Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

First, do no harm: Study finds danger in standard treatment for a serious lung disease

21.05.2012
Results show importance of rigorous, placebo-controlled, independent evaluation of treatments for any disease

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.

In addition to Martinez, who serves as corresponding author, the research paper was written by Ganesh Raghu, M.D., University of Washington; Kevin J. Anstrom, Ph.D., Duke Clinical Research Institute, Duke University; Talmadge E. King, Jr., M.D., University of California at San Francisco; and Joseph A. Lasky, M.D., Tulane University.

The research was supported by NIH grants U10HL080413, to the data coordinating center at the Duke Clinical Research Institute; NHLBI grants U10HL080274, U10HL080370, U10HL080371, U10HL080383, U10HL080411, U10HL080509, U10HL080510, U10HL080513, U10HL080543, U10HL080571, and U10HL080685, to the clinical centers; and the Cowlin Family Fund at the Chicago Community Trust. NAC and matching placebo were donated by Zambon.

Patients interested in learning more about IPF care at the U-M Health System should call 888-287-1084 or visit www.uofmhealth.org/medical-services/lungs-breathing.

Volunteers are often needed for U-M clinical trials related to IPF; for more information see www.umclinicalstudies.org. Past clinical research conducted at U-M is summarized at http://www.med.umich.edu/intmed/pulmonary/edu/ipf.htm .

U-M's Quest for Breath effort, which raises money for IPF research and offers support for IPF patients, offers more information at (866) 860-0026, questforbreath@umich.edu or www.questforbreath.org.

Kara Gavin | EurekAlert!
Further information:
http://www.umich.edu

More articles from Studies and Analyses:

nachricht Self-organising system enables motile cells to form complex search pattern
07.05.2019 | Westfälische Wilhelms-Universität Münster

nachricht Mouse studies show minimally invasive route can accurately administer drugs to brain
02.05.2019 | Johns Hopkins Medicine

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Self-repairing batteries

UTokyo engineers develop a way to create high-capacity long-life batteries

Engineers at the University of Tokyo continually pioneer new ways to improve battery technology. Professor Atsuo Yamada and his team recently developed a...

Im Focus: Quantum Cloud Computing with Self-Check

With a quantum coprocessor in the cloud, physicists from Innsbruck, Austria, open the door to the simulation of previously unsolvable problems in chemistry, materials research or high-energy physics. The research groups led by Rainer Blatt and Peter Zoller report in the journal Nature how they simulated particle physics phenomena on 20 quantum bits and how the quantum simulator self-verified the result for the first time.

Many scientists are currently working on investigating how quantum advantage can be exploited on hardware already available today. Three years ago, physicists...

Im Focus: Accelerating quantum technologies with materials processing at the atomic scale

'Quantum technologies' utilise the unique phenomena of quantum superposition and entanglement to encode and process information, with potentially profound benefits to a wide range of information technologies from communications to sensing and computing.

However a major challenge in developing these technologies is that the quantum phenomena are very fragile, and only a handful of physical systems have been...

Im Focus: A step towards probabilistic computing

Working group led by physicist Professor Ulrich Nowak at the University of Konstanz, in collaboration with a team of physicists from Johannes Gutenberg University Mainz, demonstrates how skyrmions can be used for the computer concepts of the future

When it comes to performing a calculation destined to arrive at an exact result, humans are hopelessly inferior to the computer. In other areas, humans are...

Im Focus: Recording embryonic development

Scientists develop a molecular recording tool that enables in vivo lineage tracing of embryonic cells

The beginning of new life starts with a fascinating process: A single cell gives rise to progenitor cells that eventually differentiate into the three germ...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

SEMANTiCS 2019 brings together industry leaders and data scientists in Karlsruhe

29.04.2019 | Event News

Revered mathematicians and computer scientists converge with 200 young researchers in Heidelberg!

17.04.2019 | Event News

First dust conference in the Central Asian part of the earth’s dust belt

15.04.2019 | Event News

 
Latest News

Synthesis of helical ladder polymers

21.05.2019 | Materials Sciences

Ultra-thin superlattices from gold nanoparticles for nanophotonics

21.05.2019 | Materials Sciences

Chaperones keep the tumor suppressor protein p53 in check: How molecular escorts help prevent cancer

21.05.2019 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>