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Intravenous alpha-1 antitrypsin augmentation therapy: systematic review
Peter C Gøtzsche1, Helle Krogh Johansen
1Rigshospitalet, The Nordic Cochrane Centre, University of Copenhagen, Denmark. pcg@cochrane.dk
Danish Medical Bulletin
|September 7, 2010
Summary
Augmentation therapy for alpha-1 antitrypsin deficiency lung disease showed no clear clinical benefits. Evidence does not support its recommendation due to lack of efficacy and high cost.
Area of Science:
- Pulmonology
- Medical Genetics
- Clinical Pharmacology
Background:
- Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder that can lead to severe lung disease.
- Augmentation therapy aims to increase AAT levels in patients with AATD-associated lung disease.
Purpose of the Study:
- To review the benefits and harms of alpha-1 antitrypsin augmentation therapy in patients with AATD and lung disease.
Main Methods:
- Systematic review of randomized controlled trials comparing AAT augmentation therapy with placebo or no treatment.
- Searched PubMed and ClinicalTrials databases up to January 7, 2010.
- Included two trials with 140 patients, followed for two to three years.
Main Results:
- No mortality data were reported. Serious adverse events occurred in both groups in one trial.
- Exacerbations and quality of life were similar between groups.
- Forced expiratory volume in one second showed a slight, non-significant deterioration with augmentation therapy. Lung density showed a slight improvement.
Conclusions:
- Current evidence does not support the recommendation of alpha-1 antitrypsin augmentation therapy due to a lack of demonstrated clinical benefit.
- The high cost of treatment further argues against its routine use in AATD lung disease.
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