PMID- 27683610
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160929
LR  - 20220419
IS  - 2045-8932 (Print)
IS  - 2045-8940 (Electronic)
IS  - 2045-8932 (Linking)
VI  - 6
IP  - 3
DP  - 2016 Sep
TI  - An observational study of inhaled-treprostinil respiratory-related safety in 
      patients with pulmonary arterial hypertension.
PG  - 329-37
LID - 10.1086/688059 [doi]
AB  - Inhaled treprostinil (Tyvaso) has been shown to be a safe and effective addition 
      to pulmonary arterial hypertension (PAH) oral therapies; however, the 
      respiratory-related safety profile of inhaled treprostinil required further 
      elucidation in the setting of routine clinical care. The objectives of this study 
      were to characterize respiratory-related adverse events (AEs) associated with 
      current or recent treatment with inhaled treprostinil and to compare the 
      incidence of respiratory-related AEs in PAH patients treated with inhaled 
      treprostinil with that in patients treated with other Food and Drug 
      Administration (FDA)-approved PAH therapies. This was a long-term, prospective, 
      observational study. All respiratory-related AEs were recorded during the study. 
      The number of PAH patients enrolled was 1,333, 666 treated with inhaled 
      treprostinil and 667 controls (treated with an FDA-approved PAH therapy other 
      than inhaled treprostinil), for a total of 958 and 1,094 patient-years of 
      exposure, respectively. In the inhaled-treprostinil group, 1,281 
      respiratory-related AEs were reported in 403 patients (61%), and in the control 
      group, 1,295 respiratory-related AEs were reported in 388 patients (58%). Cough, 
      throat irritation, nasal discomfort, and hemoptysis were the most common 
      respiratory-related AEs (occurring in >/=2% of patients in either treatment group) 
      that demonstrated a higher number of events per patient-year of exposure in the 
      inhaled-treprostinil group than in the control group (risk ratio [95% confidence 
      interval]: 1.487 [1.172-1.887], 3.777 [2.050-6.956], 2.039 [1.072-3.879], and 
      1.957 [1.024-3.741], respectively). Overall, inhaled treprostinil was well 
      tolerated by PAH patients in routine clinical care, with respiratory-related AEs 
      consistent with the known safety profile (trial registration: clinicaltrials.gov 
      identifier: NCT01266265).
FAU - Zamanian, R T
AU  - Zamanian RT
AD  - Vera Moulton Wall Center for Pulmonary Vascular Disease at Stanford University, 
      Stanford, California, USA.
FAU - Levine, D J
AU  - Levine DJ
AD  - University of Texas Health Science Center, San Antonio, Texas, USA.
FAU - Bourge, R C
AU  - Bourge RC
AD  - University of Alabama at Birmingham, Birmingham, Alabama, USA.
FAU - De Souza, S A
AU  - De Souza SA
AD  - Winthrop University Hospital, Mineola, New York, USA.
FAU - Rosenzweig, E B
AU  - Rosenzweig EB
AD  - Columbia University Medical Center, New York, New York, USA.
FAU - Alnuaimat, H
AU  - Alnuaimat H
AD  - University of Florida, Gainesville, Florida, USA.
FAU - Burger, C
AU  - Burger C
AD  - Mayo Clinic Jacksonville, Jacksonville, Florida, USA.
FAU - Mathai, S C
AU  - Mathai SC
AD  - Johns Hopkins University, Baltimore, Maryland, USA.
FAU - Leedom, N
AU  - Leedom N
AD  - United Therapeutics, Research Triangle Park, North Carolina, USA.
FAU - DeAngelis, K
AU  - DeAngelis K
AD  - United Therapeutics, Research Triangle Park, North Carolina, USA.
FAU - Lim, A
AU  - Lim A
AD  - United Therapeutics, Research Triangle Park, North Carolina, USA.
FAU - De Marco, T
AU  - De Marco T
AD  - University of California, San Francisco, California, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01266265
PT  - Journal Article
PL  - United States
TA  - Pulm Circ
JT  - Pulmonary circulation
JID - 101557243
PMC - PMC5019086
OTO - NOTNLM
OT  - adverse events
OT  - prostacyclin
OT  - tolerability
EDAT- 2016/09/30 06:00
MHDA- 2016/09/30 06:01
PMCR- 2016/09/01
CRDT- 2016/09/30 06:00
PHST- 2016/09/30 06:00 [entrez]
PHST- 2016/09/30 06:00 [pubmed]
PHST- 2016/09/30 06:01 [medline]
PHST- 2016/09/01 00:00 [pmc-release]
AID - PC2013358 [pii]
AID - 10.1086/688059 [doi]
PST - ppublish
SO  - Pulm Circ. 2016 Sep;6(3):329-37. doi: 10.1086/688059.