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Insulin therapy in acute coronary syndromes: an appraisal of completed and ongoing randomised trials with important clinical end points.

ABSTRACT: Insulin therapy was first proposed as an adjunctive therapy in patients with acute coronary syndromes (ACS) in the 1960s. Since then, numerous randomised clinical trials have been conducted to determine the efficacy and to define the role of insulin therapy in ACS. This review will discuss: 1) completed trials of insulin therapy in ACS, including both glucose-insulin-potassium (GIK) approaches and non-GIK approaches; 2) trials of insulin therapy in critically ill non-ACS patients and the lessons from these trials that can be applied to trials of insulin in ACS patients; and 3) a summary of ongoing and planned trials of insulin in ACS patients.

SUBMITTER: Goyal A

PROVIDER: S-EPMC3746495 | biostudies-other | 2008 Nov

REPOSITORIES: biostudies-other

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Insulin therapy in acute coronary syndromes: an appraisal of completed and ongoing randomised trials with important clinical end points.

Goyal Abhinav A Nerenberg Kara K Gerstein Hertzel C HC Umpierrez Guillermo G Wilson Peter W F PW

Diabetes & vascular disease research 20081101 4

Insulin therapy was first proposed as an adjunctive therapy in patients with acute coronary syndromes (ACS) in the 1960s. Since then, numerous randomised clinical trials have been conducted to determine the efficacy and to define the role of insulin therapy in ACS. This review will discuss: 1) completed trials of insulin therapy in ACS, including both glucose-insulin-potassium (GIK) approaches and non-GIK approaches; 2) trials of insulin therapy in critically ill non-ACS patients and the lessons ...[more]

PMID: 18958837

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Project description:Introduction: We sought to provide an overview of the published and currently ongoing movement disorders clinical trials employing gene therapy, defined as a technology aiming to modulate the expression of one or more genes to achieve a therapeutic benefit. Methods: We systematically reviewed movement disorders gene therapy clinical trials from PubMed and ClinicalTrials.gov using a searching strategy that included Parkinson disease (PD), Huntington disease (HD), amino acid decarboxylase (AADC) deficiency, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), dystonia, tremor, ataxia, and other movement disorders. Data extracted included study characteristics, investigational product, route of administration, safety/tolerability, motor endpoints, and secondary outcomes (i.e., neuroimaging, biomarkers). Results: We identified a total of 46 studies focusing on PD (21 published and nine ongoing), HD (2 published and 5 ongoing), AADC deficiency (4 published and 2 ongoing), MSA (2 ongoing), and PSP (1 ongoing). In PD, intraparenchymal infusion of viral vector-mediated gene therapies demonstrated to be safe and showed promising preliminary data in trials aiming at restoring the synthesis of dopamine, enhancing the production of neurotrophic factors, or modifying the functional interaction between different nodes of the basal ganglia. In HD, monthly intrathecal delivery of an antisense oligonucleotide (ASO) targeting the huntingtin protein (HTT) mRNA proved to be safe and tolerable, and demonstrated a dose-dependent reduction of the cerebrospinal fluid levels of mutated HTT, while a small phase-I study testing implantable capsules of cells engineered to synthesize ciliary neurotrophic factor failed to show consistent drug delivery. In AADC deficiency, gene replacement studies demonstrated to be relatively safe in restoring catecholamine and serotonin synthesis, with promising outcomes. Ongoing movement disorders clinical trials are focusing on a variety of gene therapy approaches including alternative viral vector serotypes, novel recombinant genes, novel delivery techniques, and ASOs for the treatment of HD, MSA, and distinct subtypes of PD (LRRK2 mutation or GBA1 mutation carriers). Conclusion: Initial phase-I and -II studies tested the safety and feasibility of gene therapy in PD, HD, and AADC deficiency. The ongoing generation of clinical trials aims to test the efficacy of these approaches and explore additional applications for gene therapy in movement disorders.

Project description:ObjectiveTo test whether providing relevant clinical trial registry information to peer reviewers evaluating trial manuscripts decreases discrepancies between registered and published trial outcomes.DesignStepped wedge, cluster-randomised trial, with clusters comprised of eligible manuscripts submitted to each participating journal between 1 November 2018 and 31 October 2019.SettingThirteen medical journals.ParticipantsManuscripts were eligible for inclusion if they were submitted to a participating journal during the study period, presented results from the primary analysis of a clinical trial, and were peer reviewed.InterventionsDuring the control phase, there were no changes to pre-existing peer review practices. After journals crossed over into the intervention phase, peer reviewers received a data sheet describing whether trials were registered, the initial registration and enrolment dates, and the registered primary outcome(s) when enrolment began.Main outcome measureThe presence of a clearly defined, prospectively registered primary outcome consistent with the primary outcome in the published trial manuscript, as determined by two independent outcome assessors.ResultsWe included 419 manuscripts (243 control and 176 intervention). Participating journals published 43% of control-phase manuscripts and 39% of intervention-phase manuscripts (model-estimated percentage difference between intervention and control trials = -10%, 95% CI -25% to 4%). Among the 173 accepted trials, published primary outcomes were consistent with clearly defined, prospectively registered primary outcomes in 40 of 105 (38%) control-phase trials and 27 of 68 (40%) intervention-phase trials. A linear mixed model did not show evidence of a statistically significant primary outcome effect from the intervention (estimated difference between intervention and control=-6% (90% CI -27% to 15%); one-sided p value=0.68).ConclusionsThese results do not support use of the tested intervention as implemented here to increase agreement between prospectively registered and published trial outcomes. Other approaches are needed to improve the quality of outcome reporting of clinical trials.Trial registration numberISRCTN41225307.

Project description:IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.Methods and analysisPRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study's trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.Ethics and disseminationThe Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.Trial registration numberISRCTN41225307; Pre-results.

Dataset Information

Insulin therapy in acute coronary syndromes: an appraisal of completed and ongoing randomised trials with important clinical end points.

Publications

Insulin therapy in acute coronary syndromes: an appraisal of completed and ongoing randomised trials with important clinical end points.

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