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Cholesterol reduction and non-illness mortality: meta-analysis of randomised clinical trials.

ABSTRACT: OBJECTIVE:To investigate the association between cholesterol lowering interventions and risk of death from suicide, accident, or trauma (non-illness mortality). DESIGN:Meta-analysis of the non-illness mortality outcomes of large, randomised clinical trials of cholesterol lowering treatments. STUDIES REVIEWED:19 out of 21 eligible trials that had data available on non-illness mortality. INTERVENTIONS REVIEWED: Dietary modification, drug treatment, or partial ileal bypass surgery for 1-10 years. MAIN OUTCOME MEASURE:Deaths from suicides, accidents, and violence in treatment groups compared with control groups. RESULTS:Across all trials, the odds ratio of non-illness mortality in the treated groups, relative to control groups, was 1.18 (95% confidence interval 0.91 to 1.52; P=0.20). The odds ratios were 1.28 (0.94 to 1.74; P=0.12) for primary prevention trials and 1.00 (0.65 to 1.55; P=0.98) for secondary prevention trials. Randomised clinical trials using statins did not show a treatment related rise in non-illness mortality (0.84, 0.50 to 1.41; P=0.50), whereas a trend toward increased deaths from suicide and violence was observed in trials of dietary interventions and non-statin drugs (1.32, 0.98 to 1.77; P=0.06). No relation was found between the magnitude of cholesterol reduction and non-illness mortality (P=0.23). CONCLUSION:Currently available evidence does not indicate that non-illness mortality is increased significantly by cholesterol lowering treatments. A modest increase may occur with dietary interventions and non-statin drugs.

SUBMITTER: Muldoon MF

PROVIDER: S-EPMC26598 | biostudies-literature | 2001 Jan

REPOSITORIES: biostudies-literature

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Cholesterol reduction and non-illness mortality: meta-analysis of randomised clinical trials.

Muldoon M F MF Manuck S B SB Mendelsohn A B AB Kaplan J R JR Belle S H SH

BMJ (Clinical research ed.) 20010101 7277

<h4>Objective</h4>To investigate the association between cholesterol lowering interventions and risk of death from suicide, accident, or trauma (non-illness mortality).<h4>Design</h4>Meta-analysis of the non-illness mortality outcomes of large, randomised clinical trials of cholesterol lowering treatments.<h4>Studies reviewed</h4>19 out of 21 eligible trials that had data available on non-illness mortality. INTERVENTIONS REVIEWED: Dietary modification, drug treatment, or partial ileal bypass sur ...[more]

PMID: 11141142

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Project description:ObjectiveTo explore the risk of industry sponsorship bias in a systematically identified set of placebo controlled and active comparator trials of statins.DesignSystematic review and network meta-analysis.EligibilityOpen label and double blind randomised controlled trials comparing one statin with another at any dose or with control (placebo, diet, or usual care) for adults with, or at risk of developing, cardiovascular disease. Only trials that lasted longer than four weeks with more than 50 participants per trial arm were included. Two investigators assessed study eligibility.Data sourcesBibliographic databases and reference lists of relevant articles published between 1 January 1985 and 10 March 2013.Data extractionOne investigator extracted data and another confirmed accuracy.Main outcome measureMean absolute change from baseline concentration of low density lipoprotein (LDL) cholesterol.Data synthesisStudy level outcomes from randomised trials were combined using random effects network meta-analyses.ResultsWe included 183 randomised controlled trials of statins, 103 of which were two-armed or multi-armed active comparator trials. When all of the existing randomised evidence was synthesised in network meta-analyses, there were clear differences in the LDL cholesterol lowering effects of individual statins at different doses. In general, higher doses resulted in higher reductions in baseline LDL cholesterol levels. Of a total of 146 industry sponsored trials, 64 were placebo controlled (43.8%). The corresponding number for the non-industry sponsored trials was 16 (43.2%). Of the 35 unique comparisons available in 37 non-industry sponsored trials, 31 were also available in industry sponsored trials. There were no systematic differences in magnitude between the LDL cholesterol lowering effects of individual statins observed in industry sponsored versus non-industry sponsored trials. In industry sponsored trials, the mean change from baseline LDL cholesterol level was on average 1.77 mg/dL (95% credible interval -11.12 to 7.66) lower than the change observed in non-industry sponsored trials. There was no detectable inconsistency in the evidence network.ConclusionsOur analysis shows that the findings obtained from industry sponsored statin trials seem similar in magnitude as those in non-industry sources. There are actual differences in the effectiveness of individual statins at various doses that explain previously observed discrepancies between industry and non-industry sponsored trials.

