College of Medicine, Houston, USA (author)
  • Ghofrani, Hossein-ArdeschirUniversity of Giessen and Marbury Lung Center, Giessen, Germany (author)
  • Hoeper, Marius MHanover Medical School and German Center of Lung Research, Hanover, Germany (author)
  • McLaughlin, Vallerie VUniversity of Michigan, USA (author)
  • Peacock, Andrew JRegional Heart and Lung Center, Glasgow, Scotland (author)
  • Simonneau, GéraldUniversity Paris-Sud, Paris, France (author)
  • Vachiery, Jean-LucHospital Erasme, Brussels, Belgium (author)
  • Grünig, EkkehardUniversity Hospital Heidelberg, Heidelberg, Germany (author)
  • Oudiz, Ronald JUCLA Medical Center, Torrance,USA (author)
  • Vonk-Noordegraaf, AntonUniversity Medical Center, Amsterdam, Netherlands (author)
  • White, R JamesUniversity of Rochester, NY, USA (author)
  • Blair, ChristianaGilead Sciences, Foster City (author)
  • Gillies, HunterGilead Sciences, Foster City (author)
  • Miller, Karen LGilead Sciences, Foster City (author)
  • Harris, Julia H NGlaxoSmith Kline, Uxbridge, UK (author)
  • Langley, JonathanGlaxoSmith Kline, Uxbridge, UK (author)
  • Rubin, Lewis JUniversity of California at San Diego, USA (author)
  • University of Bologna, ItalyUniversity of Barcelona and Biomedical Research Networking Center on Respiratory Diseases, Madrid, Spain (creator_code:org_t)

Related titles

  • In:New England Journal of Medicine373:90028-47931533-4406

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