What is the role of HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, commonly referred to as statins, in the management of hyperlipidemia in the elderly population?

From the Guidelines

Statins are recommended for elderly patients with established cardiovascular disease or at high risk for cardiovascular events, with individualized treatment decisions and careful consideration of potential side effects and drug interactions. When prescribing statins to elderly patients, it is essential to prioritize their morbidity, mortality, and quality of life outcomes. The primary benefit of statins in the elderly is secondary prevention, as demonstrated by studies such as the Heart Protection Study (HPS) and the PROSPER trial 1, which showed significant reductions in major vascular events and mortality in older adults with established cardiovascular disease. For elderly patients, typically those over 75 years, moderate-intensity statins like atorvastatin 10-20 mg daily or rosuvastatin 5-10 mg daily are often preferred over high-intensity regimens to minimize adverse effects, as recommended by the 2016 ESC/EAS guidelines for the management of dyslipidaemias 1. Some key points to consider when prescribing statins to elderly patients include:

• Starting at a lower dose and titrating up as tolerated while monitoring for side effects such as muscle pain, which occurs more frequently in older adults
• Considering drug interactions, particularly with simvastatin, which has more significant interaction concerns compared to atorvastatin or rosuvastatin
• Regular monitoring of liver function, muscle symptoms, and potential cognitive effects, with medication reviews at least annually to assess ongoing benefit versus risk, as suggested by the 2013 American Heart Association scientific statement on secondary prevention of atherosclerotic cardiovascular disease in older adults 1. Overall, the use of statins in elderly patients requires careful consideration of their individual risk factors, comorbidities, and potential side effects, as well as regular monitoring and adjustment of treatment as needed, to maximize their benefits and minimize their risks, as discussed in the 2018 Journal of the American College of Cardiology article on primary prevention with statins in the elderly 1.

From the FDA Drug Label

Of the total number of atorvastatin calcium-treated patients in clinical trials, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these patients and younger patients. Advanced age (≥65 years) is a risk factor for atorvastatin calcium tablets-associated myopathy and rhabdomyolysis Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy.

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 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

Key Points:

• Advanced age (≥65 years) is a risk factor for myopathy and rhabdomyolysis in patients taking statins.
• Dose selection for elderly patients should be cautious, considering decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
• Elderly patients (≥65 years) have an increased risk of myopathy, including rhabdomyolysis, when taking simvastatin 80 mg daily.
• No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients taking atorvastatin. 2 3

From the Research

Benefits of Statins in the Elderly

• Statins have been shown to decrease the risk of stroke and coronary artery disease in all age groups, including the elderly 4.
• The benefits of statin therapy in the elderly clearly outweigh the low risk of serious side effects 5.
• Statins have proven benefit in the elderly in those with coronary heart disease and diabetes mellitus 5.
• Primary prevention is the most important way of preventing cardiovascular disease in elderly individuals, and statins play a crucial role in this process 4.

Considerations for Statin Therapy in the Elderly

• The decision to initiate and sustain statin treatment should be a well-informed and collaborative decision, taking into account the potential risks and benefits 6.
• Elderly patients are more likely to experience side effects from statin therapy, such as diabetes mellitus, myopathy, and rhabdomyolysis, due to their multiple associated comorbidities and drugs that may interact with statins 4.
• Lower doses of statins may be required in the elderly due to drug interactions and differences in metabolism related to aging 5.
• The choice of statin may be important, with some statins (such as rosuvastatin) having advantages in treating older patients due to their efficacy and safety profile 7.

Efficacy of Statins in the Elderly

• Ezetimibe/simvastatin combination therapy has been shown to be effective in reducing LDL cholesterol levels in elderly patients, with a significantly greater percentage of patients achieving LDL cholesterol targets compared to atorvastatin alone 8.
• Rosuvastatin has been shown to be efficacious and well tolerated in elderly patients, with advantages in treating older patients due to its efficacy and safety profile 7.
• Statin therapy has been shown to reduce the risk of coronary heart disease and cerebrovascular accidents in the elderly, with significant benefits observed in secondary prevention 4, 5.