The conclusions of this study were a foregone conclusion! The extent and degree of conflicts of interest are hard not to ignore. I am not saying they are not valid, but they require much more scrutiny than a cursory reading.
Competing interests
Robert A Stockley has received an unrestricted grant from Talecris Biotherapeutics for the Alpha-1 Detection and Programme for Treatment (ADAPT UK registry). He has advised Baxter and Kamada on their augmentation programmes and received international lecture fees from Talecris. He has lectured widely as part of pharmaceutical sponsored symposia, sat on numerous advisory boards for drug design and trial implementation and received non-commercial grant funding from some companies. David G Parr has served on company advisory board meetings for Talecris Biotherapeutics and acts as a consultant on the technical steering committees of Talecris Biotherapeutics and F Hoffmann-La Roche. He has received honoraria and payment of expenses from Talecris Biotherapeutics for presentations at international meetings. Eeva Piitulainen has no conflicts of interest to disclose. Jan Stolk has served on company advisory board meetings of various companies and served as consultant to some of them. Fees were directly donated to the bank account of the Alpha-1 International Registry Foundation. Berend C Stoel has received honoraria for presentations from Talecris Biotherapeutics. He is a consultant for Roche Pharmaceuticals, Talecris Biotherapeutics, Bioclinica and CSL Behring. His institution has received grant monies from Bio-Imaging (now Bioclinica), Roche, Talecris and Medis Medical Imaging Systems for a research project. Asger Dirksen, as the principal investigator of the 2 multicenter, randomised clinical trials of augmentation therapy with alpha-1 antitrypsin that are integrated in the manuscript, has received grant monies from Bayer and Talecris Biotherapeutics, and has participated in travel and meetings sponsored by Bayer and Talecris. Furthermore, he has received grant funding from the Danish Lung Association for a PhD, who shall analyse data from the Danish Lung Cancer Screening Trial that has no relation to the manuscript.
Acknowledgments
Support Statement - This study was sponsored by Talecris Biotherapeutics, Inc. (Research Triangle Park, NC 27709, USA). Technical editorial assistance was provided under the direction of the authors by M Kenig at PAREXEL (Worthing, UK) and was supported by Talecris Biotherapeutics, Inc.
Stockley R, Parr D, Piitulainen E, Stolk J, Stoel B, Dirksen A. Therapeutic efficacy of alpha-1 antitrypsin augmentation therapy on the loss of lung tissue: an integrated analysis of 2 randomised clinical trials using computed tomography densitometry. Respiratory Research 2010;11(1):136. http://respiratory-research.com/content/pdf/1465-9921-11-136.pdf
BACKGROUND: Two randomised, double-blind, placebo-controlled trials have investigated the efficacy of IV alpha-1 antitrypsin (AAT) augmentation therapy on emphysema progression using CT densitometry.
METHODS: Data from these similar trials, a 2-center Danish-Dutch study (n = 54) and the 3-center EXAcerbations and CT scan as Lung Endpoints (EXACTLE) study (n = 65), were pooled to increase the statistical power. The change in 15th percentile of lung density (PD15) measured by CT scan was obtained from both trials. All subjects had 1 CT scan at baseline and at least 1 CT scan after treatment. Densitometric data from 119 patients (AAT [Alfalastin or Prolastin], n = 60; placebo, n = 59) were analysed by a statistical/endpoint analysis method. To adjust for lung volume, volume correction was made by including the change in log-transformed total lung volume as a covariate in the statistical model.
RESULTS: Mean follow-up was approximately 2.5 years. The mean change in lung density from baseline to last CT scan was -4.082 g/L for AAT and -6.379 g/L for placebo with a treatment difference of 2.297 (95% CI, 0.669 to 3.926; p = 0.006). The corresponding annual declines were -1.73 and -2.74 g/L/yr, respectively.
CONCLUSIONS: The overall results of the combined analysis of 2 separate trials of comparable design, and the only 2 controlled clinical trials completed to date, has confirmed that IV AAT augmentation therapy significantly reduces the decline in lung density and may therefore reduce the future risk of mortality in patients with AAT deficiency-related emphysema.
Trial registration: The EXACTLE study was registered in ClinicalTrials.gov as 'Antitrypsin (AAT) to Treat Emphysema in AAT-Deficient Patients'; ClinicalTrials.gov Identifier: NCT00263887.
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