~Breathing on Facebook~
I would love to see you there! :)
Friday, February 28, 2014
Rare Disease Day~ February 28, 2014
I will never forget the day my husband and I walked into our family doctor's office for what we thought was allergies he had developed. Our doctor listened to his symptoms, and sent us down the hall for an X-Ray. Back in the room we waited about 15 minutes for the doctor to come back and tell us what he thinks is the problem. I remember looking at my husband, who had normally been so strong and fit, and thinking how vulnerable he looked sitting in his chair. At 49 years old, he had rarely had the need to ever go to the doctors, and with such slight, but persistent symptoms, we just thought it would be a good idea to go in and get him some allergy meds. The fact he rarely ever had the need to go into the doctor is why he looked so vulnerable. It was just plain uncomfortable for him to be there in the first hand.
I squeezed his hand and gave him a little wink and told him it is nothing to fret about and everything was going to be okay. I was sure of it. Soon the doctor entered the room holding the X-Rays of my husband's lungs in his hand. As he whisked the door open, I will never forget the very first words he said to us.
With a big smile on his face he said, "Good news~ it's not cancer!"
Relief swept over us as he told us what he thought it was~ Pulmonary Fibrosis. He then sent us to get a CAT Scan to confirm this and sent us on our way home with a business card and appointment to a local Pulmonologist. On the way home, I told my husband, I would Google the disease for him and we both felt assured based on the doctors presentation, that it was nothing too serious.
We couldn't have been more wrong. As I began to Google the information, I found dryly written medical documents that provided some information. But, I could read between the lines. This is a very serious, life threatening disease. In some aspects, I slowly began to yearn for the doctor to have said it was cancer. That is a pretty horrible thing to wish for, although I could not help it. It seemed that there were more treatments, information, and support available for cancer than there was for Idiopathic Pulmonary Fibrosis.
Without knowing very much, I resolved to start writing about our personal experience. At that time it was solely for the idea that if, unfortunately, another person was diagnosed with my husband's disease and they Googled its name, that there would be more of a human aspect behind the diagnosis.
Today is Rare Disease Day and the idea behind this project is similar to my initial efforts. To raise awareness and connect those who have a disease that is considered rare and may not receive the support and information that comes with a better known disease.
From their website the classify a rare disease as:
- 80% of rare diseases have identified genetic origins whilst others are the result of infections (bacterial or viral), allergies and environmental causes, or are degenerative and proliferative.
- 50% of rare diseases touch children.
This year, the Rare Disease Day theme is CARE.
Please give their website a visit and show of support!
Wednesday, February 26, 2014
InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF)
BRISBANE, Calif., Feb. 25, 2014 /PRNewswire/ -- InterMune, Inc. (ITMN) today announced that top-line data from ASCEND, a Phase 3 trial evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF), demonstrated that pirfenidone significantly reduced IPF disease progression as measured by change in percent predicted forced vital capacity (FVC) from Baseline to Week 52 (rank ANCOVA p
"We are pleased to report these top-line ASCEND Phase 3 results," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "Based on the strength of the ASCEND results, InterMune is preparing a resubmission of our New Drug Application for pirfenidone to the U.S. Food and Drug Administration (FDA), which we expect to submit by early third quarter of this year. We would like to thank our collaborators, patients and their families for their participation in ASCEND and their contributions to IPF research."
Primary Endpoint
The magnitude of the treatment effect of pirfenidone was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a clinically meaningful change in FVC, or death. A 10% decline in FVC in an individual IPF patient is considered clinically meaningful and strongly predicts mortality. At Week 52, 16.5% of patients in the pirfenidone group experienced an FVC decline of 10% or more or death, compared with 31.8% in the placebo group, representing a 47.9% reduction in the proportion of patients who experienced a meaningful change in FVC or death. Additionally, at Week 52 the data demonstrated that 22.7% of patients in the pirfenidone group experienced no decline in FVC, compared with 9.7% in the placebo group, representing a 132.5% increase in the proportion of patients whose FVC did not decrease between Baseline and Week 52.
