Lyme Disease Support Group

By John Gever, Senior Editor, MedPage Today

Published: March 30, 2012

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania.

Action Points

Note that children with asthma typically have reduced lung function by early school age. It is not known, however, if the loss of lung function precedes the development of asthma or is a consequence of asthma.

Point out that this study found that children developing asthma by age 7 had a lung function deficit and increased bronchial responsiveness as neonates and the lung function deficit progressed to age 7.

Asthmatic 7-year-olds very often had impaired lung function soon after birth, a prospective cohort study in Denmark found.

Low scores on forced expiratory flow at 50% of vital capacity (FEF50) one month after birth were associated with significantly increased risk for developing asthma by age 7, with an increase of 57% (95% CI 4% to 137%, P=0.03) in risk for each interquartile reduction in FEF50, Hans Bisgaard, MD, of the University of Copenhagen, and colleagues reported online in the American Journal of Respiratory and Critical Care Medicine.

But, they noted that only 40% of the impaired lung function present in 7-year-old asthmatics was apparent during infancy -- therefore leaving 60% that developed later on.

The researchers also found that exposure to second-hand tobacco smoke helped accelerate development of disease, whereas allergic sensitization was not a significant factor.

"Research should consider prenatal programming in search of the origins and prevention of asthma," Bisgaard and colleagues wrote.

But they also noted that, since more than half of the eventual airflow impairment developed postnatally, there is "a potential window of opportunity for early clinical intervention."

The findings came from a prospective study of 411 newborns in Copenhagen considered at risk for asthma because their mothers had the disease. The infants underwent spirometry and airway reactivity studies at 1 month and were followed until they were 7, at which point follow-up spirometry and other evaluations were performed.

Exposure to environmental tobacco smoke was evaluated at age 3, and allergen sensitization was measured several times during follow-up with skin-prick and serum IgE testing.

Of 336 who remained in the study, 14% met criteria for asthma at age 7. These children had significantly lower FEF50 scores when they were neonates (z-score difference -0.34, P=0.03) compared with nonasthmatic 7-year-olds after adjusting for gender and maternal smoking during pregnancy.

There was a similar trend for the relationship between neonatal forced expiratory volume in 0.5 seconds and later asthma, but it fell just short of statistical significance (z-score -0.29, P=0.07).

Neonatal airway reactivity, measured with a methacholine challenge test, also strongly predicted subsequent asthma (OR per interquartile reduction 1.59, 95% CI 1.11 to 2.28, P=0.01).

Not surprisingly, all measures of lung function were impaired in the asthmatic 7-year-olds compared with nonasthmatics.

The only factor besides neonatal lung function that was significantly associated with risk of progressive airflow deficit was environmental tobacco smoke exposure at age 3, and the effect was relatively small (z-score for FEF50 at age 7 was -0.02, P=0.01).

There was no independent effect seen with positive skin-prick or IgE results, diagnosis of atopic dermatitis, or eosinophil counts.

Bisgaard and colleagues noted that, as part of the study, children were monitored more closely than usual and were put on inhaled corticosteroids immediately when chronic airway symptoms were detected.

The study results therefore confirm that drug treatment does not alter the underlying disease process, the researchers asserted, and may even help explain the lack of effect.

"Our study suggests that a significant loss of lung function already took place before onset of symptoms, indicating irreversible changes and/or a process that cannot be modified at the symptomatic stage," they wrote.

Also, they argued, "steroids are most effective against eosinophilic airway inflammation, while our findings suggest that lung function loss is independent of sensitization or increased eosinophil levels.

Drugs targeting other pathways may therefore be needed."

The study was funded by the Lundbeck Foundation, the Pharmacy Foundation of 1991, the Augustinus Foundation, the Danish Medical Research Council, and the Danish Pediatric Asthma Centre.

Study authors declared they had no relevant financial interests.

