Evidence map›Paper›PMID 29102979›Full record

Trial reportJournal of the American Heart Association2017

Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

Lhanoo Gunawardhana, Lachy McLean, Henry A Punzi, Barbara Hunt, Robert N Palmer, Andrew Whelton, Daniel I Feig

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01496469 (A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 3% 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.

NCT01496469 phase2completednot on this map

A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension

TypeinterventionalSponsorTakedaRan2012 to 2014Enrolled121ConditionsHypertensionArmsFebuxostat, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pharmacotherapy for hyperuricaemia in hypertensive patients.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
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  11. Review
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  13. Gout and hyperuricaemia: modifiable cardiovascular risk factors?Frontiers in cardiovascular medicine · 2023
    Review
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  15. Article
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  17. Review
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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

7 authors at 4 institutions in 1 country.

Lhanoo GunawardhanaTakeda Pharmaceuticals USA, Deerfield, IL lhanoo.gunawardhana@takeda.com.
Lachy McLeanTakeda Pharmaceuticals USA, Deerfield, IL.
Henry A PunziPunzi Medical Center, Carrollton, TX.
Barbara HuntTakeda Pharmaceuticals USA, Deerfield, IL.
Robert N PalmerTakeda Pharmaceuticals USA, Deerfield, IL.
Andrew WheltonJohns Hopkins University, Baltimore, MD.
Daniel I FeigUniversity of Alabama, Birmingham, AL.
Deerfield (United States) · USTakeda (United States) · USJohns Hopkins University · USUniversity of Alabama · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHyperuricemia is associated with hypertension, with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. Consequently, serum uric acid reduction may help lower blood pressure (BP). A Phase 2, double-blind, placebo-controlled trial was conducted to assess the potential BP-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ≥0.42 mmol/L [≥7.0 mg/dL]). METHODS AND

resultsSubjects (n=121) were randomized 1:1 to febuxostat 80 mg once daily or to placebo. The primary end point was change from baseline to Week 6 in 24-hour mean ambulatory systolic BP (SBP). Additional end points included the following: change from baseline to Week 3 in 24-hour mean SBP and changes from baseline to Weeks 3 and 6 in 24-hour mean ambulatory diastolic BP, serum uric acid, mean daytime and nighttime ambulatory SBP/diastolic BP, and clinic SBP/diastolic BP. For the overall study population, there were no significant differences between febuxostat and placebo for changes from baseline to Weeks 3 or 6 in ambulatory, daytime or nighttime, or clinic SBP or diastolic BP. However, in a preplanned subgroup analysis, there was a significant decrease in SBP from baseline to Week 6 in subjects with normal renal function (estimated glomerular filtration rate ≥90 mL/min) treated with febuxostat versus placebo; least squares mean difference, -6.7; 95% confidence interval -13.3 to -0.0;

conclusionsThis study suggests that febuxostat may lower BP in hyperuricemic patients with hypertension and normal renal function; further studies should be conducted to confirm this finding. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01496469.

Indexed as

AdultAgedAntihypertensive AgentsBiomarkersBlood PressureBlood Pressure Monitoring, AmbulatoryDouble-Blind MethodEnzyme InhibitorsFebuxostatFemaleHumansHypertensionHyperuricemiaMaleMiddle AgedNorth AmericaAntihypertensive AgentsBiomarkersEnzyme InhibitorsFebuxostatUric AcidXanthine Oxidaseambulatory blood pressure monitoringfebuxostathypertensionhyperuricemiaserum urateuric acid

Identifiers

PMID29102979
PMCPMC5721765
OpenAlexW2765598589

What Socratic 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 Socratic graph.