PMID- 31208414
OWN - NLM
STAT- MEDLINE
DCOM- 20200330
LR  - 20221207
IS  - 1475-2840 (Electronic)
IS  - 1475-2840 (Linking)
VI  - 18
IP  - 1
DP  - 2019 Jun 17
TI  - New dual peroxisome proliferator activated receptor agonist-Saroglitazar in 
      diabetic dyslipidemia and non-alcoholic fatty liver disease: integrated analysis 
      of the real world evidence.
PG  - 80
LID - 10.1186/s12933-019-0884-3 [doi]
LID - 80
AB  - BACKGROUND: Saroglitazar, a novel dual peroxisome proliferator activated receptor 
      (PPAR) agonist, in clinical trials, has shown an improvement in lipid and 
      glycemic parameters through the PPAR-alpha and gamma agonist actions, respectively. It 
      was granted marketing authorization in India in 2013 for diabetic dyslipidemia. 
      This review was conducted to summarize the effects of Saroglitazar in patients 
      with diabetic dyslipidemia in real world clinical studies conducted after 
      marketing authorization in India. METHODS: In this review, we selected real world 
      clinical studies of Saroglitazar published as manuscripts and abstracts presented 
      at scientific conferences. In all these studies, patients with diabetic 
      dyslipidemia were treated with Saroglitazar 4 mg once daily for at least 12 weeks 
      and different lipid and glycemic parameters were measured at the baseline and end 
      of the study. RESULTS: In 18 selected studies (5 published manuscripts and 13 
      abstracts), a total of 5824 patients with diabetic dyslipidemia were prescribed 
      Saroglitazar 4 mg for a duration ranging from 12 to 58 weeks. Across all the 
      studies, mean age of patients ranged from 49.6 to 59.1 years and the proportion 
      of female patients ranged from 22% to 42%. Across all the studies, there was a 
      consistent mean reduction in triglyceride levels (~ 45% to 62%), total 
      cholesterol levels (~ 17% to 26%), non-high-density lipoprotein cholesterol 
      levels (~ 21% to 36%), low-density lipoprotein cholesterol levels (~ 11% to 27%), 
      and glycosylated hemoglobin levels (~ 0.7% to 1.6%) with an increase in mean 
      high-density lipoprotein cholesterol levels (up to 9%) from baseline to end of 
      the study. Saroglitazar also improved alanine aminotransferase levels and fatty 
      liver (evaluated by FibroScan) in non-alcoholic fatty liver disease patients 
      with diabetic dyslipidemia. Body weight remained unchanged and no significant 
      adverse events (AEs) were reported in the studies. CONCLUSION: Saroglitazar 
      effectively improved lipid and glycemic parameters without significant AEs in 
      patients with diabetic dyslipidemia in real-world clinical studies of up to 
      58 weeks duration.
FAU - Kaul, Upendra
AU  - Kaul U
AD  - Batra Hospital and Medical Research Centre, New Delhi, India.
FAU - Parmar, Deven
AU  - Parmar D
AD  - Zydus Discovery DMCC, Dubai, UAE.
FAU - Manjunath, K
AU  - Manjunath K
AD  - Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, India.
FAU - Shah, Mitesh
AU  - Shah M
AD  - Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, India.
FAU - Parmar, Krupi
AU  - Parmar K
AD  - Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, India.
FAU - Patil, Kishor P
AU  - Patil KP
AD  - Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, India.
FAU - Jaiswal, Ashok
AU  - Jaiswal A
AD  - Zydus Healthcare Limited, Zydus Tower, CTS No-460/6 of Village Pahadi, Off I. B. 
      Patel Road, Goregaon (East), Mumbai, 400 063, India. 
      ashokd.jaiswal@zyduscadila.com.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20190617
PL  - England
TA  - Cardiovasc Diabetol
JT  - Cardiovascular diabetology
JID - 101147637
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Hypolipidemic Agents)
RN  - 0 (Lipids)
RN  - 0 (PPAR alpha)
RN  - 0 (PPAR gamma)
RN  - 0 (PPARA protein, human)
RN  - 0 (PPARG protein, human)
RN  - 0 (Phenylpropionates)
RN  - 0 (Pyrroles)
RN  - 0 (hemoglobin A1c protein, human)
RN  - E0YMX3S4JD (saroglitazar)
SB  - IM
MH  - Biomarkers/blood
MH  - Blood Glucose/*drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy/epidemiology
MH  - Dyslipidemias/blood/diagnosis/*drug therapy/epidemiology
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Hypolipidemic Agents/adverse effects/*therapeutic use
MH  - India/epidemiology
MH  - Lipids/*blood
MH  - Male
MH  - Middle Aged
MH  - Non-alcoholic Fatty Liver Disease/blood/diagnosis/*drug therapy/epidemiology
MH  - PPAR alpha/*agonists/metabolism
MH  - PPAR gamma/*agonists/metabolism
MH  - Phenylpropionates/adverse effects/*therapeutic use
MH  - Pyrroles/adverse effects/*therapeutic use
MH  - Signal Transduction
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC6580520
OTO - NOTNLM
OT  - Alanine aminotransferase
OT  - Diabetic dyslipidemia
OT  - Dual PPAR agonist
OT  - Glycosylated hemoglobin
OT  - Non-alcoholic fatty liver disease
OT  - Saroglitazar
OT  - Triglyceride
COIS- The authors declare that they have no competing interests with respect to the 
      research, authorship, and/or publication of this review. DP is an employee of 
      Zydus Discovery DMCC, Dubai, UAE. AJ is an employee of Zydus Healthcare Limited, 
      Mumbai, India. MK, MS, KP, and KPP are employees of Zydus Research Centre, Cadila 
      Healthcare Limited, Ahmedabad, India.
EDAT- 2019/06/19 06:00
MHDA- 2020/03/31 06:00
PMCR- 2019/06/17
CRDT- 2019/06/19 06:00
PHST- 2019/05/16 00:00 [received]
PHST- 2019/06/08 00:00 [accepted]
PHST- 2019/06/19 06:00 [entrez]
PHST- 2019/06/19 06:00 [pubmed]
PHST- 2020/03/31 06:00 [medline]
PHST- 2019/06/17 00:00 [pmc-release]
AID - 10.1186/s12933-019-0884-3 [pii]
AID - 884 [pii]
AID - 10.1186/s12933-019-0884-3 [doi]
PST - epublish
SO  - Cardiovasc Diabetol. 2019 Jun 17;18(1):80. doi: 10.1186/s12933-019-0884-3.