What is the ACC/AHA 10-year ASCVD risk score of this patient?
ACC/AHA 10-year ASCVD risk score is around 7.8%. According to the 2018 ACC/AHA Guideline on the Management of Blood Cholesterol, RS is considered “intermediate risk” because his 10-year ASCVD risk score is ≥7.5%.
This is underestimated because of factors not accounted for by the ASCVD risk calculator, including her family history of ASCVD and presence of metabolic syndrome, both of which are risk-enhancing factors. His risk score and the presence of risk enhancers indicate the need for moderate-intensity statin therapy to reduce LDL-C by 30% to 49%.
To improve risk-stratification and guide initiation and intensity of statin therapy, the 2018 ACC/AHA Cholesterol Guideline introduced risk-enhancing factors. The risk-enhancing factors have been identified primarily from epidemiologic data. When present, risk-enhancing factors indicate a greater overall ASCVD risk and are often proportional to the degree and duration of the specific condition. Therefore, his 10-year risk of a CV event is much higher than suggested by the 10-year ASCVD risk score alone.
How do you address the concerns about statin-associated Diabetes Mellitus?
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) each released statements in 2012 about the association between statin therapy and elevated A1C and FBG, and increased risk of new-onset diabetes (NOD) among those predisposed to DM. Several studies have reinforced these statements, but with mixed results. An analysis evaluating data from 13 major RCTs noted a 9% increase in incident DM with statin therapy. Conversely, a meta-analysis of observational studies reported a more robust association with statins (RR, 1.44; 95% confidence interval [CI] 1.31 to 1.58).14 Differences among individual agents also have been evaluated, and most data indicate that statin potency and dosage play a role. Specific statins appear less diabetogenic with no dose dependency. Atorvastatin, rosuvastatin, and simvastatin have the strongest associations compared with minimal or no association with fluvastatin, lovastatin, pitavastatin, and pravastatin.Given the inconclusive data, the FDA and EMA indicate the risk/benefit ratio favors the use of statin therapy among patients at risk for DM. Nonetheless, monitoring glycemic indices at baseline and during statin therapy is recommended.
How would you manage this patient?
Patient has Metabolic Syndrome with impaired glycemic indices indicating prediabetes. His family history also is significant because his parent developed T2DM. RS expresses concern about statin-associated DM and does not want to further worsen his glucose parameters.
RS has a 10-year ASCVD risk above the 7.8% calculated by the ACC/AHA risk estimator and, therefore, he needs lipid lowering therapy. The challenge is to balance the need for lipid lowering therapy without aggravating the patient’s already impaired glucose. Reasonable options discussed with patient were pitavastatin, 2 to 4 mg/d, or rosuvastatin, 10 mg/d. To improve adherence, RS was actively involved in the decision regarding the risk/benefit ratio of statin therapy, with reinforcement that the statin is unlikely to worsen his glycemia. RS decided to proceed with Rosuvastatin 10 mg daily.
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1046-e1081. doi: 10.1161/CIR.0000000000000624. Epub 2018 Nov 10. Erratum in: Circulation. 2019 Jun 18;139(25):e1178-e1181. PMID: 30565953.
- Gami AS, Witt BJ, Howard DE, et al. Metabolic syndrome and risk of incident cardiovascular events and death: a systematic review and meta-analysis of longitudinal studies. J Am Coll Cardiol. 2007 Jan 30;49(4):403-14. doi: 10.1016/j.jacc.2006.09.032. Epub 2007 Jan 12. PMID: 17258085.
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- Cholesterol Treatment Trialists’ (CTT) Collaboration, Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8. PMID: 21067804; PMCID: PMC2988224.
- Introduction: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S1-S2. doi: 10.2337/dc20-Sint. PMID: 31862741.
- US Food and Drug Administration. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. Published 2012. https://www.fda.gov/Drugs/DrugSafety/ucm293101.htm. Accessed November 28, 2022.
- Beckett RD, Schepers SM, Gordon SK. Risk of new-onset diabetes associated with statin use. SAGE Open Med. 2015 Sep 30;3:2050312115605518. doi: 10.1177/2050312115605518. PMID: 26770803; PMCID: PMC4679326.
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- Maki KC, Ridker PM, Brown WV, et al. An assessment by the Statin Diabetes Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S17-29. doi: 10.1016/j.jacl.2014.02.012. PMID: 24793439.