PMID- 30898163
OWN - NLM
STAT- MEDLINE
DCOM- 20190423
LR  - 20200225
IS  - 1475-2840 (Electronic)
IS  - 1475-2840 (Linking)
VI  - 18
IP  - 1
DP  - 2019 Mar 21
TI  - Efficacy and safety of pemafibrate administration in patients with dyslipidemia: 
      a systematic review and meta-analysis.
PG  - 38
LID - 10.1186/s12933-019-0845-x [doi]
LID - 38
AB  - BACKGROUND: Using a meta-analysis of randomized controlled trials (RCTs), this 
      study aimed to investigate the efficacy and safety of pemafibrate, 
      a novel selective peroxisome proliferator-activated receptor alpha modulator, in 
      patients with dyslipidemia. METHODS: A search was performed using the MEDLINE, 
      Cochrane Controlled Trials Registry, and ClinicalTrials.gov databases. We decided 
      to employ RCTs to evaluate the effects of pemafibrate on lipid and glucose 
      metabolism-related parameters in patients with dyslipidemia. For statistical 
      analysis, standardized mean difference (SMD) or odds ratio (OR) and 95% 
      confidence intervals (CIs) were calculated using the random effect model. 
      RESULTS: Our search yielded seven RCTs (with a total of 1623 patients) that 
      satisfied the eligibility criteria of this study; hence, those studies were 
      incorporated into this meta-analysis. The triglyceride concentration 
      significantly decreased in the pemafibrate group (SMD, - 1.38; 95% CI, - 1.63 to 
      - 1.12; P < 0.001) than in the placebo group, with a reduction effect similar to 
      that exhibited by fenofibrate. Compared with the placebo group, the pemafibrate 
      group also showed improvements in high-density and non-high-density lipoprotein 
      cholesterol levels as well as in homeostasis model assessment for insulin 
      resistance. Furthermore, the pemafibrate group showed a significant decrease in 
      hepatobiliary enzyme activity compared with the placebo and fenofibrate groups; 
      and, total adverse events (AEs) were significantly lower in the pemafibrate group 
      than in the fenofibrate group (OR, 0.60; 95% CI, 0.49-0.73; P < 0.001). In 
      contrast, the low-density lipoprotein cholesterol level was significantly higher 
      in the pemafibrate group than in the placebo (P = 0.006) and fenofibrate 
      (P < 0.001) groups. CONCLUSIONS: The lipid profile significantly improved in the 
      pemafibrate group than in the placebo group. In addition to the pemafibrate group 
      having an improved lipid profile, which was comparable with that of the 
      fenofibrate group, the AEs were significantly lower than in the fenofibrate group 
      and an improvement in hepatobiliary enzyme activity was also recognized. However, 
      we believe that actual clinical data as well as long-term efficacy and safety 
      need to be investigated in the future.
FAU - Ida, Satoshi
AU  - Ida S
AD  - Department of Diabetes and Metabolism, Ise Red Cross Hospital, 1-471-2, Funae, 
      1-Chome, Ise-shi, Mie, 516-8512, Japan. bboy98762006@yahoo.co.jp.
FAU - Kaneko, Ryutaro
AU  - Kaneko R
AD  - Department of Diabetes and Metabolism, Ise Red Cross Hospital, 1-471-2, Funae, 
      1-Chome, Ise-shi, Mie, 516-8512, Japan.
FAU - Murata, Kazuya
AU  - Murata K
AD  - Department of Diabetes and Metabolism, Ise Red Cross Hospital, 1-471-2, Funae, 
      1-Chome, Ise-shi, Mie, 516-8512, Japan.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20190321
PL  - England
TA  - Cardiovasc Diabetol
JT  - Cardiovascular diabetology
JID - 101147637
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 (Hypolipidemic Agents)
RN  - 0 (Lipids)
RN  - 0 (PPAR alpha)
SB  - IM
MH  - Benzoxazoles/adverse effects/*therapeutic use
MH  - Biliary Tract/drug effects/enzymology
MH  - Biomarkers/blood
MH  - Butyrates/adverse effects/*therapeutic use
MH  - Dyslipidemias/blood/diagnosis/*drug therapy
MH  - Female
MH  - Humans
MH  - Hypolipidemic Agents/adverse effects/*therapeutic use
MH  - Lipids/*blood
MH  - Liver/drug effects/enzymology
MH  - Male
MH  - Middle Aged
MH  - PPAR alpha/*drug effects/metabolism
MH  - Treatment Outcome
PMC - PMC6429757
OTO - NOTNLM
OT  - Adverse events
OT  - Dyslipidemia
OT  - Fibrate
OT  - Hepatobiliary enzyme activity
OT  - Lipid profile
OT  - Meta-analysis
OT  - Pemafibrate
COIS- The authors declare that they have no competing interests.
EDAT- 2019/03/23 06:00
MHDA- 2019/04/24 06:00
PMCR- 2019/03/21
CRDT- 2019/03/23 06:00
PHST- 2019/01/30 00:00 [received]
PHST- 2019/03/13 00:00 [accepted]
PHST- 2019/03/23 06:00 [entrez]
PHST- 2019/03/23 06:00 [pubmed]
PHST- 2019/04/24 06:00 [medline]
PHST- 2019/03/21 00:00 [pmc-release]
AID - 10.1186/s12933-019-0845-x [pii]
AID - 845 [pii]
AID - 10.1186/s12933-019-0845-x [doi]
PST - epublish
SO  - Cardiovasc Diabetol. 2019 Mar 21;18(1):38. doi: 10.1186/s12933-019-0845-x.