Re: PIRFENIDONE SLOWS IPF LUNG DELCINES

[Guest guest]

Intermune had a bad reputation for the interfueron gamma 1 b However

it was not designed for PF they just thought it was possible it would

help with PF. AS FAR AS the Pirfenidone they are doing a rather

large study here in the U.S. I have been in it since Feb 07 and it

has showed some very promising results. Myself as well as the local

study Doc. believe that I have been on the real thing and not the

Placebo, Because of some of the results of my blood testing they

have been conducting. My PFT numbers have also leveled off over the

past year, as a matter of fact there has been some minor improvement

Here in the very near future they are going to do what they call a

roll out which means they will be giving LABELED Pirfenidone to

EVERYONE in the study that chooses to continue. This will give them

more safety data when they apply to the FDA.

>

> > ATS: Pirfenidone Slows IPF Lung Declines

> > By , North American Correspondent, MedPage Today

> > Published: May 20, 2008

> > Reviewed by Zalman S. Agus, MD; Emeritus Professor

> > University of Pennsylvania School of Medicine. Earn CME/CE credit

> > for reading medical news

> >

> >

> > TORONTO, May 20 -- An investigational anti-fibrotic agent is

showing

> > promise in the treatment of idiopathic pulmonary fibrosis (IPF), a

> > researcher said here. Action Points

> > ----------------------------------------------------------

> > ----------

> >

> > Explain to interested patients that there are no approved

treatments

> > for idiopathic pulmonary fibrosis.

> >

> > Note that this clinical study suggests a new investigational agent

> > may reduce the rate of decline in lung function in patients with

the

> > disease.

> >

> > Note that this study was published as an abstract and presented

> > orally at a conference. These data and conclusions should be

> > considered to be preliminary until published in a peer-reviewed

> > journal.

> > In a randomized, double-blind phase III study, pirfenidone, at

either

> > of two doses, significantly reduced (at P<0.05) the loss of lung

> > capacity compared with placebo, according to Takashi Ogura, M.D.,

of

> > the Kanagawa Cardiovascular and Respiratory Center in Yokohama,

> > Japan.

> >

> > " I expect our study will guide new therapies for IPF in the

future, "

> > Dr. Ogura said at a press conference at the American Thoracic

Society

> > meeting.

> >

> > The drug, licensed in the U.S. to InterMune Inc., got fast-track

> > status from the FDA yesterday.

> >

> > Dr. Ogura said the drug is an anti-inflammatory and an anti-

oxidant,

> > but that its key mechanism of action in IPF is anti-fibrotic.

> >

> > After promising earlier studies, he and colleagues enrolled 267

> > patients and randomized them to placebo, or to one of two doses of

> > the drug -- 1,200 and 1,800 milligrams a day.

> >

> > The primary endpoint of the 52-week study was change from

baseline in

> > lung vital capacity, while secondary endpoints included

progression-

> > free survival, Dr. Ogura said.

> >

> > For this study, progression-free survival was defined as a period

> > without either death or a decrease of more than 10% in vital

> > capacity, Dr. Ogura said.

> >

> > The researchers found that the drug significantly affected vital

> > capacity:

> >

> > Patients on placebo lost 70 milliliters more vital capacity on

> > average than did patients getting the higher dose, a difference

that

> > was significant at P<0.05.

> > Patients on placebo lost 80 milliliters more vital capacity on

> > average than did patients getting the lower dose, also

significant at

> > P=0.05.

> >

> > Also, Dr. Ogura said, progression-free survival was significantly

> > better (at P<0.05) for both treatment groups than for placebo.

> >

> > There was no significant difference in oxygen saturation at the

end

> > of a six-minute walk test nor in the risk of acute exacerbation,

he

> > noted.

> >

> > The most common adverse events were photosensitivity, loss of

> > appetite, dizziness, and elevated gamma-glutamyl transpeptidase, a

> > marker of poor liver function.

> >

> > While both doses appeared to improve outcomes, it's not clear that

> > the lower dose is as effective as the higher dose, because of the

> > smaller sample size, Dr. Ogura said.

> >

> > The researchers made the high-dose cohort larger because of a

> > relatively high dropout rate in earlier studies, Dr. Ogura said.

