PMID- 29628483
OWN - NLM
STAT- MEDLINE
DCOM- 20180928
LR  - 20181114
IS  - 1880-3873 (Electronic)
IS  - 1340-3478 (Print)
IS  - 1340-3478 (Linking)
VI  - 25
IP  - 6
DP  - 2018 Jun 1
TI  - Efficacy and Safety of Pemafibrate Versus Fenofibrate in Patients with High 
      Triglyceride and Low HDL Cholesterol Levels: A Multicenter, Placebo-Controlled, 
      Double-Blind, Randomized Trial.
PG  - 521-538
LID - 10.5551/jat.44412 [doi]
AB  - AIM: To verify the superiority of pemafibrate over placebo and the 
      non-inferiority of pemafibrate to the maximum dose of fenofibrate for determining 
      the percent change in fasting serum triglyceride (TG) levels and to investigate 
      safety by assessing the incidence of adverse events (AEs) and adverse drug 
      reactions (ADRs). METHODS: This phase III, placebo/active drug-controlled, 
      randomized, double-blind, parallel group comparison study enrolled patients with 
      high TG and low high-density lipoprotein cholesterol levels. Patients were 
      randomly assigned to receive placebo; pemafibrate 0.1 mg/day, 0.2 mg/day, or 0.4 
      mg/day; or fenofibrate 100 mg/day or 200 mg/day for 12 weeks. RESULTS: Among 526 
      randomized patients, 489 completed the study, with drop-out rates of 0%, 6.7%, 
      5.5%, 5.9%, 8.2%, and 10.7% in the placebo; pemafibrate 0.1 mg/day, 0.2 mg/day, 
      and 0.4 mg/day; and fenofibrate 100 mg/day and 200 mg/day groups. The study 
      showed the non-inferiority of pemafibrate 0.4 mg/day and 0.2 mg/day to 
      fenofibrate 200 mg/day as well the non-inferiority and superiority of all 
      pemafibrate doses to fenofibrate 100 mg/day for reducing TG levels. No 
      dose-dependent increase in the incidence of AEs or ADRs was observed among the 
      pemafibrate dose groups. The incidence of AEs and ADRs for all pemafibrate doses 
      was similar to that for placebo and fenofibrate 100 mg/day and significantly 
      lower than that for fenofibrate 200 mg/day (P＜0.05). CONCLUSIONS: The favorable 
      safety profile of pemafibrate, with fewer adverse effects on kidney/liver-related 
      laboratory tests and fewer AEs/ADRs, including those leading to treatment 
      discontinuation, over fenofibrate 200 mg/day may justify the use of this novel 
      and potent treatment option for reducing TG levels in a broader range of 
      patients.
FAU - Arai, Hidenori
AU  - Arai H
AD  - National Center for Geriatrics and Gerontology.
FAU - Yamashita, Shizuya
AU  - Yamashita S
AD  - Department of Community Medicine and Department of Cardiovascular Medicine, Osaka 
      University Graduate School of Medicine.
AD  - Rinku General Medical Center.
FAU - Yokote, Koutaro
AU  - Yokote K
AD  - Department of Diabetes, Metabolism and Endocrinology, Chiba University Graduate 
      School of Medicine.
AD  - Department of Clinical Cell Biology and Medicine, Chiba University Graduate 
      School of Medicine.
FAU - Araki, Eiichi
AU  - Araki E
AD  - Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University.
FAU - Suganami, Hideki
AU  - Suganami H
AD  - Clinical Data Science Department, Kowa Company, Ltd.
FAU - Ishibashi, Shun
AU  - Ishibashi S
AD  - Division of Endocrinology and Metabolism, Department of Medicine, Jichi Medical 
      University.
