Judith Hey-Hadavi, MD, director, Medical and Regulatory Affairs, Metabolic and Cardiovascular Division, Pfizer Global Pharmaceuticals, New York, New York, United States, and colleagues, reviewed data from 50 clinical trials to compare the tolerability profiles of atorvastatin 10 mg, 20 mg, 40 mg, 80 mg, and placebo in individuals 65 years of age or older. Overall, 5,924 patients were included in the analysis.

"Almost 40% of Americans with cardiovascular disease are 65 years of age or older," Dr. Hey-Hadavi noted. "Most new coronary heart disease events and deaths occur in persons in this age group, and 40% of patients hospitalised for myocardial infarction are at least 75 years old."

While the National Cholesterol Education Program has stated that there is a strong justification for intensive low-density lipoprotein therapy in older persons with or without established cardiovascular disease, physicians may be reluctant to prescribe evidence-based therapies like statins in older patients because of concern about adverse events and drug interactions, she added.

Almost 27% of subjects in her study were 75 years of age or older, 42% were female, 62% had hypertension, 23% had diabetes, and 63% had known cardiovascular disease. Clinically important concomitant medications included warfarin in 6.7% of patients, verapamil in 3.8%, clopidogrel in 2.5%, digoxin in 9.4%, and amiodarone in 1.2%.

The frequency of adverse events in the atorvastatin-treated cohorts did not increase with increasing doses the drug and was similar to that observed with placebo. The most common events secondary to treatment were related to the digestive system (< 7.5% in all groups). Serious drug-related adverse effects were rare and rarely led to treatment withdrawal, Dr. Hey-Hadavi said.

Persistent elevations in liver function tests (defined as > 3 times the upper limit of normal) in the atorvastatin groups (10-mg, 20-mg, 40-mg, and 80-mg groups, respectively) were observed in 3 (0.2%), 0 (0%), 1 (0.2%), and 7 (0.4%). The placebo arm had 2 patients (0.2%) with elevations in liver function tests.

Persistent creatine phosphokinase elevations (> 10 times the upper limit of normal) were not seen in any group. The incidence of treatment-associated myalgia was low, Dr. Hey-Hadavi said. There were no instances of albuminuria or rhabdomyolysis related to the study medication, and haematuria was rare.

Dr. Hey-Hadavi said the results should help guide physicians when they manage cardiovascular risk in older patients.


[Presentation title: Atorvastatin Safety in Patients 65 Years and Older. Abstract P01.052]

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