Evidence map›Paper›PMID 27230988›Full record

Observational studyAdvances in therapy2016

Comorbidity Burden in Trial-Aligned Patients with Established Gout in Germany, UK, US, and France: a Retrospective Analysis.

Fredrik Nyberg, Laura Horne, Robert Morlock, Javier Nuevo, Chris Storgard, Lalitha Aiyer, Dionne M Hines, Xavier Ansolabehere, Pierre Chevalier

Registry-linked trialOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Advances in therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05698680 (Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 22% 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.

NCT05698680 phase4terminatednot on this mapstarted 2023, after this paper: background citation

Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care

TypeinterventionalSponsorUniversity Medicine GreifswaldRan2023 to 2026Enrolled186ConditionsAcute GoutArmsPrednisolone 30 mg Tablet, Colchicine 0.5 mg Oral Tablet
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 18 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Ethanol Extract ofEvidence-based complementary and alternative medicine : eCAM · 2018
    Article
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  7. Review
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

9 authors at 5 institutions in 4 countries.

Fredrik NybergMedical Evidence and Observational Research, Global Medical Affairs, AstraZeneca, Mölndal, Sweden. Fredrik.Nyberg@astrazeneca.com.
Laura HorneMedical Evidence and Observational Research, Global Medical Affairs, AstraZeneca, Wilmington, DE, USA.
Robert MorlockArdea Biosciences, San Diego, CA, USA.
Javier NuevoMedical Evidence and Observational Research, Global Medical Affairs, AstraZeneca, Madrid, Spain.
Chris StorgardArdea Biosciences, San Diego, CA, USA.
Lalitha AiyerArdea Biosciences, San Diego, CA, USA.
Dionne M HinesIMS Health, Alexandria, VA, USA.
Xavier AnsolabehereIMS Health, Paris, France.
Pierre ChevalierIMS Health, Vilvoorde, Belgium.
AstraZeneca (Spain) · ESAstraZeneca (United States) · USInstitut Polytechnique de Bordeaux · FRIQVIA (United States) · USUniversity of Gothenburg · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with gout have numerous comorbidities. We aimed to estimate the prevalence and incidence rates of renal and cardiovascular morbidities in trial-aligned patients with established gout in Germany (DE), the United Kingdom (UK), the United States (US), and France (FR).

methodsThis longitudinal cohort study used retrospective data from IMS Disease Analyzer™ (DE, FR), Clinical Practice Research Datalink-Hospital Episode Statistics (UK), and IMS' PharMetrics Plus database linked with outpatient laboratory results (US). Included patients were ≥18 years at index date (January 1, 2010; all dates +1 year for FR), with continuous enrollment during the pre-index year, had "prevalent established gout" determined by data in the pre-index year, and ≥1 documented visit after index date; additional inclusion/exclusion criteria were aligned with recent gout clinical trials. Look-back for comorbidity prevalence extended to January 1, 2003 (US: January 1, 2009). Follow-up for incidence extended from index date to at most March 26, 2013 (FR: May 31, 2014). Events of interest were identified by diagnostic codes and/or laboratory data.

resultsThe trial-aligned cohorts included 35,118 (DE), 24,607 (UK), 121,591 (US), and 17,338 (FR) patients. Among renal conditions, baseline diagnosis of chronic kidney disease/renal failure was most prevalent in the UK followed by DE; abnormal serum creatinine was most prevalent in the UK. Hypertension was the most prevalent cardiovascular diagnosis in all countries, followed by ischemic heart disease (IHD) and myocardial infarction. Incidence rates (per 100 patient-years) for new/worsening renal impairment ranged from 1.67 (DE) to 4.34 (US) and for nephrolithiasis diagnosis from 0.31 (FR) to 3.79 (US). The incidence rates for hypertension diagnosis were highest among cardiovascular-related events, ranging from 3.23 (UK) to 20.27 (US), followed by IHD.

conclusionsPatients with established gout such as those included in gout trials have a high burden of established morbidity and new diagnoses of morbid events. Consideration of comorbidities, which greatly exacerbate disease burden, is important in gout management.

fundingAstraZeneca.

Indexed as

AdultAgedCardiovascular DiseasesDatabases, FactualFemaleFranceGermanyGoutHumansIncidenceKidney DiseasesMaleMiddle AgedMyocardial InfarctionPrevalenceRetrospective StudiesCardiovascularComorbiditiesEuropean UnionGoutIncidencePrevalenceRenalSerum uric acidUnited States

Identifiers

PMID27230988
PMCPMC4939171
OpenAlexW2405569672

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.