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Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine.

dc.contributor.author Chow, SC
dc.contributor.author Douglas, Pamela Susan
dc.contributor.author Kellerman, DJ
dc.contributor.author Kori, S
dc.contributor.author Mangum, B
dc.contributor.author Noveck, Robert
dc.coverage.spatial New Zealand
dc.date.accessioned 2015-12-15T16:21:19Z
dc.date.issued 2013
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/23926420
dc.identifier dddt-7-619
dc.identifier.uri https://hdl.handle.net/10161/11172
dc.description.abstract OBJECTIVE: MAP0004 is an investigational product which delivers dihydroergotamine (DHE) through the lung via a breath-synchronized metered dose inhaler. The objective of this study was to compare the acute effects of orally inhaled and intravenous (IV) DHE to placebo on maximum change and area under the curve for pulmonary arterial systolic pressure (PASP). RESEARCH DESIGN AND METHODS: A randomized, double-blind, placebo-controlled, 3-period, crossover study of 24 health adults. Trial registration NCT01089062. Study assessments included pharmacokinetics, electrocardiograms (ECG), and validated echocardiographic (Doppler)-derived measures of PASP by echocardiogram. The primary endpoint was the absolute change in calculated PASP using area under the curve, 0 to 2 hours (AUC(0-2h)). RESULTS: The change in PASP with IV DHE was significantly different than MAP0004 and placebo (AUC(0-2h)2857, 2624, and 2453 mmHg*min, respectively). After a second dose of MAP0004, AUC(0-4h) remained lower with MAP0004 than with a single dose of IV DHE. Adverse events were more common with IV DHE than with MAP0004 or placebo. None of the treatments produced clinically significant changes in PASP or other cardiac parameters. Changes in PASP were significantly smaller with MAP0004 compared with IV DHE. CONCLUSION: These results indicate the effects 1 mg of orally inhaled DHE on the cardiovascular system are less than with 1 mg of IV DHE, and that serial echocardiography can be a useful noninvasive means of assessing acute systemic effects.
dc.language eng
dc.relation.ispartof Drug Des Devel Ther
dc.relation.isversionof 10.2147/DDDT.S44093
dc.subject MAP0004
dc.subject dihydroergotamine
dc.subject echo
dc.subject echocardiogram
dc.subject inhaled
dc.subject intravenous
dc.subject pulmonary artery systolic pressure
dc.subject Administration, Inhalation
dc.subject Administration, Intravenous
dc.subject Adolescent
dc.subject Adult
dc.subject Cross-Over Studies
dc.subject Dihydroergotamine
dc.subject Double-Blind Method
dc.subject Echocardiography
dc.subject Female
dc.subject Humans
dc.subject Male
dc.subject Metered Dose Inhalers
dc.subject Middle Aged
dc.subject Migraine Disorders
dc.subject Pulmonary Artery
dc.subject Systole
dc.title Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine.
dc.type Journal article
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/23926420
pubs.begin-page 619
pubs.end-page 625
pubs.organisational-group Basic Science Departments
pubs.organisational-group Biostatistics & Bioinformatics
pubs.organisational-group Clinical Science Departments
pubs.organisational-group Duke
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Faculty
pubs.organisational-group Institutes and Centers
pubs.organisational-group Medicine
pubs.organisational-group Medicine, Cardiology
pubs.organisational-group School of Medicine
pubs.organisational-group Staff
pubs.publication-status Published online
pubs.volume 7
dc.identifier.eissn 1177-8881


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