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To examine the safety and efficiency of Lesinurad in a 6 month, phase 3 clinical trial and extension analysis.
Management of serum uric acid sUA level is the most recommended
therapy for gout patients. Until recently, the only uricosuric available in the
USA was probenecid, while only probenecid and benzbromarone were available in
the European Union. The results of the present study showed that Lesinurad 200
mg in combination with a xanthine oxidase inhibitor (XOI) significantly lowered
the sUA.
To examine the safety and efficiency of Lesinurad in a 6
month, phase 3 clinical trial and extension analysis.
The gout patients with ⩾6.5 mg/dl serum uric acid (sUA)
and cannot take a xanthine oxidase inhibitor (XOI) were categorized to take
oral 400 mg Lesinurad every day or placebo. The proportion of patients with sUA
<6.0 mg/dl at sixth month was considered as the primary outcome.
Treatment-emergent adverse events (TEAEs) and laboratory data were utilised for
safety assessments. Patients who accomplished the analysis were suitable for an
open-label, uncontrolled extension analysis of 400 mg Lesinurad monotherapy.
The patients took Lesinurad obtained significant primary outcome as
compared to the placebo group. Overall TEAE rates were raised within Lesinurad
group; renal-related serious TEAEs, renal-related TEAEs and increased serum
creatinine levels present only among patients received Lesinurad. One hundred
forty-three participants selected for the extension study. A fast and sustained
reduced sUA obtained with the 400 mg Lesinurad treatment which continued for up
to 18 months before the investigation was stopped prematurely. No new safety
verdicts were seen during the extension analysis.
Lesinurad 400 mg monotherapy showed higher sUA lowering
than placebo, with maintained outcomes for up to 18 months within gout patients
who intolerated to XOIs. Lesinurad should not be employed as monotherapy due to
renal-related adverse events and high prevalence of serum creatinine
elevations.
Rheumatology, Volume 56, Issue 12, 1 December 2017, Pages 2170–2178
https://academic.oup.com/rheumatology/article-abstract/56/12/2170/4191370?redirectedFrom=fulltext
Lesinurad monotherapy in gout patients intolerant to a xanthine oxidase inhibitor: a 6 month phase 3 clinical trial and extension study
Anne-Kathrin Tausche et al.
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