PMID- 21415917
OWN - NLM
STAT- MEDLINE
DCOM- 20110613
LR  - 20220409
IS  - 1178-2048 (Electronic)
IS  - 1176-6344 (Print)
IS  - 1176-6344 (Linking)
VI  - 7
DP  - 2011
TI  - Assessing the general safety and tolerability of vildagliptin: value of pooled 
      analyses from a large safety database versus evaluation of individual studies.
PG  - 49-57
LID - 10.2147/VHRM.S16925 [doi]
AB  - AIM: Analyzing safety aspects of a drug from individual studies can lead to 
      difficult-to-interpret results. The aim of this paper is therefore to assess the 
      general safety and tolerability, including incidences of the most common adverse 
      events (AEs), of vildagliptin based on a large pooled database of Phase II and 
      III clinical trials. METHODS: Safety data were pooled from 38 studies of >/= 12 to 
      >/= 104 weeks' duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were 
      evaluated relative to a pool of comparators (placebo and active comparators; N = 
      6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), 
      discontinuations due to AEs, and deaths. RESULTS: Overall AEs, SAEs, 
      discontinuations due to AEs, and deaths were all reported with a similar 
      frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, 
      respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, 
      respectively), whereas drug-related AEs were seen with a lower frequency in 
      vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences 
      of the most commonly reported specific AEs were also similar between vildagliptin 
      and comparators, except for increased incidences of hypoglycemia, tremor, and 
      hyperhidrosis in the comparator group related to the use of sulfonylureas. 
      CONCLUSIONS: The present pooled analysis shows that vildagliptin was overall well 
      tolerated in clinical trials of up to >2 years in duration. The data further 
      emphasize the value of a pooled analysis from a large safety database versus 
      assessing safety and tolerability from individual studies.
FAU - Schweizer, Anja
AU  - Schweizer A
AD  - Novartis Pharma AG, Basel, Switzerland. anja.schweizer@novartis.com
FAU - Dejager, Sylvie
AU  - Dejager S
FAU - Foley, James E
AU  - Foley JE
FAU - Kothny, Wolfgang
AU  - Kothny W
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20110204
PL  - New Zealand
TA  - Vasc Health Risk Manag
JT  - Vascular health and risk management
JID - 101273479
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/adverse effects/*analogs & derivatives/therapeutic use
MH  - Clinical Trials, Phase II as Topic
MH  - Clinical Trials, Phase III as Topic
MH  - Consumer Product Safety
MH  - Databases, Factual
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Evidence-Based Medicine
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Odds Ratio
MH  - Pyrrolidines/adverse effects/*therapeutic use
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vildagliptin
PMC - PMC3049539
OTO - NOTNLM
OT  - dipeptidyl peptidase-4
OT  - edema
OT  - safety
OT  - type 2 diabetes
OT  - vildagliptin
EDAT- 2011/03/19 06:00
MHDA- 2011/06/15 06:00
PMCR- 2011/02/04
CRDT- 2011/03/19 06:00
PHST- 2011/02/03 00:00 [received]
PHST- 2011/03/19 06:00 [entrez]
PHST- 2011/03/19 06:00 [pubmed]
PHST- 2011/06/15 06:00 [medline]
PHST- 2011/02/04 00:00 [pmc-release]
AID - vhrm-7-049 [pii]
AID - 10.2147/VHRM.S16925 [doi]
PST - ppublish
SO  - Vasc Health Risk Manag. 2011;7:49-57. doi: 10.2147/VHRM.S16925. Epub 2011 Feb 4.