CN  - K-877 Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180407
PL  - Japan
TA  - J Atheroscler Thromb
JT  - Journal of atherosclerosis and thrombosis
JID - 9506298
RN  - 0 ((R)-2-(3-((benzoxazol-2-yl-d4 
      (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid)
RN  - 0 (Benzoxazoles)
RN  - 0 (Biomarkers)
RN  - 0 (Butyrates)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Hypolipidemic Agents)
RN  - 0 (Triglycerides)
RN  - U202363UOS (Fenofibrate)
SB  - IM
MH  - Benzoxazoles/*therapeutic use
MH  - Biomarkers/*blood
MH  - Butyrates/*therapeutic use
MH  - Cholesterol, HDL/*metabolism
MH  - Double-Blind Method
MH  - Female
MH  - Fenofibrate/*therapeutic use
MH  - Follow-Up Studies
MH  - Humans
MH  - Hypertriglyceridemia/*drug therapy/metabolism/pathology
MH  - Hypolipidemic Agents/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Triglycerides/*metabolism
PMC - PMC6005227
OTO - NOTNLM
OT  - Fibrate
OT  - Residual risk
OT  - Safety
OT  - Selective PPARalpha modulator
OT  - Triglycerides
COIS- H.A. reports personal fees from Kowa during the conduct of the study as well as 
      grants from Daiichi Sankyo and personal fees from Daiichi Sankyo, MSD, and Otsuka 
      Pharmaceutical outside the submitted work. S.Y. reports grants and personal fees 
      from Kowa during the conduct of the study as well as grants from Nippon 
      Boehringer Ingelheim, Otsuka Pharmaceutical, Shionogi, Bayer Yakuhin, National 
      Institute of Biomedical Innovation, MSD, Japan Tobacco, Kyowa Medex, Takeda 
      Pharmaceutical, Sanwa Kagaku Kenkyusho, Astellas Pharma, Daiichi Sankyo, Mochida 
      Pharmaceutical, AstraZeneca, Izumisano City, Kaizuka City, Hayashibara, Teijin 
      Pharma, Kaken Pharmaceutical, Kissei Pharmaceutical and personal fees from Otsuka 
      Pharmaceutical, Shionogi, Bayer Yakuhin, MSD, Takeda Pharmaceutical, Sanwa Kagaku 
      Kenkyusho, Ono Pharmaceutical, Astellas Pharma, Daiichi Sankyo, Astra-Zeneca, 
      Medical Review, Skylight Biotech, Kaken Pharmaceutical, Pfizer Japan, 
      Bristol-Myers Squibb, Amgen Astellas BioPharma, Sanofi, and Toa Eiyo outside the 
      submitted work; in addition, S.Y. has a patent Fujirebio pending. K.Y. reports 
      personal fees from Kowa during the conduct of the study as well as grants from 
      Astellas Pharma, Otsuka Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, 
      Mitsubishi Tanabe Pharma, and Bristol-Myers Squibb and personal fees from 
      Astellas Pharma, AstraZeneca, Eisai, MSD, Ono Pharmaceutical, Kyowa Hakko Kirin, 
      Kowa Pharmaceutical, Shionogi, Daiichi Sankyo, Takeda Pharmaceutical, Mitsubishi 
      Tanabe Pharma, Pfizer Japan, and Mochida Pharmaceutical outside the submitted 
      work. E.A. reports personal fees from Kowa during the conduct of the study as 
      well as grants from Nippon Boehringer Ingelheim, Novo Nordisk Pharma, Ono 
      Pharmaceutical, Sanofi, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Novartis 
      Pharma, Kowa Pharmaceutical, Astellas Pharma, AstraZeneca, Takeda Pharmaceutical, 
      Taisho Toyama Pharmaceutical, and Pfizer Japan and personal fees from MSD, Nippon 
      Boehringer Ingelheim, Novo Nordisk Pharma, Ono Pharmaceutical, Sanofi, Daiichi 
      Sankyo, Mitsubishi Tanabe Pharma, Novartis Pharma, Kowa Pharmaceutical, Astellas 
      Pharma, AstraZeneca, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical and Eli 
      Lilly Japan outside the submitted work. H.S. is an employee of Kowa. S.I. reports 
      personal fees from Kowa during the conduct of the study as well as grants from 
      Astellas Pharma, Daiichi Sankyo, Teijin Pharma, Takeda Pharmaceutical, Ono 
      Pharmaceutical, Taisho Toyama Pharmaceutical, and Nippon Boehringer Ingelheim and 
      personal fees from MSD, AstraZeneca, Sanwa Kagaku Kenkyusho, and Nippon 
      Boehringer Ingelheim outside the submitted work.
EDAT- 2018/04/10 06:00
MHDA- 2018/10/03 06:00
PMCR- 2018/06/01
CRDT- 2018/04/10 06:00
PHST- 2018/04/10 06:00 [pubmed]
PHST- 2018/10/03 06:00 [medline]
PHST- 2018/04/10 06:00 [entrez]
PHST- 2018/06/01 00:00 [pmc-release]
AID - 10.5551/jat.44412 [doi]
PST - ppublish
SO  - J Atheroscler Thromb. 2018 Jun 1;25(6):521-538. doi: 10.5551/jat.44412. Epub 2018 
      Apr 7.