Featured Research

from universities, journals, and other organizations

Commonly used three-drug regimen for idiopathic pulmonary fibrosis found harmful

Date:
October 21, 2011
Source:
NIH/National Heart, Lung and Blood Institute
Summary:
A multi-center, clinical trial studying treatments for the lung-scarring disease idiopathic pulmonary fibrosis has been stopped for safety concerns. The trial found that people with IPF receiving a currently used triple-drug therapy consisting of prednisone, azathioprine, and N-acetylcysteine had worse outcomes than those who received placebos.

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has stopped one arm of a three arm multi-center, clinical trial studying treatments for the lung-scarring disease idiopathic pulmonary fibrosis (IPF) for safety concerns. The trial found that people with IPF receiving a currently used triple-drug therapy consisting of prednisone, azathioprine, and N-acetylcysteine (NAC) had worse outcomes than those who received placebos or inactive substances.

"These findings underscore why treatments must be evaluated in a rigorous manner," said Susan B. Shurin, M.D., acting director of the NHLBI. "This combination therapy is widely used in patients with IPF, but has not previously been studied in direct comparison to a placebo for all three drugs."

The interim results from this study showed that compared to placebo, those assigned to triple therapy had greater mortality (11 percent versus 1 percent), more hospitalizations (29 percent versus 8 percent), and more serious adverse events (31 percent versus 9 percent) and also had no difference in lung function test changes. Participants randomly assigned to the triple- therapy arm also remained on their assigned treatment at a much lower rate (78 percent adherence versus 98 percent adherence).

"Anyone on some combination of these medications with questions or concerns should consult with their health care provider and not simply stop taking the drugs," said Ganesh Raghu, M.D., professor of medicine at the University of Washington, Seattle and a co-chair of this IPF study. "It is important to realize that these results definitively apply only to patients with well-defined IPF and not to people taking a combination of these drugs for other lung diseases or conditions."

The other two study arms, or intervention groups, of this IPF trial comparing NAC alone to placebo alone will continue. In stopping this part of the trial, the NHLBI accepted the recommendation of the Data and Safety Monitoring Board (DSMB) -- an independent advisory group of experts in lung disease, biostatistics, medical ethics, and clinical trial design. The DSMB has been monitoring the study since it began.

This study, called PANTHER-IPF (Prednisone, Azathioprine, and N-acetylcysteine: A Study that Evaluates Response in Idiopathic Pulmonary Fibrosis) was designed and conducted by the Idiopathic Pulmonary Fibrosis Clinical Research Network, funded by the NHLBI. The PANTHER-IPF study was designed to evaluate whether this commonly used triple-therapy regimen could slow disease progression and improve lung function in people with moderate IPF.

PANTHER-IPF was the first study in IPF comparing the effectiveness of this combined treatment to a placebo for all three drugs. Each participant had a one in three chance of being randomized to receive the triple drug regimen, NAC alone, or placebo for a period of up to 60 weeks.

"We will continue to analyze the data to try to understand why this particular combination may be detrimental in people with IPF," said Fernando Martinez, M.D., professor of medicine, University of Michigan, Ann Arbor and co-chair of the PANTHER-IPF study. "The results are not explained by any differences between the two groups before the treatments started."

IPF is a progressive and currently incurable disease characterized by the buildup of fibrous scar tissue within the lungs. This accumulation of scar tissue leads to breathing difficulties, coughing, chest pain, and fatigue. Approximately 200,000 people in the United States have IPF. The cause or causes of IPF remain unknown; as a result treatment options remain limited. PANTHER-IPF began enrollment in October 2009.

The study had enrolled 238 of a planned 390 participants prior to the stop announcement. Participants ranged from 48 to 85 years of age, with an average age of 68. The placebo and NAC arms will continue enrolling and following their participants, and this part of the PANTHER-IPF study is expected to be completed by late 2013.

In addition to NIH funding, the Cowlin Family Fund at Chicago Community Trust provided financial support for this study. Zambon donated the NAC and matching placebo; the prednisone, azathioprine, and their matching placebos were purchased using study funds.

Find more information about this clinical trial at http://clinicaltrials.gov/ct2/show/NCT00650091


Story Source:

The above story is based on materials provided by NIH/National Heart, Lung and Blood Institute. Note: Materials may be edited for content and length.


Cite This Page:

NIH/National Heart, Lung and Blood Institute. "Commonly used three-drug regimen for idiopathic pulmonary fibrosis found harmful." ScienceDaily. ScienceDaily, 21 October 2011. <www.sciencedaily.com/releases/2011/10/111021162251.htm>.
NIH/National Heart, Lung and Blood Institute. (2011, October 21). Commonly used three-drug regimen for idiopathic pulmonary fibrosis found harmful. ScienceDaily. Retrieved July 25, 2014 from www.sciencedaily.com/releases/2011/10/111021162251.htm
NIH/National Heart, Lung and Blood Institute. "Commonly used three-drug regimen for idiopathic pulmonary fibrosis found harmful." ScienceDaily. www.sciencedaily.com/releases/2011/10/111021162251.htm (accessed July 25, 2014).

Share This




More Health & Medicine News

Friday, July 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Beatings and Addiction: Pakistan Drug 'clinic' Tortures Patients

Beatings and Addiction: Pakistan Drug 'clinic' Tortures Patients

AFP (July 24, 2014) A so-called drugs rehab 'clinic' is closed down in Pakistan after police find scores of ‘patients’ chained up alleging serial abuse. Duration 03:05 Video provided by AFP
Powered by NewsLook.com
Too Few Teens Receiving HPV Vaccination, CDC Says

Too Few Teens Receiving HPV Vaccination, CDC Says

Newsy (July 24, 2014) The Centers for Disease Control and Prevention is blaming doctors for the low number of children being vaccinated for HPV. Video provided by Newsy
Powered by NewsLook.com
New Painkiller Designed To Discourage Abuse: Will It Work?

New Painkiller Designed To Discourage Abuse: Will It Work?

Newsy (July 24, 2014) The FDA approved Targiniq ER on Wednesday, a painkiller designed to keep users from abusing it. Like any new medication, however, it has doubters. Video provided by Newsy
Powered by NewsLook.com
Doctor At Forefront Of Fighting Ebola Outbreak Gets Ebola

Doctor At Forefront Of Fighting Ebola Outbreak Gets Ebola

Newsy (July 24, 2014) Sheik Umar Khan has treated many of the people infected in the Ebola outbreak, and now he's become one of them. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

    Health News

      Environment News

        Technology News



          Save/Print:
          Share:

          Free Subscriptions


          Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

          Get Social & Mobile


          Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

          Have Feedback?


          Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
          Mobile: iPhone Android Web
          Follow: Facebook Twitter Google+
          Subscribe: RSS Feeds Email Newsletters
          Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins