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Personalizing cholesterol treatment recommendations for primary cardiovascular disease prevention.

ABSTRACT: Statin therapy is the cornerstone of preventing atherosclerotic cardiovascular disease (ASCVD), primarily by reducing low density lipoprotein cholesterol (LDL-C) levels. Optimal statin therapy decisions rely on shared decision making and may be uncertain for a given patient. In areas of clinical uncertainty, personalized approaches based on real-world data may help inform treatment decisions. We sought to develop a personalized statin recommendation approach for primary ASCVD prevention based on historical real-world outcomes in similar patients. Our retrospective cohort included adults from a large Northern California electronic health record (EHR) aged 40-79 years with no prior cardiovascular disease or statin use. The cohort was split into training and test sets. Weighted-K-nearest-neighbor (wKNN) regression models were used to identify historical EHR patients similar to a candidate patient. We modeled four statin decisions for each patient: none, low-intensity, moderate-intensity, and high-intensity. For each candidate patient, the algorithm recommended the statin decision that was associated with the greatest percentage reduction in LDL-C after 1 year in similar patients. The overall cohort consisted of 50,576 patients (age 54.6 ± 9.8 years) with 55% female, 48% non-Hispanic White, 32% Asian, and 7.4% Hispanic patients. Among 8383 test-set patients, 52%, 44%, and 4% were recommended high-, moderate-, and low-intensity statins, respectively, for a maximum predicted average 1-yr LDL-C reduction of 16.9%, 20.4%, and 14.9%, in each group, respectively. Overall, using aggregate EHR data, a personalized statin recommendation approach identified the statin intensity associated with the greatest LDL-C reduction in historical patients similar to a candidate patient. Recommendations included low- or moderate-intensity statins for maximum LDL-C lowering in nearly half the test set, which is discordant with their expected guideline-based efficacy. A data-driven personalized statin recommendation approach may inform shared decision making in areas of uncertainty, and highlight unexpected efficacy-effectiveness gaps.

SUBMITTER: Sarraju A

PROVIDER: S-EPMC8742083 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe recent guidelines for preventing atherosclerotic cardiovascular events are an important advancement. For primary prevention, statins are recommended if the ten-year risk is ≥ 5% (consideration for therapy) or ≥ 7.5% (definitive treatment unless contraindication after discussion). We rationalized that a significant cohort with ten-year risk below the treatment thresholds would predictably surpass them within the recommended 4-6 year window for reassessing the ten-year risk. As atherosclerosis is a progressive disease, these individuals may therefore benefit with more aggressive therapies even at baseline.Methods and findingsWe used publicly available NHANES dataset for ten-year risk calculation. There were 1805 participants. To evaluate the ten-year risk change at five years, we considered two scenarios: no change in the baseline parameters except increased age by five (No Change) and alternatively 10% improvement in systolic BP, total and HDL-c, no smoking with five-year increase in age (Reduced Risk Profile). Amongst non-diabetics with <5% risk at baseline, 35% reached or exceeded 5% risk in five years (5% reached or exceed the 7.5% risk) with No Change and 9% reached or exceeded 5% risk in five years (none reached 7.5% risk) with Reduced Risk Profile; furthermore, 94% of the non-diabetic cohort with baseline risk between 3.5%-5% would exceed the 5% and/or 7.5% boundary limit with No Change. Amongst non-diabetics with 5-7.5% baseline risks, 87% reached or exceeded 7.5% with No Change while 30% reached or exceeded 7.5% risk with Reduced Risk Profile.ConclusionsA significant population cohort at levels below the treatment thresholds will predictably exceed these limits with time with or without improvement in modifiable risk factors and may benefit with more aggressive therapy at baseline. We provide an improved risk calculator that allows for integrating expected risk modification into discussion with an individual. This needs to be prospectively tested in clinical trials.

Project description:AimsThe total cholesterol (TC)/high-density lipoprotein (HDL) cholesterol ratio may carry additional information not available in more commonly used single cholesterol measures. Analysis of discordance between lipid parameters might help assess the impact of such additional information on the risk of atherosclerotic cardiovascular disease. We aimed to investigate the role of the TC/HDL-cholesterol ratio in determining atherosclerotic cardiovascular disease risk when discordant with low-density lipoprotein (LDL) cholesterol and non-HDL-cholesterol.MethodsWe studied 14,403 Atherosclerosis Risk in Communities (ARIC) study participants who were free of atherosclerotic cardiovascular disease at baseline. TC/HDL-cholesterol discordance with LDL-cholesterol (estimated by the novel Martin/Hopkins method) and non-HDL-cholesterol was assessed at five visits and determined by being at or above the median for each lipid parameter. We constructed Cox proportional hazard models to estimate the risk for incident atherosclerotic cardiovascular disease events associated with each lipid concordance/discordance category using a time-varying approach.ResultsMean age of participants was 54.1 years, 56% women and 25% black. There were 2634 atherosclerotic cardiovascular disease events over a median (interquartile range) follow-up of 24.2 (16.0-25.4) years. Among individuals with LDL-cholesterol and non-HDL-cholesterol less than the median, 26% and 21% had discordant TC/HDL-cholesterol at or above the median, respectively. These individuals had a 24% (hazard ratio (HR) 1.24, 95% confidence interval (CI) 1.09, 1.41) and 29% (HR 1.29, 95% CI 1.13, 1.46) greater risk of incident atherosclerotic cardiovascular disease, respectively, compared to those with TC/HDL-cholesterol less than the median after multivariable adjustment. In individuals with diabetes with LDL-cholesterol or non-HDL-cholesterol less than the median, discordant TC/HDL-cholesterol at or above the median was more prevalent at 48% and 38%, respectively.ConclusionClinically significant discordance exists between TC/HDL-cholesterol, available from the standard lipid profile, and the routinely used non-HDL-cholesterol and LDL-cholesterol. Such discordance may help inform atherosclerotic cardiovascular disease risk management, particularly in individuals with diabetes in whom discordance is more common.

