Evidence map›Paper›PMID 29531784›Full record

ArticleRMD open2018

Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with allopurinol in adults with gout: a phase IIa, open-label study.

Roy Fleischmann, Peter Winkle, Jeffrey N Miner, Xiaohong Yan, Liz Hicks, Shakti Valdez, Jesse Hall, Sha Liu, Zancong Shen, Michael Gillen and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in RMD open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02498652 (A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT02498652 phase2completednot on this map

A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout

TypeinterventionalSponsorArdea Biosciences, Inc.Ran2015 to 2016Enrolled41ConditionsGoutArmsRDEA3170 2.5 mg, allopurinol 300 mg
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Interventions for tophi in gout.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Clinical Effects of Xanthine Oxidase Inhibitors in Hyperuricemic Patients.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2021
    Review
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Roy FleischmannMetroplex Clinical Research Center, University of Texas, SW Medical Center, Dallas, Texas, USA.
Peter WinkleAnaheim Clinical Trials, Anaheim, California, USA.
Jeffrey N MinerArdea Biosciences, San Diego, California, USA.
Xiaohong YanArdea Biosciences, San Diego, California, USA.
Liz HicksArdea Biosciences, San Diego, California, USA.
Shakti ValdezArdea Biosciences, San Diego, California, USA.
Jesse HallArdea Biosciences, San Diego, California, USA.
Sha LiuMetroplex Clinical Research Center, University of Texas, SW Medical Center, Dallas, Texas, USA.
Zancong ShenArdea Biosciences, San Diego, California, USA.
Michael GillenAstraZeneca LP, Gaithersburg, Maryland, USA.
Martha Hernandez-IllasQPS MRA (Miami Clinical Research), Miami, Florida, USA.
Anaheim Clinical Trials · USAstraZeneca (United States) · USMetroplex Clinical Research Center · USThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesVerinurad (RDEA3170) is a high affinity, selective uric acid transporter (URAT1) inhibitor indevelopment for treating gout and asymptomatic hyperuricaemia. This phase IIa study evaluated the pharmacodynamics, pharmacokinetics and safety of verinurad combined with allopurinol versus allopurinol alone in adults with gout.

methodsForty-one subjects were randomised into two cohorts of verinurad (2.5-20 mg) plus allopurinol (300 mg once daily) versus allopurinol 300 mg once daily, 600 mg once daily or 300 mg twice daily alone. Each treatment period was 7 days. Serial plasma/serum and urine samples were assayed for verinurad, allopurinol, oxypurinol and uric acid.

resultsSerum pharmacodynamic data pooled across cohorts demonstrated maximum per cent decreases in serum urate (sUA) from baseline (E

conclusionVerinurad coadministered with allopurinol produced dose-dependent decreases in sUA. All dose combinations of verinurad and allopurinol were generally well tolerated. These data support continued investigation of oral verinurad in patients with gout. TRIAL REGISTRATION NUMBER: NCT02498652.

Indexed as

goutpharmacokineticstreatment

Identifiers

PMID29531784
PMCPMC5845419
OpenAlexW2785995518

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.