Effects of lesinurad: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Lesinurad, a selective uric acid reabsorption inhibitor, has been shown to be effective in lowering uric acid levels in patients with gout. 23 showed that lesinurad monotherapy was effective in reducing uric acid levels and gout flares in patients with gout who were intolerant to xanthine oxidase inhibitors. 17 showed that lesinurad combined with febuxostat was effective in reducing uric acid levels and tophi size in patients with tophaceous gout. 12 showed that lesinurad in combination with allopurinol was effective in lowering uric acid levels in patients with gout who had an inadequate response to standard of care. 10 explained that lesinurad works by inhibiting URAT1, a renal urate transporter, thus reducing serum uric acid levels. 8 suggested that lesinurad may have a positive effect on metabolic diseases such as type 2 diabetes by acting as a PPARγ modulator.

Benefits and Risks

Benefit Summary

Lesinurad may be useful in effectively lowering uric acid levels and preventing gout attacks. 23 , 17 , 12 Lesinurad may also help reduce the size of tophi in patients with gout. 17 Lesinurad may be beneficial in treating metabolic diseases as well. 8

Risk Summary

Lesinurad may cause a number of side effects. 3 suggested that lesinurad may increase the risk of muscle injury. 18 indicated that lesinurad may be associated with higher mortality. Lesinurad can interact with other drugs. 7 , 22 Lesinurad may affect renal function. 21 Lesinurad may affect liver function. 13

Comparison Between Studies

Commonalities

Multiple studies have shown that lesinurad is effective in lowering uric acid levels. 23 , 17 , 12 , 10 Lesinurad has also been shown to be effective in lowering uric acid levels when used in combination with other uric acid-lowering drugs. 17 , 12

Differences

The effectiveness of lesinurad varies between studies. 23 showed that lesinurad monotherapy was effective in reducing uric acid levels and gout flares, while 17 showed that lesinurad was more effective in reducing tophi size when combined with febuxostat. The side effects of lesinurad also vary between studies. 3 suggested that lesinurad may increase the risk of muscle injury, while 18 indicated that lesinurad may be associated with higher mortality.

Consistency and Contradictions in Results

Multiple studies have shown that lesinurad effectively lowers uric acid levels. 23 , 17 , 12 , 10 However, research on the side effects of lesinurad has shown inconsistent results. 3 indicated a potential risk of muscle injury, while 18 pointed toward a potential risk of increased mortality. Further research is needed to explain these contradictory findings.

Practical Application Considerations

Lesinurad is a potential drug for treating gout; however, it is important to consider the risk of side effects. 3 , 18 It's crucial to have a conversation with your doctor to carefully weigh the risks and benefits of taking lesinurad. Additionally, lesinurad can interact with other medications, so it is vital to inform your doctor about all other medications you are taking. 7 , 22

Current Research Limitations

Research on lesinurad remains limited, especially regarding its long-term safety and efficacy. Additionally, the risk of side effects from lesinurad may vary among individuals. Further research is required to address these limitations.

Future Research Directions

Long-term studies are needed to evaluate the safety and efficacy of lesinurad. Research into ways to mitigate the risk of lesinurad side effects is crucial. Additional research should investigate the interactions between lesinurad and other medications. 7 , 22

Conclusion

Lesinurad has been shown to effectively lower uric acid levels, but it is essential to consider the associated risks. 3 , 18 Consult your physician to carefully evaluate the risks and benefits of taking lesinurad. Further research is necessary to provide a more comprehensive understanding of its effects.

Literature analysis of 24 papers
Positive Content
22
Neutral Content
1
Negative Content
1
Article Type
4
1
1
7
24
3.

Urate-Lowering Drugs and Muscle Injury: A Systematic Review and Network Meta-Analysis.

Author: MitsuboshiSatoru, MorizumiMakoto, KotakeKazumasa, KasedaRyohei, NaritaIchiei

Muscle injury

A study found no increased risk of muscle injury with 6 different urate-lowering drugs compared to placebo.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

[Gout: what's new?].

Author: ChalèsGérard, GuggenbuhlPascal

Gout treatment
Urate lowering

Gout, despite being undertreated, has seen increased research. The prevalence in Metropolitan France is estimated at 0.9%. New diagnostic tools, imaging techniques, and treatment options, including low-dose colchicine and interleukin-1 blockers, have emerged.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : French

5.

