PMID- 24742013
OWN - NLM
STAT- MEDLINE
DCOM- 20141218
LR  - 20231110
IS  - 1472-6823 (Print)
IS  - 1472-6823 (Electronic)
IS  - 1472-6823 (Linking)
VI  - 14
DP  - 2014 Apr 18
TI  - Efficacy and safety of canagliflozin compared with placebo in older patients with 
      type 2 diabetes mellitus: a pooled analysis of clinical studies.
PG  - 37
LID - 10.1186/1472-6823-14-37 [doi]
AB  - BACKGROUND: Canagliflozin is a sodium glucose co-transporter 2 inhibitor 
      developed for the treatment of patients with type 2 diabetes mellitus (T2DM). The 
      efficacy and safety of canagliflozin were evaluated in patients with T2DM <65 and 
      >/=65 years of age. METHODS: Pooled data from 4 randomised, placebo-controlled, 
      26-week, Phase 3 studies (N = 2,313) evaluating canagliflozin 100 and 300 mg were 
      analysed by age: <65 years (n = 1,868; mean age, 52.8 years) or >/=65 years 
      (n = 445; mean age, 69.3 years). Efficacy evaluations included change from 
      baseline in glycaemic parameters and systolic blood pressure (BP), and percent 
      change from baseline in body weight. Assessment of safety/tolerability included 
      adverse event (AE) reports, incidence of documented hypoglycaemia, and percent 
      change from baseline in fasting plasma lipids. RESULTS: Canagliflozin 100 and 
      300 mg reduced HbA1c and fasting plasma glucose relative to placebo in patients 
      <65 and >/=65 years of age. Both canagliflozin doses reduced body weight and 
      systolic BP relative to placebo in patients <65 and >/=65 years of age. Incidence 
      of overall AEs was similar across all treatment groups in patients <65 and 
      >/=65 years of age. Incidences of serious AEs and AE-related discontinuations were 
      similar across all treatment groups in patients <65 years of age and higher with 
      canagliflozin 100 mg than other groups in patients >/=65 years of age. As in 
      patients <65 years of age, incidences of genital mycotic infections and osmotic 
      diuresis-related AEs were higher with canagliflozin relative to placebo in those 
      >/=65 years of age. Incidences of urinary tract infections (UTIs), renal-related 
      AEs, AEs related to volume depletion, and documented hypoglycaemia episodes were 
      similar across all treatment groups in patients >/=65 years of age; no notable 
      trends were observed with canagliflozin 100 and 300 mg relative to placebo in 
      these AEs among patients <65 years of age. Changes in lipid parameters with 
      canagliflozin were similar in both age subsets. CONCLUSIONS: Canagliflozin 
      improved glycaemic control, body weight, and systolic BP, and was generally well 
      tolerated in older patients with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov, 
      NCT01081834; NCT01106677; NCT01106625; NCT01106690.
FAU - Sinclair, Alan
AU  - Sinclair A
AD  - Luton & Dunstable University Hospital; Bedfordshire and Hertfordshire 
      Postgraduate Medical School, University of Bedfordshire, Putteridge Bury Campus, 
      Hitchin Road, Luton LU2 8LE, UK. Alan.Sinclair@beds.ac.uk.
FAU - Bode, Bruce
AU  - Bode B
FAU - Harris, Stewart
AU  - Harris S
FAU - Vijapurkar, Ujjwala
AU  - Vijapurkar U
FAU - Mayer, Cristiana
AU  - Mayer C
FAU - Fung, Albert
AU  - Fung A
FAU - Shaw, Wayne
AU  - Shaw W
FAU - Usiskin, Keith
AU  - Usiskin K
FAU - Desai, Mehul
AU  - Desai M
FAU - Meininger, Gary
AU  - Meininger G
LA  - eng
SI  - ClinicalTrials.gov/NCT01081834
SI  - ClinicalTrials.gov/NCT01106625
SI  - ClinicalTrials.gov/NCT01106677
SI  - ClinicalTrials.gov/NCT01106690
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140418
PL  - England
TA  - BMC Endocr Disord
JT  - BMC endocrine disorders
JID - 101088676
RN  - 0 (Glucosides)
RN  - 0 (Thiophenes)
RN  - 0SAC974Z85 (Canagliflozin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Canagliflozin
MH  - *Clinical Trials, Phase III as Topic
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glucosides/*therapeutic use
MH  - Humans
MH  - Male
MH  - Meta-Analysis as Topic
MH  - Middle Aged
MH  - Prognosis
MH  - *Randomized Controlled Trials as Topic
MH  - Thiophenes/*therapeutic use
MH  - Young Adult
PMC - PMC4021426
EDAT- 2014/04/20 06:00
MHDA- 2014/12/19 06:00
PMCR- 2014/04/18
CRDT- 2014/04/19 06:00
PHST- 2013/12/31 00:00 [received]
PHST- 2014/04/10 00:00 [accepted]
PHST- 2014/04/19 06:00 [entrez]
PHST- 2014/04/20 06:00 [pubmed]
PHST- 2014/12/19 06:00 [medline]
PHST- 2014/04/18 00:00 [pmc-release]
AID - 1472-6823-14-37 [pii]
AID - 10.1186/1472-6823-14-37 [doi]
PST - epublish
SO  - BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.