Primary source: American Journal of Respiratory and Critical Care Medicine

Source reference:

Bisgaard H, et al "Interaction between asthma and lung function growth in early life" Am J Resp Crit Care Med 2012; DOI: 10.1164/rccm.201110-1922OC.

http://www.medpagetoday.com/Pediatrics/Asthma/31956? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 Everyday Health, Inc. All rights reserved.

By Michael Smith, North American Correspondent, MedPage Today

Published: March 27, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, RN, BC-ADM, Nurse Planner

Video source: JAMA

Action Points

Explain that a retrospective study found increased cost-sharing for asthma prescriptions was associated with decreased use of medication and a higher rate of hospitalization in children over the age of 5 with asthma.

Note that emergency department visits did not appear to be affected by cost-sharing, and none of the outcomes differed based on cost-sharing for children under 5.

Higher copayments for asthma drugs were associated with reduced use of the medications by older children, researchers reported.

Children ages 5 to 18 whose families' out-of-pocket costs were highest also were more likely to be admitted to hospital because of their asthma, according to Dana Goldman, PhD, of the University of Southern California in Los Angeles, and colleagues.

But neither effect was seen in children younger than 5, Goldman and colleagues reported in the March 28 Journal of the American Medical Association.

Previous research has shown that, in adults, increased cost-sharing – imposed by private insurance companies to help control costs – leads to lower medication use and increases in emergency department (ED) visits and hospital admissions, Goldman and colleagues noted.

But research in children -- where any additional costs are borne by parents -- has been limited, they added.

To help fill the gap, they undertook a retrospective study of insurance claims for 8,834 American children with asthma who started control therapy between 1997 and 2007.

They created a fixed "basket" of asthma medications and used variation in out-of-pocket costs across 37 employers to examine differences in asthma medication use, asthma-related hospital admissions, and ED visits.

In multivariable analyses, they found:

On average, the annual out-of-pocket asthma drug cost was $154 among children 5 to 18 and $151 among those younger than 5.

Among the 5,913 children 5 to 18 years, filled asthma prescriptions covered 40.9% of days, on average, and during a year of follow-up, 121 children were admitted to hospital and 220 visited an ED for asthma.

Among the younger 2,921 children, average medication use was 46.2% of days, 136 children had inpatient care for asthma, and 231 went to the ED.

Among older children, a cost increase from the 25th to the 75th percentile was associated with a small reduction in medication use – from 41.7% to 40.3% of days (P=0.02).

There was no such change among younger children.

Among the older children, the rate of asthma-related admission was higher for those in the top quartile of out-of-pocket costs compared with the bottom quartile -- 2.4 versus 1.7 admissions per 100 children (P=0.004).

Again, there was no such change among younger children.

Annual rates of emergency department use didn't vary across out-of-pocket quartiles for either age group.

The researchers cautioned that the study lacked measures of clinical severity, so that overall asthma control could not be investigated. In addition, they noted, the sample was not representative of all privately insured children and could have included children with seasonal asthma who would not be expected to use medication year-round.

Nonetheless, the findings emphasize that there is often a "misalignment" between the need for a medication and its price, according to Wendy Ungar, PhD, of the Hospital for Sick Children in Toronto.

In an accompanying editorial, Ungar argued that "cost-sharing levels of necessary drugs need to remain low enough so as not to deter acquisition and shift program costs to families."

Various ideas have been floated to achieve those ends, she noted, including such things as tiered formularies and value-based insurance design, which would "set copayment levels in proportion to potential health benefit."

A key insight, she concluded, is that "fully covering services and interventions that promote child health may deter or prevent serious or chronic diseases in the adult years."

"The best form of value in drug policy reform," Ungar said, would be to base changes on that understanding.

The study had support from the National Institute of Child Health and Human Development, the National Institute on Aging, and the Roybal Center for Health Policy Simulation. The journal said Jena reported no conflicts.

The journal said Ungar did not report any financial links with industry.

Primary source: Journal of the American Medical Association

Source reference:

Karaca-Mandic P, et al "Out-of-pocket medication costs and use of medications and health care services among children with asthma" JAMA 2012; 307(12): 1284-1291.

