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An allopurinol-controlled, randomized, double-dummy, double-blind, 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 3 clinical study.
J Clin Rheumatol. 2011 Jun; 17(4 Suppl 2):S13-8.JC

Abstract

BACKGROUND

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

OBJECTIVES

Febuxostat or allopurinol was administered to patients with hyperuricemia including gout for 8 weeks to compare the efficacy and safety of these drugs.

METHODS

Doses of febuxostat and allopurinol were 10 and 100 mg/d, respectively, during a 12-day introduction period and were increased to 40 and 200 mg/d for the subsequent treatment period of 44 days.

RESULTS

: The percent changes in serum uric acid levels after 8 weeks were -40.75% for the febuxostat group and -34.41% for the allopurinol group (P < 0.001, analysis of variance, closing testing procedure). The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less after 8 weeks was 82.0% for the febuxostat group and 70.0% for the allopurinol group (P = 0.019, logistic regression analysis). Regarding safety, 213 adverse events were observed in the febuxostat group and 220 events in the allopurinol group. For 10 patients (8.2%) in the febuxostat group and 14 patients (11.6%) in the allopurinol group, association with the study drugs could not be ruled out. There were no severe adverse drug reactions in the febuxostat group other than a high frequency of gout attacks induced by the sudden reduction in blood uric acid levels during the early treatment period.

CONCLUSIONS

Febuxostat at 40 mg/d demonstrated more potent hypouricemic effects than allopurinol at 200 mg/d, was efficacious regardless of medical history of gout, and is considered safe for treatment of hyperuricemia.

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 available

Pub Type(s)

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

Language

eng

PubMed ID

21654265

Citation

Kamatani, Naoyuki, et al. "An Allopurinol-controlled, Randomized, Double-dummy, Double-blind, 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 3 Clinical Study." Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, vol. 17, no. 4 Suppl 2, 2011, pp. S13-8.
Kamatani N, Fujimori S, Hada T, et al. An allopurinol-controlled, randomized, double-dummy, double-blind, 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 3 clinical study. J Clin Rheumatol. 2011;17(4 Suppl 2):S13-8.
Kamatani, N., Fujimori, S., Hada, T., Hosoya, T., Kohri, K., Nakamura, T., Ueda, T., Yamamoto, T., Yamanaka, H., & Matsuzawa, Y. (2011). An allopurinol-controlled, randomized, double-dummy, double-blind, 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 3 clinical study. Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, 17(4 Suppl 2), S13-8. https://doi.org/10.1097/RHU.0b013e31821d36cc
Kamatani N, et al. An Allopurinol-controlled, Randomized, Double-dummy, Double-blind, 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 3 Clinical Study. J Clin Rheumatol. 2011;17(4 Suppl 2):S13-8. PubMed PMID: 21654265.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An allopurinol-controlled, randomized, double-dummy, double-blind, 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 3 clinical study. AU - Kamatani,Naoyuki, AU - Fujimori,Shin, AU - Hada,Toshikazu, AU - Hosoya,Tatsuo, AU - Kohri,Kenjiro, AU - Nakamura,Toshitaka, AU - Ueda,Takanori, AU - Yamamoto,Tetsuya, AU - Yamanaka,Hisashi, AU - Matsuzawa,Yuji, PY - 2011/6/10/entrez PY - 2011/7/29/pubmed PY - 2011/12/13/medline SP - S13 EP - 8 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 is potentially a safe and efficacious alternative. OBJECTIVES: Febuxostat or allopurinol was administered to patients with hyperuricemia including gout for 8 weeks to compare the efficacy and safety of these drugs. METHODS: Doses of febuxostat and allopurinol were 10 and 100 mg/d, respectively, during a 12-day introduction period and were increased to 40 and 200 mg/d for the subsequent treatment period of 44 days. RESULTS: : The percent changes in serum uric acid levels after 8 weeks were -40.75% for the febuxostat group and -34.41% for the allopurinol group (P < 0.001, analysis of variance, closing testing procedure). The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less after 8 weeks was 82.0% for the febuxostat group and 70.0% for the allopurinol group (P = 0.019, logistic regression analysis). Regarding safety, 213 adverse events were observed in the febuxostat group and 220 events in the allopurinol group. For 10 patients (8.2%) in the febuxostat group and 14 patients (11.6%) in the allopurinol group, association with the study drugs could not be ruled out. There were no severe adverse drug reactions in the febuxostat group other than a high frequency of gout attacks induced by the sudden reduction in blood uric acid levels during the early treatment period. CONCLUSIONS: Febuxostat at 40 mg/d demonstrated more potent hypouricemic effects than allopurinol at 200 mg/d, was efficacious regardless of medical history of gout, and is considered safe for treatment of hyperuricemia. SN - 1536-7355 UR - https://www.unboundmedicine.com/medline/citation/21654265/An_allopurinol_controlled_randomized_double_dummy_double_blind_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_3_clinical_study_ L2 - http://dx.doi.org/10.1097/RHU.0b013e31821d36cc DB - PRIME DP - Unbound Medicine ER -