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An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study.
J Clin Rheumatol. 2011 Jun; 17(4 Suppl 2):S44-9.JC

Abstract

BACKGROUND

Allopurinol has been widely used for the treatment of hyperuricemia, however, it may be associated with various adverse effects. Febuxostat has been identified as a potentially safe and efficacious alternative.

OBJECTIVES

Febuxostat was administered to patients with hyperuricemia including gout in Japan to compare its efficacy and safety with those of allopurinol.

METHODS

The starting dose of febuxostat and allopurinol was 10 and 100 mg/d, respectively, and was increased to the fixed maintenance dose of 40 or 60 mg/d for febuxostat and 300 mg/d for allopurinol for 16 weeks.

RESULTS

: The percent change in the serum uric acid level at 16 weeks compared with the baseline serum uric acid level was -42.96% ± 13.33% and -52.47% ± 9.79% for the febuxostat 40- and 60-mg/d groups, respectively, and -36.55% ± 18.59% for the allopurinol group, indicating that the hypouricemic effects of febuxostat increased in a dose-dependent manner and equaled to or surpassed those of allopurinol (P = 0.0239, 2-sample t test). The percentage of patients with serum uric acid levels of 6.0 mg/dL or less at 16 weeks was 88.9% and 100% for the febuxostat 40- and 60-mg/d groups, respectively, and 68.8% for the allopurinol group, showing higher achievements for the febuxostat groups compared with the allopurinol group. All adverse drug reactions were mild to moderate in severity, and there were no severe symptoms or reactions leading to drug discontinuation.

CONCLUSIONS

These results suggest that febuxostat is safe at doses of 40 and 60 mg/d and has equal or greater efficacy than 300 mg/d allopurinol.

Authors+Show Affiliations

Institute of Rheumatology, Tokyo Women's Medical University, Teikyo University, Tokyo, Japan. kamatani@msb.biglobe.ne.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21654269

Citation

Kamatani, Naoyuki, et al. "An Allopurinol-controlled, Multicenter, Randomized, Open-label, Parallel Between-group, Comparative Study of Febuxostat (TMX-67), a Non-purine-selective Inhibitor of Xanthine Oxidase, in Patients With Hyperuricemia Including Those With Gout in Japan: Phase 2 Exploratory Clinical Study." Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, vol. 17, no. 4 Suppl 2, 2011, pp. S44-9.
Kamatani N, Naoyuki K, Fujimori S, et al. An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study. J Clin Rheumatol. 2011;17(4 Suppl 2):S44-9.
Kamatani, N., Naoyuki, K., Fujimori, S., Shin, F., Hada, T., Toshikazu, H., Hosoya, T., Tatsuo, H., Kohri, K., Kenjiro, K., Nakamura, T., Toshitaka, N., Ueda, T., Takanori, U., Yamamoto, T., Tetsuya, Y., Yamanaka, H., Hisashi, Y., Matsuzawa, Y., & Yuji, M. (2011). An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study. Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, 17(4 Suppl 2), S44-9. https://doi.org/10.1097/RHU.0b013e31821d352f
Kamatani N, et al. An Allopurinol-controlled, Multicenter, Randomized, Open-label, Parallel Between-group, Comparative Study of Febuxostat (TMX-67), a Non-purine-selective Inhibitor of Xanthine Oxidase, in Patients With Hyperuricemia Including Those With Gout in Japan: Phase 2 Exploratory Clinical Study. J Clin Rheumatol. 2011;17(4 Suppl 2):S44-9. PubMed PMID: 21654269.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An allopurinol-controlled, multicenter, randomized, open-label, parallel between-group, comparative study of febuxostat (TMX-67), a non-purine-selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study. AU - Kamatani,Naoyuki, AU - Naoyuki,Kamatani, AU - Fujimori,Shin, AU - Shin,Fujimori, AU - Hada,Toshikazu, AU - Toshikazu,Hada, AU - Hosoya,Tatsuo, AU - Tatsuo,Hosoya, AU - Kohri,Kenjiro, AU - Kenjiro,Kohri, AU - Nakamura,Toshitaka, AU - Toshitaka,Nakamura, AU - Ueda,Takanori, AU - Takanori,Ueda, AU - Yamamoto,Tetsuya, AU - Tetsuya,Yamamoto, AU - Yamanaka,Hisashi, AU - Hisashi,Yamanaka, AU - Matsuzawa,Yuji, AU - Yuji,Matsuzawa, PY - 2011/6/10/entrez PY - 2011/7/29/pubmed PY - 2011/12/13/medline SP - S44 EP - 9 JF - Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases JO - J Clin Rheumatol VL - 17 IS - 4 Suppl 2 N2 - BACKGROUND: Allopurinol has been widely used for the treatment of hyperuricemia, however, it may be associated with various adverse effects. Febuxostat has been identified as a potentially safe and efficacious alternative. OBJECTIVES: Febuxostat was administered to patients with hyperuricemia including gout in Japan to compare its efficacy and safety with those of allopurinol. METHODS: The starting dose of febuxostat and allopurinol was 10 and 100 mg/d, respectively, and was increased to the fixed maintenance dose of 40 or 60 mg/d for febuxostat and 300 mg/d for allopurinol for 16 weeks. RESULTS: : The percent change in the serum uric acid level at 16 weeks compared with the baseline serum uric acid level was -42.96% ± 13.33% and -52.47% ± 9.79% for the febuxostat 40- and 60-mg/d groups, respectively, and -36.55% ± 18.59% for the allopurinol group, indicating that the hypouricemic effects of febuxostat increased in a dose-dependent manner and equaled to or surpassed those of allopurinol (P = 0.0239, 2-sample t test). The percentage of patients with serum uric acid levels of 6.0 mg/dL or less at 16 weeks was 88.9% and 100% for the febuxostat 40- and 60-mg/d groups, respectively, and 68.8% for the allopurinol group, showing higher achievements for the febuxostat groups compared with the allopurinol group. All adverse drug reactions were mild to moderate in severity, and there were no severe symptoms or reactions leading to drug discontinuation. CONCLUSIONS: These results suggest that febuxostat is safe at doses of 40 and 60 mg/d and has equal or greater efficacy than 300 mg/d allopurinol. SN - 1536-7355 UR - https://www.unboundmedicine.com/medline/citation/21654269/An_allopurinol_controlled_multicenter_randomized_open_label_parallel_between_group_comparative_study_of_febuxostat__TMX_67__a_non_purine_selective_inhibitor_of_xanthine_oxidase_in_patients_with_hyperuricemia_including_those_with_gout_in_Japan:_phase_2_exploratory_clinical_study_ L2 - https://doi.org/10.1097/RHU.0b013e31821d352f DB - PRIME DP - Unbound Medicine ER -