Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout.
BACKGROUND
Dotinurad is a novel selective urate reabsorption inhibitor (SURI) which reduces serum uric acid levels by selectively inhibiting urate transporter 1 (URAT1). This study was intended to verify the efficacy and safety of dotinurad following treatment for 34 or 58 weeks in hyperuricemic patients with or without gout.


METHODS
This long-term study had an open-label design with dose escalation. The dose of dotinurad started at 0.5 mg/day and was increased progressively to 2 mg/day. If the serum uric acid level of patients did not reach ≤ 6 mg/dL at week 14, the dose was increased to 4 mg/day. The primary endpoint was the percent change in serum uric acid level from the baseline to each visit.


RESULTS
At a dose of 2 mg, serum uric acid levels at week 34 and 58 were reduced from the baseline by 46.73% and 47.17%, respectively; at 4 mg, the respective values were 54.92% and 57.35%. At week 34 and 58, the percentages of patients achieving a serum uric acid levels ≤ 6.0 mg/dL with 2-mg dose were 89.11% and 91.30%, respectively; with 4 mg, the respective rates were 97.50% and 100.00%. In addition, the incidences of adverse events and adverse drug reactions were 65.2% and 21.8%, respectively.


CONCLUSION
Dotinurad at doses of 2-4-mg sufficiently reduced serum uric acid levels in hyperuricemic patients with or without gout, and its efficacy and safety were verified for long-term administration. ClinicalTrials.gov Identifier: NCT03006445.
['Hosoya|Tatsuo|T|', 'Fushimi|Masahiko|M|', 'Okui|Daisuke|D|', 'Sasaki|Tomomitsu|T|', 'Ohashi|Tetsuo|T|']
D000328:Adult D052160:Benzothiazoles D005260:Female D006073:Gout D006801:Humans D033461:Hyperuricemia D007564:Japan D008297:Male D008875:Middle Aged D027361:Organic Anion Transporters D027701:Organic Cation Transport Proteins D013997:Time Factors D016896:Treatment Outcome D014527:Uric Acid D014528:Uricosuric Agents
Dotinurad Gout Selective urate reabsorption inhibitor FYU-981 Hyperuricemia URAT1 inhibitor