PMID- 35605678
OWN - NLM
STAT- MEDLINE
DCOM- 20220726
LR  - 20220822
IS  - 1539-7262 (Electronic)
IS  - 0022-2275 (Print)
IS  - 0022-2275 (Linking)
VI  - 63
IP  - 7
DP  - 2022 Jul
TI  - Saroglitazar is noninferior to fenofibrate in reducing triglyceride levels in 
      hypertriglyceridemic patients in a randomized clinical trial.
PG  - 100233
LID - S0022-2275(22)00066-9 [pii]
LID - 10.1016/j.jlr.2022.100233 [doi]
LID - 100233
AB  - Saroglitazar, being a dual PPAR-alpha/gamma agonist, has shown beneficial effect in 
      diabetic dyslipidemia and hypertriglyceridemia. Fibrates are commonly used to 
      treat severe hypertriglyceridemia. However, the effect of saroglitazar in 
      patients with moderate to severe hypertriglyceridemia was not evaluated. We 
      conducted a study to compare the efficacy and safety of saroglitazar (4 mg) with 
      fenofibrate (160 mg) in patients with moderate to severe hypertriglyceridemia. 
      This was a multicenter, randomized, double-blinded, double-dummy, active-control, 
      and noninferiority trial in adult patients with fasting triglyceride (TG) levels 
      of 500-1,500 mg/dl. The patients were randomized in a 1:1 ratio to receive daily 
      dose of saroglitazar or fenofibrate for 12 weeks. The primary efficacy end point 
      was the percent change in TG levels at week 12 relative to baseline. The study 
      comprised of 41 patients in the saroglitazar group and 41 patients in the 
      fenofibrate group. We found that the percent reduction from baseline in TG levels 
      at week 12 was significantly higher in the saroglitazar group (least square 
      mean = -55.3%; SE = 4.9) compared with the fenofibrate group (least square 
      mean = -41.1%; SE = 4.9; P = 0.048). Overall, 37 treatment-emergent adverse 
      events (AEs) were reported in 24 patients (saroglitazar: 13; fenofibrate: 11). No 
      serious AEs were reported, and no patient discontinued the study because of AEs. 
      We conclude that saroglitazar (4 mg) is noninferior to fenofibrate (160 mg) in 
      reducing TG levels after 12 weeks of treatment, was safe, and well tolerated.
CI  - Copyright (c) 2022 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Rodriguez-Gutierrez, Rene
AU  - Rodriguez-Gutierrez R
AD  - UANL,Monterrey, Mexico and Mayo Clinic, Rochester, MN, USA, Endocrinology, 
      Monterrey, Mexico.
FAU - Gonzalez, Jose Gerardo
AU  - Gonzalez JG
AD  - UANL,Monterrey, Mexico. Facultad de Medicina y Hospital Universitario "Dr. Jose 
      Eleuterio Gonzalez" Endocrinology, Monterrey, Mexico.
FAU - Parmar, Deven
AU  - Parmar D
AD  - ZydusTherapeutics Inc., Clinical Research and Development, Pennington, New 
      Jersey, USA. Electronic address: dparmar@zydustherapeutics.com.
FAU - Shaikh, Farheen
AU  - Shaikh F
AD  - Zydus Worldwide DMCC, Clinical Research and Development, Dubai, United Arab 
      Emirates.
FAU - Cruz-Lopez, Pio
AU  - Cruz-Lopez P
AD  - Avant Sante Research Center SA de CV., Clinical Development, Monterrey, Mexico.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220521
PL  - United States
TA  - J Lipid Res
JT  - Journal of lipid research
JID - 0376606
RN  - 0 (Hypolipidemic Agents)
RN  - 0 (Phenylpropionates)
RN  - 0 (Pyrroles)
RN  - 0 (Triglycerides)
RN  - E0YMX3S4JD (saroglitazar)
RN  - U202363UOS (Fenofibrate)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - *Fenofibrate/adverse effects
MH  - Humans
MH  - *Hyperlipidemias
MH  - *Hypertriglyceridemia/chemically induced/drug therapy
MH  - Hypolipidemic Agents/adverse effects
MH  - *Phenylpropionates/adverse effects
MH  - Pyrroles/adverse effects
MH  - Triglycerides
PMC - PMC9240860
OTO - NOTNLM
OT  - LDL/metabolism
OT  - PPARs
OT  - atherosclerosis
OT  - cholesterol/metabolism
OT  - dyslipidemias
OT  - fatty acid metabolism
OT  - lipids
OT  - lipolysis
OT  - obesity
OT  - triglycerides
COIS- Conflict of interest The authors declare that they have no conflicts of interest 
      with the contents of this article. D. P. was from Zydus Therapeutics, Inc.; F. S. 
      was from Zydus Worldwide DMCC; R. R.-G. and J. G. G. are from the School of 
      Medicine and University Hospital, Autonomous University of Nuevo Leon, Mexico. P. 
      C.-L. is from the Avant Sante Research Center. Clinical trial registration: 
      SARO.17.001.02.PROT.
EDAT- 2022/05/24 06:00
MHDA- 2022/07/27 06:00
PMCR- 2022/05/21
CRDT- 2022/05/23 19:23
PHST- 2022/01/20 00:00 [received]
PHST- 2022/05/17 00:00 [revised]
PHST- 2022/05/18 00:00 [accepted]
PHST- 2022/05/24 06:00 [pubmed]
PHST- 2022/07/27 06:00 [medline]
PHST- 2022/05/23 19:23 [entrez]
PHST- 2022/05/21 00:00 [pmc-release]
AID - S0022-2275(22)00066-9 [pii]
AID - 100233 [pii]
AID - 10.1016/j.jlr.2022.100233 [doi]
PST - ppublish
SO  - J Lipid Res. 2022 Jul;63(7):100233. doi: 10.1016/j.jlr.2022.100233. Epub 2022 May 
      21.