Dr. Talmadge King, Chair, Department of Medicine, University of California San Francisco and Co-chair of the ASCEND protocol steering committee, said, "IPF is an unpredictable, debilitating and ultimately fatal disease, and safe and effective treatments are desperately needed to alter the course of this challenging and complex condition. The ASCEND data demonstrated that pirfenidone significantly reduced decline in lung function and significantly increased the proportion of patients who had no decline, which is an important advance in the field. The results for 6MWT distance, PFS and mortality provide important supportive evidence of pirfenidone's efficacy."
Key Secondary Endpoints
The ASCEND protocol pre-specified 6MWD and PFS as the two key secondary endpoints. Change from Baseline to Week 52 in 6MWD is a measure of exercise tolerance. A 50-meter decrement in walk distance is considered an independent predictor of mortality in an individual patient with IPF. In ASCEND, pirfenidone reduced by 27.5% the proportion of patients who experienced a decline in 6MWD of 50 meters or greater (p=0.0360).
PFS is a measure of time before death or a disease-progression event. A PFS event was defined in the protocol as any of the following: death, percent predicted FVC decrement of 10% or greater or 6MWD decrement of 50 meters or greater. In ASCEND, pirfenidone reduced the risk of death or disease progression by 43% compared to placebo (Hazard Ratio [HR]=0.57; 95% confidence interval, 0.43-0.77; p=0.0001).
Additional Secondary Endpoints
Three additional secondary endpoints were pre-specified in the ASCEND protocol: all-cause mortality, treatment-emergent IPF-related mortality and change from Baseline to Week 52 in dyspnea (shortness of breath). The two mortality analyses were pre-specified for both the ASCEND study and the pooled population of the ASCEND study and the previous Phase 3 CAPACITY studies through 52 weeks. Due to the relatively low overall mortality rate in patient populations in the time frames studied in a single IPF study such as ASCEND, pooled analyses of ASCEND and CAPACITY data provide more statistical power and a more precise estimate of the treatment effect of pirfenidone on mortality.
In the pre-specified mortality analysis of the ASCEND study alone, there were fewer events of all-cause mortality (HR=0.55, log rank p=0.1045) and of treatment-emergent IPF-related mortality (HR=0.44, log rank p=0.2258) in the pirfenidone group compared to the placebo group. ASCEND was not powered to show a difference on these endpoints. The relationship of death to IPF was determined in ASCEND by a blinded adjudication committee.
The pre-specified analyses of the pooled population (N=1,247) across ASCEND and the two Phase 3 CAPACITY studies (taking CAPACITY mortality data through Week 52) showed that the risk of all-cause mortality was reduced by 48% in the pirfenidone group compared to the placebo group (HR=0.52, log rank p=0.0107). Additionally, in the pooled population the risk of treatment-emergent IPF-related death in the pirfenidone group compared to placebo was reduced by 68% (HR=0.32, log rank p=0.0061).
The secondary endpoint of dyspnea, measured by the UCSD SOBQ questionnaire, was not achieved (p=0.1577).
Safety and Tolerability
In ASCEND, pirfenidone showed a favorable safety profile and was generally well tolerated.
A total of 93.5% and 94.6% of patients completed the study, died or had a lung transplant by study day 365 in the pirfenidone and placebo groups, respectively. The percentage of patients discontinuing treatment due to an adverse event was 14.4% in the pirfenidone group and 10.8% in the placebo group. Serious adverse events (SAEs) were reported in 19.8% of patients in the pirfenidone group and 24.9% in the placebo group. Hospitalizations due to respiratory, thoracic and mediastinal SAEs were reported in 3.6% of patients in the pirfenidone group and 11.2% in the placebo group.
The most common AEs with higher incidence in the pirfenidone group were primarily gastrointestinal (e.g., nausea and dyspepsia) and skin-related (e.g., rash). The GI and rash AEs were generally mild to moderate in severity, manageable, reversible and only infrequently led to treatment discontinuations.
Elevations of aminotransferase levels at least 3 times the upper limit of normal occurred in 2.9% of pirfenidone patients (including one case associated with a bilirubin increase) vs. 0.7% of placebo patients. In general, these elevations occurred early, were manageable and reversible, and were similar to those observed in previous pirfenidone studies.
