Dataset Information

Net benefit of statins for primary prevention of cardiovascular disease in people 75 years or older: a benefit-harm balance modeling study.

ABSTRACT:

Background

We determined the risk thresholds above which statin use would be more likely to provide a net benefit for people over the age of 75?years without history of cardiovascular disease (CVD).

Methods

An exponential model was used to estimate the differences in expected benefit and harms in people treated with statins over a 10-year horizon versus not treated. The analysis was repeated 100,000 times to consider the statistical uncertainty and produce a distribution of the benefit-harm balance index from which we determined the 10-year CVD risk threshold where benefits outweighed the harms. We considered treatment estimates from trials and observational studies, baseline risks, patient preferences, and competing risks of non-CVD death, and statistical uncertainty.

Results

Based on average preferences, statins were more likely to provide a net benefit at a 10-year CVD risk of 24% and 25% for men aged 75-79?years and 80-84?years, respectively, and 21% for women in both age groups. However, these thresholds varied significantly depending on differences in individual patient preferences for the statin-related outcomes, with interquartile ranges of 21-33% and 23-36% for men aged 75-79?years and 80-84?years, respectively, as well as 20-32% and 21-32% for women aged 75-79?years and 80-84?years, respectively.

Conclusions

Statins would more likely provide a net benefit for primary prevention in older people taking the average preferences if their CVD risk is well above 20%. However, the thresholds could be much higher or lower depending on preferences of individual patients, which suggests more emphasis should be placed on individual-based decision-making, instead of recommending statins for everyone based on a single or a small number of thresholds.

SUBMITTER: Yebyo HG

PROVIDER: S-EPMC6764041 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Net benefit of statins for primary prevention of cardiovascular disease in people 75 years or older: a benefit-harm balance modeling study.

Yebyo Henock G HG Aschmann Hélène E HE Menges Dominik D Boyd Cynthia M CM Puhan Milo A MA

Therapeutic advances in chronic disease 20190925

<h4>Background</h4>We determined the risk thresholds above which statin use would be more likely to provide a net benefit for people over the age of 75 years without history of cardiovascular disease (CVD).<h4>Methods</h4>An exponential model was used to estimate the differences in expected benefit and harms in people treated with statins over a 10-year horizon <i>versus</i> not treated. The analysis was repeated 100,000 times to consider the statistical uncertainty and produce a distribution of ...[more]

PMID: 31598209

Similar Datasets

Project description:BACKGROUND:We previously showed that the 10-year cardiovascular disease (CVD) risk threshold to initiate statins for primary prevention depends on the baseline CVD risk, age, sex, and the incidence of statin-related harm outcome and competing risk for non-CVD death. As these factors appear to vary across countries, we aimed in this study to determine country-specific thresholds and provide guidelines a quantitative benefit-harm assessment method for local adaptation. METHODS:For each of the 186 countries included, we replicated the benefit-harm balance analysis using an exponential model to determine the thresholds to initiate statin use for populations aged 40 to 75?years, with no history of CVD. The analyses took data inputs from a priori studies, including statin effect estimates (network meta-analysis), patient preferences (survey), and baseline incidence of harm outcomes and competing risk for non-CVD (global burden of disease study). We estimated the risk thresholds above which the benefits of statins were more likely to outweigh the harms using a stochastic approach to account for statistical uncertainty of the input parameters. RESULTS:The 5th and 95th percentiles of the 10-year risk thresholds above which the benefits of statins outweigh the harms across 186 countries ranged between 14 and 20% in men and 19-24% in women, depending on age (i.e., 90% of the country-specific thresholds were in the ranges stated). The median risk thresholds varied from 14 to 18.5% in men and 19 to 22% in women. The between-country variability of the thresholds was slightly attenuated when further adjusted for age resulting, for example, in a 5th and 95th percentiles of 14-16% for ages 40-44?years and 17-21% for ages 70-74?years in men. Some countries, especially the islands of the Western Pacific Region, had higher thresholds to achieve net benefit of statins at 25-36% 10-year CVD risks. CONCLUSIONS:This extensive benefit-harm analysis modeling shows that a single CVD risk threshold, irrespective of age, sex and country, is not appropriate to initiate statin use globally. Instead, countries need to carefully determine thresholds, considering the national or subnational contexts, to optimize benefits of statins while minimizing related harms and economic burden.

