Evaluation of Guideline and Trial Based Approaches for Statin Use as an Effective Primary Prevention Strategy- A Proposal for a Prospective Cohort Study in the United States

Evaluation of Guideline and Trial Based Approaches for Statin Use as an Effective Primary Prevention Strategy- A Proposal for a Prospective Cohort Study in the United States.

Outline. Epidemiological importance of heart disease Discuss dyslipidemia as a risk factor for cardiovascular disease Discuss primary intervention measures Discuss current statin use guidelines Discuss randomized control trials Research gap Research project proposal to address gap Methods & statistical analysis Study design limitations and strengths.

Leading causes of death in the U.S.. Graphical user interface Description automatically generated.

Heart disease deaths by sex, race and ethnicity. Table Description automatically generated.

Lipoprotein profile. Table Description automatically generated.

Dyslipidemia. Dyslipidemia Atherosclerosis Atherosclerotic cardiovascular disease.

Primary Prevention Measures. Lifestyle modifications Dietary changes Physical activity Medications Bile acid sequestrants Fibrates Niacin cholesterol-absorption inhibitors Statins (most common).

Impact of medications. Chart, bar chart Description automatically generated.

Statin use primary prevention guidelines. 2018 American College of Cardiology/American Heart Association (ACC/AHA) guidelines ACC/AHA prediction model 2016 Canadian Cardiovascular guidelines Framingham risk score (FRS) 2014 UK National Institute for Health and Care Excellence (NICE) guidelines QRISK2 prediction model 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines Systematic Coronary Risk Evaluation (SCORE) prediction model.

Randomized Control Trials. JUPITER AFCAPS ASCOT-LLA CARDS MEGA HOPE-3.

Which is better?. Guideline eligibility or RCT eligibility Copenhagen General Population Study (CGPS).

Research Gap. CPBS Homogenous source population All participants had health insurance Race and ethnicity are determinates of dyslipidemia as well as a risk factor for CVD.

Project Proposal. Evaluation of Guideline and Trial Based Approaches for Statin Use as an Effective Primary Prevention Strategy- A Proposal for a Prospective Cohort Study in the United States.

Methods. Source Population Kaiser Permanente Exposures RCT eligibility Outcomes ASCVD events.

Statistical Analysis. examine the extent to which RCT evidence supports each of guideline-based recommendations examine RCTs demonstrating statin efficacy for persons in different guidelines-based risk groups Evaluate clinical performance of the guidelines- and RCT approaches Incidence rate s & hazard rations with 95% CI estimate the number needed to treat (NNT) to avert one instance of ASCVD in 10 years, stratified by guideline- and RCT eligibility groups.

Strengths and Limitations. unable to account for preventative drug use, such as statins, during follow-up, which could influence the incidence of ASCVD participant’s baseline characteristics may change over time -> misclassification Long follow-up period Susceptible to non-response bias.

References. Centers for Disease Control and Prevention. (2022, January 13). FASTSTATS - deaths and mortality . Centers for Disease Control and Prevention. Retrieved July 27, 2022, from https:// www.cdc.gov / nchs / fastats / deaths.htm Ford E.S., Capewell S. (2013) Trends in Total and Low-density Lipoprotein Cholesterol Among US adults: Contributions of Changes in Dietary Fat Intake and Use of Cholesterol-lowering Medications. PLoS One. 2013;8(5):e65228. Jun, Jeong , I.-K., Ahn , K. J., Chung, H. Y., & Hwang, Y.-C. (2021). Statin Use for Primary Prevention in Patients with Type 2 Diabetes: Can it Benefit all Ages? – A Nationwide Propensity-Matched Cohort Study. Diabetes Research and Clinical Practice , 180 , 109044–109044. https://doi.org/10.1016/j.diabres.2021.109044 Kashef , & Giugliano , G. (2016). Legacy effect of statins: 20-year follow up of the West of Scotland Coronary Prevention Study (WOSCOPS). Global Cardiology Science & Practice , 2016 (4), e201635–e201635. https:// doi.org /10.21542/gcsp.2016.35 Khunti , Jung, H., Dans, A. L., Held, C., Dagenais , G. R., Yusuf, S., & Lonn , E. (2019). Statin Use in Primary Prevention: A Simple Trial-Based Approach Compared with Guideline-Recommended Risk Algorithms for Selection of Eligible Patients. Canadian Journal of Cardiology , 35 (5), 644–652. https://doi.org/10.1016/j.cjca.2019.03.002 Kim, Choi, H., & Won, C. W. (2020). Effects of Statin Use for Primary Prevention among Adults Aged 75 Years and Older in the National Health Insurance Service Senior Cohort (2002-2015). Annals of Geriatric Medicine and Research , 24 (2), 91–98. https://doi.org/10.4235/agmr.20.0028 Michos , & Blumenthol , R. S. (2009). Prevalence of Low Low-Density Lipoprotein Cholesterol With Elevated High Sensitivity C-Reactive Protein in the U.S: Implications of the JUPITER (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) Study. Journal of the American College of Cardiology , 53 (11), 931–935. https:// doi.org /10.1016/j.jacc.2008.12.010.

References. Mora, & Ridker , P. M. (2006). Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER)—Can C-Reactive Protein Be Used to Target Statin Therapy in Primary Prevention? The American Journal of Cardiology , 97 (2), 33–41. https://doi.org/10.1016/j.amjcard.2005.11.014 Mortensen, & Nordestgaard , B. G. (2022). Guidelines versus trial-evidence for statin use in primary prevention: The Copenhagen General Population Study. Atherosclerosis , 341 , 20–26. https://doi.org/10.1016/j.atherosclerosis.2021.12.002 Remington, P. L., Brownson, R. C., & Wegner, M. V. (2016). Chronic Disease Epidemiology, Prevention, and Control (4th ed.). Alpha Press, an imprint of American Public Health Association. Ridker , P. M., Danielson, E., Fonseca, F. A. H., Genest, J., Gotto , A. M., Kastelein , J. J. P., Koenig, W., Libby, P., Lorenzatti , A. J., MacFadyen , J. G., Nordestgaard , B. G., Shepherd, J., Willerson , J. T., & Glynn, R. J. (2008). Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. New England Journal of Medicine , 359 (21), 2195–2207. https://doi.org/10.1056/nejmoa0807646 US Preventive Services Taskforce. (2016, November 13). Statin use for the primary prevention of cardiovascular disease in adults: Preventive medication . Recommendation: Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication | United States Preventive Services Taskforce. Retrieved July 27, 2022, from https:// www.uspreventiveservicestaskforce.org / uspstf /recommendation/statin-use-in-adults-preventive-medication.