PMID- 22436129
OWN - NLM
STAT- MEDLINE
DCOM- 20130408
LR  - 20211021
IS  - 1471-2318 (Electronic)
IS  - 1471-2318 (Linking)
VI  - 12
DP  - 2012 Mar 21
TI  - The efficacy and safety of febuxostat for urate lowering in gout patients >/=65 
      years of age.
PG  - 11
LID - 10.1186/1471-2318-12-11 [doi]
AB  - BACKGROUND: The incidence of gout rises with increasing age. Management of 
      elderly (>/=65 years) gout patients can be challenging due to high rates of 
      comorbidities, such as renal impairment and cardiovascular disease, and 
      concomitant medication use. However, there is little data specifically addressing 
      the efficacy and safety of available urate-lowering therapies (ULT) in the 
      elderly. The objective of this post hoc analysis was to examine the efficacy and 
      safety of ULT with febuxostat or allopurinol in a subset of elderly subjects 
      enrolled in the CONFIRMS trial. METHODS: Hyperuricemic (serum urate [sUA] levels 
      >/= 8.0 mg/dL) gout subjects were enrolled in the 6-month, double-blind, 
      randomized, comparative CONFIRMS trial and randomized, 1:1:1, to receive 
      febuxostat, 40 mg or 80 mg, or allopurinol (200 mg or 300 mg based on renal 
      function) once daily. Flare prophylaxis was provided throughout the study 
      duration.Study endpoints were the percent of elderly subjects with sUA <6.0 mg/dL 
      at the final visit, overall and by renal function status, percent change in sUA 
      from baseline to final visit, flare rates, and rates of adverse events (AEs). 
      RESULTS: Of 2,269 subjects enrolled, 374 were elderly. Febuxostat 80 mg was 
      significantly more efficacious (82.0%) than febuxostat 40 mg (61.7%; p < 0.001) 
      or allopurinol (47.3%; p < 0.001) for achieving the primary efficacy endpoint. 
      Febuxostat 40 mg was also superior to allopurinol in this population (p = 0.029). 
      In subjects with mild-to-moderate renal impairment, significantly greater ULT 
      efficacy was observed with febuxostat 40 mg (61.6%; p = 0.028) and febuxostat 80 
      mg (82.5%; p < 0.001) compared to allopurinol 200/300 mg (46.9%). Compared to 
      allopurinol 200/300 mg, the mean percent change in sUA from baseline was 
      significantly greater for both febuxostat 80 mg (p < 0.001) and febuxostat 40 mg 
      (p = 0.011) groups. Flare rates declined steadily in all treatment groups. Rates 
      of AEs were low and comparable across treatments. CONCLUSIONS: These data suggest 
      that either dose of febuxostat is superior to commonly prescribed fixed doses of 
      allopurinol (200/300 mg) in subjects >/=65 years of age with high rates of renal 
      dysfunction. In addition, in this high-risk population, ULT with either drug was 
      well tolerated. TRIAL REGISTRATION: clinicaltrials.gov NCT#00430248.
FAU - Jackson, Robert L
AU  - Jackson RL
AD  - Takeda Global Research & Development Centers, Inc, One Takeda Parkway, Deerfield, 
      Illinois 60015, USA. Robert.Jackson@takeda.com
FAU - Hunt, Barbara
AU  - Hunt B
FAU - MacDonald, Patricia A
AU  - MacDonald PA
LA  - eng
SI  - ClinicalTrials.gov/NCT00430248
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120321
PL  - England
TA  - BMC Geriatr
JT  - BMC geriatrics
JID - 100968548
RN  - 0 (Biomarkers)
RN  - 0 (Gout Suppressants)
RN  - 0 (Thiazoles)
RN  - 101V0R1N2E (Febuxostat)
RN  - 268B43MJ25 (Uric Acid)
RN  - EC 1.17.3.2 (Xanthine Oxidase)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Biomarkers/blood
MH  - Cohort Studies
MH  - Double-Blind Method
MH  - Febuxostat
MH  - Female
MH  - Gout/*blood/*drug therapy
MH  - Gout Suppressants/*therapeutic use
MH  - Humans
MH  - Hyperuricemia/blood/enzymology/*prevention & control
MH  - Male
MH  - Thiazoles/*therapeutic use
MH  - Treatment Outcome
MH  - Uric Acid/*antagonists & inhibitors/blood
MH  - Xanthine Oxidase/antagonists & inhibitors
PMC - PMC3368715
EDAT- 2012/03/23 06:00
MHDA- 2013/04/09 06:00
PMCR- 2012/03/21
CRDT- 2012/03/23 06:00
PHST- 2011/10/03 00:00 [received]
PHST- 2012/03/21 00:00 [accepted]
PHST- 2012/03/23 06:00 [entrez]
PHST- 2012/03/23 06:00 [pubmed]
PHST- 2013/04/09 06:00 [medline]
PHST- 2012/03/21 00:00 [pmc-release]
AID - 1471-2318-12-11 [pii]
AID - 10.1186/1471-2318-12-11 [doi]
PST - epublish
SO  - BMC Geriatr. 2012 Mar 21;12:11. doi: 10.1186/1471-2318-12-11.