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 |
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| Authors: | M.A. Banerji D. Purkayastha B.H. Francis |
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| Affiliation: | 1. SUNY Health Science Center, Brooklyn, NY, USA;2. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA;1. Section of Geriatric and Medicine, Careggi Teaching Hospital, Via delle Oblate 4, 50141 Florence, Italy;2. Obesity Agency, Careggi Teaching Hospital, Via delle Oblate 4, 50141 Florence, Italy;3. Diabetes Agency, Careggi Teaching Hospital, Via delle Oblate 4, 50141 Florence, Italy;1. Division of Nephrology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, and School of Medicine, Tzu Chi University, Hualien, Taiwan;2. Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan;3. Division of Nephrology, Department of Internal Medicine, Taipei City Hospital Yang-Ming Branch, Taipei, Taiwan;4. Department of Health Services Administration, China Medical University, Taichung, Taiwan;5. Institutes of Physiology and Clinical Medicine, National Yang-Ming University, and Division of Nephrology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan;1. Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea;2. Department of Surgery, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea;3. Department of Nuclear Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea;4. Department of Pathology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea;1. Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium;2. Shire-Movetis NV, Turnhout, Belgium;1. VA Boston Healthcare System, West Roxbury, MA;2. Eastern Colorado Health Care System, Department of Veterans Affairs, Denver, CO;3. University of Colorado School of Medicine at the Anschutz Medical Campus, Aurora, CO;4. Northport VA Medical Center, Northport, NY;5. Cooperative Studies Program Coordinating Center, Veterans Affairs Medical Center, Perry Point, MD;6. Retired;1. Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard (Hamdard University), New Delhi, India;2. Department of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India |
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| Abstract: | ObjectiveThis 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 > 80 mL/min/1.73 m2) and mild renal impairment (GFR: >50 to ≤80 mL/min/1.73 m2).MethodsAdverse events (AE) from this 12-week, randomized, open-label study comparing Vilda 100 mg and thiazolidinediones (TZD) as an add-on therapy in patients with T2DM inadequately controlled (HbA1c: 7–10%) on a stable dose of metformin (≥1000 mg/day) were analyzed.ResultsOf 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%).ConclusionThe safety profile of Vilda or TZD as an add-on to metformin was similar in patients with mild renal impairment and normal renal function. |
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