Abstract
This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy. 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. 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%...Continue Reading
References
Oct 6, 1998·Lancet·K HenryJ Simpson
Jun 5, 1999·AIDS·R G HewittL D Esch
Aug 18, 1999·Circulation·D PériardV Mooser
Mar 10, 2001·Journal of Acquired Immune Deficiency Syndromes : JAIDS·M SchmitzT Demant
Mar 29, 2001·AIDS·L BarilF Bricaire
Sep 8, 2001·The Journal of Infection·R Manfredi, F Chiodo
Mar 6, 2002·Infection·L CalzaF Chiodo
May 1, 2002·The Brazilian Journal of Infectious Diseases : an Official Publication of the Brazilian Society of Infectious Diseases·B CaramelliD Uip
Oct 23, 2002·Journal of General Internal Medicine·Michael L Green
Oct 24, 2002·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Rosario PalaciosPedro González-Santos
Nov 1, 2002·AIDS·John MillerAndrew Carr
Jan 25, 2003·The Pediatric Infectious Disease Journal·Ethan G Leonard, Grace A McComsey
May 15, 2003·American Journal of Physiology. Endocrinology and Metabolism·D N ReedsS Klein
Jan 28, 2004·Circulation·Scott M GrundyUNKNOWN National Heart, Lung, and Blood Institute
Mar 17, 2004·Atherosclerosis·Stephanie BadiouJacques Reynes
May 14, 2004·HIV Medicine·F BonnetUNKNOWN Groupe d'Epidémiologie Clinique du SIDA en Aquitaine (GECSA)
May 29, 2004·Current Opinion in Lipidology·Ashok BalasubramanyamHenry J Pownall
Jun 18, 2004·The American Journal of the Medical Sciences·Archana RaoMario Maldonado
Sep 10, 2004·The New England Journal of Medicine·Hannele Yki-Järvinen
Nov 4, 2004·The Journal of Clinical Endocrinology and Metabolism·Mohsen ShahmaneshA Margot Umpleby
Oct 13, 2005·AIDS Research and Human Retroviruses·Judith A AbergUNKNOWN ACTG 5087 Study Team
May 1, 2007·Diabetes Care·Yiqing SongSimin Liu
Jul 31, 2007·HIV Medicine·C McGoldrick, C L S Leen
Nov 13, 2007·Atherosclerosis·Erdembileg AnuuradLars Berglund
Dec 20, 2008·PPAR Research·Jussi Sutinen
Dec 25, 2010·Current Atherosclerosis Reports·J Gregory Troll
Jun 7, 2011·The Open Cardiovascular Medicine Journal·Eoin R Feeney, Patrick W G Mallon
Feb 2, 2013·Journal of the American College of Cardiology·Franck BoccaraAriel Cohen
Sep 26, 2013·Clinical Drug Investigation·Rajendra H JaniHarilal Patel
Oct 22, 2013·Diabetes Technology & Therapeutics·Rajendrakumar H JaniShashank Joshi
May 31, 2014·Journal of Diabetes Science and Technology·Vikas PaiPankaj Patel
Citations
Mar 21, 2017·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Cristina MaccalliniRosa Amoroso
Jun 6, 2017·Future Cardiology·Lu HanSalman Azhar
May 18, 2016·Biomedical Chromatography : BMC·Ashok GhoghariNuggehally R Srinivas
Jul 10, 2019·Vascular Pharmacology·Festus KamauRuduwaan Salie