title: A Prospective, Multicentre, Open-Label Single-Arm Exploratory Study to Evaluate Efficacy and Safety of Saroglitazar on Hypertriglyceridemia in HIV Associated Lipodystrophy.
abstract: OBJECTIVE
  This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy.
  
  
  METHODS
  During this 12-week prospective, multi-centric, open-label, single arm exploratory study, 50 patients were enrolled to receive saroglitazar 4 mg orally once daily in the morning before breakfast. The primary efficacy endpoint was the percent change in triglyceride (TG) levels from baseline to Week 6 and Week 12. The secondary efficacy endpoints were assessment of low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL), high-density-lipoprotein (HDL), non-HDL cholesterol, total cholesterol, apo-lipoprotein (Apo) A1, Apo B, and C-peptide and fasting insulin for HOMA beta and HOMA IR. Safety assessment was performed during the study.
  
  
  RESULTS
  Saroglitazar 4 mg significantly decreased the serum TG levels from baseline at Week 6 (percent change: -40.98; 95% CI: -50.82, -31.15) and Week 12 (percent change -45.11; 95% CI: -52.37, -37.86). Reduction in VLDL cholesterol (percent change: -46.33; 95% CI: -52.89, -39.76) and total cholesterol (percent change: 7.37; 95% CI: 1.96, 12.78) was observed at week 12 from baseline. Saroglitazar increased HDL cholesterol (percent change: 34.56, 95% CI: 22.22, 46.90), Apo A1 (percent change: 33.16; 95% CI: 18.69, 47.63) and Apo B (percent change: 10.55, 95% CI: 2.86, 18.25) levels at week 12 from baseline. Saroglitazar treatment led to increase in the C-peptide (percent change: 59.42, 95% CI: 48.78, 70.06), fasting insulin levels (percent change: 47.10; 95% CI: 38.63, 55.57), HOMA of beta cell function for C-peptide (percent change: 71.67; 95% CI: 39.09, 104.26) and HOMA of insulin resistance for C-peptide (percent change: 58.29, 95% CI: 46.74, 69.83) at week 12 from baseline. Saroglitazar treatment was safe and well tolerated in this study.
  
  
  CONCLUSIONS
  Overall, the observed changes in lipid profile after 12 weeks of saroglitazar treatment were in the direction of improvement in patients with HIV associated lipodystrophy.
  
  
  BACKGROUND
  Clinical Trial Registry of India Phase II/CTRI/2010/091/000107.
authors.affiliation: Grant Medical College & Sir J.J. Group of Hospitals, Mumbai, Maharashtra, India.
authors.forename: Alka
authors.initials: A
authors.lastname: Deshpande
authors.affiliation: IDTM Clinic, Ahmedabad, Gujarat, India.
authors.forename: Harsh
authors.initials: H
authors.lastname: Toshniwal
authors.affiliation: Joshi Clinic, 12, Golden Palace, Behind Union Bank of India, Turner Road, Bandra West, Mumbai, India.
authors.forename: Shashank
authors.initials: S
authors.lastname: Joshi
authors.affiliation: Clinical R & D, Cadila Healthcare Limited, Zydus Research Centre, Sarkhej-Bavla N.H. No. 8A, Moriaya, Ahmedabad, Gujarat, India.
authors.forename: Rajendrakumar H
authors.initials: RH
authors.lastname: Jani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002784:Cholesterol / Q000097:blood; D005260:Female; D039682:HIV-Associated Lipodystrophy Syndrome / Q000097:blood* / Q000188:drug therapy*; D006801:Humans; D015228:Hypertriglyceridemia / Q000097:blood* / Q000188:drug therapy*; D007328:Insulin / Q000097:blood; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D010666:Phenylpropionates / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D007328:Insulin; D008074:Lipoproteins; D010666:Phenylpropionates; D011758:Pyrroles; D002784:Cholesterol; C000588741:saroglitazar