Tags

Type your tag names separated by a space and hit enter

The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age.
BMC Geriatr. 2012 Mar 21; 12:11.BG

Abstract

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.

Authors+Show Affiliations

Takeda Global Research & Development Centers, Inc, One Takeda Parkway, Deerfield, Illinois 60015, USA. Robert.Jackson@takeda.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22436129

Citation

Jackson, Robert L., et al. "The Efficacy and Safety of Febuxostat for Urate Lowering in Gout Patients ≥65 Years of Age." BMC Geriatrics, vol. 12, 2012, p. 11.
Jackson RL, Hunt B, MacDonald PA. The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age. BMC Geriatr. 2012;12:11.
Jackson, R. L., Hunt, B., & MacDonald, P. A. (2012). The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age. BMC Geriatrics, 12, 11. https://doi.org/10.1186/1471-2318-12-11
Jackson RL, Hunt B, MacDonald PA. The Efficacy and Safety of Febuxostat for Urate Lowering in Gout Patients ≥65 Years of Age. BMC Geriatr. 2012 Mar 21;12:11. PubMed PMID: 22436129.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age. AU - Jackson,Robert L, AU - Hunt,Barbara, AU - MacDonald,Patricia A, Y1 - 2012/03/21/ PY - 2011/10/03/received PY - 2012/03/21/accepted PY - 2012/3/23/entrez PY - 2012/3/23/pubmed PY - 2013/4/9/medline SP - 11 EP - 11 JF - BMC geriatrics JO - BMC Geriatr VL - 12 N2 - 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. SN - 1471-2318 UR - https://www.unboundmedicine.com/medline/citation/22436129/The_efficacy_and_safety_of_febuxostat_for_urate_lowering_in_gout_patients_≥65_years_of_age_ L2 - https://bmcgeriatr.biomedcentral.com/articles/10.1186/1471-2318-12-11 DB - PRIME DP - Unbound Medicine ER -