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Long-term efficacy ...
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)
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- McElvaney, Noel G. (författare)
- Royal College of Surgeons in Ireland
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- Burdon, Jonathan (författare)
- St Vincent's Hospital, Sydney
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- Holmes, Mark (författare)
- University of Adelaide
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- Glanville, Allan (författare)
- St Vincent's Hospital, Sydney
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- Wark, Peter A B (författare)
- Hunter Medical Research Institute, Australia
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- Thompson, Philip J. (författare)
- University of Western Australia, Crawley
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- Hernandez, Paul (författare)
- Dalhousie University
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- Chlumsky, Jan (författare)
- Charles University in Prague
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- Teschler, Helmut (författare)
- University of Duisburg-Essen
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- Ficker, Joachim H. (författare)
- Klinikum Nürnberg
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Seersholm, Niels (författare)
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Altraja, Alan (författare)
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Mäkitaro, Riitta (författare)
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Chorostowska-Wynimko, Joanna (författare)
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Sanak, Marek (författare)
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Stoicescu, Paul I. (författare)
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- Piitulainen, Eeva (författare)
- Lund 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
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Vit, Oliver (författare)
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Wencker, Marion (författare)
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Tortorici, Michael A. (författare)
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Fries, Michael (författare)
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Edelman, Jonathan M. (författare)
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Chapman, Kenneth R. (författare)
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(creator_code:org_t)
- 2017
- 2017
- Engelska 10 s.
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Ingår i: The Lancet Respiratory Medicine. - 2213-2600. ; 5:1, s. 51-60
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
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Till lärosätets databas
- Av författaren/redakt...
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McElvaney, Noel ...
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Burdon, Jonathan
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Holmes, Mark
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Glanville, Allan
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Wark, Peter A B
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Thompson, Philip ...
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visa fler...
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Hernandez, Paul
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Chlumsky, Jan
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Teschler, Helmut
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Ficker, Joachim ...
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Seersholm, Niels
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Altraja, Alan
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Mäkitaro, Riitta
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Chorostowska-Wyn ...
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Sanak, Marek
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Stoicescu, Paul ...
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Piitulainen, Eev ...
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Vit, Oliver
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Wencker, Marion
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Tortorici, Micha ...
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Fries, Michael
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Edelman, Jonatha ...
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Chapman, Kenneth ...
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