Optimal range of serum urate concentrations to minimize risk of gouty attacks during antihyperuricemic treatment

Yamanaka, H; Togashi, Riko; Hakoda, Masayuki; Terai, Chihiro; Kashiwazaki, Sadao; Dan, Takashi; Kamatani, Naoyuki

doi:10.1016/s0009-9120(97)87849-6

Cited by 7 publications

(7 citation statements)

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“…An independent organization conducted randomized block allocation of the study drug. To minimize the risk of gouty arthritis due to rapid serum uric acid reduction, the dose titration method was adopted [11]. Most hyperuricemic patients treated with benzbromarone have a stably controlled serum uric acid level at a dose of 25-50 mg/day, thus the initial and maintenance doses of benzbromarone were set to 25 mg/day and 50 mg/day, respectively [12].…”

Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study

Hosoya

Sano²,

Sasaki³

et al. 2020

Clin Exp Nephrol

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Background Dotinurad is a novel selective urate reabsorption inhibitor that reduces serum urate levels in hyperuricemic patients with or without gout by selectively inhibiting urate transporter 1. This study was conducted to compare the efficacy and safety of dotinurad with those of benzbromarone. Methods In this 14-week, randomized, multicenter, double-blind, parallel-group, dose escalation, benzbromarone-controlled, phase 3 study, hyperuricemic patients with or without gout were randomized to two groups that received either dotinurad 2 mg or benzbromarone 50 mg. Dotinurad or benzbromarone was administered once a day for 14 weeks. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit. Results A total of 201 Japanese hyperuricemic patients with or without gout (dotinurad: 102, benzbromarone: 99) received at least one dose of the study drug. The mean percent change in serum uric acid level from the baseline to the final visit in the dotinurad and benzbromarone groups was 45.9% and 43.8%, respectively. Non-inferiority of dotinurad 2 mg to benzbromarone 50 mg in lowering serum uric acid was verified by the predefined non-inferiority margin (95% CI − 1.27 to 5.37%). The incidence of adverse events and adverse drug reactions was comparable between the two groups. Conclusion Dotinurad 2 mg was verified to have a non-inferior serum uric acid lowering effect compared with benzbromarone 50 mg, in Japanese hyperuricemic patients with or without gout. ClinicalTrials.gov Identifier NCT03100318.

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Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study

Hosoya

Sano²,

Sasaki³

et al. 2020

Clin Exp Nephrol

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“…Patients took allocated drug once daily after breakfast throughout the study. To minimize the risk of gouty arthritis in due to rapid serum uric acid reduction, we adopted the dose titration method [12]. The initial dose of dotinurad was 0.25 mg/day for the first 2 weeks and then 0.5 mg/day for 2 weeks.…”

Section: Inclusion and Exclusion Criteriamentioning

confidence: 99%

Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study

Hosoya

Sano²,

Sasaki³

et al. 2019

Clin Exp Nephrol

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Background Dotinurad, a novel selective urate reabsorption inhibitor (SURI) that has a future potential for the treatment of hyperuricemia, reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1). We evaluated the efficacy and safety of dotinurad in hyperuricemic Japanese patients with or without gout. Methods The study design was an exploratory, early phase 2 study that ran for 8 weeks. It was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study, and performed in a dose escalation manner. There were four study arms consisting of dotinurad 1, 2, or 4 mg, and placebo. The primary endpoint was the percent change in serum uric acid level from the baseline to the final visit. The secondary endpoint was the percentage of patients achieving a serum uric acid level ≤ 6.0 mg/dL at the final visit. Results A total of 80 hyperuricemic patients with or without gout were enrolled and randomly assigned to the dotinurad or placebo groups. The mean percent change in serum uric acid level from the baseline to the final visit in the dotinurad 1, 2, 4 mg, and placebo groups was 37.03%, 50.91%, 64.37%, and 0.85%, respectively. The percentages of patients achieving a serum uric acid level ≤ 6.0 mg/dL at the final visit in each group were 75.0%, 89.5%, 95.2%, and none, respectively. The incidence of adverse events was comparable among all groups. Conclusion Dotinurad has a substantial serum uric acid lowering effect in patients with hyperuricemia. No serious adverse event was found. ClinicalTrials.gov Identifier NCT02344862

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“…[1] Untreated or inadequately treated acute gout can develop into chronic gout, which is characterized by joint inflammation and destruction, persistent pain and the development of tophi (MSU crystals surrounded by chronic mononuclear and giant-cell reactions). [7] Moreover, since many patients with gout have chronic inflammation, some patients may require long-term anti-inflammatory treatment. [1,2,5] This article provides a summary of a recent review on the treatment of gout by Schlesinger.…”

Section: Caused By Hyperuricaemiamentioning

confidence: 99%

Treat gout with anti-inflammatories and urate-lowering therapies, unless such treatment is ineffective or inappropriate

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2012

Drugs & Therapy Perspectives

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Optimal range of serum urate concentrations to minimize risk of gouty attacks during antihyperuricemic treatment

Cited by 7 publications

References 0 publications

Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study

Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study

Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study

Treat gout with anti-inflammatories and urate-lowering therapies, unless such treatment is ineffective or inappropriate

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