Trial reportClinical and experimental nephrology2020
Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study.
Trial report in Clinical and experimental nephrology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03100318 (Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981), which is not on this map. Cited by 28 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)
Who cites it
28 citing papers in PubMed, 55 citations in OpenAlex.
- Efficacy and Safety of Dotinurad Versus Febuxostat for the Treatment of Gout: A Randomized, Multicenter, Double-Blind, Phase 3 Trial in China.Arthritis & rheumatology (Hoboken, N.J.) · 2025Trial
- Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis.Clinical and experimental nephrology · 2025Trial
- Efficacy and safety of epaminurad, a potent hURAT1 inhibitor, in patients with gout: a randomized, placebo-controlled, dose-finding study.Arthritis research & therapy · 2025Trial
- Redefining Uric Acid and Cardiovascular Risk: Vascular Gout and Crystal-Driven Vascular Inflammation in Asymptomatic Hyperuricemia.JACC. Asia · 2026Review
- Targeted Treatment for Hyperuricemia: The Drug Pipeline.Drugs & aging · 2026Review
- A Novel Dual URAT1/GLUT9 Inhibitor Reduces Hyperuricemia by Enhancing Uric Acid Excretion and Attenuating Renal Fibrosis.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease.Internal medicine (Tokyo, Japan) · 2026Observational
- URAT1 inhibition in hyperuricemia and gout: from transporter biology to clinical precision therapy.Frontiers in immunology · 2026Review
- A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults.Clinical drug investigation · 2025Article
- Hyperuricemia in Chronic Kidney Disease: Emerging Pathophysiology and a Novel Therapeutic Strategy.International journal of molecular sciences · 2025Review
- [Diagnostics and treatment of gout : Short version of the German S3 guideline].Zeitschrift fur Rheumatologie · 2025Review
- Review
- Dotinurad Treatment for Patients With Hyperuricemia Complicating CKD.Kidney international reports · 2025Article
- Article
- Current Challenges and Emerging Therapies in the Treatment of Gout.Current rheumatology reviews · 2025Review
- Research progress on multidimensional intervention strategies for hyperuricemia: Western medicine, Traditional Chinese Medicine, and emerging therapies.Frontiers in endocrinology · 2025Review
- Hyperuricemia and its related diseases: mechanisms and advances in therapy.Signal transduction and targeted therapy · 2024Review
- Pipeline Therapies for Gout.Current rheumatology reports · 2024Review
- Article
- Discovery of Novel Biphenyl Carboxylic Acid Derivatives as Potent URAT1 Inhibitors.Molecules (Basel, Switzerland) · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDotinurad 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.
methodsIn 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.
resultsA 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.
conclusionDotinurad 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.