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.

Project description:ObjectiveRecent studies suggest that a systolic blood pressure (SBP) target of 120?mm Hg is appropriate for people with hypertension, but this is debated particularly in people with multiple chronic conditions (MCC). We aimed to quantitatively determine whether benefits of a lower SBP target justify increased risks of harm in people with MCC, considering patient-valued outcomes and their relative importance.DesignHighly stratified quantitative benefit-harm assessment based on various input data identified as the most valid and applicable from a systematic review of evidence and based on weights from a patient preference survey.SettingOutpatient care.ParticipantsHypertensive patients, grouped by age, gender, prior history of stroke, chronic heart failure, chronic kidney disease and type 2 diabetes mellitus.InterventionsSBP target of 120 versus 140?mm Hg for patients without history of stroke.Primary and secondary outcome measuresProbability that the benefits of a SBP target of 120?mm Hg outweigh the harms compared with 140?mm Hg over 5 years (primary) with thresholds >0.6 (120 mm Hg better), <0.4 (140?mm Hg better) and 0.4 to 0.6 (unclear), number of prevented clinical events (secondary), calculated with the Gail/National Cancer Institute approach.ResultsConsidering individual patient preferences had a substantial impact on the benefit-harm balance. With average preferences, 120?mm Hg was the better target compared with 140?mm Hg for many subgroups of patients without prior stroke, especially in patients over 75. For women below 65 with chronic kidney disease and without diabetes and prior stroke, 140?mm Hg was better. The analyses did not include mild adverse effects, and apply only to patients who tolerate antihypertensive treatment.ConclusionsFor most patients, a lower SBP target was beneficial, but this depended also on individual preferences, implying individual decision-making is important. Our modelling allows for individualised treatment targets based on patient preferences, age, gender and co-morbidities.

Project description:BACKGROUND:Patient preferences are key parameters to evaluate benefit-harm balance of statins for primary prevention but they are not readily available to guideline developers and decision makers. Our study aimed to elicit patient preferences for benefit and harm outcomes related to use of statins for primary cardiovascular disease prevention and to examine how the preferences differ across economically and socio-culturally different environments. METHODS:We conducted preference-eliciting surveys using best-worst scaling designed with a balanced incomplete-block design (BIBD) on 13 statins-related outcomes on 220 people in Ethiopia and Switzerland. The participants made tradeoff decisions and selected the most and least worrisome outcomes concurrently from each scenario generated using the BIBD. The design yielded 34,320 implied paired-comparisons and 2860 paired-responses as unit of analysis for eliciting the preferences that were analyzed using a conditional-logit model on a relative scale and surface under the cumulative ranking curve from multivariate random-effects meta-analysis model on a scale of 0 to 1. RESULTS:There was high internal consistency of responses and minimal amount of measurement error in both surveys. Severe stroke was the most worrisome outcome with a ceiling preference of 1 (on 0 to 1 scale) followed by severe myocardial infarction, 0.913 (95% CI, 0.889-0.943), and cancer, 0.846 (0.829-0.855); while treatment discontinuation, 0.090 (0.023-0.123), and nausea/headache, 0.060 (0.034-0.094) were the least worrisome outcomes. Preferences were similar between Ethiopia and Switzerland with overlapping uncertainty intervals and concordance correlation of 0.97 (0.90-0.99). CONCLUSIONS:Our study provides much needed empirical evidence on preferences that help clinical guidelines consider for weighing the benefit and harm outcomes when recommending for or against statins for primary prevention of cardiovascular disease. The preferences are consistent across the disparate settings; however, we recommend inclusion of more countries in future studies to ensure the generalizability of the preferences to all environments.

Dataset Information

Net benefit of statins for primary prevention of cardiovascular disease in people 75 years or older: a benefit-harm balance modeling study.

Background

Methods

Results

Conclusions

Publications

Net benefit of statins for primary prevention of cardiovascular disease in people 75 years or older: a benefit-harm balance modeling study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets