(Press-News.org) 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
To arrange an interview with an NHLBI spokesperson, please contact the NHLBI Communications Office at 301-496-4236 or nhlbi_news@nhlbi.nih.gov.
Resources:
What is Idiopathic pulmonary fibrosis?
http://www.nhlbi.nih.gov/health/health-topics/topics/ipf/
Idiopathic Pulmonary Fibrosis Clinical Research Network
https://www.ipfnet.org/
Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
Commonly used 3-drug regimen for idiopathic pulmonary fibrosis found harmful
NIH stops one treatment arm of trial; Other two treatments to continue
2011-10-22
ELSE PRESS RELEASES FROM THIS DATE:
Trio of studies support use of PET/CT scans as prostate cancer staging tool
2011-10-22
ROCHESTER, Minn. -- Recent studies have suggested that C-11 choline positron emission tomography/computerized tomography (PET/CT) scans can be utilized as a staging and potentially therapeutic tool in prostate cancer. The results of three studies, released today during a meeting of the North Central Section of the American Urological Association (http://www.ncsaua.org/default.aspx), validate findings in Europe and expand the potential use of C-11 choline PET scans.
One study found that C-11 choline PET/CT scans can be used as a staging tool rather than multiple x-rays, ...
Divorced Children Receive Less Financial Help From Their Parents
2011-10-22
A recent study conducted by Rice University reveals that children of divorced parents typically receive less college financial aid from their parents as compared with children of intact marriages.
The study surveyed 2,400 undergraduate students and was published in SAGE Publications' June 2011 issue of its "Journal of Family Issues."
The study examined whether divorced/separated and remarried parents contribute less in absolute dollars, as a proportion of their income, and as a proportion of their children's financial need, toward their children's college ...
Mayo Clinic study: PSA test valuable in predicting biopsy need, low-risk prostate cancer
2011-10-22
ROCHESTER, Minn. -- The prostate-specific antigen test, commonly known as the PSA test, is valuable in predicting which men should have biopsies and which are likely to be diagnosed with low-risk prostate cancer, a Mayo Clinic study has found. The findings were released today during a meeting of the North Central Section of the American Urological Association (http://www.ncsaua.org/default.aspx) in Rancho Mirage, Calif.
"The decision to use the PSA test is best made by the patient, in consultation with his doctor," says R. Jeffrey Karnes, M.D. (http://www.mayoclinic.org/bio/12463493.html), ...
Study finds no correlation between primary kidney stone treatment and diabetes
2011-10-22
ROCHESTER, Minn. -- A Mayo Clinic study finds no correlation between the use of shock waves to break up kidney stones and the long-term development of diabetes. The study was released Friday during a meeting of the North Central Section of the American Urological Association (http://www.ncsaua.org/default.aspx) in Rancho Mirage, Calif.
"We did not identify a significant correlation between shockwave lithotripsy and the long-term development of diabetes mellitus," says Matthew Gettman, M.D. (http://www.mayoclinic.org/bio/11940808.html), a Mayo Clinic urologist and co-author ...
November 2011 Geology highlights: New research posted Oct. 5
2011-10-22
Boulder, CO, USA - Another packed issue of GEOLOGY, The Geological Society of America's premier journal and the top-most cited geoscience journal in the world (http://www.scimagojr.com/journalrank.php?category=1907) is online in pre-issue publication. Topics include the San Andreas Fault and SAFOD; the 1944 Tonankai earthquake, Japan; Bonin Island beach sands; the fluid properties of ice; fracturing of the Panamanian Isthmus; diatoms from Ocean Drilling Program Site U1304; China's Loess Plateau; deglaciation and climate change in Turkey; an ancient Death Valley landslide; ...
Preventing cancer development inside the cell cycle
2011-10-22
Researchers from the NYU Cancer Institute, an NCI-designated cancer center at NYU Langone Medical Center, have identified a cell cycle-regulated mechanism behind the transformation of normal cells into cancerous cells. The study shows the significant role that protein networks can play in a cell leading to the development of cancer. The study results, published in the October 21 issue of the journal Molecular Cell, suggest that inhibition of the CK1 enzyme may be a new therapeutic target for the treatment of cancer cells formed as a result of a malfunction in the cell's ...