The safety and tolerability profile of pirfenidone was generally consistent with observations from the previous Phase 3 CAPACITY studies, open-label extension studies and post-marketing experience.
"These results from the ASCEND trial provide compelling evidence of a clinically meaningful treatment effect of pirfenidone with generally favorable safety and tolerability findings, which is very encouraging for patients suffering from this fatal and relentless disease," said Paul W. Noble, Chair, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, Calif. and Co-chair of the ASCEND protocol steering committee. "Importantly, the overall safety observations from ASCEND complement and corroborate the robust safety database that already exists from the InterMune-sponsored clinical studies of pirfenidone and extensive post-marketing experience outside the United States."
InterMune intends to present additional data from the ASCEND study at the 2014 American Thoracic Society International Conference in May.
About ASCEND
ASCEND (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF) is a multinational, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of pirfenidone in patients with IPF. Patients (N=555) were randomly assigned 1:1 to receive oral pirfenidone (2403 mg/day) or placebo and were enrolled at 127 centers in the United States, Australia, Brazil, Croatia, Israel, Mexico, New Zealand, Peru and Singapore.
More than 95 percent of eligible patients (those patients who remained on blinded pirfenidone or placebo therapy) who completed the ASCEND study decided to enter the open-label RECAP extension study. RECAP is a study in which all patients receive pirfenidone. RECAP also includes patients rolled over from the company's prior CAPACITY studies which completed in late 2008 and enrolled 779 patients in two Phase 3 studies. RECAP provides valuable long-term safety data that further expands the already large safety database for pirfenidone in patients with IPF.
About CAPACITY
Pirfenidone has been studied in multiple Phase 3 clinical trials in patients with IPF, including the two Phase 3 CAPACITY trials sponsored by InterMune.
The CAPACITY program consisted of two concurrent 72-week trials which enrolled a total of 779 patients. Both trials were multinational, randomized, double-blind, and placebo-controlled. The studies were designed to evaluate the safety and efficacy of pirfenidone in IPF patients with mild to moderate impairment in lung function. The primary endpoint in both studies was the change from Baseline to Week 72 in percent predicted FVC. This endpoint was met with statistical significance in CAPACITY 2 (p=0.001). The secondary endpoints of PFS and categorical change in FVC also achieved statistical significance (p
Pirfenidone demonstrated a favorable safety profile and was generally well tolerated in both CAPACITY studies. The most frequent side effects reported were photosensitivity rash, gastrointestinal symptoms such as nausea and dyspepsia, and dizziness.
About Esbriet® (pirfenidone)
Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet® (pirfenidone) for the treatment of adults with mild to moderate IPF. The approval authorized marketing of Esbriet in all 28 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. In 2011, InterMune launched commercial sales of pirfenidone in Germany under the trade name Esbriet, and Esbriet is now also commercially available in various European countries, including key markets such as France, Italy and the UK.
On October 1, 2012, Health Canada approved Esbriet for the treatment of mild to moderate IPF in adult patients. Health Canada designated Esbriet for Priority Review and completed the accelerated review according to target guidelines of 180 days. InterMune launched Esbriet in Canada in January 2013.
Pirfenidone has been marketed as Pirespa® since 2008 in Japan and since 2012 in South Korea by Shionogi & Co. Ltd. Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, Argentina and Mexico.
Pirfenidone is not approved for sale in the United States.
About IPF
Idiopathic pulmonary fibrosis (IPF) is an irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis (scarring) in the lungs, which hinders the ability of lungs to absorb oxygen. IPF inevitably causes shortness of breath, and a deterioration in lung function and exercise tolerance. IPF patients follow different and unpredictable clinical courses and it is not possible to predict if a patient will progress slowly or rapidly, or when the rate of decline may change. Periods of transient clinical stability in IPF, when they occur, inevitably give way to continued disease progression. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers. IPF typically occurs in patients over the age of 45, and tends to affect slightly more men than women.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible, unpredictable and ultimately fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU and Canada under the trade name Esbriet®. Pirfenidone is not approved for sale in the United States but has completed three Phase 3 clinical trials to support regulatory registration in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visitwww.intermune.com.
