A 44-year-old woman has a 10-year history of type 2 diabetes. She is a nonsmoker with well-controlled hypertension and microalbuminuria. She is on dietary management, metformin, and takes one omega-3 fatty acid capsule with 840 mg of EPA and DHA. She also takes lisinopril/hydrochlorothiazide for her blood pressure. She has a family history of diabetes, but not premature ASCVD. She has a BP 134/78 and a BMI of 36.0. Her fasting lipid panel reveals an LDL–C 95 mg/dL, triglycerides 350 mg/dL, and HDL–C 38 mg/dL. Her hemoglobin A1c is 7.5%.
Which of the following statements is the best answer?
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The correct answer is: e. Her 10-year ASCVD risk should be calculated to determine if she needs a high- or moderate-intensity statin.
This patient has diabetes, is between the ages of 40 and 75 years, and has an LDL–C between 70 and 189 mg/dL, placing her in a statin benefit group. The primary prevention CARDS trial showed that men and women with diabetes, but without clinical ASCVD, experienced a reduction in ASCVD events from a moderate intensity statin, atorvastatin 10 mg/day. Although no RCTs have evaluated a high intensity statin in a primary prevention population of individuals with diabetes, such a trial has been performed in a lower risk primary prevention population without diabetes. In the JUPITER trial, rosuvastatin 20 mg/day reduced ASCVD events compared to placebo. In addition, the Cholesterol Treatment Trialists (CTT) 2008 and 2010 meta-analyses have found that statins reduce ASCVD events in proportion to the magnitude of LDL–C lowering in individuals with and without diabetes, and in individuals with diabetes with and without clinical ASCVD. Therefore, a high-intensity statin is also an option for individuals with diabetes and 10-year ASCVD risk ≥7.5%, as it is in those without diabetes. (Note: the Pooled Cohort Equations can be used to estimate 10-year ASCVD risk in Black and nonHispanic White women and men with or without diabetes). In addition, the 2010 CTT meta-analysis also found the reduction in the relative risk of ASCVD was similar across the range of LDL–C levels ≥70 mg/dL.
While some might order an apolipoprotein B or LDL particle number, neither is needed to make a decision to start a statin because she is already in a statin benefit group due to having diabetes.
The ACCORD trial did not show benefit of fenofibrate added to a statin in women with elevated triglycerides and low HDL–C levels. Moreover, the 2008 and 2010 CTT meta-analyses found that statins reduce ASCVD events regardless of HDL-C or triglyceride levels, and are therefore the drugs of choice for ASCVD risk reduction in individuals with abnormal triglyceride or HDL–C levels.
Although the JELIS trial evaluated 1800 mg of EPA added to a low dose statin in Japanese women, no benefit was seen in primary prevention individuals in that trial.
Although bile acid sequestrants can lower hemoglobin A1c, they can also markedly elevate triglyceride levels. Bile acid sequestrants are best started with the triglycerides are <250-300 mg/dL. Tighter diabetes control and lifestyle modification with more physical activity and a heart healthy diet with vegetables, fruits, and less sugar sweetened foods and drinks (often a Mediterranean style diet) would help control the diabetes as well as lower the triglycerides. To date, there are no HDL–C raising drugs that have been shown to reduce ASCVD events in statin-treated individuals.
References
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Ridker P, Danielson E, Fonseca F, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008; 359:2195 - 2207.
Cholesterol Treatment Trialists Collaborators. Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lancet. 2008; 371:117-125.
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