Navigation Links
First, do no harm: Study finds danger in standard treatment for a serious lung disease
Date:5/20/2012

A combination of three drugs used worldwide as the standard of care for a serious lung disease puts patients in danger of death or hospitalization, and should not be used together to treat the disease, called idiopathic pulmonary fibrosis, according to the surprising results of a rigorous independent study.

The study, which will appear online May 20 in the New England Journal of Medicine to coincide with a presentation at the annual meeting of the American Thoracic Society, was conducted by IPF Clinical Research Network, funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health.

"The findings show the importance of testing even those treatments that doctors give routinely for any type of condition -- to see if they truly help, and don't harm, patients," says University of Michigan Health System lung specialist Fernando Martinez, M.D., who will present the results.

Martinez and his colleagues report that patients in the mild to moderate stages of the progressive lung-scarring disease had a far higher chance of dying or being hospitalized if they were taking a three-drug combination used worldwide, compared with those taking a placebo.

What's more, the three-drug combo yielded no improvement in lung function, or even slowing of loss of lung function, compared with placebo. 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, federally funded trial that included patients with a definitive diagnosis of IPF who were treated at 25 centers taking part in the IPF Clinical Research Network or IPFNet. The study was stopped early when an interim analysis showed signs of harm from the three-drug combination of prednisone, azathioprine and NAC.

The findings should cause physicians worldwide to stop using this combination to treat IPF patients similar to those in the trial, say the authors.

And, the dramatic finding of harm from a standard treatment should cause physicians to apply rigorous testing methods to other types of treatment, and highlights the importance of independent federal funding for such studies, says Martinez.

The authors salute the volunteer IPF patients who agreed to be randomly assigned to a treatment or placebo for 60 weeks.

Martinez, an internationally known IPF researcher and clinician in the U-M Medical School's Division of Pulmonary Medicine, remarks that results will soon be known for the group taking NAC alone, compared with those taking placebo. The current paper and presentation do not include results from this group.

In the results presented this week, the authors report that eight patients in the group of 77 assigned to the three-drug combination died, compared with one in the placebo group. A total of 23 of the three-drug patients were hospitalized during the trial, compared with 7 in the placebo group. There was no sign that the three-drug combination slowed the progression of IPF or improved lung function, as measured by forced vital capacity.

The study is called PANTHER-IPF, for Prednisone, Azathioprine, and N-Acetylcysteine: a Study That Evaluates Response in Idiopathic Pulmonary Fibrosis. Except for a donation of NAC and a matched placebo by the company that makes the drug, there was no industry support for the work.

IPF, which affects nearly 100,000 Americans, slowly steals the ability to breathe freely. Its cause or causes are not clear, which is why it is called "idiopathic." Over time it leads to the buildup of scar tissue in the lungs that accumulates in a distinctive honeycomb pattern that can be seen on biopsy or CT scan. It is known as an interstitial lung disease because it affects the tissue around the air sacs in the lungs.

IPF patients live an average of five years after diagnosis, though a lung transplant at a center such as U-M's Transplant Center can extend life for years beyond. Most patients are over the age of 65 when diagnosed, but IPF can strike younger people as well.

Because lung transplants are such a dramatic and rarely available therapy, researchers at U-M and other centers are working to find new treatments while also studying the underlying biological factors in the disease. The PANTHER-IPF trial was designed to test a standard therapy in a rigorous way.


'/>"/>

Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert  

Related medicine news :

1. First, Second Kidney Transplants Have Similar Success: Study
2. Second Cancer Often Same Type as the First, Study Finds
3. Cells talk more in areas Alzheimers hits first, boosting plaque component
4. More Young People Delay Sex, Try Oral Sex First, CDC Says
5. 24x7 Infection Control, Inc. Announces World's First, Modern “Shield” Against Microbial Contamination
6. Health care volunteers and disasters: First, be prepared
7. One in 12 Teens Engages in Self-Harm: Report
8. Colon Cleansing Has No Health Benefit, May Harm: Report
9. Study examines treatments for relieving breathing difficulties among patients with lung effusions
10. Study evaluates use of inhaled saline for young children with cystic fibrosis
11. Study says children exposed to tobacco smoke face long-term respiratory problems
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
First, do no harm: Study finds danger in standard treatment for a serious lung disease
(Date:12/8/2016)... MA (PRWEB) , ... December 08, 2016 , ... ... Workers Compensation Research Institute (WCRI) officially opened registration today for its 33rd ... Hotel in Boston, MA . , The theme of the conference is “Persistent ...
(Date:12/8/2016)... PLAINS, N.Y., and JENNERSVILLE, Pa. (PRWEB) , ... ... ... to announce that Penn Medicine Southern Chester County, a Property owned by an ... The $23 million, 72,000 square foot Penn Medicine Southern Chester County ambulatory care ...
(Date:12/8/2016)... , ... December 08, 2016 , ... With the increasing ... the “What’s In Your Mouth?” (WIYM) campaign to inform dentists and patients about the ... the dental implant and prosthetic market in the U.S. is projected to reach $6.4 ...
(Date:12/8/2016)... ... 08, 2016 , ... SunView Software aims to redefine IT ... both engaging and easy to use. Coming off the heels of a successful ... its plans to roll out new AI-powered self-service enhancements to help organizations implement ...
(Date:12/8/2016)... ... December 08, 2016 , ... STATEN ... been recognized for adherence to the highest standards of trauma, maternity, cancer and ... the center's president and CEO, Dr. Daniel Messina. , Among the recognitions, the ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016  Diplomat Pharmacy, Inc. (NYSE: DPLO) has ... 2016 Top Workplaces National Standard. To learn ... ... (PRNewsFoto/Diplomat Pharmacy, Inc.) ... an employee survey administered by WorkplaceDynamics, LLC, a research firm specializing ...
(Date:12/8/2016)... 8, 2016  Eli Lilly and Company (NYSE: ... phase 3 EXPEDITION3 trial at the 9 th ... disclosed, solanezumab did not meet the primary endpoint in ... in people with mild dementia due to Alzheimer,s disease ... solanezumab for the treatment of mild dementia due to ...
(Date:12/8/2016)... DUBLIN , Dec 8, 2016 Research ... Electrodes Market Analysis and Trends - Adhesion Type, Application, Usability - ... ... The Global Cardiology Electrodes Market is poised to grow at a ... prominent trends that the market is witnessing include advancements in extracellular ...
Breaking Medicine Technology: