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Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol.
Arthritis Care Res (Hoboken). 2012 Feb; 64(2):256-61.AC

Abstract

OBJECTIVE

To compare the characteristics of female versus male gout patients and assess urate-lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout.

METHODS

This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate-lowering efficacy, which was defined as the proportion of subjects with sUA levels <6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function.

RESULTS

Female gout subjects (n = 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels <6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate-lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P < 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea.

CONCLUSION

These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities.

Authors+Show Affiliations

University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA. schohan@medicine.bsd.uchicago.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22052584

Citation

Chohan, Saima, et al. "Women With Gout: Efficacy and Safety of Urate-lowering With Febuxostat and Allopurinol." Arthritis Care & Research, vol. 64, no. 2, 2012, pp. 256-61.
Chohan S, Becker MA, MacDonald PA, et al. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012;64(2):256-61.
Chohan, S., Becker, M. A., MacDonald, P. A., Chefo, S., & Jackson, R. L. (2012). Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care & Research, 64(2), 256-61. https://doi.org/10.1002/acr.20680
Chohan S, et al. Women With Gout: Efficacy and Safety of Urate-lowering With Febuxostat and Allopurinol. Arthritis Care Res (Hoboken). 2012;64(2):256-61. PubMed PMID: 22052584.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. AU - Chohan,Saima, AU - Becker,Michael A, AU - MacDonald,Patricia A, AU - Chefo,Solomon, AU - Jackson,Robert L, PY - 2011/11/5/entrez PY - 2011/11/5/pubmed PY - 2012/3/14/medline SP - 256 EP - 61 JF - Arthritis care & research JO - Arthritis Care Res (Hoboken) VL - 64 IS - 2 N2 - OBJECTIVE: To compare the characteristics of female versus male gout patients and assess urate-lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout. METHODS: This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate-lowering efficacy, which was defined as the proportion of subjects with sUA levels <6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function. RESULTS: Female gout subjects (n = 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels <6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate-lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P < 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea. CONCLUSION: These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities. SN - 2151-4658 UR - https://www.unboundmedicine.com/medline/citation/22052584/Women_with_gout:_efficacy_and_safety_of_urate_lowering_with_febuxostat_and_allopurinol_ L2 - https://doi.org/10.1002/acr.20680 DB - PRIME DP - Unbound Medicine ER -