> >

> > In this study, however, there was a 32% overall dropout rate,

broken

> > down into 37% in the high-dose group, 28% in the low-dose group,

and

> > 27% in the placebo group.

> >

> > He said drop-outs in the treatment groups were mainly due to

adverse

> > effects, while the patients in the placebo groups tended to stop

> > because of lack of benefit.

> >

> > The results of the trial, " done in Japanese patients, may

represent a

> > sub-population of patients with IPF, " said Ganesh Raghu, M.D., of

the

> > University of Washington Medical Center in Seattle, who led one of

> > the early studies on the drug.

> >

> > Among other things, he said, the study allowed patients to use

> > medications such as prednisone as well, rather than " true placebo

> > controls. "

> >

> > He called for further trials " in a well-defined larger patient

> > population with IPF at different clinical stages. "

> >

> > The study was supported by Shionogi & Co. of Osaka, Japan. Dr.

Ogura

> > said he had no disclosures.

> >

> > Primary source: American Journal of Respiratory and Critical Care

> > Medicine

> > Source reference:

> > Ogura T, et al " Phase III, double-blind, placebo-controlled

clinical

> > trial of pirfenidone in patients with idiopathic pulmonary

fibrosis

> > in Japan " Am J Respir Crit Care Med 2008; 177: A768.

> >

> > Complete ATS Coverage

> >

> > mlp IPF/2003

> >

> >

> >

> >-------------------------------------------------------------------

-----

> >

> >

> >No virus found in this incoming message.

> >Checked by AVG.

> >Version: 8.0.100 / Virus Database: 269.23.21/1458 - Release Date:

5/21/2008 7:21 AM

> >

> >

>

[Guest guest]

Jon, I really hope that this study shows

positive results...especially for you!

Please keep us posted!!!

Z fibriotic NSIP/05

Z 64,

fibriotic NSIP/o5/PA

And “mild”

PH/10/07 and Reynaud’s too!!

No, NSIP was not

self-inflicted…I never smoked!

Potter,

reader,carousel lover and MomMom to

Darah

and Sara

“I’m gonna be

iron like a lion in Zion” Bob Marley

JON wrote:

Intermune had a bad reputation for the interfueron gamma 1 b

However

it was not designed for PF they just thought it was possible it would

help with PF. AS FAR AS the Pirfenidone they are doing a rather

large study here in the U.S. I have been in it since Feb 07 and it

has showed some very promising results. Myself as well as the local

study Doc. believe that I have been on the real thing and not the

Placebo, Because of some of the results of my blood testing they

have been conducting. My PFT numbers have also leveled off over the

past year, as a matter of fact there has been some minor improvement

Here in the very near future they are going to do what they call a

roll out which means they will be giving LABELED Pirfenidone to

EVERYONE in the study that chooses to continue. This will give them

more safety data when they apply to the FDA.

>

> > ATS: Pirfenidone Slows IPF Lung Declines

> > By , North American Correspondent, MedPage Today

> > Published: May 20, 2008

> > Reviewed by Zalman S. Agus, MD; Emeritus Professor

> > University of Pennsylvania School of Medicine. Earn CME/CE

credit

> > for reading medical news

> >

> >

> > TORONTO, May 20 -- An investigational anti-fibrotic agent is

showing

> > promise in the treatment of idiopathic pulmonary fibrosis

(IPF), a

> > researcher said here. Action Points

> > ----------------------------------------------------------

> > ----------

> >

> > Explain to interested patients that there are no approved

treatments

> > for idiopathic pulmonary fibrosis.

> >

> > Note that this clinical study suggests a new investigational

agent

> > may reduce the rate of decline in lung function in patients

with

the

> > disease.

> >

> > Note that this study was published as an abstract and

presented

> > orally at a conference. These data and conclusions should be

> > considered to be preliminary until published in a

peer-reviewed

> > journal.

> > In a randomized, double-blind phase III study, pirfenidone,

at

either

> > of two doses, significantly reduced (at P<0.05) the loss

of lung

> > capacity compared with placebo, according to Takashi Ogura,

M.D.,

of

> > the Kanagawa Cardiovascular and Respiratory Center in

Yokohama,

> > Japan.

