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  1. AU="Dumbleton, Jennifer S"
  2. AU="Le Cam Bouveret, Nancy"
  3. AU="Shetty, Sharanya B"
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  34. AU="Robles-Musso Castillo, Emilio"
  35. AU="Vahdatihassani, Faezeh"
  36. AU="Maria Pala"
  37. AU=Singh Indra
  38. AU="Gallacher, Nicola"
  39. AU="Chen, Pei-Min"
  40. AU=Andre L
  41. AU="Aleksandra I. Pivovarova"
  42. AU="Cruz, Thainá Gabriele Camargo da"
  43. AU="Atkins, Peter"

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  1. Artikel ; Online: Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease: the ALL-HEART RCT and economic evaluation.

    Mackenzie, Isla S / Hawkey, Christopher J / Ford, Ian / Greenlaw, Nicola / Pigazzani, Filippo / Rogers, Amy / Struthers, Allan D / Begg, Alan G / Wei, Li / Avery, Anthony J / Taggar, Jaspal S / Walker, Andrew / Duce, Suzanne L / Barr, Rebecca J / Dumbleton, Jennifer S / Rooke, Evelien D / Townend, Jonathan N / Ritchie, Lewis D / MacDonald, Thomas M

    Health technology assessment (Winchester, England)

    2024  Band 28, Heft 18, Seite(n) 1–55

    Abstract: Background: Allopurinol is a xanthine oxidase inhibitor that lowers serum uric acid and is used to prevent acute gout flares in patients with gout. Observational and small interventional studies have suggested beneficial cardiovascular effects of ... ...

    Abstract Background: Allopurinol is a xanthine oxidase inhibitor that lowers serum uric acid and is used to prevent acute gout flares in patients with gout. Observational and small interventional studies have suggested beneficial cardiovascular effects of allopurinol.
    Objective: To determine whether allopurinol improves major cardiovascular outcomes in patients with ischaemic heart disease.
    Design: Prospective, randomised, open-label, blinded endpoint multicentre clinical trial.
    Setting: Four hundred and twenty-four UK primary care practices.
    Participants: Aged 60 years and over with ischaemic heart disease but no gout.
    Interventions: Participants were randomised (1 : 1) using a central web-based randomisation system to receive allopurinol up to 600 mg daily that was added to usual care or to continue usual care.
    Main outcome measures: The primary outcome was the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes were non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, all-cause mortality, hospitalisation for heart failure, hospitalisation for acute coronary syndrome, coronary revascularisation, hospitalisation for acute coronary syndrome or coronary revascularisation, all cardiovascular hospitalisations, quality of life and cost-effectiveness. The hazard ratio (allopurinol vs. usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis.
    Results: From 7 February 2014 to 2 October 2017, 5937 participants were enrolled and randomised to the allopurinol arm (
    Limitations: The results may not be generalisable to younger populations, other ethnic groups or patients with more acute ischaemic heart disease. One thousand six hundred and thirty-seven participants (57.4%) in the allopurinol arm withdrew from randomised treatment, but an on-treatment analysis gave similar results to the main analysis.
    Conclusions: The ALL-HEART study showed that treatment with allopurinol 600 mg daily did not improve cardiovascular outcomes compared to usual care in patients with ischaemic heart disease. We conclude that allopurinol should not be recommended for the secondary prevention of cardiovascular events in patients with ischaemic heart disease but no gout.
    Future work: The effects of allopurinol on cardiovascular outcomes in patients with ischaemic heart disease and co-existing hyperuricaemia or clinical gout could be explored in future studies.
    Trial registration: This trial is registered as EU Clinical Trials Register (EudraCT 2013-003559-39) and ISRCTN (ISRCTN 32017426).
    Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/36/41) and is published in full in
    Mesh-Begriff(e) Humans ; Male ; Middle Aged ; Aged ; Female ; Allopurinol/therapeutic use ; Cost-Benefit Analysis ; Acute Coronary Syndrome ; Quality of Life ; Prospective Studies ; Uric Acid ; Myocardial Ischemia/drug therapy ; Gout/drug therapy ; Stroke/drug therapy ; Myocardial Infarction/drug therapy
    Chemische Substanzen Allopurinol (63CZ7GJN5I) ; Uric Acid (268B43MJ25)
    Sprache Englisch
    Erscheinungsdatum 2024-03-29
    Erscheinungsland England
    Dokumenttyp Randomized Controlled Trial ; Journal Article
    ZDB-ID 2006765-3
    ISSN 2046-4924 ; 1366-5278
    ISSN (online) 2046-4924
    ISSN 1366-5278
    DOI 10.3310/ATTM4092
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT).

    Stevenson, Diane J / Avery, Anthony J / Coupland, Carol / Hobbs, F D Richard / Kendrick, Denise / Moore, Michael V / Morris, Clive / Rubin, Greg P / Smith, Murray D / Hawkey, Christopher J / Dumbleton, Jennifer S

    Trials

    2022  Band 23, Heft 1, Seite(n) 140

    Abstract: Background: The Helicobacter Eradication Aspirin Trial (HEAT) is a multicentre, double blind, randomised controlled trial investigating whether Helicobacter (H.) pylori eradication reduces hospitalisation for peptic ulcer bleeding. Recruited ... ...

