scholarly journals Legacy effects of statins on cardiovascular and all-cause mortality: a meta-analysis

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e020584 ◽  
Author(s):  
Agnish Nayak ◽  
Andrew Hayen ◽  
Lin Zhu ◽  
Kevin McGeechan ◽  
Paul Glasziou ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Meta Analysis ◽  
Legacy Effects ◽  
Legacy Effect ◽  
All Cause Mortality ◽  
Prevention Studies ◽  
Prevention Trials ◽  
Post Trial ◽  
Cvd Mortality

ObjectivesTo assess evidence for ‘legacy’ (post-trial) effects on cardiovascular disease (CVD) mortality and all-cause mortality among adult participants of placebo-controlled randomised controlled trials (RCTs) of statins.DesignMeta-analysis of aggregate data.Setting/ParticipantsPlacebo-controlled statin RCTS for primary and secondary CVD prevention.MethodsData sources: PubMed, Embase from inception and forward citations of Cholesterol Treatment Trialists’ Collaborators RCTs to 16 June 2016.Study selection: Two independent reviewers identified all statin RCT follow-up reports including ≥1000 participants, and cardiovascular and all-cause mortality.Data extraction and synthesis: Two independent reviewers extracted data in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Main outcomes: Post-trial CVD and all-cause mortality.ResultsWe included eight trials, with mean post-trial follow-up ranging from 1.6 to 15.1 years, and including 13 781 post-trial deaths (6685 CVD). Direct effects of statins within trials were greater than legacy effects post-trials. The pooled data from all eight studies showed no evidence overall of legacy effects on CVD mortality, but some evidence of legacy effects on all-cause mortality (p=0.01). Exploratory subgroup analysis found possible differences in legacy effect for primary prevention trials compared with secondary prevention trials for both CVD mortality (p=0.15) and all-cause mortality (p=0.02). Pooled post-trial HR for the three primary prevention studies demonstrated possible post-trial legacy effects on CVD mortality (HR=0.87; 95% CI 0.79 to 0.95) and on all-cause mortality (HR=0.90; 95% CI 0.85 to 0.96).ConclusionsPossible post-trial statin legacy effects on all-cause mortality appear to be driven by the primary prevention studies. Although these relative benefits were smaller than those observed within the trial, the absolute benefits may be similar for the two time periods. Analysis of individual patient data from follow-up studies after placebo-controlled statin RCTs in lower-risk populations may provide more definitive evidence on whether early treatment of subclinical atherosclerosis is likely to be beneficial.

scholarly journals 932Using marginal structural models to account for selection bias in the analysis of legacy effect

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
Lin Zhu ◽  
Andrew Hayen ◽  
Katy Bell
Keyword(s):  
Selection Bias ◽  
Event Rate ◽  
Marginal Structural Models ◽  
Legacy Effects ◽  
Follow Up Study ◽  
Legacy Effect ◽  
Trial Analysis ◽  
Post Trial ◽  
Biased Estimates

Abstract Background Analyses of legacy effects are mainly based on post-trial follow-up study after initial randomized controlled trials (RCT). However, the differential event rates between arms may cause a violation of randomization balance and induce selection bias in the post-trial analysis. We conducted a simulation to illustrate the bias and explore if marginal structural model (MSM) can address it. Methods Our simulation combined an RCT and an extended follow-up study. The scenarios investigated include different settings of direct treatment effect, legacy effect and underlying event rate. To fit the MSM, we used the inverse probability weighting method. The performance of MSM was compared to the standard model with and without adjustment of baseline covariate. Results Post-trial analysis without making adjustment resulted in biased estimates, and the bias increased with the underlying event rate and treatment effect. Both MSM and standard baseline covariate adjustment equally corrected for the bias if no patients took treatment after the trial. We are currently undertaking analysis for scenarios where some people continue treatment post-trial, and there is treatment confounder feedback; these results will be presented at the Congress. Conclusions Estimation of legacy effects using post-trial data without adjusting for differential survival between randomised treatment arms results in biased estimates. Although both standard covariate adjustment and MSM correct the bias if no patients take treatment in the post-trial period, MSM is expected to be the best method in the more realistic scenario where some patients continue to take treatment, and there is treatment confounder feedback. Key messages Post-trial analysis without making adjustment results in biased estimation of legacy effect. Marginal structural models may be used to address the selection bias.

scholarly journals Dose–Response Relation between Tea Consumption and Risk of Cardiovascular Disease and All-Cause Mortality: A Systematic Review and Meta-Analysis of Population-Based Studies

