PMID- 28699846
OWN - NLM
STAT- MEDLINE
DCOM- 20180501
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 33
IP  - 12
DP  - 2017 Dec
TI  - Safety and effectiveness of tadalafil in pediatric patients with pulmonary 
      arterial hypertension: a sub-group analysis based on Japan post-marketing 
      surveillance.
PG  - 2241-2249
LID - 10.1080/03007995.2017.1354832 [doi]
AB  - OBJECTIVE: To evaluate the long-term safety and effectiveness of tadalafil in 
      pediatric patients with pulmonary arterial hypertension (PAH) in real-world 
      clinical practice. METHODS: This is an observational surveillance of PAH patients 
      receiving tadalafil in the contracted sites. A sub-group analysis was performed 
      of 391 pediatric PAH patients (<18 years) who were included from 1,704 total 
      patients in this surveillance. Safety was assessed from the frequency of adverse 
      drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious 
      adverse drug reactions (SADRs). Effectiveness measurements included change in 
      World Health Organization (WHO) functional classification of PAH, cardiac 
      catheterization (pulmonary arterial pressure: PAP), and echocardiography 
      (tricuspid regurgitation pressure gradient: TRPG). Survival rate was also 
      measured. RESULTS: The mean patient age was 5.7 +/- 5.34 years. Associated PAH 
      (APAH) and idiopathic PAH (IPAH) accounted for 76.0% and 17.6%, respectively, of 
      the PAH patients. Patients were followed for up to 2 years. Among 391 patients 
      analyzed for safety, the overall incidence rate of ADRs was 16.6%. The common 
      ADRs (>/= 1%) were headache (2.8%), hepatic function abnormal, platelet count 
      decreased (1.3% each), and epistaxis, (1.0%). Eleven patients (2.8%) reported 16 
      SADRs. Three patients died secondary to SADRs. For the effectiveness analysis, 
      the incidence of WHO functional class improvement at 3 months, 1 year, and 2 
      years after the initiation of tadalafil and last observation in pediatric 
      patients were 16.5%, 19.7%, and 16.3%, respectively. Both PAP and TRPG showed a 
      statistically significant reduction at last observation. CONCLUSION: This 
      manuscript reveals the use of tadalafil in the real-world pediatric population 
      with an acceptable safety profile in Japan.
FAU - Yamazaki, Hiroyoshi
AU  - Yamazaki H
AD  - a Global Patient Safety Japan , Quality & Patient Safety, Eli Lilly Japan K.K. , 
      Kobe , Japan.
FAU - Kobayashi, Noriko
AU  - Kobayashi N
AD  - b Post Marketing Study Management, Medicines Development Unit Japan , Eli Lilly 
      Japan K. K. , Kobe , Japan.
FAU - Taketsuna, Masanori
AU  - Taketsuna M
AD  - c Statistical Sciences, Medicines Development Unit Japan , Eli Lilly Japan K.K. , 
      Kobe , Japan.
FAU - Tajima, Koyuki
AU  - Tajima K
AD  - d Post Marketing Surveillance Clinical Research Department , Nippon Shinyaku CO., 
      Ltd , Kobe , Japan.
FAU - Suzuki, Nahoko
AU  - Suzuki N
AD  - e Biometrics, Medicines Development Unit Japan , Eli Lilly Japan K.K. , Tokyo , 
      Japan.
FAU - Murakami, Masahiro
AU  - Murakami M
AD  - f Medical Science, Medicines Development Unit Japan , Eli Lilly Japan K.K. , Kobe 
      , Japan.
LA  - eng
PT  - Journal Article
DEP - 20170720
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy
MH  - Infant
MH  - Japan
MH  - Male
MH  - Phosphodiesterase 5 Inhibitors/adverse effects/*therapeutic use
MH  - Product Surveillance, Postmarketing
MH  - Tadalafil/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Pediatric
OT  - Phosphodiesterase type 5 inhibitor
OT  - Post-marketing surveillance
OT  - Pulmonary arterial hypertension
OT  - Tadalafil
EDAT- 2017/07/13 06:00
MHDA- 2018/05/02 06:00
CRDT- 2017/07/13 06:00
PHST- 2017/07/13 06:00 [pubmed]
PHST- 2018/05/02 06:00 [medline]
PHST- 2017/07/13 06:00 [entrez]
AID - 10.1080/03007995.2017.1354832 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2017 Dec;33(12):2241-2249. doi: 10.1080/03007995.2017.1354832. 
      Epub 2017 Jul 20.