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Lesinurad monotherapy in gout patients intolerant to a xanthine oxidase inhibitor: a 6 month phase 3 clinical trial and extension study.

Author: AdlerScott, AltenRieke, BaumgartnerScott, BhaktaNihar, DalbethNicola, FungMaple, KopickoJeff, SaagKenneth, StorgardChris, TauscheAnne-Kathrin

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

In patients with gout and intolerance/contraindication to XOIs, lesinurad 400 mg monotherapy demonstrated superior sUA lowering compared with placebo, with sustained effects for up to 18 months. Due to a high incidence of serum creatinine elevations and renal-related adverse events, including serious adverse events with lesinurad 400 mg, lesinurad should not be used as monotherapy.
Paper Details　
Original Abstract of the Article :
OBJECTIVE: To investigate the efficacy and safety of lesinurad, a selective uric acid reabsorption inhibitor, in a 6 month, phase 3 clinical trial and extension study. METHODS: Patients with gout who cannot take a xanthine oxidase inhibitor (XOI) and have serum uric acid (sUA) ⩾6.5 mg/dl were rando...See full text at original site
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引用元：
https://doi.org/10.1093/rheumatology/kex350

データ提供：米国国立医学図書館（NLM）

Lesinurad: A New Frontier in Gout Treatment

Gout, a painful condition caused by high levels of uric acid in the blood, can be challenging to manage. This study explores the efficacy and safety of lesinurad, a selective uric acid reabsorption inhibitor, in patients with gout who cannot tolerate xanthine oxidase inhibitors (XOIs). The researchers conducted a phase 3 clinical trial and extension study to assess the effectiveness of lesinurad monotherapy in reducing serum uric acid levels and managing gout symptoms.

Navigating the Uric Acid Desert

The trial demonstrated that lesinurad monotherapy effectively reduced serum uric acid levels in patients intolerant to XOIs. However, the researchers also identified a significant incidence of serum creatinine elevations and renal-related adverse events. This suggests that lesinurad should not be used as monotherapy due to potential kidney-related risks.

A New Chapter in Gout Treatment

This study highlights the importance of considering alternative treatment options for patients with gout who cannot tolerate traditional medications. Lesinurad, while effective, requires careful monitoring and may not be suitable for all individuals. Further research is needed to develop safer and more effective treatments for gout, minimizing the risk of adverse effects.

Dr.Camel's Conclusion

This study provides valuable insights into the potential benefits and risks of lesinurad in treating gout. While lesinurad demonstrates efficacy in reducing uric acid levels, the study's findings emphasize the importance of careful monitoring and potential risks associated with its use. This research highlights the ongoing search for safer and more effective treatment options for gout, ensuring optimal care for individuals navigating this challenging condition.

Date :
  1. Date Completed 2017-12-07
  2. Date Revised 2018-05-04
Further Info :

Pubmed ID

29029210

DOI: Digital Object Identifier

10.1093/rheumatology/kex350

Related Literature

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SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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