2020 ◽  
Vol 11 (4) ◽  
pp. 790-814 ◽  
Author(s):  
Mei Chung ◽  
Naisi Zhao ◽  
Deena Wang ◽  
Marissa Shams-White ◽  
Micaela Karlsen ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Cohort Studies ◽  
Prospective Cohort ◽  
Lower Risk ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Tea Consumption ◽  
All Cause Mortality ◽  
Specific Mortality ◽  
Cvd Mortality

ABSTRACT Tea flavonoids have been suggested to offer potential benefits to cardiovascular health. This review synthesized the evidence on the relation between tea consumption and risks of cardiovascular disease (CVD) and all-cause mortality among generally healthy adults. PubMed, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, Food Science and Technology Abstracts, and Ovid CAB Abstract databases were searched to identify English-language publications through 1 November 2019, including randomized trials, prospective cohort studies, and nested case-control (or case-cohort) studies with data on tea consumption and risk of incident cardiovascular events (cardiac or peripheral vascular events), stroke events (including mortality), CVD-specific mortality, or all-cause mortality. Data from 39 prospective cohort publications were synthesized. Linear meta-regression showed that each cup (236.6 mL)  increase in daily tea consumption (estimated 280 mg  and 338 mg  total flavonoids/d for black and green tea, respectively) was associated with an average 4% lower risk of CVD mortality, a 2% lower risk of CVD events, a 4% lower risk of stroke, and a 1.5% lower risk of all-cause mortality. Subgroup meta-analysis results showed that the magnitude of association was larger in elderly individuals for both CVD mortality (n = 4; pooled adjusted RR: 0.89; 95% CI: 0.83, 0.96; P = 0.001), with large heterogeneity (I2 = 72.4%), and all-cause mortality (n = 3; pooled adjusted RR: 0.92; 95% CI: 0.90, 0.94; P < 0.0001; I2 = 0.3%). Generally, studies with higher risk of bias appeared to show larger magnitudes of associations than studies with lower risk of bias. Strength of evidence was rated as low and moderate (depending on study population age group) for CVD-specific mortality outcome and was rated as low for CVD events, stroke, and all-cause mortality outcomes. Daily tea intake as part of a healthy habitual dietary pattern may be associated with lower risks of CVD and all-cause mortality among adults.

scholarly journals Prediction of all-cause mortality with malnutrition assessed by controlling nutritional status score in patients with heart failure: a systematic review and meta-analysis

2021 ◽  
pp. 1-8
Author(s):  
Huiyang Li ◽  
Peng Zhou ◽  
Yikai Zhao ◽  
Huaichun Ni ◽  
Xinping Luo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Systematic Review ◽  
Nutritional Status ◽  
Meta Analysis ◽  
Predictive Values ◽  
Increased Risk ◽  
Patients With Heart Failure ◽  
All Cause Mortality ◽  
Conut Score

Abstract Objective: The aim of this meta-analysis was to investigate the association between malnutrition assessed by the controlling nutritional status (CONUT) score and all-cause mortality in patients with heart failure. Design: Systematic review and meta-analysis. Settings: A comprehensively literature search of PubMed and Embase databases was performed until 30 November 2020. Studies reporting the utility of CONUT score in prediction of all-cause mortality among patients with heart failure were eligible. Patients with a CONUT score ≥2 are grouped as malnourished. Predictive values of the CONUT score were summarized by pooling the multivariable-adjusted risk ratios (RR) with 95 % CI for the malnourished v. normal nutritional status or per point CONUT score increase. Participants: Ten studies involving 5196 patients with heart failure. Results: Malnourished patients with heart failure conferred a higher risk of all-cause mortality (RR 1·92; 95 % CI 1·58, 2·34) compared with the normal nutritional status. Subgroup analysis showed the malnourished patients with heart failure had an increased risk of in-hospital mortality (RR 1·78; 95 % CI 1·29, 2·46) and follow-up mortality (RR 2·01; 95 % CI 1·58, 2·57). Moreover, per point increase in CONUT score significantly increased 16% risk of all-cause mortality during the follow-up. Conclusions: Malnutrition defined by the CONUT score is an independent predictor of all-cause mortality in patients with heart failure. Assessment of nutritional status using CONUT score would be helpful for improving risk stratification of heart failure.

scholarly journals Daily sodium consumption and CVD mortality in the general population: systematic review and meta-analysis of prospective studies

2014 ◽  
Vol 18 (4) ◽  
pp. 695-704 ◽  
Author(s):  
Rosana Poggio ◽  
Laura Gutierrez ◽  
María G Matta ◽  
Natalia Elorriaga ◽  
Vilma Irazola ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
General Population ◽  
Prospective Studies ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Random Effects Models ◽  
Meta Regression ◽  
Cvd Mortality