Additional source: Journal of the American Medical Association

Source reference:

Ungar WJ "Medication cost sharing and health outcomes in children with asthma" JAMA 2012; 307(12): 1316-1318.

http://www.medpagetoday.com/AllergyImmunology/Asthma/31883? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 Everyday Health, Inc. All rights reserved.

By Nancy Walsh, Staff Writer, MedPage Today

Published: August 27, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Action Points

Discontinuation of long-acting beta-agonist (LABA) therapy in patients whose asthma is well controlled is associated with a worsening of symptom control and quality of life.

Point out that in 2010 the FDA determined that LABAs should carry a black box warning and advised that discontinuation of the drugs should begin once patients gain and maintain adequate asthma control.

Discontinuation of long-acting beta-agonist therapy in patients whose asthma is well controlled is associated with a worsening of symptom control and quality of life, a systematic review suggested.

Withdrawing a long-acting beta-agonist resulted in a 0.24 point (95% CI 0.13 to 0.35) rise in the seven-point Asthma Control Questionnaire score, according to Jan L. Brozek, MD, PhD, of McMaster University in Hamilton, Ontario, and colleagues.

In addition, the "step-off" approach was associated with a lowering of 0.32 points (95% CI 0.14 to 0.51) on the Asthma Quality of Life Questionnaire, the researchers reported online in Archives of Internal Medicine.

Recommendations from the National Asthma Education and Prevention Program have favored the consideration of step-down therapy for asthma in patients whose disease has been under control "for several months."

And although most research has focused on lowering the doses of inhaled steroids to avoid potential adverse effects, during the past two decades concerns have been raised about potentially severe adverse outcomes associated with treatment with long-acting beta-agonists.

In 2010 the FDA determined that these drugs should carry a black box warning and advised that discontinuation of the drugs should begin once patients gain and maintain adequate asthma control.

But some experts disagreed, arguing that abrupt withdrawal of this component of treatment could result in a loss of symptom control.

To address this controversy, Brozek and colleagues conducted a systematic review of the literature, identifying only five randomized trials that compared step-off therapy with continued maintenance with long-acting beta-agonists in conjunction with inhaled corticosteroids.

Four of the studies had been published in the peer-reviewed literature; the fifth had been presented as an abstract at a conference.

In none of the studies was a benefit seen for withdrawal of the beta-agonist, according to the authors of the review.

Rather, step-off therapy was associated with a difference of 9.15% (95% CI 1.62 to 16.69) in the number of symptom-free days and a greater likelihood of study withdrawal because of symptom persistence (RR 3.27, 95% CI 2.16 to 4.96).

Patients who stopped the long-acting beta-agonist also required 0.71 (95% CI 0.29 to 1.14) more doses of a rescue bronchodilator per day and had a nonsignificant increase in use of oral corticosteroids (RR 1.68, 95% CI 0.84 to 3.38).

A trend also was seen for a lower proportion of nights when patients were awakened, with a mean difference of 1.47% (95% CI −3.18 to 0.23).

A striking finding of this analysis was the few number of studies that had attempted to address the question of whether the long acting bronchodilators should or should not be continued, according to the authors.

They noted that, although the available evidence suggested that better symptom control was maintained with continuation of the bronchodilator, "there is uncertainty about estimated effects because of the risk of bias in the included studies, imprecision of the estimates, and indirectness of the evidence."

Furthermore, they faulted the included studies for brief duration, failure to consider adherence to treatment, and large numbers of patients who withdrew.

There also may have been publication bias, the researchers noted.

The rationale behind the FDA's decision to require the black box warning originated with two studies in which there was an increase in mortality among patients receiving salmeterol.

However, Brozek and colleagues criticized those studies, noting that in one, short-acting beta-agonists may have been overused and inhaled corticosteroids underused.

The other study had "many flaws," including follow-up that included only a single physician visit.

"In contrast to FDA recommendations of stepping off [long-acting beta-agonist] therapy when asthma is controlled, our analysis supports the continued use of [these agents] to maintain asthma control," the researchers stated.