> >

> > "I expect our study will guide new therapies for IPF in the

future,"

> > Dr. Ogura said at a press conference at the American Thoracic

Society

> > meeting.

> >

> > The drug, licensed in the U.S. to InterMune Inc., got

fast-track

> > status from the FDA yesterday.

> >

> > Dr. Ogura said the drug is an anti-inflammatory and an anti-

oxidant,

> > but that its key mechanism of action in IPF is anti-fibrotic.

> >

> > After promising earlier studies, he and colleagues enrolled

267

> > patients and randomized them to placebo, or to one of two

doses of

> > the drug -- 1,200 and 1,800 milligrams a day.

> >

> > The primary endpoint of the 52-week study was change from

baseline in

> > lung vital capacity, while secondary endpoints included

progression-

> > free survival, Dr. Ogura said.

> >

> > For this study, progression-free survival was defined as

a period

> > without either death or a decrease of more than 10% in vital

> > capacity, Dr. Ogura said.

> >

> > The researchers found that the drug significantly affected

vital

> > capacity:

> >

> > Patients on placebo lost 70 milliliters more vital capacity on

> > average than did patients getting the higher dose, a

difference

that

> > was significant at P<0.05.

> > Patients on placebo lost 80 milliliters more vital capacity on

> > average than did patients getting the lower dose, also

significant at

> > P=0.05.

> >

> > Also, Dr. Ogura said, progression-free survival was

significantly

> > better (at P<0.05) for both treatment groups than for

placebo.

> >

> > There was no significant difference in oxygen saturation at

the

end

> > of a six-minute walk test nor in the risk of acute

exacerbation,

he

> > noted.

> >

> > The most common adverse events were photosensitivity, loss of

> > appetite, dizziness, and elevated gamma-glutamyl

transpeptidase, a

> > marker of poor liver function.

> >

> > While both doses appeared to improve outcomes, it's not clear

that

> > the lower dose is as effective as the higher dose, because of

the

> > smaller sample size, Dr. Ogura said.

> >

> > The researchers made the high-dose cohort larger because of a

> > relatively high dropout rate in earlier studies, Dr. Ogura

said.

> >

> > In this study, however, there was a 32% overall dropout rate,

broken

> > down into 37% in the high-dose group, 28% in the low-dose

group,

and

> > 27% in the placebo group.

> >

> > He said drop-outs in the treatment groups were mainly due to

adverse

> > effects, while the patients in the placebo groups tended to

stop

> > because of lack of benefit.

> >

> > The results of the trial, "done in Japanese patients, may

represent a

> > sub-population of patients with IPF," said Ganesh Raghu,

M.D., of

the

> > University of Washington Medical Center in Seattle, who led

one of

> > the early studies on the drug.

> >

> > Among other things, he said, the study allowed patients to use

> > medications such as prednisone as well, rather than "true

placebo

> > controls."

> >

> > He called for further trials "in a well-defined larger patient

> > population with IPF at different clinical stages."

> >

> > The study was supported by Shionogi & Co. of Osaka,

Japan. Dr.

Ogura

> > said he had no disclosures.

> >

> > Primary source: American Journal of Respiratory and Critical

Care

> > Medicine

> > Source reference:

> > Ogura T, et al "Phase III, double-blind, placebo-controlled

clinical

> > trial of pirfenidone in patients with idiopathic pulmonary

fibrosis

> > in Japan" Am J Respir Crit Care Med 2008; 177: A768.

> >

> > Complete ATS Coverage

> >

> > mlp IPF/2003

> >

> >

> >

> >----------------------------------------------------------

-----

> >

> >

> >No virus found in this incoming message.

> >Checked by AVG.

> >Version: 8.0.100 / Virus Database: 269.23.21/1458 - Release

Date:

5/21/2008 7:21 AM

> >

> >

>

No virus found in this incoming message.

Checked by AVG. Version: 8.0.100 / Virus Database: 269.24.0/1460 - Release Date: 5/22/2008 7:06 AM

[Guest guest]

Jon,

Will you still be in the trial when they begin giving labeled Pirfenidone to everyone.

I am so thankful that you are stable. Improvement, even minor, is a blessing. Perhaps you will be a trailblazer for many others coming down the track. I wish you many, many more years upon this earth.

