COPD Info

Boehringer Ingelheim has informed the FDA that their respiratory inhaler, Spiriva Handihaler, may increase the risk of stroke in those who use it. As a result, the FDA has issued an alert stating that based on data from 29 placebo-controlled trials of tiotropium (Spiriva), ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva.

These studies indicate an increased risk factor of 2 per 1000 patients over a 1 year period. (2/10ths of a percent)

The FDA report also states that it is important to interpret these preliminary results with caution. More data is expected when the results of a large, four-year randomized trial called UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) is reported. These results are expected to be released in June 2008

The FDA also recommends that patients should NOT stop taking Spiriva, but should discuss its use with their medical professionals.

Sources:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium
http://www.fda.gov/cder/drug/early_comm/tiotropium.htm

On March 3rd, Larry Taylor started his series, The Hospice Experience (A Patient's Perspective), chronicling this subject as a COPD patient. As he promised, he has made several additions to that initial article, providing more information about the Hospice program as well as additional insight into his own feelings and decisions as a patient as well as his families.

http://www.COPD-International.com/library/Hospice-experience.htm

Larry Taylor (aka Larry/ga on our message boards) has been an active contributor to information, support and COPD education since July of 2004, with over 4400 posts.

As Larry enters another phase in his dealing with COPD, he has started an article series that will help us all to better understand and prepare for dealing with the life limiting aspects of the disease.

As Larry points out in the beginning paragraphs, this will compliment The Hospice Story, by Betty Baareman, which detailed the decisions about the Hospice program and other related end of life issues as experienced from a caregivers perspective. http://www.COPD-International.com/Library/Hospice-story.htm

As Larry travels this road, he will be making periodic additions to this, providing insight into his own feelings and decisions as a patient as well as his families.

This gift to us all from Larry is at:
http://www.COPD-International.com/library/Hospice-experience.htm

Spiriva and Foradil inhalation powder capsules.

Audience: Pulmonologists, inhalation therapists, pharmacists, other healthcare professionals, patients

[Posted 02/29/2008]

FDA informed healthcare professionals and consumers of the correct way to use Spiriva and Foradil inhalation powder capsules. FDA and the National Poison Control Center have received many reports of patients swallowing Spiriva and Foradil capsules rather than placing the capsules in the inhalation devices. Both products are to be used in the HandiHaler (Spiriva) and Aerolizer (Foradil) devices to deliver the medicine to the lungs to improve breathing in patients with asthma, and in individuals affected by chronic obstructive lung disease and bronchitis. Both products will not treat a patient's breathing condition if the contents of a capsule are swallowed rather than inhaled. Healthcare professionals should discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. See the Public Health Advisory for important information on the correct use of both products.

[February 29, 2008 - Public Health Advisory - FDA]

In the field of organ donation,excluding older patients from receiving transplants because of limited donor supply and lower survival rates has been common practice.

However, a new UCLA Medical Center survey shows that select patients age 65 and older can safely undergo lung transplantation and have acceptable outcomes.

Based on a study of 48 older patients, as compared to a control group of 50 younger patients, the early survival rates results were very similar (95.7 percent, compared with 95.9 percent for the younger group). The study's findings further suggest that the increased mortality rate among older patients during the period from one month to one year following transplantation, which was due predominantly to infection, may actually result from the gradual deterioration of the immune system with age.

"This finding warrants adjustments in the immunosuppresion protocols for older patients," said lead author Dr. Raja Mahidhara, UCLA assistant professor of cardiothoracic surgery. "In addition, future studies should look at the effects of lung transplantation in older recipients on the donor pool and on other, younger patients on the waiting list."

The findings are reported in the February issue of the peer-reviewed Journal of Thoracic and Cardiovascular Surgery. Since 1999, UCLA has been one of the few transplant centers in the country to offer lung transplants to patients 65 and older who were otherwise healthy candidates for the procedure.

See Article: http://www.medicalnewstoday.com/articles/96249.php

Air pollution can make breathing difficult for susceptible populations including those with lung conditions such as asthma and chronic bronchitis. Older adults and young children are also at increased risks. Pollutants come in many forms with both gaseous and particulate pollutants as health risk factors.

