What is the role of statin (HMG-CoA reductase inhibitor) therapy in the management of hypercholesterolemia in individuals over 70 years of age?

From the Guidelines

Cholesterol medication is recommended for adults over 70 who are already on statin therapy, as it is reasonable to continue statin treatment in this age group, according to the most recent guidelines 1. When considering cholesterol medication for adults over 70, it is essential to individualize decisions based on overall health, life expectancy, and cardiovascular risk.

• For healthy older adults with elevated cholesterol and no contraindications, statins remain the first-line treatment, with moderate-intensity options often preferred to minimize side effects.
• Treatment should focus on those most likely to benefit—individuals with existing cardiovascular disease, diabetes, or multiple risk factors.
• Side effect monitoring is crucial in this age group, particularly for muscle pain, which affects older adults on statins. Key considerations for cholesterol medication in adults over 70 include:
• The benefit-to-risk ratio generally decreases with advancing age, especially beyond 75-80 years, so periodic medication reviews are important.
• The goal is to prevent cardiovascular events while maintaining quality of life, recognizing that the time to benefit from cholesterol medication may be longer than remaining life expectancy for some very elderly patients. As stated in the guidelines, for adults with diabetes aged >75 years already on statin therapy, it is reasonable to continue statin treatment 1. In terms of specific treatment options, moderate-intensity statin therapy is recommended for patients with diabetes who are 75 years or older, with routine evaluation of the risk-benefit profile and downward titration of dose as needed 1.

From the FDA Drug Label

Of the total number of simvastatin-treated patients in clinical studies 1,021 (23%) patients, 5,366 (52%) patients, and 363 (15%) patients were ≥65 years old, respectively. In Study HPS, 615 (6%) patients were ≥75 years old [see CLINICAL STUDIES (14)] In a clinical study of patients treated with simvastatin 80 mg daily, patients ≥65 years of age had an increased risk of myopathy, including rhabdomyolysis, compared to patients <65 years of age A pharmacokinetic study with simvastatin use showed the mean plasma level of total inhibitors to be approximately 45% higher in geriatric patients between 70-78 years of age compared with patients between 18-30 years of age [see CLINICAL PHARMACOLOGY (12.3)]

The use of simvastatin in patients over 70 years old may be associated with an increased risk of myopathy, including rhabdomyolysis.

• Geriatric patients between 70-78 years of age had a 45% higher mean plasma level of total inhibitors compared to patients between 18-30 years of age.
• Patients ≥65 years of age had an increased risk of myopathy, including rhabdomyolysis, compared to patients <65 years of age when treated with simvastatin 80 mg daily 2.

From the Research

Cholesterol Medication in Those Over 70

• The use of statins in individuals over 70 years old is a topic of discussion, with some studies suggesting that high-intensity statin therapy may not be suitable for this age group due to limited evidence and potential risks 3.
• However, statins are still considered beneficial in the elderly population for secondary atherosclerotic cardiovascular prevention, stroke reduction, and decreased morbidity and mortality 3.
• Alternative treatments, such as ezetimibe and PCSK9 inhibitors, may be considered for patients who cannot tolerate statins or require additional lipid-lowering effects 4, 5, 6.
• The combination of ezetimibe and atorvastatin has been shown to be effective in reducing atherogenic lipids and may be useful for patients who cannot reach their lipid targets with maximally tolerated statin doses 7.
• PCSK9 inhibitors, such as evolocumab and alirocumab, have been found to be safe and effective in reducing LDL-C levels and may be used in combination with statins for high-risk patients 5, 6.

Safety and Efficacy

• The safety profile of statin alternatives, including ezetimibe and PCSK9 inhibitors, has been found to be excellent, with no major drug interactions or increased risk of new onset diabetes 5.
• However, injectable PCSK9 inhibitors may be associated with a small increase in injection site reactions, and bempedoic acid may be associated with a small increase in plasma uric acid and episodes of gout in susceptible subjects 5.
• The efficacy of these alternative treatments in reducing LDL-C levels and cardiovascular events has been demonstrated in clinical trials, and they may be considered for patients who require additional lipid-lowering effects 4, 5, 6.

Treatment Considerations

• The decision to initiate and sustain statin therapy in individuals over 70 years old should be a well-informed and collaborative decision, taking into account the benefits and potential risks 3.
• The choice of statin alternative may depend on factors such as cost, availability, and the degree of LDL-C lowering required, rather than safety issues 5.
• Further studies are needed to determine the long-term effects and potential benefits of combining different lipid-lowering therapies in this age group 4, 6.