Hugs, Joyce D.Pulmonary Fibrosis 1997 Bronchiectasis 2004 Pulmonary Hypertension 2008 Mixed Connective Tissue Disease (Lupus, RA, Sjogren's, etc) Rejected for Transplant 2006 .....I will not forget you. Behold, I have engraved you on the palm of my hands. Isaiah 49: 15-16 > > > > > ATS: Pirfenidone Slows IPF Lung Declines> > > By , North American Correspondent, MedPage Today> > > Published: May 20, 2008> > > Reviewed by Zalman S. Agus, MD; Emeritus Professor> > > University of Pennsylvania School of Medicine. Earn CME/CE credit> > > for reading medical news> > >> > >> > > TORONTO, May 20 -- An investigational anti-fibrotic agent is > showing> > > promise in the treatment of idiopathic pulmonary fibrosis (IPF), a> > > researcher said here. Action Points> > > ----------------------------------------------------------> > > ----------> > >> > > Explain to interested patients that there are no approved > treatments> > > for idiopathic pulmonary fibrosis.> > >> > > Note that this clinical study suggests a new investigational agent> > > may reduce the rate of decline in lung function in patients with > the> > > disease.> > >> > > Note that this study was published as an abstract and presented> > > orally at a conference. These data and conclusions should be> > > considered to be preliminary until published in a peer-reviewed> > > journal.> > > In a randomized, double-blind phase III study, pirfenidone, at > either> > > of two doses, significantly reduced (at P<0.05) the loss of lung> > > capacity compared with placebo, according to Takashi Ogura, M.D., > of> > > the Kanagawa Cardiovascular and Respiratory Center in Yokohama,> > > Japan.> > >> > > "I expect our study will guide new therapies for IPF in the > future,"> > > Dr. Ogura said at a press conference at the American Thoracic > Society> > > meeting.> > >> > > The drug, licensed in the U.S. to InterMune Inc., got fast-track> > > status from the FDA yesterday.> > >> > > Dr. Ogura said the drug is an anti-inflammatory and an anti-> oxidant,> > > but that its key mechanism of action in IPF is anti-fibrotic.> > >> > > After promising earlier studies, he and colleagues enrolled 267> > > patients and randomized them to placebo, or to one of two doses of> > > the drug -- 1,200 and 1,800 milligrams a day.> > >> > > The primary endpoint of the 52-week study was change from > baseline in> > > lung vital capacity, while secondary endpoints included > progression-> > > free survival, Dr. Ogura said.> > >> > > For this study, progression-free survival was defined as a period> > > without either death or a decrease of more than 10% in vital> > > capacity, Dr. Ogura said.> > >> > > The researchers found that the drug significantly affected vital> > > capacity:> > >> > > Patients on placebo lost 70 milliliters more vital capacity on> > > average than did patients getting the higher dose, a difference > that> > > was significant at P<0.05.> > > Patients on placebo lost 80 milliliters more vital capacity on> > > average than did patients getting the lower dose, also > significant at> > > P=0.05.> > >> > > Also, Dr. Ogura said, progression-free survival was significantly> > > better (at P<0.05) for both treatment groups than for placebo.> > >> > > There was no significant difference in oxygen saturation at the > end> > > of a six-minute walk test nor in the risk of acute exacerbation, > he> > > noted.> > >> > > The most common adverse events were photosensitivity, loss of> > > appetite, dizziness, and elevated gamma-glutamyl transpeptidase, a> > > marker of poor liver function.> > >> > > While both doses appeared to improve outcomes, it's not clear that> > > the lower dose is as effective as the higher dose, because of the> > > smaller sample size, Dr. Ogura said.> > >> > > The researchers made the high-dose cohort larger because of a> > > relatively high dropout rate in earlier studies, Dr. Ogura said.> > >> > > In this study, however, there was a 32% overall dropout rate, > broken> > > down into 37% in the high-dose group, 28% in the low-dose group, > and> > > 27% in the placebo group.> > >> > > He said drop-outs in the treatment groups were mainly due to > adverse> > > effects, while the patients in the placebo groups tended to stop> > > because of lack of benefit.> > >> > > The results of the trial, "done in Japanese patients, may > represent a> > > sub-population of patients with IPF," said Ganesh Raghu, M.D., of > the> > > University of Washington Medical Center in Seattle, who led one of> > > the early studies on the drug.> > >> > > Among other things, he said, the study allowed patients to use> > > medications such as prednisone as well, rather than "true placebo> > > controls."> > >> > > He called for further trials "in a well-defined larger patient> > > population with IPF at different clinical stages."> > >> > > The study was supported by Shionogi & Co. of Osaka, Japan. Dr. > Ogura> > > said he had no disclosures.> > >> > > Primary source: American Journal of Respiratory and Critical Care> > > Medicine> > > Source reference:> > > Ogura T, et al "Phase III, double-blind, placebo-controlled > clinical> > > trial of pirfenidone in patients with idiopathic pulmonary > fibrosis> > > in Japan" Am J Respir Crit Care Med 2008; 177: A768.> > >> > > Complete ATS Coverage> > >> > > mlp IPF/2003> > >> > > > > >> > >-------------------------------------------------------------------> -----> > >> > >> > >No virus found in this incoming message.> > >Checked by AVG. > > >Version: 8.0.100 / Virus Database: 269.23.21/1458 - Release Date: > 5/21/2008 7:21 AM> > > > > >> >>