The FDA has requested that manufacturers of long-acting bronchodilators conduct further large safety studies of their products, but the results are unlikely to be available for several more years.

In an invited commentary published with the systematic review, Chee M. Chan, MD, and Andrew F. Schorr, MD, of Washington Hospital Center in Washington, D.C., described the history of long-acting beta-agonists as "a case study for precisely how not to make public policy for complicated diseases."

They argued that the goal of management for a disease such as asthma should not be total elimination of risk, but a balancing of multiple risks.

Furthermore, they called on the FDA to reconsider the black box warning for these agents based on the findings of Brozek and colleagues, particularly in light of the possibility that the mandated safety trial may not even provide conclusive evidence 5 years in the future.

"We hope that this meta-analysis helps to lift some of the black clouds in the debate surrounding [long-acting beta-agonists]," wrote Chan and Shorr.

They further argued that, in the meantime, clinicians themselves "must now reevaluate the contents of the black box," particularly for patients whose disease is currently under control with a regimen of inhaled corticosteroids and long-acting beta-agonists.

Funding and support for this work was provided by McMaster University, the American Academy of Allergy, Asthma and Immunology, and the American Thoracic Society.

The authors reported receiving grants from GlaxoSmithKline, Merck, Asthmatix, Eumedics, Novartis, Genentech, AstraZeneca, and sanofi-aventis, as well as stock holdings in Abbott, Novartis, and Johnson and Johnson.

Primary source: Archives of Internal Medicine

Source reference:

Brozek J, et al "Long-acting beta2-agonist step-off in patients with controlled asthma: systematic review with meta-analysis" Arch Intern Med 2012; DOI: 10.1001/archinternmed.2012.3250.

Additional source: Archives of Internal Medicine

Source reference:

Chan C, Shorr A "Black clouds and black boxes" Arch Intern Med 2012; DOI:10.1001/archinternmed.2012.3650.

http://www.medpagetoday.com/Pulmonology/Asthma/34413? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 Everyday Health, Inc. All rights reserved.

By Kristina Fiore, Staff Writer, MedPage Today

Published: September 11, 2012

Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Video source: JAMA

Action Points

A randomized, controlled trial showed no difference in time to treatment failure whether inhaled corticosteroids were adjusted by physician assessment (current guidelines), using exhaled nitric oxide as a biomarker, or by symptoms.

Note that all patients had mild to moderate asthma.

When it comes to adjusting the dose of inhaled corticosteroids for better asthma control, periodic physician assessment was as good a gauge as using a biomarker or day-to-day symptom occurrence, researchers found.

In a randomized, controlled trial, there were no significant differences in time to treatment failure for any of those three options in adults with asthma controlled with low-dose inhaled corticosteroid therapy, reported William Calhoun, MD, of the University of Texas Medical Branch in Galveston, and colleagues in the Sept. 12 issue of the Journal of the American Medical Association.

"Adjusting inhaled corticosteroid doses based on symptoms was just as effective as the NIH guidelines [for physicians] and just as effective as with biomarkers [of] exhaled nitric oxide," Calhoun told The JAMA Report.

Asthma patients periodically require adjustments in inhaled corticosteroid therapy, which have largely been based on guidelines recommending clinician assessment of the patient's needs.

But it's been unclear whether adjusting based on specific patient symptoms or on a biomarker of exhaled nitric oxide could be superior to clinician assessment.

So the researchers conducted the Best Adjustment Strategy for Asthma in the Long Term (BASALT) trial of 342 patients with mild-to-moderate asthma between 2007 and 2010.

Patients were randomized to one of three groups for 36 weeks:

Standard care, with clinicians assessing rescue albuterol use and pulmonary function at 6-week intervals to determine dose adjustment

Biomarker-based adjustment using exhaled nitric oxide every 6 weeks

Symptom-based adjustment in which patients took two puffs of low-dose beclomethasone (40 mcg/puff) every time they took 2 puffs of albuterol for symptom relief

The primary outcome was disease worsening as measured by time to treatment failure.

