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Switching from generic to brand clopidogrel in male patients after ST-elevated myocardial infarction
Vitaliy V Syvolap1, Ludmila V Franskavichene, Elena Z Golukhova
1HeartDrug™ Research Laboratories, Johns Hopkins University, Towson, Md., USA.
Insights
Switching from generic clopidogrel to brand clopidogrel in male STEMI patients significantly reduced ADP-induced platelet aggregation. This finding suggests potential implications for antiplatelet therapy management, especially in regions where generic formulations are standard.
Area of Science:
- Cardiology
- Pharmacology
- Thrombosis
Background:
- Clopidogrel is a P2Y12 inhibitor crucial for preventing thrombotic events in patients with ST-elevated myocardial infarction (STEMI).
- Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is standard post-STEMI care.
- Concerns exist regarding the bioequivalence and clinical efficacy of generic versus brand-name medications.
Purpose of the Study:
- To evaluate residual platelet aggregation after switching from generic clopidogrel (GC) to brand clopidogrel (BC).
- To compare the antiplatelet effects of GC and BC in male patients following STEMI.
Main Methods:
- An open-label, prospective cohort study involving 33 male STEMI patients on DAPT (aspirin and GC).
- Patients were switched from GC to BC after two weeks of therapy.
- Platelet aggregation induced by adrenaline and adenosine diphosphate (ADP) was measured before and after the switch.
Main Results:
- Adrenaline-induced platelet aggregation showed no significant difference between GC and BC.
- A statistically significant reduction in 5 µM ADP-induced platelet aggregation was observed after switching to BC (23.9 ± 2.1% vs. 28.0 ± 2.5%, p=0.03).
- A smaller, yet significant, reduction was noted with 20 µM ADP-induced aggregation favoring BC (34.6 ± 2.8% vs. 36.2 ± 2.9%, p=0.04).
Conclusions:
- Switching from GC to BC resulted in a mild but significant decrease in ADP-induced platelet aggregation in male post-STEMI patients.
- The findings warrant confirmation in larger, randomized controlled trials.
- The observed differences may have clinical relevance, particularly in healthcare systems relying heavily on generic clopidogrel for post-MI patients.
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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