When to initiate antidyslipidemic (anti-dyslipidemia) medications?

From the Guidelines

Initiation of anti-dyslipidemia medications should be considered when lifestyle modifications alone are insufficient to achieve target lipid levels, particularly in patients with established cardiovascular disease (CVD), diabetes, or high cardiovascular risk, as recommended by the most recent guidelines 1. When deciding to start anti-dyslipidemia medications, it is essential to assess the patient's cardiovascular risk factors, such as dyslipidemia, diabetes, hypertension, or smoking, and their calculated 10-year CVD event risk.

• For people with diabetes aged 40–75 years without ASCVD, moderate-intensity statin therapy is recommended in addition to lifestyle therapy 1.
• For people with diabetes aged 40–75 years at higher cardiovascular risk, high-intensity statin therapy is recommended to reduce LDL cholesterol by ≥50% of baseline and to obtain an LDL cholesterol goal of <70 mg/dL (<1.8 mmol/L) 1.
• In adults with diabetes aged >75 years already on statin therapy, it is reasonable to continue statin treatment 1. The decision to initiate therapy should reflect an assessment of patients’ specific circumstances and their preference for a potential small benefit relative to the potential harms and inconvenience of taking a lifelong daily medication, as noted in previous guidelines 1. However, the most recent guidelines 1 provide a more comprehensive approach to managing cardiovascular risk in patients with diabetes. Regular monitoring of lipid levels and liver function tests is essential, typically at 4-12 weeks after initiation and then annually, with dose adjustments as needed to achieve target LDL-C reductions of 30-50% or more depending on risk category. Key considerations in the management of dyslipidemia include:
• The use of statins as first-line therapy, with options including atorvastatin, rosuvastatin, and simvastatin.
• The addition of ezetimibe or a PCSK9 inhibitor to maximum tolerated statin therapy in patients with persistently elevated LDL-C levels.
• The importance of individualizing treatment based on cardiovascular risk assessment, with more aggressive therapy for higher-risk patients. Overall, the initiation of anti-dyslipidemia medications should be guided by the most recent evidence-based guidelines, with a focus on reducing cardiovascular risk and improving patient outcomes 1.

From the FDA Drug Label

To reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease As an adjunct to diet, alone or in combination with other low density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

The decision to start anti-dyslipidemia medications, such as alirocumab, should be based on the presence of established cardiovascular disease or primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

• Key considerations for starting treatment include:
  • The patient's cardiovascular risk
  • The presence of hyperlipidemia
  • The patient's LDL-C levels There is no specific information in the label about when to start anti-dyslipidemia medications in general, only when to use alirocumab. 2

From the Research

Initiating Anti-Dyslipidemia Medications

The decision on when to start anti-dyslipidemia medications depends on several factors, including the patient's risk for atherosclerotic cardiovascular disease (ASCVD) and their current lipid profile.

• Patients at extreme ASCVD risk should be treated with high-intensity statin therapy to achieve a goal low-density lipoprotein cholesterol (LDL-C) of <55 mg/dL, and those at very high ASCVD risk should be treated to achieve LDL-C <70 mg/dL 3.
• Treatment for moderate and high ASCVD risk patients may begin with a moderate-intensity statin to achieve an LDL-C <100 mg/dL, while the LDL-C goal is <130 mg/dL for those at low risk 3.
• It is recommended to start therapy before the patient is at high risk of a fatal cardiovascular event, addressing both dyslipidemia and hypertension concurrently if they co-occur 4.

Considerations for Therapy Initiation

• The treatment of lipid disorders begins with lifestyle therapy to improve nutrition, physical activity, weight, and other factors that affect lipids, with pharmacologic therapy initiated based on a patient's risk for ASCVD 3.
• Statins are still considered the first-line option for the management of hypercholesterolemia in a large percentage of patients, with the choice of statin and dose depending on the patient's specific needs and the differences in lipid-lowering potency across different medications 5.
• Non-statin lipid-lowering therapies, including bile acid sequestrants, fibrates, nicotinic acid, ezetimibe, and PCSK9 inhibitors, among others, may be considered for patients who cannot tolerate statins or require additional lipid lowering 6.

Patient Adherence and Persistence

• Improving patient adherence and persistence to lipid-lowering treatments is a main challenge in the treatment of lipid disorders, with strategies including using the appropriate drugs at adequate doses, avoiding drug interactions, monitoring possible side effects, and tailoring treatment strategies to each patient 5.
• Combination therapy with statins and other agents, such as omega-3 fatty acids, may enhance lipid profiles but should be cautiously recommended due to potential safety issues 7.