Safety and tolerability of vildagliptin vs. thiazolidinedione as add-on to metformin in type 2 diabetic patients with and without mild renal impairment: a retrospective analysis of the GALIANT study

Diabetes Research and Clinical Practice
M A BanerjiB H Francis

Abstract

This retrospective analysis assessed safety and tolerability of vildagliptin (Vilda) as an add-on to metformin in type 2 diabetes mellitus (T2DM) patients with normal renal function (GFR >80mL/min/1.73m(2)) and mild renal impairment (GFR: >50 to ≤80mL/min/1.73m(2)). Adverse events (AE) from this 12-week, randomized, open-label study comparing Vilda 100mg and thiazolidinediones (TZD) as an add-on therapy in patients with T2DM inadequately controlled (HbA(1c): 7-10%) on a stable dose of metformin (≥1000mg/day) were analyzed. Of 2627 randomized patients, 1278 in the Vilda and 635 in the TZD groups had normal renal function; 463 in the Vilda and 230 in the TZD groups had mild renal impairment. Higher incidence of headache and rash was noted in both Vilda groups, whereas those with mild renal impairment receiving TZD experienced a higher incidence of peripheral edema and URI. Fewer patients in the Vilda group discontinued the study due to AEs compared to TZD group. Serious AEs were greater in TZD groups (normal: 2.4%; mild renal impairment: 3.0%) compared to Vilda groups (normal: 1.6%; mild renal impairment: 2.4%). The safety profile of Vilda or TZD as an add-on to metformin was similar in patients with mild renal impairment and nor...Continue Reading

References

Aug 14, 2002·Annals of Medicine·Michael Stumvoll, Hans-Ulrich Häring
May 6, 2004·The Journal of Clinical Endocrinology and Metabolism·Bo AhrénAnja Schweizer
Mar 25, 2005·Diabetic Medicine : a Journal of the British Diabetic Association·B H CharbonnelUNKNOWN QUARTET Study Group
Dec 6, 2006·The New England Journal of Medicine·Steven E KahnUNKNOWN ADOPT Study Group
Jan 16, 2007·Diabetes Research and Clinical Practice·F Xavier Pi-SunyerSylvie Dejager
Jul 12, 2007·JAMA : the Journal of the American Medical Association·Renee E AmoriAnastassios G Pittas
Oct 29, 2008·BMC Endocrine Disorders·Debora Williams-HermanJohn M Amatruda
Mar 15, 2010·World Journal of Diabetes·Claudia FilozofJames E Foley

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Citations

Jul 13, 2011·Experimental Diabetes Research·Ilaria DicembriniCarlo Maria Rotella
Dec 14, 2011·Expert Opinion on Pharmacotherapy·André J Scheen
Mar 7, 2013·Expert Opinion on Drug Metabolism & Toxicology·André J Scheen
Apr 7, 2011·Journal of the European Academy of Dermatology and Venereology : JEADV·K SkandalisI D Bassukas
Apr 24, 2016·Nutrition, Metabolism, and Cardiovascular Diseases : NMCD·G PennoS Del Prato
Oct 7, 2017·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Roberto Trevisan
Jun 13, 2013·Endocrine Practice : Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists·German RamirezPolly A Bittle
Jun 13, 2012·Clinical Pharmacokinetics·Larry K GolightlyMichael T McDermott
Mar 1, 2011·Expert Review of Endocrinology & Metabolism·Philip E Otterbeck, Mary Ann Banerji

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