3.3.2.0 Initiating Statin Therapy Based on Risk
Patients with type 2 diabetes have an increased prevalence of lipid abnormalities, contributing to their high risk of ASCVD. Multiple clinical trials have demonstrated the beneficial effects of statin therapy on ASCVD outcomes in subjects with and without CHD (77,78). Subgroup analyses of patients with diabetes in larger trials (79-83) and trials in patients with diabetes (84,85) showed significant primary and secondary prevention of ASCVD events and CHD death in patients with diabetes. Meta-analyses, including data from over 18,000 patients with diabetes from 14 randomized trials of statin therapy (mean follow-up 4.3 years), demonstrate a 9% proportional reduction in all-cause mortality and 13% reduction in vascular mortality for each mmol/L (39 mg/dL) reduction in LDL cholesterol (86). Accordingly, statins are the drugs of choice for LDL cholesterol lowering and cardioprotection. Table 10.2 shows recommended lipid-lowering strategies, and Table 10.3 shows the two statin dosing intensities that are recommended for use in clinical practice: high-intensity statin therapy will achieve approximately a 50% reduction in LDL cholesterol, and moderate-intensity statin regimens achieve 30–50% reductions in LDL cholesterol. Low-dose statin therapy is generally not recommended in patients with diabetes but is sometimes the only dose of statin that a patient can tolerate. For patients who do not tolerate the intended intensity of statin, the maximally tolerated statin dose should be used.
As in those without diabetes, absolute reductions in ASCVD outcomes (CHD death and nonfatal MI) are greatest in people with high baseline ASCVD risk (known ASCVD and/or very high LDL cholesterol levels), but the overall bene- fits of statin therapy in people with diabetes at moderate or even low risk for ASCVD are convincing (87,88). The relative benefit of lipid-lowering therapy has been uniform across most subgroups tested (78,86), including subgroups that varied with respect to age and other risk factors.
|
Table 10.2—Recommendations for statin and combination treatment in adults with diabetes |
|
|---|---|
|
Recommended statin intensity^ and combination treatment* |
|
|
Age <40 years |
|
|
No |
None† |
|
Yes |
High |
|
|
In patients with ASCVD, if LDL cholesterol ≥70 mg/dL despite maximally tolerated statin dose, consider adding additional LDL-lowering therapy (such as ezetimibe or PCSK9 inhibitor)# |
|
Age ≥40 years |
|
|
No |
Moderate‡ |
|
Yes |
High |
|
|
In patients with ASCVD, if LDL cholesterol ≥70 mg/dL despite maximally tolerated statin dose, consider adding additional LDL-lowering therapy (such as ezetimibe or PCSK9 inhibitor) |
ASCVD, atherosclerotic cardiovascular disease; PCSK9, proprotein convertase subtilisin/kexin type 9.
*In addition to lifestyle therapy.
^For patients who do not tolerate the intended intensity of statin, the maximally tolerated statin dose should be used.
†Moderate-intensity statin may be considered based on risk-benefit profile and presence of ASCVD risk factors. ASCVD risk factors include LDL cholesterol ≥100 mg/dL (2.6 mmol/L), high blood pressure, smoking, chronic kidney disease, albuminuria, and family history of premature ASCVD.
‡High-intensity statin may be considered based on risk-benefit profile and presence of ASCVD risk factors.
#Adults aged <40 years with prevalent ASCVD were not well represented in clinical trials of non-statin–based LDL reduction. Before initiating combination lipid-lowering therapy, consider the potential for further ASCVD risk reduction, drug-specific adverse effects, and patient preferences.
|
Table 10.3—High-intensity and moderate-intensity statin therapy* |
|
|---|---|
|
High-intensity statin therapy (lowers LDL cholesterol by ≥50%) |
Moderate-intensity statin therapy (lowers LDL cholesterol by 30–50%) |
|
Atorvastatin 40–80 mg |
Atorvastatin 10–20 mg |
|
Rosuvastatin 20–40 mg |
Rosuvastatin 5–10 mg |
|
|
Simvastatin 20–40 mg |
|
|
Pravastatin 40–80 mg |
|
|
Lovastatin 40 mg |
|
|
Fluvastatin XL 80 mg |
|
|
Pitavastatin 2–4 mg |
*Once-daily dosing. XL, extended release.