    Abstract Background: The Helicobacter Eradication Aspirin Trial (HEAT) is a multicentre, double blind, randomised controlled trial investigating whether Helicobacter (H.) pylori eradication reduces hospitalisation for peptic ulcer bleeding. Recruited participants were aged 60 and over and taking aspirin (≤325 mg daily) for at least four months prior to consent. Based on results of a pilot study, a sample size calculation predicted 6600 H. pylori-positive randomised participants would be required, from 33,000 volunteers, recruited from 170,000 invited patients. Methodology was therefore designed for recruitment of large numbers of patients from primary care using a novel electronic search tool, automated mail-out and electronic follow-up. Recruitment started in 2012 and completed in 2017.
    Methods: All participants were recruited from GP practices, with assistance from the UK Clinical Research Network (UKCRN). H. pylori-positive participants were randomised to one week of eradication treatment or placebo. Recruitment was managed using a bespoke web-based database that communicated directly with a programmed search tool downloaded at participating practices. The primary endpoint is hospitalisation due to peptic ulcer bleeding. The trial will end when 87 adjudicated events have occurred, identified from searches of GP databases, review of secondary care admission data and mortality data, and reported events from randomised participants and GPs.
    Results: HEAT has recruited participants from 1208 GP practices across the UK. Of the 188,875 invitation letters sent, 38,771 returned expressions of interest. Of these, 30,166 patients were consented to the trial, of whom 5355 H. pylori-positive participants (17.8% of those consented) were randomised. Mean age at consent was 73.1 ± 6.9 (SD) years and 72.2% of participants were male. Of the randomised (H. pylori-positive) participants, 531 have died (as of 17 Sep 2020); none of the deaths was due to trial treatment.
    Conclusion: The HEAT trial methodology has demonstrated that recruitment of large numbers of patients from primary care is attainable, with the assistance of the UKCRN, and could be applied to other clinical outcomes studies.
    Trial registration: ClinicalTrials.gov

    registration number NCT01506986 . Registered on 10 Jan 2012.
    Mesh-Begriff(e) Aged ; Aspirin/adverse effects ; Helicobacter ; Hot Temperature ; Humans ; Male ; Middle Aged ; Pilot Projects ; Primary Health Care ; Treatment Outcome
    Chemische Substanzen Aspirin (R16CO5Y76E)
    Sprache Englisch
    Erscheinungsdatum 2022-02-14
    Erscheinungsland England
    Dokumenttyp Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-022-06054-w
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Allopurinol versus usual care in UK patients with ischaemic heart disease (ALL-HEART): a multicentre, prospective, randomised, open-label, blinded-endpoint trial.

    Mackenzie, Isla S / Hawkey, Christopher J / Ford, Ian / Greenlaw, Nicola / Pigazzani, Filippo / Rogers, Amy / Struthers, Allan D / Begg, Alan G / Wei, Li / Avery, Anthony J / Taggar, Jaspal S / Walker, Andrew / Duce, Suzanne L / Barr, Rebecca J / Dumbleton, Jennifer S / Rooke, Evelien D / Townend, Jonathan N / Ritchie, Lewis D / MacDonald, Thomas M

    Lancet (London, England)

    2022  Band 400, Heft 10359, Seite(n) 1195–1205

    Abstract: Background: Allopurinol is a urate-lowering therapy used to treat patients with gout. Previous studies have shown that allopurinol has positive effects on several cardiovascular parameters. The ALL-HEART study aimed to determine whether allopurinol ... ...

