Evidence map›Paper›PMID 26725997›Full record

ArticleThe Journal of allergy and clinical immunology2016

Changing patterns of asthma medication use related to US Food and Drug Administration long-acting β2-agonist regulation from 2005-2011.

Melissa G Butler, Esther H Zhou, Fang Zhang, Yu-te Wu, Ann Chen Wu, Mark S Levenson, Pingsheng Wu, Sally Seymour, Sengwee Toh, Aarthi Iyer and 2 more

Abstract readHistorical Article
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of allergy and clinical immunology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Systematic Literature Review of Systemic Corticosteroid Use for Asthma Management.American journal of respiratory and critical care medicine · 2020
    Pooled it
  2. Article
  3. Article
  4. Article
  5. The impact of FDA regulatory activities on incident dispensing of LABA-containing medication: 2005-2011.The Journal of asthma : official journal of the Association for the Care of Asthma · 2018
    Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

Melissa G ButlerCenter for Clinical and Outcomes Research, Kaiser Permanente Georgia, Atlanta, Ga; Evidence Space, Hamilton, Bermuda.
Esther H ZhouOffice of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
Fang ZhangDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
Yu-te WuOffice of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
Ann Chen WuDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
Mark S LevensonOffice of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
Pingsheng WuDepartment of Medicine and Biostatistics, Vanderbilt University School of Medicine, Nashville, Tenn.
Sally SeymourOffice of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
Sengwee TohDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
Aarthi IyerDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass.
Solomon IyasuOffice of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Md.
Meghan A BakerDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Mass; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, Mass. Electronic address: meghan_baker@harvardpilgrim.org.
Center for Drug Evaluation and Research · USHarvard University · USBrigham and Women's Hospital · USKaiser Permanente · USVanderbilt University · US

Funding

Age-Dependent Pharmacogenomics of Asthma Treatment (ADAPT)R01HD085993 · NICHD · HARVARD PILGRIM HEALTH CARE, INC. · PI WU, ANN CHEN · 2016 to 2020
$3.1M
FDA HHS HHSF223200910006INICHD NIH HHS R01 HD085993
6 · The paper itself

Abstract

backgroundSafety concerns associated with long-acting β2-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities for this class of drugs. Little is known about the effect of these regulatory activities on use of LABA-containing agents or other asthma medications.

methodsWe created rolling cohorts of pediatric and adult asthmatic patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011. The proportions of asthmatic patients using LABA-containing products, inhaled corticosteroids (ICSs), leukotriene modifiers, short-acting β2-agonists, oral corticosteroids, other bronchodilators, and no medications were measured on a monthly basis, and the changes were evaluated by using interrupted time series with segmented regression analysis.

resultsWhen the 2005 regulatory activity was announced, there were statistically significant decreases in the use of fixed-dose ICS-LABA agents in children (-0.98 percentage points) and adults (-1.24 percentage points). Increased use of ICSs and leukotriene modifiers was observed just after the regulatory activities were announced in both children and adults. Although of smaller magnitude, continued favorable changes in the use of LABA agents were observed after the 2010 FDA regulatory activity.

conclusionThe 2005 and 2010 FDA regulatory activities might have contributed to reduced use of LABA agents, as intended; however, their effect, independent of other factors, cannot be determined. Use of other classes of asthma medications was similarly affected.

Indexed as

Practice Patterns, Physicians'AdolescentAdrenergic beta-2 Receptor AgonistsAdultAnti-Asthmatic AgentsAsthmaChildChild, PreschoolDrug and Narcotic ControlFemaleHistory, 21st CenturyHumansMaleMiddle AgedTreatment OutcomeUnited StatesAdrenergic beta-2 Receptor AgonistsAnti-Asthmatic Agentsasthmadrug safetyLong-acting β(2)-agonistmedication useUS Food and Drug Administration

Identifiers

PMID26725997
PMCPMC7065027
OpenAlexW2221937545

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.