The researchers found no significant differences in the primary outcome, with failure rates of 22% for physician assessment, 20% for biomarker-based adjustment, and 15% for symptom-based adjustment.

Even when multiple episodes of treatment failure were included, treatment failure rates were not different among groups (P=0.21):

0.43 events/person-years for physician-based assessment (97.5% CI 0.23 to 0.64)

0.27 events/person-years for biomarker-based adjustment (97.5% CI 0.14 to 0.39)

0.25 events/person-years for symptom-based adjustment (97.5% CI 0.10 to 0.39)

Neither of the alternate strategies were significantly different from standard physician assessment, the researchers reported, and asthma exacerbation rates didn't differ either.

While airway responsiveness worsened in the physician-based assessment group compared with the biomarker-based assessment (P<.0006), it did not differ when the symptom-based assessment group was compared with the other two groups.

Also, measures of lung function and asthma symptoms were not significantly different among the groups.

Few days were lost from school or work, although the likelihood of missing days was significantly higher for the biomarker-based assessment group than for the standard care or symptom-based assessment groups (OR 2.0, 95% CI 1.1 to 3.8, P=0.01 and OR 4.3, 95% CI 1.9 to 9.6, P<0.001).

Predictors of time to treatment failure included race (P=0.001) and albuterol reversibility (P=0.004), the researchers added.

The study was limited by its small sample size, they noted, and findings in highly controlled clinical trials may not translate directly to clinical practice.

Still, they concluded that neither the symptom-based nor the biomarker-based assessment "was superior to the standard strategy for the outcome of treatment failure."

In an accompanying editorial, George O'Connor, MD, of Boston University, and Joan Reibman, MD, of New York University, wrote that on the basis of this trial and previous trials, there is "no compelling rationale to alter the current approach to inhaled corticosteroid dosing for mild or mild-to-moderate, persistent asthma."

They added that the study also makes it "difficult to justify additional healthcare expenditures" for routine nitric oxide monitoring of asthma patients, which has been an area of controversy.

They noted that further research "including adequately powered equivalence trials, could change this in the future."

The study was supported by the National Heart, Lung, and Blood Institute, UTMB, and the National Center for Advancing Translational Sciences.

The researchers reported relationships with

Aerovance, AstraZeneca, Boehringer, Centocor, GlaxoSmithKline, Genentech, Merck, Novartis, Pfizer, Roche, MedImmune, Ception, Amgen, Forest, sanofi-aventis, Schering, AsthmaTx, IPS, Pulmogen, CSL Behring, Dyax, Viropharma, Shire, Cytokinetics, Amira, Oxagen, Gilead, Portola, Five Prime Therapeutics, Baxter, Pharming, Lev Pharma, Abbott, Astellas, Cowen, Icagen, Infinity, newMentor, NKT, Ono, PDL, Pumatrix, Regeneron, Sepracor, Teva, Agenzia, Biota, GE Healthcare, N30, SA Boney, AIR, Double Helix, AsthmaNet, Aerocrine, Airsonnet, Delmedica, Day, Ross, MapPharma, Kalblos, Pharmaxis, and Johnson & Johnson.

The editorialists reported relationships with Sunovion, Novartis, GlaxoSmithKline, and Genentech.

Primary source: Journal of the American Medical Association

Source reference:

Calhoun WJ, et al "Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma" JAMA 2012; 308: 987-997.

Additional source: Journal of the American Medical Association

Source reference:

O'Connor GT, Reibman J "Inhaled corticosteroid dose adjustment in mild persistent asthma" JAMA 2012; 308: 1036-1037.

http://www.medpagetoday.com/AllergyImmunology/Asthma/34701? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 Everyday Health, Inc. All rights reserved.

By Deanna Pogorelc, MedCity News

Published: September 25, 2012

Frustrated by the challenges of giving her young son his daily asthma treatments, Sarah Cota came up with an idea.

Why not ease the burden of using a nebulizer by taking away the mask and using it while the child is sleeping?

