Branded Versus Generic Clopidogrel in Cardiovascular Diseases

Caldeira, Daniel; Fernandes, Ricardo M; Costa, João; David, Cláudio; Sampaio, Cristina; Ferreira, Joaquim J.

doi:10.1097/fjc.0b013e31827e5c60

Cited by 22 publications

(14 citation statements)

References 27 publications

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“…There have been numerous studies demonstrating comparable levels of effectiveness and safety for various generic drugs [10–12]. Despite this growing level of evidence, the perception that generic drugs are inferior remains among some patients and physicians.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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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.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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“…Brand name and generic drugs that are FDA approved should have identical strengths and levels of quality, the Agency added. However, there is still some room for skepticism based on the lack of any outcome-driven studies with GC, the growing number of complaints for the manufacturing quality of GC, and the lack of any large randomized platelet studies comparing GC and BC formulations with regard to their antiplatelet potency or/and bleeding risks [1]. …”

Section: Novel Insightsmentioning

confidence: 99%

Switching from Generic to Brand Clopidogrel in Male Patients after ST-Elevated Myocardial Infarction

Syvolap¹,

Franskavichene²,

Golukhova³

et al. 2014

Cardiology

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Objective: To detect residual platelet aggregation following the switch from generic (GC) to brand clopidogrel (BC) in male patients after ST-elevated myocardial infarction (STEMI). Methods: The study was designed as an open-label, prospective cohort trial. Thirty-three male STEMI patients were enrolled. All patients received dual antiplatelet therapy with aspirin (100 mg/daily) and one of six GC at a daily dose of 75 mg. After 2 weeks, all patients were switched to BC. Adrenaline- and adenosine diphosphate (ADP)-induced platelet aggregation was assessed twice: on day 14 (before the switch) and on day 21 (after 1 week of BC therapy). Results: Adrenaline-induced platelet aggregation did not differ among clopidogrel formulations. In contrast, residual 5 µM ADP-induced platelet aggregation after BC differs from GC by 14% (28.0 ± 2.5 vs. 23.9 ± 2.1%; p = 0.03). When 20 µM ADP was used as agonist, the difference was smaller (36.2 ± 2.9 vs. 34.6 ± 2.8%) but still significant (p = 0.04) favoring BC. Conclusions: After 2 weeks of therapy, switching from GC to BC was associated with a mild but significant reduction in ADP-induced platelet aggregation in male post-STEMI patients. The observed differences between GC and BC should be confirmed in a larger randomized study, but may represent a risk in underdeveloped countries, where GC therapy is mandatory for post-MI inpatients.

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“…3 Giving the current worldwide economic downturn, the use of generic medications can further reduce overhead costs for most National Healthcare Providers and this trend is expected to continue in the near future. 4 Development of generic medications is based on the pharmacological properties of the innovator brands, which connotes proof of bioequivalence in terms of standard kinetic profile, efficacy and safety in healthy subjects. [5][6][7] There are two questions prescribers and other healthcare professionals are asking regarding generic medications; 1.…”

Section: Introductionmentioning

confidence: 99%

Extents of Generic Prescribing in Hospitals and Community Pharmacies for Diabetic and Hypertensive Outpatients in Eastern Region of Saudi Arabia

Emeka¹,

Ahmed²

2017

JYP

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Objective: As population increase, Healthcare resources are stretched and the need to reduce prescription drug spending becomes obvious. The aim of this study was to evaluate the levels of generic prescribing in place of their branded counterparts among type 2 diabetic and hypertensive outpatients in Eastern region of Saudi Arabia. Method: A cross section of 13 Hospitals and 17 Community Pharmacies located in Al Ahsa, Dhahran, Khobar and Dammam (both Government and private) were visited. Out of which 58 Physicians and Pharmacists were interviewed with a structured questionnaire. Reasons for prescribing and serving either generic or branded were also ascertained. Patients' prescriptions were also examined at the various hospital and community pharmacies. Our focus was on prescription drugs for type 2 diabetic and hypertensive patients only and the study lasted for 6 months. Results: Findings revealed that only 26.9% generic medications were prescribed for both type 2 diabetic and hypertensive patients in the 13 hospitals sampled. It was also observed that while Government hospital prescribed 33.3% generics, private hospitals had 28.6% for same patient category. In the Community Pharmacies, only 23.5% generic were served for diabetics and 11.8% for hypertensive patients. Overall Hospitals branded prescription were 73.1% whereas in community Pharmacies, they represented 82.4% served medications. Conclusion: Levels of generic medication usage appeared to be significantly low. Majority of the Physicians and Pharmacists were of the belief that branded medications give better outcome to patients and this attitude could potentially render Government policies on the use of generic medication ineffective.

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Branded Versus Generic Clopidogrel in Cardiovascular Diseases

Cited by 22 publications

References 27 publications

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

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

Switching from Generic to Brand Clopidogrel in Male Patients after ST-Elevated Myocardial Infarction

Extents of Generic Prescribing in Hospitals and Community Pharmacies for Diabetic and Hypertensive Outpatients in Eastern Region of Saudi Arabia

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