Conference Call and Webcast Details
InterMune will host a live webcast of a conference call today at 8:00 a.m. EST to discuss the top-line ASCEND Phase 3 results. Interested investors and others may participate in the conference call by dialing 800-738-1032 (U.S.) or +1-212-231-2905 (international), conference ID# 21709573. A replay of the webcast and teleconference will be available approximately three hours after the call.
To access the webcast, please log on to the company's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140 (international), and entering conference ID# 21709573.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation InterMune's expectations regarding the timing for resubmission of its new drug application with the FDA for pirfenidone; the potential to make pirfenidone available as a medicine to IPF patients in the United States and InterMune's intention to present additional data on the ASCEND trial at the American Thoracic Society meeting in May 2014. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 21, 2014 (the "Form 10-K") and other periodic reports filed with the SEC, including but not limited to the following: (i) the risks related to the uncertain, lengthy and expensive clinical development process for the company's product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays, in particular in connection with our planned resubmission of a Class 2 NDA with the FDA seeking approval of pirfenidone or other government regulation generally; (iv) risks related to our ability to successfully launch and commercialize pirfenidone in the United States, if approved by the FDA and (v) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.
Monday, February 24, 2014
Sacramento study finds oral hygiene to be a factor in hospital pneumonia cases
Published: Saturday, Feb. 22, 2014 - 10:02 pm
Last Modified: Saturday, Feb. 22, 2014 - 10:54 pm
Frequent flossing is not just a good habit for hospital patients – it’s a lifesaver.
Good oral hygiene by patients is key to combating hospital-acquired pneumonia, a recent study from California State University, Sacramento, researchers and Sutter Medical Center staff found.
The study puts a spotlight on non-ventilator hospital-acquired pneumonia (NV-HAP), which has been largely unreported due to a focus on ventilated patients, who are more likely to contract pneumonia because their airways are more exposed. Barbara Quinn, a clinical nurse specialist at Sutter, initiated the study after noticing a prevalence of hospital-acquired pneumonia among patients not on ventilators.
Quinn contacted Dian Baker, a CSUS nursing professor and researcher, to investigate the scope of the problem. During a yearlong study funded by the medical center, the duo discovered that about 10 non-ventilated patients per month contract pneumonia while at the Sutter Medical Center, which includes Sutter General Hospital in midtown and Sutter Memorial in east Sacramento.
While some causes of NV-HAP such as age and a patient’s diagnosis cannot be changed, researchers saw an opportunity in oral hygiene factors.
By merely breathing, patients with compromised immune systems and limited mobility risk bringing bacteria from their mouths into their lungs, leading to more serious conditions, including pneumonia, Quinn said. Patients often become lax about brushing and flossing when they are tired and sick, Baker added, leaving them susceptible to sometimes life-threatening bacterial buildup.
“Once people are in the hospital for a day or two, the bacteria in their mouth changes and becomes more like the bacteria in the hospital environment,” Quinn said. “Unfortunately, hospitals have bad germs. Bacteria replicates so quickly in the mouth that it can take a matter of hours.”
As part of a pilot program between spring 2012 and 2013, Sutter staff designed and funded a new oral-care protocol, which includes distribution of American Dental Association-recommended brushes, sodium bicarbonate toothpaste and antiseptic mouthwash. They also added special suction toothbrushes with larger, firmer handles, and lip moisturizer, for patients whose conditions make it difficult for them to brush.
A year’s supply of oral products for all of the adult patients in the two Sutter hospitals costs a total of $117,600. The supplies, combined with additional staff training focused on oral hygiene, reduced the number of NV-HAP cases at Sutter to about six or seven a month – a 37 percent decrease over the one-year period. The results of the study were published in the January 2014 issue of the Journal of Nursing Scholarship.
U.S. hospitals are required to monitor only ventilated patients for pneumonia – a standard that Baker and Quinn hope to change by promoting their study at national conferences.
