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Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study.

ABSTRACT: To assess whether statin treatment is associated with a reduction in atherosclerotic cardiovascular disease (CVD) and mortality in old and very old adults with and without diabetes.Retrospective cohort study.Database of the Catalan primary care system (SIDIAP), Spain, 2006-15.46 864 people aged 75 years or more without clinically recognised atherosclerotic CVD. Participants were stratified by presence of type 2 diabetes mellitus and as statin non-users or new users.Incidences of atherosclerotic CVD and all cause mortality compared using Cox proportional hazards modelling, adjusted by the propensity score of statin treatment. The relation of age with the effect of statins was assessed using both a categorical approach, stratifying the analysis by old (75-84 years) and very old (≥85 years) age groups, and a continuous analysis, using an additive Cox proportional hazard model.The cohort included 46 864 participants (mean age 77 years; 63% women; median follow-up 5.6 years). In participants without diabetes, the hazard ratios for statin use in 75-84 year olds were 0.94 (95% confidence interval 0.86 to 1.04) for atherosclerotic CVD and 0.98 (0.91 to 1.05) for all cause mortality, and in those aged 85 and older were 0.93 (0.82 to 1.06) and 0.97 (0.90 to 1.05), respectively. In participants with diabetes, the hazard ratio of statin use in 75-84 year olds was 0.76 (0.65 to 0.89) for atherosclerotic CVD and 0.84 (0.75 to 0.94) for all cause mortality, and in those aged 85 and older were 0.82 (0.53 to 1.26) and 1.05 (0.86 to 1.28), respectively. Similarly, effect analysis of age in a continuous scale, using splines, corroborated the lack of beneficial statins effect for atherosclerotic CVD and all cause mortality in participants without diabetes older than 74 years. In participants with diabetes, statins showed a protective effect against atherosclerotic CVD and all cause mortality; this effect was substantially reduced beyond the age of 85 years and disappeared in nonagenarians.In participants older than 74 years without type 2 diabetes, statin treatment was not associated with a reduction in atherosclerotic CVD or in all cause mortality, even when the incidence of atherosclerotic CVD was statistically significantly higher than the risk thresholds proposed for statin use. In the presence of diabetes, statin use was statistically significantly associated with reductions in the incidence of atherosclerotic CVD and in all cause mortality. This effect decreased after age 85 years and disappeared in nonagenarians.

SUBMITTER: Ramos R

PROVIDER: S-EPMC6123838 | biostudies-other | 2018 Sep

REPOSITORIES: biostudies-other

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Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study.

Ramos Rafel R Comas-Cufí Marc M Martí-Lluch Ruth R Balló Elisabeth E Ponjoan Anna A Alves-Cabratosa Lia L Blanch Jordi J Marrugat Jaume J Elosua Roberto R Grau María M Elosua-Bayes Marc M García-Ortiz Luis L Garcia-Gil Maria M

BMJ (Clinical research ed.) 20180905

<h4>Objective</h4>To assess whether statin treatment is associated with a reduction in atherosclerotic cardiovascular disease (CVD) and mortality in old and very old adults with and without diabetes.<h4>Design</h4>Retrospective cohort study.<h4>Setting</h4>Database of the Catalan primary care system (SIDIAP), Spain, 2006-15.<h4>Participants</h4>46 864 people aged 75 years or more without clinically recognised atherosclerotic CVD. Participants were stratified by presence of type 2 diabetes mellit ...[more]

PMID: 30185425

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Project description:ObjectivesTo test new cardiovascular (CV) risk models in very old adults with and without a history of CV disease (CVD), based on traditional risk factors and biomarkers.DesignCross-validated prospective cohort study. The models were tested in the BELFRAIL Study and externally validated in the Leiden 85-plus Study.SettingGeneral practice, Belgium and The Netherlands.ParticipantsThe BELFRAIL cohort consisted of 266 patients aged 80 years or older without a history of CVD and 260 with a history of CVD. The Leiden 85-plus Study consisted of 264 patients aged 85 years without a history of CVD and 282 with a history of CVD.Outcome measuresThe model with traditional risk factors and biomarkers, as well as the model using only biomarkers, was compared with the model with only traditional risk factors to predict 3-year CV morbidity and mortality. A competing-risk analysis was performed, and the continuous net reclassification improvement (NRI), integrated discrimination improvement (IDI) and net benefit were used to compare the predictive value of the different models.ResultsTraditional risk factors poorly predicted CV mortality and morbidity. In participants without a history of CVD, adding N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) improved the prediction (NRI 0.56 (95% CI 0.16 to 0.99) and relative IDI 4.01 (95% CI 2.19 to 6.28)). In participants with a history of CVD, the NRI with the addition of NT-pro-BNP and high-sensitivity C reactive protein was 0.38 (95% CI 0.09 to 0.70), and the relative IDI was 0.53 (95% CI 0.23 to 0.90). Moreover, in participants without a history of CVD, NT-pro-BNP performed well as a stand-alone predictor (NRI 0.32 (95% CI -0.12 to 0.74) and relative IDI 3.44 (95% CI 1.56 to 6.09)).ConclusionsThis study tested new risk models to predict CV morbidity and mortality in very old adults. Especially, NT-pro-BNP showed a strong added predictive value. This opens perspectives for clinicians who are in need of an easily applicable strategy for CV risk prediction in very old adults.

