Evidence map›Paper›PMID 28910559›Full record

ArticleThe Journal of asthma : official journal of the Association for the Care of Asthma2018

The impact of FDA regulatory activities on incident dispensing of LABA-containing medication: 2005-2011.

Meghan A Baker, Melissa G Butler, Sally Seymour, Fang Zhang, Yute Wu, Ann Chen Wu, Mark S Levenson, Pingsheng Wu, Aarthi Iyer, Sengwee Toh and 2 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of asthma : official journal of the Association for the Care of Asthma, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.8field-weighted citation impact, top 20% 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

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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 6 institutions in 1 country.

Meghan A Bakera Department of Population Medicine , Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston , MA , USA.
Melissa G Butlerc Center for Clinical and Outcomes Research , Kaiser Permanente Georgia , Atlanta , GA , USA.ORCID 0000-0001-6821-3617
Sally Seymoure Office of New Drugs, Center for Drug Evaluation and Research , Food and Drug Administration , Silver Spring , MD , USA.
Fang Zhanga Department of Population Medicine , Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston , MA , USA.
Yute Wuf Office of Biostatistics, Center for Drug Evaluation and Research , Food and Drug Administration , Silver Spring , MD , USA.
Ann Chen Wua Department of Population Medicine , Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston , MA , USA.
Mark S Levensonf Office of Biostatistics, Center for Drug Evaluation and Research , Food and Drug Administration , Silver Spring , MD , USA.
Pingsheng Wug Vanderbilt University School of Medicine , Department of Medicine and Biostatistics , Nashville , TN , USA.
Aarthi Iyera Department of Population Medicine , Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston , MA , USA.
Sengwee Toha Department of Population Medicine , Harvard Medical School and Harvard Pilgrim Health Care Institute , Boston , MA , USA.
Solomon Iyasuh Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , MD , USA.
Esther H Zhouh Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , MD , USA.
Harvard University · USCenter for Drug Evaluation and Research · USUnited States Food and Drug Administration · USBrigham and Women's Hospital · USKaiser Permanente · USVanderbilt University · US

Funding

The Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) NetworkR01HS019669 · AHRQ · HARVARD PILGRIM HEALTH CARE, INC. · PI SOUMERAI, STEPHEN B · 2010 to 2010
$4.5M
Age-Dependent Pharmacogenomics of Asthma Treatment (ADAPT)R01HD085993 · NICHD · HARVARD PILGRIM HEALTH CARE, INC. · PI WU, ANN CHEN · 2016 to 2020
$3.1M
Real-world patient responsiveness & safety of long-acting beta agonists in asthmaR01HS022093 · AHRQ · VANDERBILT UNIVERSITY MEDICAL CENTER · PI WU, PINGSHENG · 2013 to 2013
$1.6M
AHRQ HHS R01 HS019669AHRQ HHS R01 HS022093FDA HHS HHSF223200910006INICHD NIH HHS R01 HD085993
6 · The paper itself

Abstract

objectiveEvidence of safety issues associated with long-acting beta

methodsA monthly rolling cohort of asthma patients who were eligible to initiate a LABA-containing product was created in the Mini-Sentinel Distributed Database between January 2005 and June 2011. Cohorts of individuals who initiated LABA were examined for the changes in the proportions of single-ingredient to fixed-dose inhaled corticosteroid (ICS)-LABA initiators, appropriate initiation of LABA-containing products, and use of controller medications. The impact of the 2005 and 2010 FDA regulatory activities associated with LABA-containing products was measured using interrupted time series with segmented regression.

resultsLABA-containing product initiation was declining prior to the 2005 regulatory activities and continued to decline over the study period, accompanied by increased initiation of fixed dose ICS-LABA among LABA initiators. While the 2010 regulatory activities had no immediate impact on the proportion of LABA initiation in patients with prior controller medication dispensing and/or poor asthma control, there was an increasing positive trend toward LABA initiation in the appropriate patient population after the regulatory activities.

conclusionThe 2005 and 2010 FDA regulatory activities likely had an impact on communicating the safety concerns of LABA products. However, the impact cannot be viewed independent of scientific publications, guidelines for asthma treatment and other regulatory activities.

Indexed as

Administration, InhalationAdolescentAdrenergic beta-2 Receptor AgonistsAdultAnti-Asthmatic AgentsAsthmaChildChild, PreschoolCohort StudiesDrug CombinationsDrug PrescriptionsDrug Utilization ReviewFemaleGlucocorticoidsHumansInfantAdrenergic beta-2 Receptor AgonistsAnti-Asthmatic AgentsDrug CombinationsGlucocorticoidsAsthmadrug safetylong-acting beta2-agonistsentinelU.S. FDA

Identifiers

PMID28910559
PMCPMC7039242
OpenAlexW2754605225

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.