Zurampic Protects Pancreatic β-Cells from High Uric Acid Induced-Damage by Inhibiting URAT1 and Inactivating the ROS/AMPK/ERK Pathways.

Author: XinYing, WangKun, JiaZhaotong, XuTao, XuQiang, ZhangChao, LiuJia, ChenRui, DuZhongcai, SunJianjing

Pancreatic β-cell protection

Zurampic has a protective effect on pancreatic β-cells against uric acid induced-damage by inhibiting URAT1 and inactivating the ROS/AMPK/ERK pathway.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Retracted PublicationCases where a publication has been formally withdrawn due to the discovery of serious errors or misconduct.

Language : English

6.

Updates on the treatment of gout, including a review of updated treatment guidelines and use of small molecule therapies for difficult-to-treat gout and gout flares.

Author: SoskindRose, AbaziaDaniel T, BridgemanMary Barna

Gout management
Urate lowering

Gout is treated with various medications to manage acute flares and lower uric acid levels. This article discusses existing and novel therapies, including interleukin-1 inhibitors, highlighting advancements in understanding the pathophysiology and treatment of gout.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Urate transporter inhibitor lesinurad is a selective peroxisome proliferator-activated receptor gamma modulator (sPPARγM) in vitro.

Author: HeitelPascal, GellrichLeonie, HeeringJan, GoebelTamara, KahntAstrid, ProschakEwgenij, Schubert-ZsilaveczManfred, MerkDaniel

Gout treatment
Metabolic disease

Lesinurad, a drug used for gout, also activates PPARγ, a protein involved in regulating metabolism. This suggests that lesinurad may have benefits for patients with gout who also have metabolic conditions like type 2 diabetes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Indirect pharmacodynamic models for responses with circadian removal.

Author: AyyarVivaswath S, KrzyzanskiWojciech, JuskoWilliam J

Improved drug response

This study proposes a mathematical model to understand how drug effects can change over time due to biological rhythms, particularly circadian rhythms. This model can capture drug responses in various scenarios, including the uricosuric effects of lesinurad. It provides a mechanistic understanding of drug effects with varying baselines.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

10.

Lesinurad, a novel, oral compound for gout, acts to decrease serum uric acid through inhibition of urate transporters in the kidney.

Author: MinerJeffrey N, TanPhilip K, HyndmanDavid, LiuSha, IversonCory, NanavatiPayal, HagertyDavid T, ManhardKimberly, ShenZancong, GirardetJean-Luc, YehLi-Tain, TerkeltaubRobert, QuartBarry

Gout treatment

Lesinurad is a new drug for gout that inhibits URAT1, a transporter involved in uric acid excretion. It offers a potential alternative to current treatments with fewer side effects and drug interactions.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Pharmacodynamic, pharmacokinetic and tolerability evaluation of concomitant administration of lesinurad and febuxostat in gout patients with hyperuricaemia.

Author: FleischmannRoy, KerrBradley, YehLi-Tain, SusterMatt, ShenZancong, PolventElizabeth, HingoraniVijay, QuartBarry, ManhardKimberly, MinerJeffrey N, BaumgartnerScott,

Lowered sUA
Well tolerated

A phase IB study of gout patients found that combining lesinurad and febuxostat resulted in 100% of subjects achieving a serum uric acid level <6 mg/dl and up to 100% achieving a serum uric acid level <5 mg/dl. No clinically relevant changes in the pharmacokinetics of either drug were noted. The combination was well tolerated.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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.

Language : English

12.

Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study).

Author: BardinThomas, KeenanRobert T, KhannaPuja P, KopickoJeff, FungMaple, BhaktaNihar, AdlerScott, StorgardChris, BaumgartnerScott, SoAlexander

Gout flare reduction
sUA lowering
Gout
Renal-related adverse events
Serious adverse events

Lesinurad, a drug for gout, added to allopurinol significantly improved serum uric acid levels compared to allopurinol alone in 610 patients. The 200mg dose of lesinurad was generally well tolerated.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

15.

Effects of Food and Antacids on Pharmacokinetics and Pharmacodynamics of Lesinurad, a Selective Urate Reabsorption Inhibitor.

