PMID- 24138536
OWN - NLM
STAT- MEDLINE
DCOM- 20140911
LR  - 20240413
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 16
IP  - 2
DP  - 2014 Feb
TI  - A multicenter, prospective, randomized, double-blind study to evaluate the safety 
      and efficacy of Saroglitazar 2 and 4 mg compared with placebo in type 2 diabetes 
      mellitus patients having hypertriglyceridemia not controlled with atorvastatin 
      therapy (PRESS VI).
PG  - 63-71
LID - 10.1089/dia.2013.0253 [doi]
AB  - BACKGROUND: Dyslipidemia due to diabetes is characterized by hypertriglyceridemia 
      and reduced levels of high-density lipoprotein cholesterol (HDL-C) and elevated 
      or normal levels of low-density lipoprotein cholesterol (LDL-C) in type 2 
      diabetes mellitus (T2DM). The objectives of this Phase III study were to evaluate 
      the safety, tolerability, and efficacy of saroglitazar (ZYH1) 2-mg and 4-mg 
      tablets (Lipaglyn; Zydus Cadila, Ahmedabad, India) compared with placebo in 
      patients with diabetic dyslipidemia who are not controlled with atorvastatin 
      10 mg therapy. SUBJECTS AND METHODS: This was a 16-week prospective, multicenter, 
      randomized, double-blind, placebo controlled, three-arm Phase III study in 
      subjects with hypertriglyceridemia (>200 and <500 mg/dL) with T2DM not controlled 
      with atorvastatin 10 mg. The study consisted of a run-in period of 4 weeks of 
      life-style modification followed by 12 weeks of treatment with saroglitazar (2-mg 
      or 4-mg) or placebo tablets. The primary end point was the change in plasma 
      triglyceride level compared with baseline and the placebo arm at the end of Week 
      12. The secondary exploratory end points were change in lipid profile and fasting 
      plasma glucose at Week 12. In total, 302 subjects were randomized to receive one 
      of the treatments, saroglitazar 2 mg (n=101) or saroglitazar 4 mg (n=99), or 
      matching placebo (n=102). Patients who received study medication and had 
      undergone at least one post baseline efficacy evaluation were included in the 
      efficacy analysis. RESULTS: At Week 12, saroglitazar 2-mg and 4-mg tablets 
      significantly reduced mean plasma triglyceride levels by -45.5+/-3.03% and 
      -46.7+/-3.02% (mean+/-SE), respectively, and the difference was significant (P<0.001) 
      compared with placebo. Saroglitazar 2 mg demonstrated significant decrease in 
      levels of non-HDL-C, very LDL-C, total cholesterol, and fasting plasma glucose. 
      Additionally, saroglitazar 4 mg also significantly reduced LDL-C and 
      apolipoprotein B levels. Saroglitazar was found to be safe and well tolerated by 
      patients. CONCLUSIONS: Saroglitazar appeared to be an effective and safe 
      therapeutic option for improving hypertriglyceridemia in patients with T2DM.
FAU - Jani, Rajendrakumar H
AU  - Jani RH
AD  - 1 Clinical R & D, Cadila Healthcare Ltd. , Ahmedabad, India .
FAU - Pai, Vikas
AU  - Pai V
FAU - Jha, Pramod
AU  - Jha P
FAU - Jariwala, Gunjan
AU  - Jariwala G
FAU - Mukhopadhyay, Satinath
AU  - Mukhopadhyay S
FAU - Bhansali, Anil
AU  - Bhansali A
FAU - Joshi, Shashank
AU  - Joshi S
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20131018
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Blood Glucose)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Heptanoic Acids)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Phenylpropionates)
RN  - 0 (Pyrroles)
RN  - 0 (Triglycerides)
RN  - A0JWA85V8F (Atorvastatin)
RN  - E0YMX3S4JD (saroglitazar)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticholesteremic Agents/pharmacology/*therapeutic use
MH  - Atorvastatin
MH  - Blood Glucose/*drug effects/metabolism
MH  - Cholesterol, HDL/blood
MH  - Cholesterol, LDL/blood
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Diabetic Angiopathies/blood/*prevention & control
MH  - Double-Blind Method
MH  - Fasting
MH  - Female
MH  - Heptanoic Acids/therapeutic use
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use
MH  - Hypertriglyceridemia/blood/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Patient Safety
MH  - Phenylpropionates/pharmacology/*therapeutic use
MH  - Prospective Studies
MH  - Pyrroles/pharmacology/*therapeutic use
MH  - Risk Reduction Behavior
MH  - Treatment Failure
MH  - Treatment Outcome
MH  - Triglycerides/blood
PMC - PMC3894674
EDAT- 2013/10/22 06:00
MHDA- 2014/09/12 06:00
PMCR- 2014/02/01
CRDT- 2013/10/22 06:00
PHST- 2013/10/22 06:00 [entrez]
PHST- 2013/10/22 06:00 [pubmed]
PHST- 2014/09/12 06:00 [medline]
PHST- 2014/02/01 00:00 [pmc-release]
AID - 10.1089/dia.2013.0253 [pii]
AID - 10.1089/dia.2013.0253 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2014 Feb;16(2):63-71. doi: 10.1089/dia.2013.0253. Epub 
      2013 Oct 18.