PMID- 35768226
OWN - NLM
STAT- MEDLINE
DCOM- 20231017
LR  - 20231017
IS  - 1880-3873 (Electronic)
IS  - 1340-3478 (Print)
IS  - 1340-3478 (Linking)
VI  - 30
IP  - 5
DP  - 2023 May 1
TI  - Efficacy and Safety of Pemafibrate Versus Bezafibrate to Treat Patients with 
      Hypertriglyceridemia: A Randomized Crossover Study.
PG  - 443-454
LID - 10.5551/jat.63659 [doi]
AB  - AIM: Pemafibrate is a highly selective agonist for peroxisome 
      proliferator-activated receptor (PPAR)-alpha, a key regulator of lipid and glucose 
      metabolism. We compared the efficacy and safety of pemafibrate with those of 
      bezafibrate, a nonselective PPAR-alpha agonist. METHODS: In this randomized crossover 
      study, 60 patients with hypertriglyceridemia (fasting triglyceride [TG] >/= 150 
      mg/dL) were treated with pemafibrate of 0.2 mg/day or bezafibrate of 400 mg/day 
      for 24 weeks. The primary endpoint was percent change (%Change) from baseline in 
      TG levels, while the secondary endpoints were %Change in high-density lipoprotein 
      cholesterol (HDL-C) and apolipoprotein A-I (Apo A-I) levels. RESULTS: The %Change 
      in TG and Apo A-I levels was significantly greater with pemafibrate than with 
      bezafibrate (-46.1% vs. -34.7%, p＜0.001; 9.2% vs. 5.7%, p =0.018, respectively). 
      %Change in HDL-C levels was not significantly different between the two 
      treatments. %Change in liver enzyme levels was markedly decreased with 
      pemafibrate than with bezafibrate. Creatinine levels significantly increased in 
      both treatments; however, its %Change was significantly lower with pemafibrate 
      than with bezafibrate (5.72% vs. 15.5%, p＜0.001). The incidence of adverse events 
      (AEs) or serious AEs did not differ between the two treatments; however, the 
      number of patients with elevated creatinine levels (>/= 0.5 mg/dL and/or 25% from 
      baseline) was significantly higher in the bezafibrate group than in the 
      pemafibrate group (14/60 vs. 3/60, p =0.004) [corrected]. CONCLUSION: Compared 
      with bezafibrate, pemafibrate is more effective in decreasing TG levels and 
      increasing Apo A-I levels and is safer regarding liver and renal function.
FAU - Nakamura, Akihiro
AU  - Nakamura A
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Kagaya, Yuta
AU  - Kagaya Y
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Saito, Hiroki
AU  - Saito H
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Kanazawa, Masanori
AU  - Kanazawa M
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Sato, Kenjiro
AU  - Sato K
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Miura, Masanobu
AU  - Miura M
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Kondo, Masateru
AU  - Kondo M
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
FAU - Endo, Hideaki
AU  - Endo H
AD  - Department of Cardiology, Iwate Prefectural Central Hospital.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220628
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  - Y9449Q51XH (Bezafibrate)
RN  - 0 (Butyrates)
RN  - 0 (Benzoxazoles)
RN  - 0 (Apolipoprotein A-I)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Peroxisome Proliferator-Activated Receptors)
RN  - 0 (Triglycerides)
SB  - IM
CIN - J Atheroscler Thromb. 2023 May 1;30(5):429-431. PMID: 36216574
EIN - J Atheroscler Thromb. 2023 Jun 1;30(6):698-699. PMID: 37150612
MH  - Humans
MH  - *Hypertriglyceridemia/drug therapy
MH  - *Bezafibrate/therapeutic use
MH  - Butyrates/therapeutic use
MH  - Benzoxazoles/therapeutic use
MH  - Cross-Over Studies
MH  - *Apolipoprotein A-I/blood/drug effects
MH  - *Cholesterol, HDL/blood/drug effects
MH  - Treatment Outcome
MH  - Peroxisome Proliferator-Activated Receptors/metabolism
MH  - Triglycerides/metabolism
MH  - Male
MH  - Female
MH  - Adult
MH  - Middle Aged
MH  - Aged
PMC - PMC10164592
OTO - NOTNLM
OT  - Bezafibrate
OT  - Comparison of pemafibrate and bezafibrate
OT  - Pemafibrate
OT  - Peroxisome proliferator-activated receptor (PPAR)-alpha
OT  - Renal function
OT  - Triglycerides
COIS- The authors declare no conflict of interests.
EDAT- 2022/06/30 06:00
MHDA- 2023/05/02 06:41
PMCR- 2023/05/01
CRDT- 2022/06/29 21:42
PHST- 2023/05/02 06:41 [medline]
PHST- 2022/06/30 06:00 [pubmed]
PHST- 2022/06/29 21:42 [entrez]
PHST- 2023/05/01 00:00 [pmc-release]
AID - DN/JST.JSTAGE/jat/63659 [pii]
AID - 10.5551/jat.63659 [doi]
PST - ppublish
SO  - J Atheroscler Thromb. 2023 May 1;30(5):443-454. doi: 10.5551/jat.63659. Epub 2022 
      Jun 28.