[Guest guest]

I am in the STEP Trial which is designed as a 6 month study. My study drug is either placebo or sidenafil, (Revatio). After 12 weeks, everyone in the study will get the drug. It is sad that Intermunne & its former CEO were criminally charged with the illegal marketing of Actimunne. But Intermunne is on probation with the FDA for 5 years. It sounds as if their trial of pirfenidone is showing some good results. I believe that there won't be just one drug to cure PF but a myriad of different drugs and maybe some lifestyle changes such as nutrition, etc. It will be interesting to watch & see.

Toodles!

Jane UIP/IPF 12/1998 Dalton, Georgia aka pianolady_musicgirl> > > > > ATS: Pirfenidone Slows IPF Lung Declines> > > By , North American Correspondent, MedPage Today> > > Published: May 20, 2008> > > Reviewed by Zalman S. Agus, MD; Emeritus Professor> > > University of Pennsylvania School of Medicine. Earn CME/CE credit> > > for reading medical news> > >> > >> > > TORONTO, May 20 -- An investigational anti-fibrotic agent is > showing> > > promise in the treatment of idiopathic pulmonary fibrosis (IPF), a> > > researcher said here. Action Points> > > ----------------------------------------------------------> > > ----------> > >> > > Explain to interested patients that there are no approved > treatments> > > for idiopathic pulmonary fibrosis.> > >> > > Note that this clinical study suggests a new investigational agent> > > may reduce the rate of decline in lung function in patients with > the> > > disease.> > >> > > Note that this study was published as an abstract and presented> > > orally at a conference. These data and conclusions should be> > > considered to be preliminary until published in a peer-reviewed> > > journal.> > > In a randomized, double-blind phase III study, pirfenidone, at > either> > > of two doses, significantly reduced (at P<0.05) the loss of lung> > > capacity compared with placebo, according to Takashi Ogura, M.D., > of> > > the Kanagawa Cardiovascular and Respiratory Center in Yokohama,> > > Japan.> > >> > > "I expect our study will guide new therapies for IPF in the > future,"> > > Dr. Ogura said at a press conference at the American Thoracic > Society> > > meeting.> > >> > > The drug, licensed in the U.S. to InterMune Inc., got fast-track> > > status from the FDA yesterday.> > >> > > Dr. Ogura said the drug is an anti-inflammatory and an anti-> oxidant,> > > but that its key mechanism of action in IPF is anti-fibrotic.> > >> > > After promising earlier studies, he and colleagues enrolled 267> > > patients and randomized them to placebo, or to one of two doses of> > > the drug -- 1,200 and 1,800 milligrams a day.> > >> > > The primary endpoint of the 52-week study was change from > baseline in> > > lung vital capacity, while secondary endpoints included > progression-> > > free survival, Dr. Ogura said.> > >> > > For this study, progression-free survival was defined as a period> > > without either death or a decrease of more than 10% in vital> > > capacity, Dr. Ogura said.> > >> > > The researchers found that the drug significantly affected vital> > > capacity:> > >> > > Patients on placebo lost 70 milliliters more vital capacity on> > > average than did patients getting the higher dose, a difference > that> > > was significant at P<0.05.