Gessler, Tobias, Ghofrani, Hossein-Ardeschir, Held, Matthias, Klose, Hans, Leuchte, Hanno, Olschewski, Horst ORCID: 0000-0002-2834-7466, Rosenkranz, Stephan, Fels, Lueder, Li, Na, Ren, Dawn, Kaiser, Andreas, Schultze-Mosgau, Marcus-Hillert, Muellinger, Bernhard, Rohde, Beate and Seeger, Werner ORCID: 0000-0003-1946-0894 (2017). The safety and pharmacokinetics of rapid iloprost aerosol delivery via the BREELIB nebulizer in pulmonary arterial hypertension. Pulm. Circ., 7 (2). S. 505 - 514. THOUSAND OAKS: SAGE PUBLICATIONS INC. ISSN 2045-8940

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Abstract

The BREELIB nebulizer was developed for iloprost to reduce inhalation times for patients with pulmonary arterial hypertension (PAH). This multicenter, randomized, unblinded, four-part study compared inhalation time, pharmacokinetics, and acute tolerability of iloprost 5 mu g at mouthpiece delivered via BREELIB versus the standard I-Neb nebulizer in 27 patients with PAH. The primary safety outcome was the proportion of patients with a maximum increase in heart rate (HR) >= 25% and/or a maximum decrease in systolic blood pressure >= 20% within 30 min after inhalation. Other safety outcomes included systolic, diastolic, and mean blood pressure, HR, oxygen saturation, and adverse events (AEs). Median inhalation times were considerably shorter with BREELIB versus I-Neb (2.6 versus 10.9 min; n = 24). Maximum iloprost plasma concentration and systemic exposure (area under the plasma concentration-time curve) were 77% and 42% higher, respectively, with BREELIB versus I-Neb. Five patients experienced a maximum systolic blood pressure decrease >= 20%, four with BREELIB (one mildly and transiently symptomatic), and one with I-Neb; none required medical intervention. AEs reported during the study were consistent with the known safety profile of iloprost. The BREELIB nebulizer offers reduced inhalation time, good tolerability, and may improve iloprost aerosol therapy convenience and thus compliance for patients with PAH.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Gessler, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ghofrani, Hossein-ArdeschirUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Held, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klose, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Leuchte, HannoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Olschewski, HorstUNSPECIFIEDorcid.org/0000-0002-2834-7466UNSPECIFIED
Rosenkranz, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fels, LuederUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Li, NaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ren, DawnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaiser, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schultze-Mosgau, Marcus-HillertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Muellinger, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rohde, BeateUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seeger, WernerUNSPECIFIEDorcid.org/0000-0003-1946-0894UNSPECIFIED
URN: urn:nbn:de:hbz:38-236126
DOI: 10.1177/2045893217706691
Journal or Publication Title: Pulm. Circ.
Volume: 7
Number: 2
Page Range: S. 505 - 514
Date: 2017
Publisher: SAGE PUBLICATIONS INC
Place of Publication: THOUSAND OAKS
ISSN: 2045-8940
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
INHALED ILOPROST; THERAPIES; PROSTACYCLIN; TREPROSTINIL; SILDENAFIL; RIOCIGUATMultiple languages
Cardiac & Cardiovascular Systems; Respiratory SystemMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/23612

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