Author: ShenZancong, LeeCaroline A, ValdezShakti, YangXiaojuan, WilsonDavid M, FlanaganTalia, GillenMichael

Uric acid reduction
Antacid interaction

Food did not significantly alter the pharmacokinetics and pharmacodynamics of lesinurad, a uric acid reabsorption inhibitor. However, high doses of antacids reduced lesinurad's AUC and uric acid-lowering effect. Low doses of antacids did not affect lesinurad's effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Determination of lesinurad in rat plasma by a UHPLC-MS/MS assay.

Author: ZhouXiao-Yang, YuanLing-Jing, ChenZhe, TangPeng-Fei, LiXiang-Yu, HuGuo-Xin, CaiJian-Ping

Gout treatment
Urate reduction

A new, validated method was developed to measure lesinurad, a drug used to treat gout, in rat plasma. The method can be used to study the drug's pharmacokinetics and optimize its use.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

17.

Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial.

Author: DalbethNicola, JonesGraeme, TerkeltaubRobert, KhannaDinesh, KopickoJeff, BhaktaNihar, AdlerScott, FungMaple, StorgardChris, BaumgartnerScott, Perez-RuizFernando

Tophi reduction
Urate reduction
Increased creatinine levels

This study investigated the efficacy and safety of lesinurad in combination with febuxostat in a 12-month phase III trial in patients with tophaceous gout. Treatment with lesinurad in combination with febuxostat demonstrated superior lowering of serum UA levels as compared with febuxostat alone, with clinically relevant added effects on tophi and an acceptable safety profile with lesinurad 200 mg.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Potential Dangers of Serum Urate-Lowering Therapy.

Author: Perez-GomezMaria Vanessa, BartschLorenz-Alexander, Castillo-RodriguezEsmeralda, Fernandez-PradoRaul, KanbayMehmet, OrtizAlberto

Increased mortality

Lowering uric acid levels with medication has been linked to higher mortality in gout patients in several clinical trials, despite observational studies showing a link between high uric acid and adverse outcomes. These trials observed higher mortality with greater uric acid reduction, suggesting a potential safety concern. Uric acid acts as an antioxidant, and further research is needed to determine the optimal uric acid levels and the safety of lowering it below certain thresholds.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Investigational drugs for hyperuricemia.

Author: ShahidHania, SinghJasvinder A

Hyperuricemia treatment

Several new drugs are in preclinical and early clinical trials for hyperuricemia. Arhalofenate, ulodesine (BCX-4208), and lesinurad are in or have completed Phase II and Phase III trials. The goal of these therapies is to address the unsatisfactory control of serum uric acid and to provide better tolerability compared to traditional agents.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Supratherapeutic dose evaluation and effect of lesinurad on cardiac repolarization: a thorough QT/QTc study.

Author: ShenZancong, GillenMichael, TieuKathy, NguyenMai, HarmonErin, WilsonDavid M, KerrBradley, LeeCaroline A

Gout treatment

Lesinurad has a defined maximum tolerated dose and does not significantly prolong the QT interval. A study determined the maximum tolerated dose of lesinurad and investigated its impact on cardiac repolarization, finding no significant QT prolongation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

22.

Lesinurad: Evaluation of Pharmacokinetic and Pharmacodynamic Interactions With Warfarin in Healthy Volunteers.

Author: ShenZancong, LeeCaroline A, WallachKathleen, ValdezShakti, WilsonDavid M, KerrBradley, GillenMichael

Safe drug interaction

Lesinurad is a drug used to treat gout. This study investigated whether lesinurad interacts with warfarin, a blood thinner. The results showed no significant interaction, suggesting that patients can safely take both medications together.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

23.

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

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

Sustained sUA lowering
Renal-related TEAEs
Serum creatinine elevations

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.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

24.

Efficacy and Safety of Lesinurad in Patients with Hyperuricemia Associated with Gout: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Author: WuJie-Ying, ChangYa-Ting, LinYing-Chin, LeeChia-Hwa, LohEl-Wui, WuMei-Yi, ChangYu-Sheng, TamKa-Wai

Reduced uric acid
Adverse events

Lesinurad combined with xanthine oxidase inhibitors is effective and well tolerated in patients with gout who have not achieved an adequate response to xanthine oxidase inhibitors alone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

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