Drunk Driving Accidents More Likely to Occur at Night Says USDOT
2011-10-22
According to the U.S. Department of Transportation, there is a drunk driving accident fatality every 23 minutes -- with most of them occurring between midnight and 3 a.m. In order to address this issue, and keep the roads safe, the agency launched the "Drive Sober or Get Pulled Over" campaign, which is designed to educate the public about the dangers of drunk driving during nighttime hours and remind drivers that law enforcement will vigilantly patrol at night to keep drunk drivers off the road.
"While we have made great strides in reducing drunk driving ...
Heroin Use in Tennessee Increasing
2011-10-22
A recent story in the Tennessean noted that law enforcement in Tennessee is getting ready for an increase of heroin use. The increase, it is suggested, is due to prescription drug users needing a less expensive replacement for their increasingly expensive drugs and dealers' aggressive marketing techniques.
The article quotes Dr. Terry Alley, as saying "What's happened is the people who sell this product have made it appear safer, made it less expensive, and they give you the misconception that it's less harmful if you smoke it." He is an addiction specialist ...
Voyages Jules Verne Launches New Classic Journeys 2011 and 2012 Brochure
2011-10-22
Voyages Jules Verne has announced the launch of its Classic Journeys 2011 and 2012 brochure, featuring a host of travel ideas including tours, cruises, trains, resorts and weekends.
In association with their longstanding overseas partners, Voyages Jules Verne is delighted to present this compendium of travel opportunities by air, boat and rail, including special sightseeing arrangements and many VJV special events. Among the selection of worldwide departures available until late 2012 are three new tours: Norway's 'Journey to the Arctic Circle' to the remote regions of ...
onShore Networks Announces the Winners of Their Non-Profit Giveaway
2011-10-22
onShore Networks, completeIT (R) services, recently announced the winners of the onShore Non-profit Giveaway. Because non-profit organizations give so much to the community, onShore Networks decided to give something back.
Chicago-area non-profit organizations were invited to select an award from a list of technology services provided by onShore Networks. Organizations that registered were encouraged to spread the word to gather votes for their organization. The contest ran for sixteen weeks. After the votes were tallied, onShore Networks awarded free technology services ...
LAST 30 PRESS RELEASES:
Sensing sickness
Cost to build multifamily housing in California more than twice as high as in Texas
Program takes aim at drinking, unsafe sex, and sexual assault on college campuses
Inability to pay for healthcare reaches record high in U.S.
Science ‘storytelling’ urgently needed amid climate and biodiversity crisis
KAIST Develops Retinal Therapy to Restore Lost Vision
Adipocyte-hepatocyte signaling mechanism uncovered in endoplasmic reticulum stress response
Mammals were adapting from life in the trees to living on the ground before dinosaur-killing asteroid
Low LDL cholesterol levels linked to reduced risk of dementia
Thickening of the eye’s retina associated with greater risk and severity of postoperative delirium in older patients
Almost one in ten people surveyed report having been harmed by the NHS in the last three years
Enhancing light control with complex frequency excitations
New research finds novel drug target for acute myeloid leukemia, bringing hope for cancer patients
New insight into factors associated with a common disease among dogs and humans
Illuminating single atoms for sustainable propylene production
New study finds Rocky Mountain snow contamination
Study examines lactation in critically ill patients
UVA Engineering Dean Jennifer West earns AIMBE’s 2025 Pierre Galletti Award
Doubling down on metasurfaces
New Cedars-Sinai study shows how specialized diet can improve gut disorders
Making moves and hitting the breaks: Owl journeys surprise researchers in western Montana
PKU Scientists simulate the origin and evolution of the North Atlantic Oscillation
ICRAFT breakthrough: Unlocking A20’s dual role in cancer immunotherapy
How VR technology is changing the game for Alzheimer’s disease
A borrowed bacterial gene allowed some marine diatoms to live on a seaweed diet
Balance between two competing nerve proteins deters symptoms of autism in mice
Use of antifungals in agriculture may increase resistance in an infectious yeast
Awareness grows of cancer risk from alcohol consumption, survey finds
The experts that can outsmart optical illusions
Pregnancy may reduce long COVID risk
[Press-News.org] Commonly used 3-drug regimen for idiopathic pulmonary fibrosis found harmfulNIH stops one treatment arm of trial; Other two treatments to continue