Evidence “beyond reasonable doubt” may never be achievable for low-volume drugs
The recent publication of a randomised controlled trial (RCT) of inhaled cyclosporin in the New England Journal of Medicine represents another milestone in the evolution of lung transplantation (LTx) as a standard therapy in the management of severe lung and pulmonary vascular diseases.1,2 RCTs have been few and far between in lung transplantation, and this is the first in such a high-profile general journal. However, the big question is: how will we integrate the study results into the clinical practice in Australia?
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- 2. Iacono AT, Johnson BA, Grgurich WF, et al. A randomized trial of inhaled cyclosporine in lung-transplant recipients. N Engl J Med 2006; 354: 141-150.
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- 6. Snell GI, Valentine VG, Vitulo P, et al. Everolimus versus azathioprine as adjunctive therapy to inhibit the lung function decline in stable lung transplant recipients: 12 and 24-month results of an international, randomized, double-blind study. Am J Transplant 2006; 6: 169-177.
- 7. Corris P, Glanville AR, McNeil KD, et al. One year analysis of an ongoing international randomized study of mycophenolate mofetil (MMF) vs azathioprine (AZA) in lung transplantation. J Heart Lung Transplant 2001; 20: 149-150.
- 8. DeCamp MM. Inhaled cyclosporine — a breath of fresh air? N Engl J Med 2006; 354: 191-193.
Greg Snell serves on the Transplant Advisory Board of Roche Pharmaceuticals. Both Greg Snell and Tom Kotsimbos have received speakers’ fees for delivering talks at Roche and Novartis Pharmaceutical meetings over the past 2 years, and travel assistance from Novartis Pharmaceuticals to attend the 2006 meeting of the International Society for Heart and Lung Transplantation.