> > > Patients on placebo lost 80 milliliters more vital capacity on> > > average than did patients getting the lower dose, also > significant at> > > P=0.05.> > >> > > Also, Dr. Ogura said, progression-free survival was significantly> > > better (at P<0.05) for both treatment groups than for placebo.> > >> > > There was no significant difference in oxygen saturation at the > end> > > of a six-minute walk test nor in the risk of acute exacerbation, > he> > > noted.> > >> > > The most common adverse events were photosensitivity, loss of> > > appetite, dizziness, and elevated gamma-glutamyl transpeptidase, a> > > marker of poor liver function.> > >> > > While both doses appeared to improve outcomes, it's not clear that> > > the lower dose is as effective as the higher dose, because of the> > > smaller sample size, Dr. Ogura said.> > >> > > The researchers made the high-dose cohort larger because of a> > > relatively high dropout rate in earlier studies, Dr. Ogura said.> > >> > > In this study, however, there was a 32% overall dropout rate, > broken> > > down into 37% in the high-dose group, 28% in the low-dose group, > and> > > 27% in the placebo group.> > >> > > He said drop-outs in the treatment groups were mainly due to > adverse> > > effects, while the patients in the placebo groups tended to stop> > > because of lack of benefit.> > >> > > The results of the trial, "done in Japanese patients, may > represent a> > > sub-population of patients with IPF," said Ganesh Raghu, M.D., of > the> > > University of Washington Medical Center in Seattle, who led one of> > > the early studies on the drug.> > >> > > Among other things, he said, the study allowed patients to use> > > medications such as prednisone as well, rather than "true placebo> > > controls."> > >> > > He called for further trials "in a well-defined larger patient> > > population with IPF at different clinical stages."> > >> > > The study was supported by Shionogi & Co. of Osaka, Japan. Dr. > Ogura> > > said he had no disclosures.> > >> > > Primary source: American Journal of Respiratory and Critical Care> > > Medicine> > > Source reference:> > > Ogura T, et al "Phase III, double-blind, placebo-controlled > clinical> > > trial of pirfenidone in patients with idiopathic pulmonary > fibrosis> > > in Japan" Am J Respir Crit Care Med 2008; 177: A768.> > >> > > Complete ATS Coverage> > >> > > mlp IPF/2003> > >> > > > > >> > >-------------------------------------------------------------------> -----> > >> > >> > >No virus found in this incoming message.> > >Checked by AVG. > > >Version: 8.0.100 / Virus Database: 269.23.21/1458 - Release Date: > 5/21/2008 7:21 AM> > > > > >> >>

[Guest guest]

I was at the American Thoracic Society session where the Japanese presented their Pirfenidone results. The room was packed. The docs were literally falling out the doors. I'm also in a study of Pirfenidone to treat the PF of HPS. I, of course, could be on placebo,, but my VFC has gone up 22 points and my DLCO has gone up 10 points. My CT remains stable. So, I'm a happy camper.

The FDA has alsos given Pirfenidone fast track status, so hopefully everyone will be able to have it soon.