“Not only are hospitals not paying attention to this, but we as a nursing profession were not aware that oral hygiene was so important for patients not on ventilators,” Baker said. “I tell all my friends now before they go to the hospital to see the dentist before they go, and brush their teeth four times a day.”
Other partners in the research included Kaiser Permanente South Sacramento and the Department of Veterans Affairs Medical Center in Salem, Va.
Kaiser Permanente’s involvement in the study reinforced its protocol in place to combat hospital-acquired pneumonia, including improving oral hygiene education and increasing distribution of mouthwash and getting patients walking early in their hospital stay.
“We provide oral care for patients at least twice a day and educate them about the importance oral care,” said Jennifer Stewart, a clinical educator at Kaiser Pemanente South Sacramento.
Friday, February 14, 2014
My Forever Valentine~ Written by Pam Brewer
This is my first
Valentines Day without my Rick. He always gave me such meaningful
cards...flowers...and always came up with special arrangements or colors of
"our" special meaning roses...jewelry, etc. But, the absolute most
important thing he has given me ever since I started dating him before we
married, was something he probably
never knew. You see throughout the years, when I'd travel either for business
or family...all the times I went to North Carolina to see my parents, sometimes
by myself in the 11 or so years they went there, or was gone all day on
appointments, etc.....you see what I mean....I'd think, "oh, I'm lonely or
I'm doing these things "alone"....well, I now know, I was never,
never alone....he was truly always with me and a part of me....I was, never,
alone!
He gave me the greatest gift any one could ever begin
to give another person! The "being together"...a part of another
person...If I was anxious to get home during the day, it was because of him. If
I saw something trivial that made me smile, I didn't even realize till now, it
was because I could share it with him. If we sat all evening and just once in
awhile reached over and grabbed each others hands, or smiled at each other, I
was so full and enjoyed that because of him.....in all these years...no matter
where I literally was on this earth, I never knew what being alone was
....because of him......Now, I "do" know what being alone is.....I
can't go there....no words....every single thing now, is
"alone"...even if I'm in a big crowd.....every little nuance or joy
has changed...
So, if you don't get the box of chocolates, or
can't afford to go out to eat at that special restaurant, "if" you
have that special person...you have THEE greatest gift of all....you are NOT
ALONE!!!! Thank you Rick Brewer for making it so that I knew not one moment, from
1968 till Oct. 21, 2013, of being ..."alone".......I had
"you"!!!!! I LOVE YOU, MY FOREVER VALENTINE!!!!
**Thank You, Pam, for sharing your heart with us on this Valentine's Day! My heart, filled with love, goes out to you. ~Breathing
Wednesday, February 12, 2014
I'm not here to answer your call right now~
So, when he passed away, my youngest child and I decided to leave his phone line alive. It helped us both a great deal. My son would often call his phone while having a hard day at school. Meanwhile, I would call my husband's line to wish him a good night or to tell him my car had broken down and I just needed to talk. We called his line every birthday, wedding anniversary and Christmas. On New Year's Eve, my son and I would dial into my husband's voice mail and put the phone on speaker and listen all the messages we had left. They were mostly tearful whispers and inaudible crying, but we could still make out the words we were trying to say.
I finally discussed with my son that we should think about cancelling his line. My son agreed. After all, deep down we knew that most of the time we talked to my hubby, it is through our hearts and not on a ten dollar a month phone line. We recorded my husbands voice mail message on another device and then I took the big step to call my phone provider and let them know.
The customer service provider apologized for our loss and indicated that we would not have to pay a cancellation fee for that line if the person was deceased and asked the date of my husband's death.
"December 15th", I responded.
"Okay" she said, "December 15th of 2013."
"No, it was actually December 15th, 2011." Realizing that two full years had gone by.
I began to explain why we kept the phone line alive and that I had not been ready to cancel it until now. She said that it was perfectly understandable and that she too, had dealt with the loss of her father and still wishes she could hear his voice. She cancelled the phone line with no issue and we ended up sending tearful wishes and blessings to each other. She was very kind.
I still have my husband listed on my speed dial. I can't imagine anyone else's name listed there.
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