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  • McElvaney, Noel G.Royal College of Surgeons in Ireland (författare)

Long-term efficacy and safety of α1 proteinase inhibitor treatment for emphysema caused by severe α1 antitrypsin deficiency : an open-label extension trial (RAPID-OLE)

  • Artikel/kapitelEngelska2017

Förlag, utgivningsår, omfång ...

  • 2017
  • 10 s.

Nummerbeteckningar

  • LIBRIS-ID:oai:lup.lub.lu.se:6dcc403c-f61d-4f57-a6cf-5806f4601028
  • https://lup.lub.lu.se/record/6dcc403c-f61d-4f57-a6cf-5806f4601028URI
  • https://doi.org/10.1016/S2213-2600(16)30430-1DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

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

Anmärkningar

  • Background Purified α1 proteinase inhibitor (A1PI) slowed emphysema progression in patients with severe α1 antitrypsin deficiency in a randomised controlled trial (RAPID-RCT), which was followed by an open-label extension trial (RAPID-OLE). The aim was to investigate the prolonged treatment effect of A1PI on the progression of emphysema as assessed by the loss of lung density in relation to RAPID-RCT. Methods Patients who had received either A1PI treatment (Zemaira or Respreeza; early-start group) or placebo (delayed-start group) in the RAPID-RCT trial were included in this 2-year open-label extension trial (RAPID-OLE). Patients from 22 hospitals in 11 countries outside of the USA received 60 mg/kg per week A1PI. The primary endpoint was annual rate of adjusted 15th percentile lung density loss measured using CT in the intention-to-treat population with a mixed-effects regression model. This trial is registered with ClinicalTrials.gov, number NCT00670007. Findings Between March 1, 2006, and Oct 13, 2010, 140 patients from RAPID-RCT entered RAPID-OLE: 76 from the early-start group and 64 from the delayed-start group. Between day 1 and month 24 (RAPID-RCT), the rate of lung density loss in RAPID-OLE patients was lower in the early-start group (−1·51 g/L per year [SE 0·25] at total lung capacity [TLC]; −1·55 g/L per year [0·24] at TLC plus functional residual capacity [FRC]; and −1·60 g/L per year [0·26] at FRC) than in the delayed-start group (−2·26 g/L per year [0·27] at TLC; −2·16 g/L per year [0·26] at TLC plus FRC, and −2·05 g/L per year [0·28] at FRC). Between months 24 and 48, the rate of lung density loss was reduced in delayed-start patients (from −2·26 g/L per year to −1·26 g/L per year), but no significant difference was seen in the rate in early-start patients during this time period (−1·51 g/L per year to −1·63 g/L per year), thus in early-start patients the efficacy was sustained to month 48. Interpretation RAPID-OLE supports the continued efficacy of A1PI in slowing disease progression during 4 years of treatment. Lost lung density was never recovered, highlighting the importance of early intervention with A1PI treatment. Funding CSL Behring.

Ämnesord och genrebeteckningar

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

  • Burdon, JonathanSt Vincent's Hospital, Sydney (författare)
  • Holmes, MarkUniversity of Adelaide (författare)
  • Glanville, AllanSt Vincent's Hospital, Sydney (författare)
  • Wark, Peter A BHunter Medical Research Institute, Australia (författare)
  • Thompson, Philip J.University of Western Australia, Crawley (författare)
  • Hernandez, PaulDalhousie University (författare)
  • Chlumsky, JanCharles University in Prague (författare)
  • Teschler, HelmutUniversity of Duisburg-Essen (författare)
  • Ficker, Joachim H.Klinikum Nürnberg (författare)
  • Seersholm, Niels (författare)
  • Altraja, Alan (författare)
  • Mäkitaro, Riitta (författare)
  • Chorostowska-Wynimko, Joanna (författare)
  • Sanak, Marek (författare)
  • Stoicescu, Paul I. (författare)
  • Piitulainen, EevaLund University,Lunds universitet,Lungmedicin, allergologi och palliativ medicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Respiratory Medicine, Allergology, and Palliative Medicine,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)lung-epi (författare)
  • Vit, Oliver (författare)
  • Wencker, Marion (författare)
  • Tortorici, Michael A. (författare)
  • Fries, Michael (författare)
  • Edelman, Jonathan M. (författare)
  • Chapman, Kenneth R. (författare)
  • Royal College of Surgeons in IrelandSt Vincent's Hospital, Sydney (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet Respiratory Medicine5:1, s. 51-602213-2600

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