PMID- 31484861
OWN - NLM
STAT- MEDLINE
DCOM- 20191011
LR  - 20191011
IS  - 1349-3299 (Electronic)
IS  - 1349-2365 (Linking)
VI  - 60
IP  - 5
DP  - 2019 Sep 27
TI  - A Prospective, Multicenter, Post-Marketing Surveillance Study to Evaluate the 
      Safety and Effectiveness of Tolvaptan in Patients with Reduced, Preserved, and 
      Mid-Range Ejection Fraction Heart Failure.
PG  - 1123-1130
LID - 10.1536/ihj.18-671 [doi]
AB  - Tolvaptan, a vasopressin V(2) receptor antagonist, is approved in Japan for the 
      treatment of fluid retention in patients with heart failure (HF), and in the 
      United States for hyponatremia. The efficacy and safety of tolvaptan in patients 
      with HF with reduced ejection fraction (HFrEF) have been demonstrated previously. 
      However, its efficacy in patients with HF having preserved (HFpEF) and mid-range 
      (HFmrEF) ejection fraction (EF) remains uncertain. The present subgroup analysis 
      from the post-marketing surveillance SMILE Study aims to explore the efficacy and 
      safety of tolvaptan across the HF subgroups (HFrEF, HFpEF, and HFmrEF).Patients 
      with HF accompanied by fluid retention who received tolvaptan were enrolled. 
      Primary endpoints were: change in body weight, 24-hour urine volume, congestive 
      symptoms, and safety over 14-day treatment. Of the 3,349 patients enrolled, left 
      ventricular EF data were available for 1,741 patients; 45.7% had HFpEF. Tolvaptan 
      treatment resulted in body weight reduction and increases in 24-hour urine volume 
      across the 3 subgroups. Congestive symptoms significantly improved over the 
      14-day treatment in all subgroups. The frequency of adverse events (AEs) was 
      comparable across the subgroups; thirst was the most common AE.Tolvaptan provides 
      a safe and effective option for treating fluid retention in patients with HFpEF, 
      as well as HFmrEF and HFrEF.
FAU - Kinugawa, Koichiro
AU  - Kinugawa K
AD  - Second Department of Internal Medicine, University of Toyama.
FAU - Sato, Naoki
AU  - Sato N
AD  - Department of Cardiovascular Medicine, Kawaguchi Cardiovascular and Respiratory 
      Hospital.
FAU - Inomata, Takayuki
AU  - Inomata T
AD  - Department of Cardiology, Kitasato University Kitasato Institute Hospital.
FAU - Yasuda, Moriyoshi
AU  - Yasuda M
AD  - Department of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd.
FAU - Shimakawa, Toshiyuki
AU  - Shimakawa T
AD  - Department of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd.
FAU - Fukuta, Yasuhiko
AU  - Fukuta Y
AD  - Department of Pharmacovigilance, Otsuka Pharmaceutical Co., Ltd.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20190904
PL  - Japan
TA  - Int Heart J
JT  - International heart journal
JID - 101244240
RN  - 21G72T1950 (Tolvaptan)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Analysis of Variance
MH  - Cohort Studies
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure/*diagnosis/*drug therapy
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing/*methods
MH  - Prospective Studies
MH  - Quality of Life
MH  - Risk Assessment
MH  - Severity of Illness Index
MH  - Stroke Volume/*drug effects/physiology
MH  - Tolvaptan/*therapeutic use
MH  - Treatment Outcome
MH  - Ventricular Dysfunction, Left/diagnosis/*drug therapy
OTO - NOTNLM
OT  - Congestive symptoms
OT  - Diuretics
OT  - Vasopressin
EDAT- 2019/09/06 06:00
MHDA- 2019/10/12 06:00
CRDT- 2019/09/06 06:00
PHST- 2019/09/06 06:00 [pubmed]
PHST- 2019/10/12 06:00 [medline]
PHST- 2019/09/06 06:00 [entrez]
AID - 10.1536/ihj.18-671 [doi]
PST - ppublish
SO  - Int Heart J. 2019 Sep 27;60(5):1123-1130. doi: 10.1536/ihj.18-671. Epub 2019 Sep 
      4.