Project description:ImportanceThere are limited data for the utility of statins for primary prevention of atherosclerotic cardiovascular disease (ASCVD) and death in adults with chronic kidney disease (CKD).ObjectiveTo evaluate the association of statin use with all-cause mortality and major adverse cardiovascular events (MACE) among US veterans older than 65 years with CKD stages 3 to 4.Design, setting, and participantsThis cohort study used a target trial emulation design for statin initiation among veterans with moderate CKD (stages 3 or 4) using nested trials with a propensity weighting approach. Linked Veterans Affairs (VA) Healthcare System, Medicare, and Medicaid data were used. This study considered veterans newly diagnosed with moderate CKD between 2005 and 2015 in the VA, with follow-up through December 31, 2017. Veterans were older than 65 years, within 5 years of CKD diagnosis, had no prior ASCVD or statin use, and had at least 1 clinical visit in the year prior to trial baseline. Eligibility criteria were assessed for each nested trial, and Cox proportional hazards models with bootstrapping were run. Analysis was conducted from July 2021 to October 2023.ExposureStatin initiation vs none.Main outcomes and measuresPrimary outcome was all-cause mortality; secondary outcome was time to first MACE (myocardial infarction, transient ischemic attack, stroke, revascularization, or mortality).ResultsIncluded in the analysis were 14 828 veterans. Mean (SD) age at CKD diagnosis was 76.9 (8.2) years, 14 616 (99%) were men, 10 539 (72%) White, and 2568 (17%) Black. After expanding to person-trials and assessing eligibility at each baseline, there were 151 243 person-trials (14 685 individuals) of nonstatin initiators and 2924 person-trials (2924 individuals) of statin initiators included. Propensity score adjustment via overlap weighting with nonparametric bootstrapping resulted in covariate balance, with mean (SD) follow-up of 3.6 (2.7) years. The hazard ratio for all-cause mortality was 0.91 (95% CI, 0.85-0.97) comparing statin initiators to noninitiators. The hazard ratio for MACE was 0.96 (95% CI, 0.91-1.02). Results remained consistent in prespecified subgroup analyses.Conclusions and relevanceIn this target trial emulation of statin initiation in US veterans older than 65 years with CKD stages 3 to 4 and no prior ASCVD, statin initiation was significantly associated with a lower risk of all-cause mortality but not MACE. Results should be confirmed in a randomized clinical trial.

Project description:ImportanceGuidelines recommend targeting preventive interventions toward older adults whose life expectancy is greater than the intervention's time to benefit (TTB). The TTB for statin therapy is unknown.ObjectiveTo conduct a survival meta-analysis of randomized clinical trials of statins to determine the TTB for prevention of a first major adverse cardiovascular event (MACE) in adults aged 50 to 75 years.Data sourcesStudies were identified from previously published systematic reviews (Cochrane Database of Systematic Reviews and US Preventive Services Task Force) and a search of MEDLINE and Google Scholar for subsequently published studies until February 1, 2020.Study selectionRandomized clinical trials of statins for primary prevention focusing on older adults (mean age >55 years).Data extraction and synthesisTwo authors independently abstracted survival data for the control and intervention groups. Weibull survival curves were fit, and a random-effects model was used to estimate pooled absolute risk reductions (ARRs) between control and intervention groups each year. Markov chain Monte Carlo methods were applied to determine time to ARR thresholds.Main outcomes and measuresThe primary outcome was time to ARR thresholds (0.002, 0.005, and 0.010) for a first MACE, as defined by each trial. There were broad similarities in the definition of MACE across trials, with all trials including myocardial infarction and cardiovascular mortality.ResultsEight trials randomizing 65 383 adults (66.3% men) were identified. The mean age ranged from 55 to 69 years old and the mean length of follow-up ranged from 2 to 6 years. Only 1 of 8 studies showed that statins decreased all-cause mortality. The meta-analysis results suggested that 2.5 (95% CI, 1.7-3.4) years were needed to avoid 1 MACE for 100 patients treated with a statin. To prevent 1 MACE for 200 patients treated (ARR = 0.005), the TTB was 1.3 (95% CI, 1.0-1.7) years, whereas the TTB to avoid 1 MACE for 500 patients treated (ARR = 0.002) was 0.8 (95% CI, 0.5-1.0) years.Conclusions and relevanceThese findings suggest that treating 100 adults (aged 50-75 years) without known cardiovascular disease with a statin for 2.5 years prevented 1 MACE in 1 adult. Statins may help to prevent a first MACE in adults aged 50 to 75 years old if they have a life expectancy of at least 2.5 years. There is no evidence of a mortality benefit.

Dataset Information

Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study.

Publications

Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study.

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