AbstractObjectiveThe purpose of the present study was to determine whether elevated dietary Na intake could be associated with CVD mortality.DesignWe performed a systematic review and meta-analysis of prospective studies representing the general population. The adjusted relative risks and their 95 % confidence intervals were pooled by the inverse variance method using random-effects models. Heterogeneity, publication bias, subgroup and meta-regression analyses were performed.SettingsMEDLINE (since 1973), Embase (since 1975), the Cochrane Library (since 1976), ISI Web of Science, Google Scholar (until September 2013) and secondary referencing were searched for inclusion in the study.SubjectEleven prospective studies with 229 785 participants and average follow-up period of 13·37 years (range 5·5–19 years).ResultsHigher Na intake was significantly associated with higher CVD mortality (relative risk=1·12; 95 % CI 1·06, 1·19). In the sensitivity analysis, the exclusion of studies with important relative weights did not significantly affect the results (relative risk=1·08; 95 % CI 1·01, 1·15). The meta-regression analysis showed that for every increase of 10 mmol/d in Na intake, CVD mortality increased significantly by 1 % (P=0·016). Age, hypertensive status and length of follow-up were also associated with increased CVD mortality.ConclusionsHigher Na intake was associated with higher CVD mortality in the general population; this result suggests a reduction in Na intake to prevent CVD mortality from any cause.

Association between selenium intake, diabetes, and mortality in adults: findings from National Health and Nutrition Examination Survey (NHANES) 2003-2014

2021 ◽  
pp. 1-24
Author(s):  
Bushra Hoque ◽  
Zumin Shi
Keyword(s):  
National Health ◽  
Cox Regression ◽  
Inverse Association ◽  
Nutrition Examination Survey ◽  
Health And Nutrition ◽  
Hazard Ratios ◽  
The Us ◽  
All Cause Mortality ◽  
Cvd Mortality

Abstract Selenium (Se) is a trace mineral that has antioxidant and anti-inflammatory properties. This study aimed to investigate the association between Se intake, diabetes, all-cause and cause-specific mortality in a representative sample of US adults. Data from 18,932 adults who attended the 2003-2014 National Health and Nutrition Examination Survey (NHANES) were analysed. Information on mortality was obtained from the US mortality registry updated to 2015. Multivariable logistic regression and Cox regression were used. Cross-sectionally, Se intake was positively associated with diabetes. Comparing extreme quartiles of Se intake, the odds ratio (OR) for diabetes was 1.44 (95% CI: 1.09–1.89). During a mean of 6.6 years follow-up, there were 1627 death (312 CVD, 386 cancer). High intake of Se was associated with a lower risk of all-cause mortality. When comparing the highest with the lowest quartiles of Se intake, the hazard ratios (HRs) for all-cause, CVD mortality, cancer mortality and other mortality were: 0.77 (95% CI 0.59-1.01), 0.62 (95% CI, 0.35-1.13), 1.42 (95% CI, 0.78-2.58) and 0.60 (95% CI,0.40-0.80), respectively. The inverse association between Se intake and all-cause mortality was only found among white participants. In conclusion, Se intake was positively associated with diabetes but inversely associated with all-cause mortality. There was no interaction between Se intake and diabetes in relation to all-cause mortality.

scholarly journals The impact of a run-in period on treatment effects in cardiovascular prevention randomised control trials: A protocol for a comprehensive review and meta-analysis

2020 ◽  
Vol 3 ◽  
pp. 82
Author(s):  
Robert Murphy ◽  
Emer McGrath ◽  
Aoife Nolan ◽  
Andrew Smyth ◽  
Michelle Canavan ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Treatment Effects ◽  
Meta Analysis ◽  
Cardiovascular Prevention ◽  
Controlled Trials ◽  
Loss To Follow Up ◽  
Relative Risks ◽  
Prevention Trials ◽  
Randomised Controlled

Background: A run-in period is often employed in randomised controlled trials to increase adherence to the intervention and reduce participant loss to follow-up in the trial population. However, it is uncertain whether use of a run-in period affects the magnitude of treatment effect. Methods: We will conduct a sensitive search for systematic reviews of cardiovascular preventative trials and a complete meta-analysis of treatment effects comparing cardiovascular prevention trials using a run-in period (“run-in trials”) with matched cardiovascular prevention trials that did not use a run-in period (“non-run-in trials”). We describe a comprehensive matching process which will match run-in trials with non-run-in trials by patient populations, interventions, and outcomes. For each pair of run-in trial and matched non-run-in trial(s), we will estimate the ratio of relative risks and 95% confidence interval. We will evaluate differences in treatment effect between run-in and non-run-in trials and our and our priamry outcome will be the ratio of relative risks for matched run-in and non-run-in trials for their reported cardiovascular composite outcome. Our secondary outcomes are comparisons of mortality, loss to follow up, frequency of adverse events and methodological quality of trials. Conclusions: This study will answer a key question about what influence a run-in period has on the magnitude of treatment effects in randomised controlled trials for cardiovascular prevention therapies.

scholarly journals Role of Aspirin for primary prevention of cardiovascular and all-cause mortality events in diabetes: An updated meta-analysis of randomized controlled trials.

