Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients Hospitalized with an Acute Coronary Syndrome.
BACKGROUND
Although generic medications are approved based on bioequivalence with brand-name medications, there remains substantial concern regarding their clinical effectiveness and safety. Lipitor(®), available as generic atorvastatin, is one of the most commonly prescribed statins. Therefore, we compared the effectiveness of generic atorvastatin products and Lipitor(®).


RESULTS
We conducted a population-based cohort study, using propensity score matching to minimize potential confounding of patients ≥65 years, discharged alive after acute coronary syndrome (ACS) hospitalization between 2008 and 2012 in Ontario, Canada, who were prescribed Lipitor(®) or generic atorvastatin within 7 days of discharge. The primary outcome was 1-year death/recurrent ACS hospitalization. Secondary outcomes included hospitalization for heart failure, stroke, new-onset diabetes, rhabdomyolysis, and renal failure. In the 7863 propensity-matched pairs (15 726 patients), mean age was 76.9 years, 56.3% were male, 87.6% had myocardial infarction, and all patients had complete follow-up. At 1 year, 17.7% of those prescribed generic atorvastatin and 17.7% of those prescribed Lipitor(®) experienced death or recurrent ACS (hazard ratio, 1.00; 95% CI, 0.93-1.08; P=0.94). No significant differences in rates of secondary outcomes between groups were observed. Prespecified subgroup analyses by age, sex, diabetes, atorvastatin dose, or admission diagnosis found no outcome difference between groups.


CONCLUSIONS
Among older adults discharged alive after ACS hospitalization, we found no significant difference in cardiovascular outcomes or serious, infrequent 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 health care plans without diminishing population clinical effectiveness.
Department of Pharmacy Practice and Administration, College of Pharmacy, Western University of Health Sciences, Pomona, CA Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada Division of Cardiology, Schulich Heart Center, Sunnybrook Health Sciences Center, University of Toronto Ontario, Canada cjackevicius@westernu.edu.
Cynthia A
CA
Jackevicius
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada University Health Network, Toronto, Ontario, Canada.
Jack V
JV
Tu
Section of Cardiovascular Medicine, Department of Medicine, Yale University, New Haven, CT Yale University School of Medicine, Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University, New Haven, CT Robert Wood Johnson Clinical Scholars Program, New Haven, CT.
Harlan M
HM
Krumholz
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada.
Peter C
PC
Austin
Yale University School of Medicine, Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, CT Section of General Internal Medicine, Department of Medicine, Yale University, New Haven, CT.
Joseph S
JS
Ross
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada.
Therese A
TA
Stukel
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada.
Maria
M
Koh
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada.
Alice
A
Chong
Institute for Clinical Evaluative Sciences, Toronto Ontario, Canada Institute of Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto Ontario, Canada University Health Network, Toronto, Ontario, Canada.
Dennis T
DT
Ko
D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D000069059:Atorvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D057186:Comparative Effectiveness Research; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D057216:Propensity Score; D016896:Treatment Outcome
D016568:Drugs, Generic; D000069059:Atorvastatin
acute coronary syndrome; comparative effectiveness; statin