PMID- 20655609
OWN - NLM
STAT- MEDLINE
DCOM- 20110202
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 90
IP  - 2
DP  - 2010 Nov
TI  - 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.
PG  - 182-90
LID - 10.1016/j.diabres.2010.06.022 [doi]
AB  - OBJECTIVE: 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)). METHODS: 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. RESULTS: 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%). CONCLUSION: The 
      safety profile of Vilda or TZD as an add-on to metformin was similar in patients 
      with mild renal impairment and normal renal function.
CI  - Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.
FAU - Banerji, M A
AU  - Banerji MA
AD  - SUNY Health Science Center, Brooklyn, NY, USA.
FAU - Purkayastha, D
AU  - Purkayastha D
FAU - Francis, B H
AU  - Francis BH
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20100723
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (Thiazolidinediones)
RN  - 9100L32L2N (Metformin)
RN  - AA68LXK93C (2,4-thiazolidinedione)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/adverse effects/*analogs & derivatives/therapeutic use
MH  - Adult
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Diabetic Nephropathies/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/therapeutic use
MH  - Drug Therapy, Combination
MH  - Drug Tolerance
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Kidney Function Tests
MH  - Male
MH  - Metformin/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Pyrrolidines/adverse effects/*therapeutic use
MH  - Retrospective Studies
MH  - Safety
MH  - Thiazolidinediones/adverse effects/*therapeutic use
MH  - Vildagliptin
EDAT- 2010/07/27 06:00
MHDA- 2011/02/03 06:00
CRDT- 2010/07/27 06:00
PHST- 2010/03/11 00:00 [received]
PHST- 2010/06/14 00:00 [revised]
PHST- 2010/06/17 00:00 [accepted]
PHST- 2010/07/27 06:00 [entrez]
PHST- 2010/07/27 06:00 [pubmed]
PHST- 2011/02/03 06:00 [medline]
AID - S0168-8227(10)00324-4 [pii]
AID - 10.1016/j.diabres.2010.06.022 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2010 Nov;90(2):182-90. doi: 
      10.1016/j.diabres.2010.06.022. Epub 2010 Jul 23.