That's the idea behind the JettPak, the flagship product being developed by Bend, Ore., startup JettStream Inc. It's a hands-free, mask-free add-on for nebulizers currently on the market.

Intended to deliver medication to the child while he's sleeping, the base of the device can slide under a pillow or mattress.

The JettPak has an adjustable arm that delivers the medication next to the child's face. According to a July blog post from Jim Harrer, an entrepreneur and chief operations officer of the company, it will retail for about $200.

Cota didn't return a call last week, but she told the Cascade Business News earlier this month that the estimated launch date for the device was spring 2013.

Right now, the startup is raising money for the launch; it's already secured $115,000 in debt and equity, and could raise up to $750,000, according to a recent U.S. Securities and Exchange Commission filing.

As the company's website notes, it has already done lab testing that shows the device delivers the same doses of medicine as a nebulizer alone, and it's planning to do a clinical trial with 50 devices at Bend Memorial Clinic.

Asthma is the most common chronic childhood disease and affects nearly 5 million U.S. children. In addition to quick-relief medications, long-term control medications taken daily are often prescribed.

Many of these medications can be used with a nebulizer for asthma sufferers who are too sick or young to use an inhaler effectively.

But some children show resistance to these administration methods, as detailed in Cota's blog.

She's working with a former product development executive, Matt Smith, and Harrer to bring the device to market.

Companion to the device is JettEducation, an online database being developed for parents, and JettCommunity, a digital support community.

This article was adapted from one that first appeared on Sept. 24, 2012, in MedCityNews.com with permission from MedCity Media.

http://www.medpagetoday.com/Pediatrics/Asthma/34953? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

2012 MedPage Today, LLC. All rights reserved.

By John Gever, Senior Editor, MedPage Today

Published: November 12, 2012

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

In a population of generally well educated, middle to upper socioeconomic strata, non-Hispanic whites with predominantly mild objective asthma characteristics, a personal history of asthma was associated with currently experiencing depressive symptoms.

Note that the observed association persisted after correcting for multiple variables suggesting more than a disease burden association.

ANAHEIM, Calif. -- Depression and asthma appear to go hand in hand, even in patients whose asthma is relatively mild and who report generally good health, a researcher said here.

Analysis of some 13,000 participants in the Cooper Institute Longitudinal Study indicated that a diagnosis of asthma was a risk factor for reports of significant current depressive symptoms with an odds ratio of 1.41 (95% CI 1.16 to 1.65, P<0.001) after adjusting for asthma severity and self-assessment of overall health status.

Asthma and a previous history of depression also were significantly associated, with an odds ratio of 1.65 (95% CI 1.40 to 1.90, P<0.001), Tim Trojan, MD, of the University of Texas Southwestern Medical Center in Dallas, told attendees at the American College of Allergy, Asthma, and Immunology annual meeting.

Associations between asthma and depression have been reported before, Trojan explained, but those studies could not rule out the possibility that patients were simply sad about feeling sick with asthma.

Consequently, he and his colleagues utilized records from the Cooper Institute Longitudinal Study, begun in 1970 by the institute's founder, Kenneth Cooper, MD, the aerobics advocate.

The database has unusually detailed information on patients including spirometry values, scores on the Center for Epidemiologic Studies Depression Scale (CES-D), medical history, body mass index, and lifestyle factors such as smoking and drinking status, as well as standard demographics.

Trojan and colleagues analyzed data on 12,944 study participants, including 1,169 with a diagnosis of asthma. Of these, only 187 were on controller medications, suggesting that the sample mostly included people with relatively mild asthma.

About 81% of the overall sample indicated that their health status was good or excellent, as opposed to fair or poor.

Current depressive symptoms (CES-D scores of 10 or higher) were present in 11% and a past history of depression in 14%.

Bivariate analyses indicated that the risk of depressive symptoms was significantly increased, not only by a diagnosis of asthma, but also by female gender, hypertension, and current smoking.

It was significantly decreased in nonwhites, those with more than a high school education, age older than 50, and current drinking.