Hermansky-Pudlak Syndrome/PF 06

www.heatherkirkwood.blogspot.com

> > > > > ATS: Pirfenidone Slows IPF Lung Declines> > > By , North American Correspondent, MedPage Today> > > Published: May 20, 2008> > > Reviewed by Zalman S. Agus, MD; Emeritus Professor> > > University of Pennsylvania School of Medicine. Earn CME/CE credit> > > for reading medical news> > >> > >> > > TORONTO, May 20 -- An investigational anti-fibrotic agent is > showing> > > promise in the treatment of idiopathic pulmonary fibrosis (IPF), a> > > researcher said here. Action Points> > > ----------------------------------------------------------> > > ----------> > >> > > Explain to interested patients that there are no approved > treatments> > > for idiopathic pulmonary fibrosis.> > >> > > Note that this clinical study suggests a new investigational agent> > > may reduce the rate of decline in lung function in patients with > the> > > disease.> > >> > > Note that this study was published as an abstract and presented> > > orally at a conference. These data and conclusions should be> > > considered to be preliminary until published in a peer-reviewed> > > journal.> > > In a randomized, double-blind phase III study, pirfenidone, at > either> > > of two doses, significantly reduced (at P<0.05) the loss of lung> > > capacity compared with placebo, according to Takashi Ogura, M.D., > of> > > the Kanagawa Cardiovascular and Respiratory Center in Yokohama,> > > Japan.> > >> > > "I expect our study will guide new therapies for IPF in the > future,"> > > Dr. Ogura said at a press conference at the American Thoracic > Society> > > meeting.> > >> > > The drug, licensed in the U.S. to InterMune Inc., got fast-track> > > status from the FDA yesterday.> > >> > > Dr. Ogura said the drug is an anti-inflammatory and an anti-> oxidant,> > > but that its key mechanism of action in IPF is anti-fibrotic.> > >> > > After promising earlier studies, he and colleagues enrolled 267> > > patients and randomized them to placebo, or to one of two doses of> > > the drug -- 1,200 and 1,800 milligrams a day.> > >> > > The primary endpoint of the 52-week study was change from > baseline in> > > lung vital capacity, while secondary endpoints included > progression-> > > free survival, Dr. Ogura said.> > >> > > For this study, progression-free survival was defined as a period> > > without either death or a decrease of more than 10% in vital> > > capacity, Dr. Ogura said.> > >> > > The researchers found that the drug significantly affected vital> > > capacity:> > >> > > Patients on placebo lost 70 milliliters more vital capacity on> > > average than did patients getting the higher dose, a difference > that> > > was significant at P<0.05.> > > Patients on placebo lost 80 milliliters more vital capacity on> > > average than did patients getting the lower dose, also > significant at> > > P=0.05.> > >> > > Also, Dr. Ogura said, progression-free survival was significantly> > > better (at P<0.05) for both treatment groups than for placebo.> > >> > > There was no significant difference in oxygen saturation at the > end> > > of a six-minute walk test nor in the risk of acute exacerbation, > he> > > noted.> > >> > > The most common adverse events were photosensitivity, loss of> > > appetite, dizziness, and elevated gamma-glutamyl transpeptidase, a> > > marker of poor liver function.> > >> > > While both doses appeared to improve outcomes, it's not clear that> > > the lower dose is as effective as the higher dose, because of the> > > smaller sample size, Dr. Ogura said.> > >> > > The researchers made the high-dose cohort larger because of a> > > relatively high dropout rate in earlier studies, Dr. Ogura said.> > >> > > In this study, however, there was a 32% overall dropout rate, > broken> > > down into 37% in the high-dose group, 28% in the low-dose group, > and> > > 27% in the placebo group.> > >> > > He said drop-outs in the treatment groups were mainly due to > adverse> > > effects, while the patients in the placebo groups tended to stop> > > because of lack of benefit.> > >> > > The results of the trial, "done in Japanese patients, may > represent a> > > sub-population of patients with IPF," said Ganesh Raghu, M.D., of > the> > > University of Washington Medical Center in Seattle, who led one of> > > the early studies on the drug.> > >> > > Among other things, he said, the study allowed patients to use> > > medications such as prednisone as well, rather than "true placebo> > > controls."> > >> > > He called for further trials "in a well-defined larger patient> > > population with IPF at different clinical stages."> > >> > > The study was supported by Shionogi & Co. of Osaka, Japan. Dr. > Ogura> > > said he had no disclosures.> > >> > > Primary source: American Journal of Respiratory and Critical Care> > > Medicine> > > Source reference:> > > Ogura T, et al "Phase III, double-blind, placebo-controlled > clinical> > > trial of pirfenidone in patients with idiopathic pulmonary > fibrosis> > > in Japan" Am J Respir Crit Care Med 2008; 177: A768.> > >> > > Complete ATS Coverage> > >> > > mlp IPF/2003> > >> > > > > >> > >-------------------------------------------------------------------> -----> > >> > >> > >No virus found in this incoming message.> > >Checked by AVG. > > >Version: 8.0.100 / Virus Database: 269.23.21/1458 - Release Date: > 5/21/2008 7:21 AM> > > > > >> >>