    Abstract Background: Allopurinol is a urate-lowering therapy used to treat patients with gout. Previous studies have shown that allopurinol has positive effects on several cardiovascular parameters. The ALL-HEART study aimed to determine whether allopurinol therapy improves major cardiovascular outcomes in patients with ischaemic heart disease.
    Methods: ALL-HEART was a multicentre, prospective, randomised, open-label, blinded-endpoint trial done in 18 regional centres in England and Scotland, with patients recruited from 424 primary care practices. Eligible patients were aged 60 years or older, with ischaemic heart disease but no history of gout. Participants were randomly assigned (1:1), using a central web-based randomisation system accessed via a web-based application or an interactive voice response system, to receive oral allopurinol up-titrated to a dose of 600 mg daily (300 mg daily in participants with moderate renal impairment at baseline) or to continue usual care. The primary outcome was the composite cardiovascular endpoint of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death. The hazard ratio (allopurinol vs usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis (excluding randomly assigned patients later found to have met one of the exclusion criteria). The safety analysis population included all patients in the modified intention-to-treat usual care group and those who took at least one dose of randomised medication in the allopurinol group. This study is registered with the EU Clinical Trials Register, EudraCT 2013-003559-39, and ISRCTN, ISRCTN32017426.
    Findings: Between Feb 7, 2014, and Oct 2, 2017, 5937 participants were enrolled and then randomly assigned to receive allopurinol or usual care. After exclusion of 216 patients after randomisation, 5721 participants (mean age 72·0 years [SD 6·8], 4321 [75·5%] males, and 5676 [99·2%] white) were included in the modified intention-to-treat population, with 2853 in the allopurinol group and 2868 in the usual care group. Mean follow-up time in the study was 4·8 years (1·5). There was no evidence of a difference between the randomised treatment groups in the rates of the primary endpoint. 314 (11·0%) participants in the allopurinol group (2·47 events per 100 patient-years) and 325 (11·3%) in the usual care group (2·37 events per 100 patient-years) had a primary endpoint (hazard ratio [HR] 1·04 [95% CI 0·89-1·21], p=0·65). 288 (10·1%) participants in the allopurinol group and 303 (10·6%) participants in the usual care group died from any cause (HR 1·02 [95% CI 0·87-1·20], p=0·77).
    Interpretation: In this large, randomised clinical trial in patients aged 60 years or older with ischaemic heart disease but no history of gout, there was no difference in the primary outcome of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death between participants randomised to allopurinol therapy and those randomised to usual care.
    Funding: UK National Institute for Health and Care Research.
    Mesh-Begriff(e) Aged ; Allopurinol/therapeutic use ; Coronary Artery Disease/drug therapy ; Female ; Gout/drug therapy ; Humans ; Male ; Myocardial Infarction/drug therapy ; Myocardial Ischemia/drug therapy ; Prospective Studies ; Stroke/drug therapy ; Treatment Outcome ; United Kingdom ; Uric Acid
    Chemische Substanzen Uric Acid (268B43MJ25) ; Allopurinol (63CZ7GJN5I)
    Sprache Englisch
    Erscheinungsdatum 2022-09-29
    Erscheinungsland England
    Dokumenttyp Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(22)01657-9
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel: The Helicobacter Eradication Aspirin Trial (HEAT): A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care.

    Dumbleton, Jennifer S / Avery, Anthony J / Coupland, Carol / Hobbs, F D Richard / Kendrick, Denise / Moore, Michael V / Morris, Clive / Rubin, Greg P / Smith, Murray D / Stevenson, Diane J / Hawkey, Chris J

    EBioMedicine

    2015  Band 2, Heft 9, Seite(n) 1200–1204

    Abstract: Background: Clinical trials measuring the effect of an intervention on clinical outcomes are more influential than those investigating surrogate measures but are costly. We developed methods to reduce costs substantially by using existing data in ... ...

    Abstract Background: Clinical trials measuring the effect of an intervention on clinical outcomes are more influential than those investigating surrogate measures but are costly. We developed methods to reduce costs substantially by using existing data in primary care systems, to ask whether Helicobacter pylori eradication would reduce the incidence of hospitalisation for ulcer bleeding in aspirin users.
    Methods: The Helicobacter Eradication Aspirin Trial (HEAT) is a National Institute of Health Research-funded, double-blind placebo controlled randomised trial of the effects of H. pylori eradication on subsequent ulcer bleeding in infected individuals taking aspirin daily, conducted in practices across the whole of England, Wales and Northern Ireland. A bespoke web-based trial management system developed for the trial (and housed within the secure NHS Data Network) communicates directly with the HEAT Toolkit software downloaded at participating practices, which issues queries searching entry criteria (≥ 60 years, on chronic aspirin ≤ 325 mg daily, not on anti-ulcer therapy or non-steroidal anti-inflammatory drugs) for GP review of eligibility. Trial participation is invited using a highly secure automated online mail management system. Interested patients are seen once for consent and breath testing. Those with a positive test are randomised to eradication treatment (lansoprazole, clarithromycin, metronidazole) or placebo, with drug sent by post. Events are tracked by upload of accumulating information in the GP database, patient contact, review of National Hospital Episode Statistics and Office of National Statistics data.
    Results: HEAT is the largest Clinical Research Network-supported drug trial, with 115,660 invitation letters sent from 850 practices, 22,922 volunteers, and 3038 H. pylori positive patients randomised to active or placebo treatment after 2.5 years of recruitment. 178 practices have performed their first follow-up data search to identify 21 potential endpoints to date.
    Discussion: HEAT is important medically, because aspirin is so widely used, and methodologically, as a successful trial would show that large-scale studies of important clinical outcomes can be conducted at a fraction of the cost of those conducted by industry, which in turn will help to ensure that trials of primarily medical rather than commercial interest can be conducted successfully in the UK.
    Mesh-Begriff(e) Aspirin/adverse effects ; Aspirin/therapeutic use ; Disease Eradication ; Helicobacter/drug effects ; Humans ; Patient Compliance ; Primary Health Care ; Sample Size ; Treatment Outcome
    Chemische Substanzen Aspirin (R16CO5Y76E)
    Sprache Englisch
    Erscheinungsdatum 2015-07-10
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2851331-9
    ISSN 2352-3964 ; 2352-3964
    ISSN (online) 2352-3964
    ISSN 2352-3964
    DOI 10.1016/j.ebiom.2015.07.012
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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