Multivariate analysis produced the odds ratio 0f 1.40 for depressive symptoms with an asthma diagnosis. When expressed as an r2 correlation coefficient, the value of 0.119 suggested that the relationship was only modest at best, Trojan said.

But a classification analysis based on the association correctly categorized 89.5% of study participants, he said.

The same held true for the association between asthma and depression history. The r2 correlation coefficient was 0.110, but the classification analysis categorized 85.7% of participants correctly, Trojan said.

He noted that the study had a number of limitations including the fact that some of the data such as depression history and smoking and drinking status were self-reported, and the Cooper Institute database consists of people who are "mostly white and mostly healthy."

Trojan added that they are probably relatively affluent as well, although income data are not collected.

Nevertheless, he said, the study findings "mean that your mild asthmatic ... who doesn't look or feel all that bad still has a significant risk, or could have a significant risk, of having depressive symptoms and should be evaluated for this."

Session co-moderator John Oppenheimer, MD, an allergist in Summit, N.J., commented that the study was "thought-provoking."

Noting the small number of asthma patients on controller medications, Oppenheimer added that it would be "interesting to tease out" whether asthma treatment changes the relationship with depression.

Trojan agreed, but noted that the available data were not adequate to track such changes over time.

The Cooper Institute study is self-funded.

Trojan said he had no relevant financial interests.

Oppenheimer reported relationships with GlaxoSmithKline, Merck, AstraZeneca, Boehringer Ingelheim, Medimmune, and Novartis.

Primary source: American College of Allergy, Asthma, and Immunology

Source reference:

Trojan T, et al "Relationship between asthma and depression: the Cooper Longitudinal Study" ACAAI 2012.

View 3 comments or Add Your Knowledge ™

http://www.medpagetoday.com/MeetingCoverage/ACAAI/35896? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 MedPage Today, LLC. All rights reserved.

By John Gever, Senior Editor, MedPage Today

Published: November 13, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Action Points

This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Clinicians at teaching hospitals may be no better than primary care physicians in the community at using spirometry to diagnose and manage asthma, a study found.

Note that controller medications were prescribed for half of the patients who did not undergo the lung function testing -- a move also not recommended by the guidelines.

ANAHEIM, Calif. -- Clinicians at teaching hospital clinics may be no better than primary care physicians in the community at using spirometry to diagnose and manage asthma, a researcher said here.

A review of records at Washington University's internal medicine clinic in St. Louis showed that nearly half of all patients with a diagnosis of asthma seen in a 2-year period never received any spirometry testing there, contrary to published treatment guidelines, said Eric Karlin, MD, who is now at Vanderbilt University in Nashville.

Moreover, controller medications were prescribed for half of the patients who did not undergo the lung function testing -- a move also not recommended by the guidelines, Karlin told attendees at the American College of Allergy, Asthma, and Immunology annual meeting.

He noted that the findings may not be generalizable to all academic medical centers -- the internal medicine clinic at Washington University was unusual in several ways -- but Karlin pointed out the results were consistent with those of earlier studies of community primary care providers.

In those studies, the percentage of asthma patients undergoing spirometry as recommended has ranged from 35% to 75%, he said.

Spirometry is recommended because the breathing problems that may be diagnosed as asthma can have other causes.

A number of previous studies have shown that asthma is overdiagnosed, especially in populations believed to have high rates of asthma, such as low-income African-Americans in urban communities.

The testing is also helpful in evaluating the effectiveness of controller therapy, Karlin explained.

But while utilization of spirometry had been evaluated in community primary care settings, its use in academic clinics staffed largely by residents had not been examined previously.

Karlin and colleagues conducted the study while he was at Washington University. They analyzed records of patients seen in the internal medicine clinic from May 2008 to May 2010, with 969 showing a diagnosis of asthma as indicated by ICD-9 code 493.90.

Reflecting the population seen at the clinic, some 81% of these patients were African-American and 79% were female. Their mean age was 46 (SD 14).