Project description:Background The purpose of this study was to determine how American College of Cardiology/American Heart Association (ACC/AHA) 2013 and European Society of Cardiology 2016 guidelines for the primary prevention of atherosclerotic cardiovascular disease (CVD) compare in reflecting the totality of accrued randomised clinical trial evidence for statin treatment at population level. Methods From 1997-2008, 7279 participants aged 45-75 years, free of atherosclerotic cardiovascular disease, from the population-based Rotterdam Study were included. For each participant, we compared eligibility for each one of 11 randomised clinical trials on statin use in primary prevention of CVD, with recommendations on lipid-lowering therapy from the ACC/AHA and European Society of Cardiology (ESC) guidelines. Atherosclerotic cardiovascular disease incidence and cardiovascular disease mortality rates were calculated. Results The proportion of participants eligible for each trial ranged from 0.4% for ALLHAT-LLT to 30.8% for MEGA. The likelihood of being recommended for lipid-lowering treatment was lowest for those eligible for low-to-intermediate risk RCTs (HOPE-3, MEGA, and JUPITER), and highest for high-risk individuals with diabetes (MRC/BHF HPS, CARDS, and ASPEN) or elderly PROSPER. Eligibility for an increasing number of randomised clinical trials correlated with a greater likelihood of being recommended lipid-lowering treatment by either guideline ( p?<?0.001 for both guidelines). Conclusion Compared to RCTs done in high risk populations, randomised clinical trials targeting low-to-intermediate risk populations are less well-reflected in the ACC/AHA, and even less so in the ESC guideline recommendations. Importantly, the low-to-intermediate risk population targeted by HOPE-3, the most recent randomised clinical trial in this field, is not well-captured by the current European prevention guidelines and should be specifically considered in future iterations of the guidelines.

Project description:BackgroundA sedentary lifestyle and stress are major risk factors for cardiovascular disease (CVD). Since yoga involves exercise and is thought to help in stress reduction it may be an effective strategy in the primary prevention of CVD.ObjectivesTo determine the effect of any type of yoga on the primary prevention of CVD.Search methodsWe searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 11) in The Cochrane Library; MEDLINE (Ovid) (1946 to November Week 3 2013); EMBASE Classic + EMBASE (Ovid) (1947 to 2013 Week 48); Web of Science (Thomson Reuters) (1970 to 4 December 2013); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (Issue 4 of 4, 2013) in The Cochrane Library. We also searched a number of Asian databases and the Allied and Complementary Medicine Database (AMED) (inception to December 2012). We searched trial registers and reference lists of reviews and articles, and approached experts in the field. We applied no language restrictions.Selection criteriaRandomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of yoga and the comparison group was no intervention or minimal intervention. Outcomes of interest were clinical CVD events and major CVD risk factors. We did not include any trials that involved multifactorial lifestyle interventions or weight loss.Data collection and analysisTwo authors independently selected trials for inclusion, extracted data and assessed the risk of bias.Main resultsWe identified 11 trials (800 participants) and two ongoing studies. Style and duration of yoga differed between trials. Half of the participants recruited to the studies were at high risk of CVD. Most of studies were at risk of performance bias, with inadequate details reported in many of them to judge the risk of selection bias.No study reported cardiovascular mortality, all-cause mortality or non-fatal events, and most studies were small and short-term. There was substantial heterogeneity between studies making it impossible to combine studies statistically for systolic blood pressure and total cholesterol. Yoga was found to produce reductions in diastolic blood pressure (mean difference (MD) -2.90 mmHg, 95% confidence interval (CI) -4.52 to -1.28), which was stable on sensitivity analysis, triglycerides (MD -0.27 mmol/l, 95% CI -0.44 to -0.11) and high-density lipoprotein (HDL) cholesterol (MD 0.08 mmol/l, 95% CI 0.02 to 0.14). However, the contributing studies were small, short-term and at unclear or high risk of bias. There was no clear evidence of a difference between groups for low-density lipoprotein (LDL) cholesterol (MD -0.09 mmol/l, 95% CI -0.48 to 0.30), although there was moderate statistical heterogeneity. Adverse events, occurrence of type 2 diabetes and costs were not reported in any of the included studies. Quality of life was measured in three trials but the results were inconclusive.Authors' conclusionsThe limited evidence comes from small, short-term, low-quality studies. There is some evidence that yoga has favourable effects on diastolic blood pressure, HDL cholesterol and triglycerides, and uncertain effects on LDL cholesterol. These results should be considered as exploratory and interpreted with caution.

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Personalizing cholesterol treatment recommendations for primary cardiovascular disease prevention.

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