Generic atorvastatin is as effective as the brand-name drug (LIPITOR®) in lowering cholesterol levels: a cross-sectional retrospective cohort study

Abstract

BackgroundIn a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs’ efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin.MethodsThis cross-sectional, retrospective cohort study was conducted at the University of Malaya Medical Centre from 1 May 2013 until 30 May 2013. We analyzed the lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) of 629 patients before and at least 3 months after switching them from proprietary atorvastatin (Lipitor®) to generic atorvastatin (atorvastatin calcium from Ranbaxy Laboratories, Inc.). We also investigated if there was any difference in the effectiveness of both atorvastatin formulations in various ethnic groups.Results266 patients were included in this study. When comparing the median values we found no statistically significant differences (Wilcoxon signed-rank test; p < 0.05) between proprietary and generic atorvastatin in lowering total cholesterol (4.60 mmol/l pre-transition vs. 4.50 mmol/l post-transition; p = 0.583), LDL-cholesterol (2.42 mmol/l vs. 2.41 mmol/l; p = 0.923) and triglycerides (1.50 mmol/l vs. 1.50 mmol/l; p = 0.513). While there was a statistically significant (p = 0.009) difference in HDL-cholesterol levels favouring proprietary atorvastatin, the extent of this change (1.26 mmol/l vs. 1.25 mmol/l) was deemed not to be clinically relevant. There was no statistically significant difference when analyzing the effects on various ethnic groups.ConclusionsSubstituting proprietary atorvastatin for its generic formulation atorvastatin calcium does not result in a less effective management of hyperlipidemia. Our findings lend support to the approach of lowering health care costs by switching patients from branded drugs to their less expensive generic analogues.

Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis

“…Mano et al [ 41 ], in a retrospective study, reported that changing from brand-name ( N = 147) to generic atorvastatin ( N = 135) did not affect treatment persistence (85.9% vs. 73.5%) in patients, after 180 days of treatment. On the basis of 266 patients, Loch et al [ 42 ] concluded that brand-name vs. generic atorvastatin achieved similar results (total and LDL cholesterol) in the clinical management of dyslipidemia, except for HDL-c levels (better with brand-name atorvastatin). Nevertheless, to our understanding, the following should be assessed: whether the sample size obtained was adequate (statistical power), where the balance would be between statistical significance and clinical relevance/impact, and when meta-analyses are performed based on these studies.…”

<p>Association of atorvastatin with the risk of hepatotoxicity: a pilot prescription sequence symmetry analysis</p>

“…Second, we did not investigate the dose-response relationship between ATO and hepatotoxicity in the study because only patients who had both the marker and index drugs were included in the analyses. Third, although generic ATO is as effective as the brand-name drug in lowering cholesterol levels,49 we didn’t distinguish whether ATO was a generic or brand name drug because of the limited sample size.…”

Consequences on economic outcomes of generic versus brand-name drugs used in routine clinical practice: the case of treating peripheral neuropathic pain or generalized anxiety disorder with pregabalin

“…Mano [48], in a retrospective study, reported that switching between brand-name (N = 147) and generic (N = 135) atorvastatin did not affect patients' treatment persistence (85.9% vs. 73.5%) after 180 days of treatment. Loch enrolled 266 patients in his study [49]. He concluded that brand-name vs. generic atorvastatin achieved similar results in terms of total cholesterol and low-density lipoprotein cholesterol in the clinical management of dyslipidemia, although brand-name atorvastatin achieved improvements in high-density lipoprotein cholesterol.…”