In 524 cases -- 54% of the total (95% CI 51% to 57%) -- there was no record that the patients ever had spirometry, Karlin said.

Of those patients, 272 (52%; 95% CI 48% to 56%) were prescribed controller medications.

"This is the most interesting aspect of what my study shows," he said. "We have 270 patients that are billed as having asthma.

They're prescribed expensive, potentially harmful medications, and we don't have objective data showing airway [restriction] reversibility. I would assume that some of these patients don't actually have a true diagnosis of asthma."

He noted that there was a barrier to performing spirometry in this clinic that others elsewhere might not face. The Washington University clinic did not have the necessary equipment on site, Karlin explained. Instead, patients had to be referred to another location.

Although it was in the same building, same-day testing and reporting of results usually was not possible, he said.

But even in the patients who did undergo spirometry, the care appeared to deviate from guideline recommendations.

The review showed that 62% of the 445 patients with spirometry did not actually meet all the criteria for an asthma diagnosis. Yet in this group, 216 patients, or 79% (95% CI 74% to 83%) were prescribed controller medications.

Karlin noted several limitations to the study besides the difficulty in performing spirometry.

The high proportion of female patients was unusual, body mass index values were not available, only the single ICD-9 code was used to indicate an asthma diagnosis, and the possibility that patients had spirometry performed outside the Washington University health system could not be ruled out.

Also, he said, the analysis was very strict in determining whether asthma diagnostic criteria were fulfilled.

Specifically, not only did spirometry have to be performed, but it had to be performed after bronchodilator treatment to demonstrate that the airway restrictions were reversible.

The study had no external funding.

Karlin declared that he had no relevant financial interests.

Primary source: American College of Allergy, Asthma, and Immunology

Source reference:

Karlin E, et al "Diagnosis of asthma at a resident-run primary care clinic" ACAAI 2012.

http://www.medpagetoday.com/MeetingCoverage/ACAAI/35913? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 MedPage Today, LLC. All rights reserved

By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today

Published: November 18, 2012

The troubled history of long-acting beta-agonists (LABAs) goes back to the 1990s when a safety signal was detected in a large clinical trial in Great Britain of the GlaxoSmithKline drug Serevent (salmeterol).

In that 16-week trial of 25,000 asthma patients, 12 people randomized to salmeterol died of asthma and respiratory causes, versus two in the control group who took a standard medication, according to results published in 1993..

In addition, there were 193 hospitalizations or life-threatening events related to asthma and respiratory causes in the users of the new drug, compared with 102 in the other group.

A second trial of the drug, this time in the United States, followed those initial findings..

That trial was halted by GlaxoSmithKline, in part because of excess deaths among African Americans.

Researchers had hoped to study 60,000 people in the trial, but only 26,000 people had been enrolled when it was stopped in 2003.

A 2006 paper that detailed the results of the U.S. trial noted there were 37 asthma and respiratory related deaths in those receiving salmeterol, compared with 14 among those on usual asthma medication who also got as placebo.

Among African Americans getting salmeterol, 15 died of asthma and respiratory causes during the 28-week study period, compared with only three in the control arm..

It is not known why African Americans may be more vulnerable to the effects of salmeterol. One theory involves genetic variations in cells in the lungs.

The leading beta-agonist/steroid combination product is Advair.

Another long-acting beta-agonist, Foradil (formoterol) also is available as a single-agent and as the combined product Symbicort, made by AstraZeneca.

In an email, GlaxoSmithKline spokeswoman Karen Collins said studies consistently have shown that Advair provides better overall asthma control than just an inhaled corticosteroid, including improvements in lung function, symptom control and less use of short-acting rescue inhalers.

She said both Advair and Serevent have improved asthma care.

"These medicines are used by millions of people worldwide and in the vast majority of people treated, they are well tolerated," she said.

View 3 comments or Add Your Knowledge ™

http://www.medpagetoday.com/AllergyImmunology/Asthma/36002? utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=

© 2012 MedPage Today, LLC. All rights reserved.