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2016 ; 5
(4
): e003350
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Comparative Effectiveness of Generic Atorvastatin and Lipitor® in Patients
Hospitalized with an Acute Coronary Syndrome
#MMPMID27098970
Jackevicius CA
; Tu JV
; Krumholz HM
; Austin PC
; Ross JS
; Stukel TA
; Koh M
; Chong A
; Ko DT
J Am Heart Assoc
2016[Apr]; 5
(4
): e003350
PMID27098970
show ga
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(®). METHODS AND
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.
|Acute Coronary Syndrome/*drug therapy
[MESH]
|Aged
[MESH]
|Atorvastatin/adverse effects/*therapeutic use
[MESH]
|Comparative Effectiveness Research
[MESH]
|Drugs, Generic/adverse effects/*therapeutic use
[MESH]