PMID- 28277870
OWN - NLM
STAT- MEDLINE
DCOM- 20170529
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 33
IP  - 5
DP  - 2017 May
TI  - Safety and effectiveness of tadalafil in patients with pulmonary arterial 
      hypertension: Japanese post-marketing surveillance data.
PG  - 963-971
LID - 10.1080/03007995.2017.1297931 [doi]
AB  - OBJECTIVE: To evaluate the long-term safety and effectiveness of tadalafil in 
      patients with pulmonary arterial hypertension (PAH) in real-world clinical 
      practice. METHODS: This prospective, multicenter, noninterventional, 
      post-marketing surveillance included patients with PAH who were observed for up 
      to 2 years after initiation of tadalafil. Safety was assessed by analyzing the 
      frequency of adverse drug reactions (ADRs), discontinuations due to adverse 
      events (AEs), and serious adverse drug reactions (SADRs). Effectiveness 
      measurements included the assessment of the change in World Health Organization 
      (WHO) functional classification of PAH, 6-minute walk test, cardiac 
      catheterization, and echocardiography. RESULTS: Among 1676 patients analyzed for 
      safety, the overall incidence of ADRs was 31.2%. The common ADRs (>/=1.0%) were 
      headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, 
      epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal 
      (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (>/=0.3%) were cardiac 
      failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count 
      decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the 
      percentages of patients with improvement of WHO functional class at 3 months, 1 
      year, and 2 years after the initiation of tadalafil, and last observation were 
      17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except 
      pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 
      6-minute walk distance, cardiac catheterization, and echocardiogram measurements 
      showed statistically significant improvement. CONCLUSION: This surveillance 
      demonstrated that tadalafil has favorable safety and effectiveness profiles for 
      long-term use in patients with PAH in Japan.
FAU - Yamazaki, Hiroyoshi
AU  - Yamazaki H
AD  - a Global Patient Safety Japan, Quality & Patient Safety, Eli Lilly Japan KK.
FAU - Kobayashi, Noriko
AU  - Kobayashi N
AD  - b Post Marketing Study Management, Medicines Development Unit Japan, Eli Lilly 
      Japan KK.
FAU - Taketsuna, Masanori
AU  - Taketsuna M
AD  - c Statistical Sciences, Medicines Development Unit Japan, Eli Lilly Japan KK.
FAU - Tajima, Koyuki
AU  - Tajima K
AD  - d Post Marketing Surveillance Clinical Research Department , Nippon Shinyaku Co. 
      Ltd.
FAU - Murakami, Masahiro
AU  - Murakami M
AD  - e Medical Science , Medicines Development Unit Japan , Eli Lilly Japan KK.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170321
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  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy
MH  - Japan
MH  - Male
MH  - Marketing
MH  - Middle Aged
MH  - Phosphodiesterase 5 Inhibitors/*therapeutic use
MH  - Prospective Studies
MH  - Tadalafil/*therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - Phosphodiesterase type 5 inhibitors
OT  - postmarketing surveillance
OT  - pulmonary arterial hypertension
OT  - tadalafil
EDAT- 2017/03/10 06:00
MHDA- 2017/05/30 06:00
CRDT- 2017/03/10 06:00
PHST- 2017/03/10 06:00 [pubmed]
PHST- 2017/05/30 06:00 [medline]
PHST- 2017/03/10 06:00 [entrez]
AID - 10.1080/03007995.2017.1297931 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2017 May;33(5):963-971. doi: 10.1080/03007995.2017.1297931. 
      Epub 2017 Mar 21.