2021 ◽  
Author(s):  
Hua Ma ◽  
QIng Gu ◽  
Huining Niu ◽  
Xiaohua Li ◽  
Rong Wang
Keyword(s):  
Cardiovascular Disease ◽  
Primary Prevention ◽  
Meta Analysis ◽  
Significant Risk ◽  
Diabetic Patients ◽  
Primary Endpoints ◽  
All Cause Mortality ◽  
Patients With Diabetes ◽  
Rule Out

Background: The use of Aspirin in the primary prevention of cardiovascular disease (CVD) is still a topic of debate, especially in patients with diabetes. The present meta-analysis aims to rule out the efficacy of Aspirin in patients with diabetes and to compare the effectiveness of Aspirin with a placebo (or no treatment) for the primary prevention of CVD and all-cause mortality events in people with diabetes. Materials and Methods: An extensive and systematic search was conducted in Medline (via PubMed), Cinahl (via Ebsco), Scopus, and Web of Sciences from 1988 to December 2020. A detailed literature search was conducted using Aspirin, cardiovascular disease (CVD), diabetes, and efficacy to identify trials of patients with diabetes who received Aspirin for primary prevention of CVD. Demographic details with the primary outcome of events and bleeding outcomes were analyzed. The risk of bias (RoB) in included studies was evaluated using the QUADAS-2 tool. Results: A total of 5 studies out of 13 were included with 23,570 diabetic patients; 11,738 allocated to Aspirin and 11,832 allocated to the placebo group. In patients with diabetes, there was no difference between Aspirin and placebo with respect to the risk of all-cause death with a confidence interval (CI) varying 0.63 to 1.17. In addition, there were no differences in the bleeding outcomes with an odds ratio of 1.4411 (CI 0.47 to 4.34). Conclusion: Aspirin has no significant risk on primary endpoints of cardiovascular events and the bleeding outcomes in diabetic patients compared to placebo. More research on the use of Aspirin alone or in combination with other antiplatelet drugs is required in patients with diabetes to supplement currently available research.

scholarly journals Fish consumption and risk of all-cause and cardiovascular mortality: a dose–response meta-analysis of prospective observational studies

2018 ◽  
Vol 21 (7) ◽  
pp. 1297-1306 ◽  
Author(s):  
Ahmad Jayedi ◽  
Sakineh Shab-Bidar ◽  
Saragol Eimeri ◽  
Kurosh Djafarian
Keyword(s):  
Relative Risk ◽  
Dose Response ◽  
Fish Consumption ◽  
Regional Differences ◽  
Observational Studies ◽  
Meta Analysis ◽  
Asian Studies ◽  
Linear Dose ◽  
All Cause Mortality ◽  
Cvd Mortality

AbstractObjectiveThere are some indications of regional differences in the association between fish consumption and clinical outcomes. We aimed to test the linear and potential non-linear dose–response relationships between fish consumption and risk of all-cause and cardiovascular (CVD) mortality, and possible confounding by region.DesignSystematic review and dose–response meta-analysis.SettingSystematic search using PubMed and Scopus, from inception up to September 2016.SubjectsProspective observational studies reporting the estimates of all-cause and CVD mortality in relation to three or more categories of fish intake were included. Random-effects dose–response meta-analysis was conducted.ResultsFourteen prospective cohort studies (ten publications) with 911 348 participants and 75 451 incident deaths were included. A 20 g/d increment in fish consumption was significantly and inversely associated with the risk of CVD mortality (relative risk=0·96; 95 % CI 0·94, 0·98; I2=0 %, n 8) and marginally and inversely associated with the risk of all-cause mortality (relative risk=0·98; 95 % CI 0·97, 1·00; I2=81·9 %, n 14). Subgroup analysis resulted in a significant association only in the subgroup of Asian studies, compared with Western studies, in both analyses. Analysis of Western studies suggested a nearly U-shaped association, with a nadir at fish consumption of ~20 g/d in analysis of both outcomes. Meanwhile, the associations appeared to be linear in Asian studies.ConclusionsThere was potential evidence of regional differences in the association between fish consumption and mortality. It may be helpful to examine the associations by considering types of fish consumed and methods of fish preparation.

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