Project description:INTRODUCTION: Patients undergoing coronary revascularization often require inotropic support that has been associated with an increased risk for death and morbidity. The purpose of this study was to evaluate the effect of levosimendan versus control on survival after coronary revascularization. METHODS: A systemic review and meta-analysis of the literature was carried out on published randomized controlled clinical trials that investigated the efficacy of levosimendan compared to other therapy in patients having coronary revascularisaion. The databases searched were Pubmed, EMBASE, the Cochrane Registry of Clinical Trials and the metaRegister of Controlled Trials. Studies that compared levosimendan to any other therapy for coronary revascularisation in adult humans and reported at least one outcome of interest were considered for inclusion. Both percutaneous coronary intervention and cardiac surgery were included. Data extraction was performed independently by two reviewers using predefined criteria. Relevant outcomes included mortality, cardiac index, cardiac enzymes, length of stay and post-procedural atrial fibrillation. RESULTS: The meta-analysis included 729 patients from 17 studies. Levosimendan was associated with a mortality reduction after coronary revascularization, (19/386 in the levosimendan group vs 39/343 in the control arm) odds ratio (OR) 0.40 (95% confidence interval (CI) 0.21 to 0.76, P for overall effect 0.005, P for heterogeneity = 0.33, I2 = 12% with a total of 729 patients. Levosimendan also had a favourable effect on cardiac index (standardised mean difference 1.63, 95% CI 1.43 to 1.83, P for overall effect < 0.00001), length of intensive care stay (random effects model, mean difference - 26.18 hours 95% CI 46.20 to 6.16, P for heterogeneity < 0.00001, I2 = 95%, P for overall effect P = 0.01), reductions in the rate of atrial fibrillation (OR 0.54, 95% CI 0.36 to 0.82, P for effect = 0.004, P for heterogeneity 0.84, I2 = 0% for 465 patients) and troponin I levels group (mean difference -1.59, 95% CI 1.78 to 1.40, P for overall effect < 0.00001, P for heterogeneity < 0.00001, I2 = 95%). Limitations of this analysis are discussed. CONCLUSIONS: Levosimendan is associated with a significant improvement in mortality after coronary revascularization. There are also improvements in several secondary endpoints. A suitably powered randomised controlled trial is required to confirm these findings and to address the unresolved questions about the timing and dosing of levosimendan.

Project description:BackgroundLittle is known about whether peer support improves outcomes for people with severe mental illness.MethodA systematic review and meta-analysis was conducted. Cochrane CENTRAL Register, Medline, Embase, PsycINFO, and CINAHL were searched to July 2013 without restriction by publication status. Randomised trials of non-residential peer support interventions were included. Trial interventions were categorised and analysed separately as: mutual peer support, peer support services, or peer delivered mental health services. Meta-analyses were performed where possible, and studies were assessed for bias and the quality of evidence described.ResultsEighteen trials including 5597 participants were included. These comprised four trials of mutual support programmes, eleven trials of peer support services, and three trials of peer-delivered services. There was substantial variation between trials in participants' characteristics and programme content. Outcomes were incompletely reported; there was high risk of bias. From small numbers of studies in the analyses it was possible to conduct, there was little or no evidence that peer support was associated with positive effects on hospitalisation, overall symptoms or satisfaction with services. There was some evidence that peer support was associated with positive effects on measures of hope, recovery and empowerment at and beyond the end of the intervention, although this was not consistent within or across different types of peer support.ConclusionsDespite the promotion and uptake of peer support internationally, there is little evidence from current trials about the effects of peer support for people with severe mental illness. Although there are few positive findings, this review has important implications for policy and practice: current evidence does not support recommendations or mandatory requirements from policy makers for mental health services to provide peer support programmes. Further peer support programmes should be implemented within the context of high quality research projects wherever possible. Deficiencies in the conduct and reporting of existing trials exemplify difficulties in the evaluation of complex interventions.

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Cholesterol reduction and non-illness mortality: meta-analysis of randomised clinical trials.

Publications

Cholesterol reduction and non-illness mortality: meta-analysis of randomised clinical trials.

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