Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma: no increase in risk

Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related hospitalization among children. This large study shows that the concomitant use of inhaled glucocorticoids with LABAs (ICS/LABA) mitigates those risks. The study was mandated by the Food and Drug Administration (FDA).

6,200 children, 4 to 11 years of age, who required daily asthma medications and had a history of asthma exacerbations in the previous year were randomized to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks.

Salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone.

References:

Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. David A. Stempel. N Engl J Med 2016; 375:840-849, September 1, 2016.
http://www.nejm.org/doi/full/10.1056/NEJMoa1606356

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Image source: Image source: FDA and Wikipedia, public domain.

Early-Life Origins of COPD


There has been a major change in our understanding of the natural history and risk factors for COPD, a frequent cause of illness and death. For example, in the United States, more people die from COPD than from any other condition except cancer and cardiovascular illnesses. Although smoking is still a major cause of COPD, genetic, environmental, and developmental factors both diminish the FEV1 and accelerate FEV1 decline in adult life. Prevention of prematurity, and especially of bronchopulmonary dysplasia, is a major public health priority. Promising advances in the development of vaccines against respiratory syncytial virus and prevention strategies for childhood asthma could decrease the risk of COPD. Efforts to reduce exposure to air contaminants during pregnancy and childhood and to decrease adolescent smoking could also decrease the incidence of COPD.

References:

Early-Life Origins of Chronic Obstructive Pulmonary Disease. Fernando D. Martinez, M.D.
N Engl J Med 2016; 375:871-878, September 1, 2016.
http://www.nejm.org/doi/full/10.1056/NEJMra1603287

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Image source: Image source: FDA and Wikipedia, public domain.

Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone: no higher risk with the combo

Concerns remain about the safety of adding long-acting beta2-agonists to inhaled glucocorticoids for the treatment of asthma (ICS/LABA combo). These are the results of the postmarketing safety study mandated by the FDA, published in NEJM.

This multicenter, double-blind, 26-week study included 11,000 patients, 12 years of age or older, who had persistent asthma, and randomized them to receive budesonide–formoterol or budesonide alone.

The risk of an asthma exacerbation was 16.5% lower with budesonide–formoterol. Among adolescents and adults with moderate-to-severe asthma, treatment with budesonide–formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.

References:

Serious Asthma Events with Budesonide plus Formoterol vs. Budesonide Alone. Stephen P. Peters et al. N Engl J Med 2016; 375:850-860, September 1, 2016.
http://www.nejm.org/doi/full/10.1056/NEJMoa1511190

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Image source: Image source: FDA and Wikipedia, public domain.

Drug allergy - top articles for September 2016

Here are my suggestions for some of the top articles about drug allergy published recently:

Optimal step doses for drug provocation tests with beta-lactams: 5%-15%-30%-50% of daily therapeutic dose? http://buff.ly/2cI7hjQ

Neuromuscular blocking agents, antibiotics, and latex are the most common causes of anesthesia-related reactions http://buff.ly/1kVa1Xk

Although allergy to antibiotics is commonly claimed, true allergy to these drugs is often absent http://buff.ly/1tIbcTl

Yes, it can happen: allergy to to cetirizine (Zyrtec) - full-blown anaphylaxis http://bit.ly/WGCTMU

Negative predictive value of drug provocation tests in children: 95.6% http://buff.ly/1t1UGNP

Allergic reactions that result from concomitant drug use are potentially overlooked risk factors for angioedema http://buff.ly/1pHO6FA

Skin testing for immediate hypersensitivity to corticosteroids - a case series and literature review http://buff.ly/1DtcRM0

Most children with a history of penicillin allergy are wrongly labeled allergic and denied treatment http://buff.ly/1wtdIge



Drug allergy management in 5 steps (click to enlarge the image).

The articles were selected from Twitter @Allergy and RSS subscriptions.

Please feel free to send suggestions for articles to AllergyGoAway AT gmail DOT com and you will receive an acknowledgement in the next edition of this publication.

Image source: Wikipedia, GNU Free Documentation License.

Once-daily tiotropium improved lung function when added to ICS maintenance therapy in adolescents with moderate symptomatic asthma

This 48-week study was conducted at 65 sites in 12 countries and included 398 patients aged 12 to 17 years. They were randomized to receive 5 μg (2 puffs of 2.5 μg) or 2.5 μg (2 puffs of 1.25 μg) of once-daily tiotropium or placebo (2 puffs) administered through the Respimat device every evening, each as add-on treatment to inhaled corticosteroid (ICS) background therapy, with or without a leukotriene receptor antagonist. Of note, long-acting beta-2-agonists were not permitted during the study.

The primary end point was improvement in peak FEV1 within 3 hours after tiotropium dosing at 24 weeks, and it was achieved during the study. Trends for improvement in asthma control and health-related quality of life over the 48-week treatment period were observed.

Once-daily tiotropium improved lung function and was well tolerated when added to ICS maintenance therapy in adolescents with moderate symptomatic asthma. The effect was larger with the higher tiotropium dose (5 μg).

Here is what wheezing sounds like (click to play the embedded video):





Asthma Treatment Options in 7 Steps (click to enlarge the image).

References:

Tiotropium add-on therapy in adolescents with moderate asthma: A 1-year randomized controlled trial. Eckard Hamelmann et al. JACI, August 2016, Volume 138, Issue 2, Pages 441–450.e8 (free full text).
http://www.jacionline.org/article/S0091-6749(16)00186-X/fulltext

The World Allergy Organization (WAO) Small Airways Working Group publishes a monthly "What's New?" summary and I have served as its editor since 2011. The summary features the top 3 asthma/small airways articles each month. The article above is a part of the project. The archive is here: http://www.worldallergy.org/small_airways_group/reviews/archive.php

Image source: Image source: FDA and Wikipedia, public domain.
Blog Widget by LinkWithin