Now, NASA satellites have made an interesting discovery on air pollution trends across the Southeast US. Apparently, you can breathe a bit easier on the weekends as air pollution levels decrease on Saturday and Sunday

Source:
http://weather.about.com/b/2008/02/11/air-pollution-worse-midweek-than-weekends.htm

Full story:
http://weather.about.com/od/climatechange/a/midweekair.htm

In the most recent FDA ALERT [2/1/2008], the FDA (US Food and Drug Administration) has highlighted important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms.

On Novembar 20, 2007, The FDA first informed the public about the possibility of serious neuropsychiatric symptoms sssociated with the use of varenicline (Chantix), .As the FDA’s review progressed, it appeared increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms, resulting in this latest Alert

Included in this new alert are the following sections:

Recommendations and Considerations for Healthcare Professionals

-- Healthcare providers should monitor all patients taking Chantix for symptoms of serious neuropsychiatric symptoms. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These symptoms have sometimes occurred in patients without pre-existing psychiatric illness and have worsened in some patients with pre-existing psychiatric illness treated with Chantix. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

-- Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder, may experience worsening of their pre-existing psychiatric illness while taking Chantix. Patients with serious psychiatric illness did not participate in the pre-marketing studies of Chantix. The safety and efficacy of Chantix in these patients has not been established.

-- While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert patients about these risks.

Information for the patient: Physicians who prescribe Chantix should discuss with their patients, patients’ families, and caregiver the following:

-- Tell the doctor about any history of psychiatric illness prior to starting Chantix. Patients taking Chantix have experienced worsening of current psychiatric illness, even if it is currently under control, and the reoccurrence of previous psychiatric illness.

-- Be alert to changes in mood and behavior. Symptoms include strange thoughts or behaviors, depressed mood, and thinking about or attempting suicide.

-- Immediately report changes in mood and behavior to the doctor.

-- Vivid, unusual, or strange dreams may occur while taking Chantix.

Note - In most cases, these symptoms developed during the actual Chantix therapy, but in others cases, symptoms developed following withdrawal from use of Chantix.

Source: http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm

The authors Chol Shin, M.D., Ph.D., of Korea University Ansan Hospital acknowledged that information on chronic bronchitis was self-reported, not documented by medical records, and the information on snoring was not verified. They also acknowledged that they could not rule out potential confounding effects of unknown and uncontrolled factors.

Their findings were as follows:

Regular snoring was associated with a 25% to 68% increased frequency of new-onset chronic bronchitis compared with those who never snored, The combination of smoking and snoring almost tripled the likelihood of chronic bronchitis compared with those who did not smoke or snore.

An examination of the joint effect of snoring and smoking on chronic bronchitis revealed a relative risk versus nonsmoking-never-snorer of:

1.39 for nonsmoking and snoring (95% CI 1.01 to 1.90)
2.31 for smoking and never-snoring (95% CI 1.38 to 3.87)
2.86 for smoking and snoring (95% CI 1.91 to 4.27)

Source article:
http://www.medpagetoday.com/PrimaryCare/SleepDisorders/dh/8141

A study in a Wiley-Blackwell journal - Respirology - finds that the development of bullous lung disease occurs in marijuana smokers approximately 20 years earlier than tobacco smokers.

At present, about 10% of young adults and 1% of the adult population smoke marijuana regularly. Researchers find that the mean age of marijuana-smoking patients with lung problems was 41, as opposed to the average age of 65 years for tobacco-smoking patients.

A condition often caused by exposure to toxic chemicals or long-term exposure to tobacco smoke, bullous lung disease (also known as bullae) is a condition where air trapped in the lungs causes obstruction to breathing and eventual destruction of the lungs.

Lead author Dr. Matthew Naughton says, "What is outstanding about this study is the relatively young ages of the lung disease patients, as well as the lack of abnormality on chest X-rays and lung functions in nearly half of the patients we tested."

The greater and earlier damage may be caused by the fact that unlike with tobacco use, marijuana is inhaled as extremely hot fumes to the peak inspiration and held for as long as possible before slow exhalation

Full Article: http://www.medicalnewstoday.com/articles/94896.php