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Placebo-controlled, double-blind study of the non-purine-selective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study.
J Clin Rheumatol. 2011 Jun; 17(4 Suppl 2):S19-26.JC

Abstract

BACKGROUND

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

OBJECTIVES

: A multicenter study with randomized, placebo-controlled, double-blind, parallel-group comparison was carried out to evaluate the efficacy and safety of febuxostat in 103 patients with hyperuricemia (including patients with gout) in Japan.

METHODS

: Subjects were treated with febuxostat (20 or 40 mg/d) or a placebo for 8 weeks. The variables evaluated were the percentage of patients achieving serum uric acid levels 6.0 mg/dL or less and the percent change in serum uric acid levels after 8 weeks.

RESULTS

: The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less after 8 weeks was 91.2% in the febuxostat 40-mg/d group, 45.7% in the 20-mg/d group, and 0.0% in the placebo group. The percent changes in serum uric acid levels after 8 weeks were -44.9% in the febuxostat 40-mg/d group, -28.9% in the 20-mg/d group, and -0.6% to -0.5% in the placebo group. No severe or medically significant adverse reaction attributable to febuxostat was noted, and there was no event that could pose a clinical problem. The efficacy did not differ depending on the presence/absence of gout history.

CONCLUSIONS

: These results suggest that febuxostat (20 or 40 mg/d) is useful as a new means of treating hyperuricemia and is capable of reducing serum uric acid levels to 6.0 mg/dL or less (goal of treatment) with high safety regardless of the presence/absence of gout history.

Authors+Show Affiliations

Institute of Rheumatology, Tokyo Women's Medical University, 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 III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21654266

Citation

Kamatani, Naoyuki, et al. "Placebo-controlled, Double-blind Study of the Non-purine-selective Xanthine Oxidase Inhibitor Febuxostat (TMX-67) in Patients With Hyperuricemia Including Those With Gout in Japan: Phase 3 Clinical Study." Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, vol. 17, no. 4 Suppl 2, 2011, pp. S19-26.
Kamatani N, Naoyuki K, Fujimori S, et al. Placebo-controlled, double-blind study of the non-purine-selective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. J Clin Rheumatol. 2011;17(4 Suppl 2):S19-26.
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). Placebo-controlled, double-blind study of the non-purine-selective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study. Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, 17(4 Suppl 2), S19-26. https://doi.org/10.1097/RHU.0b013e31821d36de
Kamatani N, et al. Placebo-controlled, Double-blind Study of the Non-purine-selective Xanthine Oxidase Inhibitor Febuxostat (TMX-67) in Patients With Hyperuricemia Including Those With Gout in Japan: Phase 3 Clinical Study. J Clin Rheumatol. 2011;17(4 Suppl 2):S19-26. PubMed PMID: 21654266.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo-controlled, double-blind study of the non-purine-selective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with hyperuricemia including those with gout in Japan: phase 3 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 - S19 EP - 26 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 treatment of hyperuricemia, however, it may be associated with various adverse effects. Febuxostat has been identified as a potentially safe and efficacious alternative. OBJECTIVES: : A multicenter study with randomized, placebo-controlled, double-blind, parallel-group comparison was carried out to evaluate the efficacy and safety of febuxostat in 103 patients with hyperuricemia (including patients with gout) in Japan. METHODS: : Subjects were treated with febuxostat (20 or 40 mg/d) or a placebo for 8 weeks. The variables evaluated were the percentage of patients achieving serum uric acid levels 6.0 mg/dL or less and the percent change in serum uric acid levels after 8 weeks. RESULTS: : The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less after 8 weeks was 91.2% in the febuxostat 40-mg/d group, 45.7% in the 20-mg/d group, and 0.0% in the placebo group. The percent changes in serum uric acid levels after 8 weeks were -44.9% in the febuxostat 40-mg/d group, -28.9% in the 20-mg/d group, and -0.6% to -0.5% in the placebo group. No severe or medically significant adverse reaction attributable to febuxostat was noted, and there was no event that could pose a clinical problem. The efficacy did not differ depending on the presence/absence of gout history. CONCLUSIONS: : These results suggest that febuxostat (20 or 40 mg/d) is useful as a new means of treating hyperuricemia and is capable of reducing serum uric acid levels to 6.0 mg/dL or less (goal of treatment) with high safety regardless of the presence/absence of gout history. SN - 1536-7355 UR - https://www.unboundmedicine.com/medline/citation/21654266/Placebo_controlled_double_blind_study_of_the_non_purine_selective_xanthine_oxidase_inhibitor_Febuxostat__TMX_67__in_patients_with_hyperuricemia_including_those_with_gout_in_Japan:_phase_3_clinical_study_ L2 - https://doi.org/10.1097/RHU.0b013e31821d36de DB - PRIME DP - Unbound Medicine ER -