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First, do no harm: danger in standard treatment for a serious lungdisease by ferujkll sdff
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First, do no harm: danger in standard treatment for a serious lungdisease |
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The study, which appeared online May 20 in the New England Journal of Medicine to coincide with a presentation at the annual meeting of theAmerican Thoracic Society, was conducted by IPF Clinical ResearchNetwork, funded by the National Heart, Lung, and Blood Institute ofthe National Institutes of Health. "The findings show the importance of testing even thosetreatments that doctors give routinely for any type of condition --to see if they truly help, and don't harm, patients," saysUniversity of Michigan Health System lung specialist FernandoMartinez, M.D., who will present the results. Martinez and his colleagues report that patients in the mild tomoderate stages of the progressive lung-scarring disease had a farhigher chance of dying or being hospitalized if they were taking athree-drug combination used worldwide, compared with those taking aplacebo. What's more, the three-drug combo yielded no improvement in lungfunction, or even slowing of loss of lung function, compared withplacebo. Results from a group taking the single drug,N-acetylcysteine (NAC), are still being gathered and analyzed.
This evidence is from a randomized, placebo-controlled,double-blind trial that included patients with a definitivediagnosis of IPF who were treated at 25 centers taking part in theIPF Clinical Research Network or IPFNet. The study was stoppedearly when an interim analysis showed signs of harm from thethree-drug combination of prednisone, azathioprine and NAC. The findings should cause physicians worldwide to stop using thiscombination to treat IPF patients similar to those in the trial,say the authors. And, the dramatic finding of harm from a standard treatment shouldcause physicians to apply rigorous testing methods to other typesof treatment, and highlights the importance of independent federalfunding for such studies, says Martinez. The authors salute the volunteer IPF patients who agreed to berandomly assigned to a treatment or placebo for 60 weeks.
Martinez, an internationally known IPF researcher and clinician inthe U-M Medical School's Division of Pulmonary Medicine, remarksthat results will soon be known for the group taking NAC alone,compared with those taking placebo. The current paper andpresentation do not include results from this group. In the results presented this week, the authors report that eightpatients in the group of 77 assigned to the three-drug combinationdied, compared with one in the placebo group. A total of 23 of thethree-drug patients were hospitalized during the trial, comparedwith 7 in the placebo group.
There was no sign that the three-drugcombination slowed the progression of IPF or improved lungfunction, as measured by forced vital capacity. The study is called PANTHER-IPF, for Prednisone, Azathioprine, andN-Acetylcysteine: a Study That Evaluates Response in IdiopathicPulmonary Fibrosis. Except for a donation of NAC and a matchedplacebo by the company that makes the drug, there was no industrysupport for the work. IPF, which affects nearly 100,000 Americans, slowly steals theability to breathe freely.
Its cause or causes are not clear, whichis why it is called "idiopathic." Over time it leads tothe buildup of scar tissue in the lungs that accumulates in adistinctive honeycomb pattern that can be seen on biopsy or CTscan. It is known as an interstitial lung disease because itaffects the tissue around the air sacs in the lungs. IPF patients live an average of five years after diagnosis, thougha lung transplant at a center such as U-M's Transplant Center canextend life for years beyond. Most patients are over the age of 65when diagnosed, but IPF can strike younger people as well. Because lung transplants are such a dramatic and rarely availabletherapy, researchers at U-M and other centers are working to findnew treatments while also studying the underlying biologicalfactors in the disease.
The PANTHER-IPF trial was designed to testa standard therapy in a rigorous way. In addition to Martinez, who serves as corresponding author, theresearch paper was written by Ganesh Raghu, M.D., University ofWashington; Kevin J. Anstrom, Ph.D., Duke Clinical ResearchInstitute, Duke University; Talmadge E. King, Jr., M.D., Universityof California at San Francisco; and Joseph A.
Lasky, M.D., TulaneUniversity. I am an expert from Bag & Luggage Making Materials, usually analyzes all kind of industries situation, such as essential oil diffuser , futuro wrist brace.
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