Impaired Responsiveness to the Platelet P2Y12 Receptor Antagonist Clopidogrel in Patients With Type 2 Diabetes and Coronary Artery Disease
Several studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk of recurrent atherothrombotic events, despite the use of dual-antiplatelet therapy. The mechanisms for impaired clopidogrel response in DM pat...
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| Published in | Journal of the American College of Cardiology Vol. 64; no. 10; pp. 1005 - 1014 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York, NY
Elsevier Inc
09.09.2014
Elsevier |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Several studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk of recurrent atherothrombotic events, despite the use of dual-antiplatelet therapy. The mechanisms for impaired clopidogrel response in DM patients have not been fully elucidated.
The aim of this study was to explore the mechanisms for impaired clopidogrel-mediated platelet inhibition in patients with DM using a comprehensive methodological approach embracing both pharmacokinetic (PK) and pharmacodynamic (PD) assessments as well as ex vivo and in vitro investigations.
Patients (DM, n = 30; non-DM, n = 30) with stable coronary artery disease taking aspirin 81 mg/day and P2Y12 antagonist naive were enrolled. Blood was collected before and at various times (0.5, 1, 2, 4, 6, and 24 h) after a 600-mg loading dose of clopidogrel. PD assessments included vasodilator-stimulated phosphoprotein, light transmission aggregometry, and VerifyNow P2Y12 ex vivo, before and after dosing and following in vitro incubation with escalating concentrations (1, 3, and 10 μM) of clopidogrel’s active metabolite (Clop-AM). Exposure to Clop-AM was also determined.
PD assessments consistently showed that during the overall 24-h study time course, residual platelet reactivity was higher in DM patients compared with non-DM patients. In vitro incubation with Clop-AM revealed altered functional status of the P2Y12 signaling pathway in DM platelets as measured by vasodilator-stimulated phosphoprotein, but not with other PD assays. Clop-AM exposure was ∼40% lower in DM patients than in non-DM patients.
The present study suggests that among DM patients, impaired P2Y12 inhibition mediated by clopidogrel is largely attributable to attenuation of clopidogrel’s PK profile. This is characterized by lower plasma levels of Clop-AM over the sampling time course in DM patients compared with non-DM patients and only modestly attributed to altered functional status of the P2Y12 signaling pathway. |
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| AbstractList | Several studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk of recurrent atherothrombotic events, despite the use of dual-antiplatelet therapy. The mechanisms for impaired clopidogrel response in DM patients have not been fully elucidated.
The aim of this study was to explore the mechanisms for impaired clopidogrel-mediated platelet inhibition in patients with DM using a comprehensive methodological approach embracing both pharmacokinetic (PK) and pharmacodynamic (PD) assessments as well as ex vivo and in vitro investigations.
Patients (DM, n = 30; non-DM, n = 30) with stable coronary artery disease taking aspirin 81 mg/day and P2Y12 antagonist naive were enrolled. Blood was collected before and at various times (0.5, 1, 2, 4, 6, and 24 h) after a 600-mg loading dose of clopidogrel. PD assessments included vasodilator-stimulated phosphoprotein, light transmission aggregometry, and VerifyNow P2Y12 ex vivo, before and after dosing and following in vitro incubation with escalating concentrations (1, 3, and 10 μM) of clopidogrel’s active metabolite (Clop-AM). Exposure to Clop-AM was also determined.
PD assessments consistently showed that during the overall 24-h study time course, residual platelet reactivity was higher in DM patients compared with non-DM patients. In vitro incubation with Clop-AM revealed altered functional status of the P2Y12 signaling pathway in DM platelets as measured by vasodilator-stimulated phosphoprotein, but not with other PD assays. Clop-AM exposure was ∼40% lower in DM patients than in non-DM patients.
