Tags

Type your tag names separated by a space and hit enter

Placebo-controlled double-blind dose-response study of the non-purine-selective xanthine oxidase inhibitor febuxostat (TMX-67) in patients with hyperuricemia (including gout patients) in japan: late phase 2 clinical study.
J Clin Rheumatol. 2011 Jun; 17(4 Suppl 2):S35-43.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

A multicenter study with randomized, placebo-controlled, double-blind, parallel, intergroup comparison was carried out to evaluate the dose-response relationship, efficacy, and safety of febuxostat in 202 patients with hyperuricemia (including patients with gout) in Japan.

METHODS

The subjects were treated with febuxostat at fixed maintenance doses (20-80 mg/d) or a placebo for 16 weeks. 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 16 weeks of treatment were evaluated.

RESULTS

The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less at 16 weeks was 87.8% in the 80-mg/d dose group, 83.3% in the 60-mg/d group, 82.9% in the 40-mg/d group, 46.5% in the 20-mg/d group, and 2.6% in the placebo group (P < 0.001, Mantel-Haenszel test). A statistically significant dose-response relationship was found. The percent change in serum uric acid levels after 16 weeks of treatment differed significantly between each febuxostat dose group and the placebo group and increased in a dose-dependent manner above 40 mg/d. No deaths, events posing a clinical problem, or serious adverse reactions attributable to febuxostat were noted. Similar results were obtained regardless of gout history.

CONCLUSIONS

Febuxostat can safely reduce serum uric acid levels to 6.0 mg/dL or less in 80% or more of patients with hyperuricemia (including gout) at doses of 40 mg/d or higher.

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

21654268

Citation

Kamatani, Naoyuki, et al. "Placebo-controlled Double-blind Dose-response Study of the Non-purine-selective Xanthine Oxidase Inhibitor Febuxostat (TMX-67) in Patients With Hyperuricemia (including Gout Patients) in Japan: Late Phase 2 Clinical Study." Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, vol. 17, no. 4 Suppl 2, 2011, pp. S35-43.
Kamatani N, Naoyuki K, Fujimori S, et al. Placebo-controlled double-blind dose-response study of the non-purine-selective xanthine oxidase inhibitor febuxostat (TMX-67) in patients with hyperuricemia (including gout patients) in japan: late phase 2 clinical study. J Clin Rheumatol. 2011;17(4 Suppl 2):S35-43.
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 dose-response study of the non-purine-selective xanthine oxidase inhibitor febuxostat (TMX-67) in patients with hyperuricemia (including gout patients) in japan: late phase 2 clinical study. Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, 17(4 Suppl 2), S35-43. https://doi.org/10.1097/RHU.0b013e31821d351d
Kamatani N, et al. Placebo-controlled Double-blind Dose-response Study of the Non-purine-selective Xanthine Oxidase Inhibitor Febuxostat (TMX-67) in Patients With Hyperuricemia (including Gout Patients) in Japan: Late Phase 2 Clinical Study. J Clin Rheumatol. 2011;17(4 Suppl 2):S35-43. PubMed PMID: 21654268.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Placebo-controlled double-blind dose-response study of the non-purine-selective xanthine oxidase inhibitor febuxostat (TMX-67) in patients with hyperuricemia (including gout patients) in japan: late phase 2 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 - S35 EP - 43 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: A multicenter study with randomized, placebo-controlled, double-blind, parallel, intergroup comparison was carried out to evaluate the dose-response relationship, efficacy, and safety of febuxostat in 202 patients with hyperuricemia (including patients with gout) in Japan. METHODS: The subjects were treated with febuxostat at fixed maintenance doses (20-80 mg/d) or a placebo for 16 weeks. 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 16 weeks of treatment were evaluated. RESULTS: The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less at 16 weeks was 87.8% in the 80-mg/d dose group, 83.3% in the 60-mg/d group, 82.9% in the 40-mg/d group, 46.5% in the 20-mg/d group, and 2.6% in the placebo group (P < 0.001, Mantel-Haenszel test). A statistically significant dose-response relationship was found. The percent change in serum uric acid levels after 16 weeks of treatment differed significantly between each febuxostat dose group and the placebo group and increased in a dose-dependent manner above 40 mg/d. No deaths, events posing a clinical problem, or serious adverse reactions attributable to febuxostat were noted. Similar results were obtained regardless of gout history. CONCLUSIONS: Febuxostat can safely reduce serum uric acid levels to 6.0 mg/dL or less in 80% or more of patients with hyperuricemia (including gout) at doses of 40 mg/d or higher. SN - 1536-7355 UR - https://www.unboundmedicine.com/medline/citation/21654268/Placebo_controlled_double_blind_dose_response_study_of_the_non_purine_selective_xanthine_oxidase_inhibitor_febuxostat__TMX_67__in_patients_with_hyperuricemia__including_gout_patients__in_japan:_late_phase_2_clinical_study_ L2 - https://doi.org/10.1097/RHU.0b013e31821d351d DB - PRIME DP - Unbound Medicine ER -