Fernando J. Martinez, MD; Sharon Safrin, MD; Derek Weycker, PhD; Karen M. Starko, MD; Williamson Z. Bradford, MD, PhD; Talmadge E. King Jr, MD; Kevin R. Flaherty, MD; David A. Schwartz, MD; Paul W. Noble, MD; Ganesh Raghu, MD; Kevin K. Brown, MD; for the IPF Study Group*
Grant Support: By InterMune, Inc.
Potential Financial Conflicts of Interest: Employment: K.M. Starko (InterMune), W.Z. Bradford (InterMune); Consultancies: F.J. Martinez (InterMune), T.E. King (InterMune), D.A. Schwartz (InterMune), P.W. Noble (InterMune, Genzyme Millenium), G. Raghu (InterMune), K.K. Brown (InterMune, Wyeth, Actelion, Genzyme Corp., FibroGen); Honoraria: T.E. King (InterMune), P.W. Noble (InterMune), G. Raghu (InterMune), K.K. Brown (InteMune, Wyeth, Actelion, Genzyme Corp., FibroGen); Stock ownership or options (other than mutual funds): S. Safrin (InterMune), K.M. Starko (InterMune), W.Z. Bradford (InterMune); Patents pending: K.M. Starko (InterMune), W.Z. Bradford (InterMune).
Requests for Single Reprints: Fernando Martinez, MD, Department of Internal Medicine, University of Michigan, 3916 Taubman Centers 0360, Ann Arbor, MI 48109; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Martinez: Department of Internal Medicine, University of Michigan, 3916 Taubman Centers 0360, Ann Arbor, MI 48109.
Drs. Safrin, Starko, and Bradford: InterMune, Inc., 3280 Bayshore Boulevard, Brisbane, CA 94005.
Dr. Weycker: Policy Analysis Inc., Four Davis Court, Brookline, MA 02445.
Dr. King: Department of Medicine, San Francisco General Hospital, 5H22, 1001 Potrero Avenue, San Francisco, CA 94110.
Dr. Flaherty: University of Michigan Health System, 1500 East Medical Center Drive, 3916 Taubman Center, Ann Arbor, MI 48109.
Dr. Schwartz: Duke University Medical Center, Box 2629, Research Drive, MSRB Room 275, Durham, NC 27710.
Dr. Noble: Pulmonary and Critical Care Medicine, Yale School of Medicine, TAC 441-C, 333 Cedar Street, New Haven, CT 06525.
Dr. Raghu: Division of Pulmonary, University of Washington, BB 1237 Health Sciences, Box 356522, Seattle, WA 98195.
Dr. Brown: National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206.
Author Contributions: Conception and design: F.J. Martinez, S. Safrin, D. Weycker, K.M. Starko, W.Z. Bradford, D.A. Schwartz, P.W. Noble, G. Raghu, K.K. Brown.
Analysis and interpretation of the data: F.J. Martinez, S. Safrin, D. Weycker, K.M. Starko, W.Z. Bradford, T.E. King Jr., P.W. Noble, G. Raghu, K.K. Brown.
Drafting of the article: F.J. Martinez, S. Safrin, D. Weycker, K.M. Starko, W.Z. Bradford, D.A. Schwartz, P.W. Noble, K.K. Brown.
Critical revision of the article for important intellectual content: F.J. Martinez, S. Safrin, D. Weycker, K.M. Starko, T.E. King Jr., K.R. Flaherty, D.A. Schwartz, P.W. Noble, G. Raghu, K.K. Brown.
Final approval of the article: F.J. Martinez, S. Safrin, D. Weycker, K.M. Starko, T.E. King Jr., K.R. Flaherty, D.A. Schwartz, P.W. Noble, G. Raghu, K.K. Brown.
Provision of study materials or patients: F.J. Martinez, K.R. Flaherty, D.A. Schwartz, K.K. Brown.
Statistical expertise: F.J. Martinez, D. Weycker.
Prospective data defining the clinical course in idiopathic pulmonary fibrosis (IPF) are sparse.
To analyze the clinical course of patients with mild to moderate IPF.
Analysis of data from the placebo group of a randomized, controlled trial evaluating interferon-γ1b.
Academic and community medical centers.
168 patients in the placebo group of a trial evaluating interferon-γ1b.
Measures of physiology and dyspnea assessed at 12-week intervals; hospitalizations; and the pace of deterioration and cause of death over a median period of 76 weeks.
Physiologic variables changed minimally during the study. However, 23% of patients required hospitalization for a respiratory disorder and 21% died. Idiopathic pulmonary fibrosis was the primary cause of death in 89% of patients who died, and an apparent acute clinical deterioration preceded death in 47% of these patients.
The instrument used to define the pace of deterioration and cause of death was applied retrospectively.
Recognition of the common occurrence of acute fatal deterioration in patients with mild to moderate IPF has important implications for monitoring patients and supports early referral for lung transplantation.
*A complete list of the IPF Study Group is available from reference 3: Raghu G, Brown KK, Bradford WZ, Starko K, Noble PW, Schwartz DA, et al. A placebo-controlled trial of interferon gamma-1b in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2004;350:125-33.
Martinez FJ, Safrin S, Weycker D, Starko KM, Bradford WZ, King TE, et al. The Clinical Course of Patients with Idiopathic Pulmonary Fibrosis. Ann Intern Med. 2005;142:963–967. doi: 10.7326/0003-4819-142-12_Part_1-200506210-00005
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Published: Ann Intern Med. 2005;142(12_Part_1):963-967.
Interstitial Lung Disease, Pulmonary/Critical Care.
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