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Multicenter, open-label study of long-term administration of febuxostat (TMX-67) in Japanese patients with hyperuricemia including gout.
J Clin Rheumatol. 2011 Jun; 17(4 Suppl 2):S50-6.JC

Abstract

BACKGROUND

In previous clinical studies of hyperuricemia including gout, although serum uric acid (sUA) levels reduced to 6.0 mg/dL or less in about 80% of patients treated with 40 mg/d febuxostat, a nonpurine selective xanthine oxidase inhibitor, a few patients did not show this result.

OBJECTIVE

The objective of the study was to evaluate the efficacy and safety of long-term febuxostat administration at up to 60 mg/d in patients with hyperuricemia and gout.

METHODS

In a 52-week, multicenter, open-label trial, febuxostat was initially administered at 10 mg/d; then, the dosage was increased in a stepwise fashion to 40 mg/d. For sUA levels greater than 6.0 mg/dL at week 10, the dosage was increased to 60 mg/d from week 14 onward (60-mg group), but it was maintained at 40 mg/d until the end of the study for patients with sUA levels 6.0 mg/dL or less at week 10 (40-mg group).

RESULTS

The sUA levels in both groups decreased dose dependently. At 52 weeks, 84.5% and 85.0% of the 40- and 60-mg groups, respectively, achieved mean sUA levels 6.0 mg/dL or less. There was no marked difference between the 2 dosage groups in terms of the incidence of adverse events. Furthermore, there were no noteworthy adverse events or adverse drug reactions in the patients with renal dysfunction, and no differences in drug efficacy up to 60 mg/d were noted between the patients with moderate or mild renal dysfunction and those with normal renal function.

CONCLUSIONS

Febuxostat seems to be a promising therapeutic drug for gout or hyperuricemia, even in patients with renal dysfunction.

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 available

Pub Type(s)

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

Language

eng

PubMed ID

21654270

Citation

Kamatani, Naoyuki, et al. "Multicenter, Open-label Study of Long-term Administration of Febuxostat (TMX-67) in Japanese Patients With Hyperuricemia Including Gout." Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, vol. 17, no. 4 Suppl 2, 2011, pp. S50-6.
Kamatani N, Fujimori S, Hada T, et al. Multicenter, open-label study of long-term administration of febuxostat (TMX-67) in Japanese patients with hyperuricemia including gout. J Clin Rheumatol. 2011;17(4 Suppl 2):S50-6.
Kamatani, N., Fujimori, S., Hada, T., Hosoya, T., Kohri, K., Nakamura, T., Ueda, T., Yamamoto, T., Yamanaka, H., & Matsuzawa, Y. (2011). Multicenter, open-label study of long-term administration of febuxostat (TMX-67) in Japanese patients with hyperuricemia including gout. Journal of Clinical Rheumatology : Practical Reports On Rheumatic & Musculoskeletal Diseases, 17(4 Suppl 2), S50-6. https://doi.org/10.1097/RHU.0b013e31822541d0
Kamatani N, et al. Multicenter, Open-label Study of Long-term Administration of Febuxostat (TMX-67) in Japanese Patients With Hyperuricemia Including Gout. J Clin Rheumatol. 2011;17(4 Suppl 2):S50-6. PubMed PMID: 21654270.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter, open-label study of long-term administration of febuxostat (TMX-67) in Japanese patients with hyperuricemia including gout. 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 - S50 EP - 6 JF - Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases JO - J Clin Rheumatol VL - 17 IS - 4 Suppl 2 N2 - BACKGROUND: In previous clinical studies of hyperuricemia including gout, although serum uric acid (sUA) levels reduced to 6.0 mg/dL or less in about 80% of patients treated with 40 mg/d febuxostat, a nonpurine selective xanthine oxidase inhibitor, a few patients did not show this result. OBJECTIVE: The objective of the study was to evaluate the efficacy and safety of long-term febuxostat administration at up to 60 mg/d in patients with hyperuricemia and gout. METHODS: In a 52-week, multicenter, open-label trial, febuxostat was initially administered at 10 mg/d; then, the dosage was increased in a stepwise fashion to 40 mg/d. For sUA levels greater than 6.0 mg/dL at week 10, the dosage was increased to 60 mg/d from week 14 onward (60-mg group), but it was maintained at 40 mg/d until the end of the study for patients with sUA levels 6.0 mg/dL or less at week 10 (40-mg group). RESULTS: The sUA levels in both groups decreased dose dependently. At 52 weeks, 84.5% and 85.0% of the 40- and 60-mg groups, respectively, achieved mean sUA levels 6.0 mg/dL or less. There was no marked difference between the 2 dosage groups in terms of the incidence of adverse events. Furthermore, there were no noteworthy adverse events or adverse drug reactions in the patients with renal dysfunction, and no differences in drug efficacy up to 60 mg/d were noted between the patients with moderate or mild renal dysfunction and those with normal renal function. CONCLUSIONS: Febuxostat seems to be a promising therapeutic drug for gout or hyperuricemia, even in patients with renal dysfunction. SN - 1536-7355 UR - https://www.unboundmedicine.com/medline/citation/21654270/Multicenter_open_label_study_of_long_term_administration_of_febuxostat__TMX_67__in_Japanese_patients_with_hyperuricemia_including_gout_ L2 - https://doi.org/10.1097/RHU.0b013e31822541d0 DB - PRIME DP - Unbound Medicine ER -