Abstract 11575: Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized With an Acute Coronary Syndrome

Abstract

Introduction: After generic atorvastatin became available in Canada in June 2010, Ontario’s public prescription benefit program mandated universal substitution of Lipitor® to generic atorvastatin to reduce expenditures. Although generic medications are approved based on bioequivalence with brand-name medications, there remains substantial concern about their clinical effectiveness and safety. This policy change afforded a unique opportunity to compare clinical outcomes between patients with acute coronary syndrome (ACS) prescribed generic atorvastatin and Lipitor®. Methods: We assembled a population-based cohort of patients ≥65 years, discharged alive after an ACS hospitalization between 2008-2012, who were prescribed generic atorvastatin or Lipitor® within 7 days of discharge. Propensity score-matching on demographics, comorbidities, medical and invasive treatment, and physician and hospital characteristics was used to adjust for confounding. The primary outcome was death or recurrent ACS hospitalization at 1-year. Secondary outcomes included hospitalization for heart failure, stroke, new-onset diabetes, rhabdomyolysis, and renal failure. Results: In the 7,863 matched pairs (15,726 patients) of ACS patients, mean age was 76.9 years, 56.3% were male, 87.6% had a myocardial infarction and 12% had unstable angina, and all patients had complete follow-up. At 1-year, 17.7% of those prescribed generic atorvastatin and 17.7% prescribed Lipitor® experienced death or recurrent ACS (HR:1.00, 95%CI 0.93-1.08, p=0.94). Pre-specified subgroup analyses by age, sex, diabetes, atorvastatin dose, admission diagnosis, or generic product also found no difference between groups. No significant differences in secondary outcomes, including side effects, between treatment groups were observed. Conclusions: Among older adults discharged alive after ACS hospitalization, we found no significant difference in cardiovascular outcomes or side effects in patients prescribed generic atorvastatin compared with those prescribed Lipitor® at 1 year. Our findings support the use of generic atorvastatin in ACS, which could lead to substantial cost saving for patients and healthcare plans without diminishing population clinical effectiveness.