The present study suggests that among DM patients, impaired P2Y12 inhibition mediated by clopidogrel is largely attributable to attenuation of clopidogrel’s PK profile. This is characterized by lower plasma levels of Clop-AM over the sampling time course in DM patients compared with non-DM patients and only modestly attributed to altered functional status of the P2Y12 signaling pathway. Several studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk of recurrent atherothrombotic events, despite the use of dual-antiplatelet therapy. The mechanisms for impaired clopidogrel response in DM patients have not been fully elucidated. The aim of this study was to explore the mechanisms for impaired clopidogrel-mediated platelet inhibition in patients with DM using a comprehensive methodological approach embracing both pharmacokinetic (PK) and pharmacodynamic (PD) assessments as well as ex vivo and in vitro investigations. Patients (DM, n = 30; non-DM, n = 30) with stable coronary artery disease taking aspirin 81 mg/day and P2Y12 antagonist naive were enrolled. Blood was collected before and at various times (0.5, 1, 2, 4, 6, and 24 h) after a 600-mg loading dose of clopidogrel. PD assessments included vasodilator-stimulated phosphoprotein, light transmission aggregometry, and VerifyNow P2Y12 ex vivo, before and after dosing and following in vitro incubation with escalating concentrations (1, 3, and 10 μM) of clopidogrel's active metabolite (Clop-AM). Exposure to Clop-AM was also determined. PD assessments consistently showed that during the overall 24-h study time course, residual platelet reactivity was higher in DM patients compared with non-DM patients. In vitro incubation with Clop-AM revealed altered functional status of the P2Y12 signaling pathway in DM platelets as measured by vasodilator-stimulated phosphoprotein, but not with other PD assays. Clop-AM exposure was ∼40% lower in DM patients than in non-DM patients. The present study suggests that among DM patients, impaired P2Y12 inhibition mediated by clopidogrel is largely attributable to attenuation of clopidogrel's PK profile. This is characterized by lower plasma levels of Clop-AM over the sampling time course in DM patients compared with non-DM patients and only modestly attributed to altered functional status of the P2Y12 signaling pathway. Several studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk of recurrent atherothrombotic events, despite the use of dual-antiplatelet therapy. The mechanisms for impaired clopidogrel response in DM patients have not been fully elucidated.BACKGROUNDSeveral studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk of recurrent atherothrombotic events, despite the use of dual-antiplatelet therapy. The mechanisms for impaired clopidogrel response in DM patients have not been fully elucidated.The aim of this study was to explore the mechanisms for impaired clopidogrel-mediated platelet inhibition in patients with DM using a comprehensive methodological approach embracing both pharmacokinetic (PK) and pharmacodynamic (PD) assessments as well as ex vivo and in vitro investigations.OBJECTIVESThe aim of this study was to explore the mechanisms for impaired clopidogrel-mediated platelet inhibition in patients with DM using a comprehensive methodological approach embracing both pharmacokinetic (PK) and pharmacodynamic (PD) assessments as well as ex vivo and in vitro investigations.Patients (DM, n = 30; non-DM, n = 30) with stable coronary artery disease taking aspirin 81 mg/day and P2Y12 antagonist naive were enrolled. Blood was collected before and at various times (0.5, 1, 2, 4, 6, and 24 h) after a 600-mg loading dose of clopidogrel. PD assessments included vasodilator-stimulated phosphoprotein, light transmission aggregometry, and VerifyNow P2Y12 ex vivo, before and after dosing and following in vitro incubation with escalating concentrations (1, 3, and 10 μM) of clopidogrel's active metabolite (Clop-AM). Exposure to Clop-AM was also determined.METHODSPatients (DM, n = 30; non-DM, n = 30) with stable coronary artery disease taking aspirin 81 mg/day and P2Y12 antagonist naive were enrolled. Blood was collected before and at various times (0.5, 1, 2, 4, 6, and 24 h) after a 600-mg loading dose of clopidogrel. PD assessments included vasodilator-stimulated phosphoprotein, light transmission aggregometry, and VerifyNow P2Y12 ex vivo, before and after dosing and following in vitro incubation with escalating concentrations (1, 3, and 10 μM) of clopidogrel's active metabolite (Clop-AM). Exposure to Clop-AM was also determined.PD assessments consistently showed that during the overall 24-h study time course, residual platelet reactivity was higher in DM patients compared with non-DM patients. In vitro incubation with Clop-AM revealed altered functional status of the P2Y12 signaling pathway in DM platelets as measured by vasodilator-stimulated phosphoprotein, but not with other PD assays. Clop-AM exposure was ∼40% lower in DM patients than in non-DM patients.RESULTSPD assessments consistently showed that during the overall 24-h study time course, residual platelet reactivity was higher in DM patients compared with non-DM patients. In vitro incubation with Clop-AM revealed altered functional status of the P2Y12 signaling pathway in DM platelets as measured by vasodilator-stimulated phosphoprotein, but not with other PD assays. Clop-AM exposure was ∼40% lower in DM patients than in non-DM patients.The present study suggests that among DM patients, impaired P2Y12 inhibition mediated by clopidogrel is largely attributable to attenuation of clopidogrel's PK profile. This is characterized by lower plasma levels of Clop-AM over the sampling time course in DM patients compared with non-DM patients and only modestly attributed to altered functional status of the P2Y12 signaling pathway.CONCLUSIONSThe present study suggests that among DM patients, impaired P2Y12 inhibition mediated by clopidogrel is largely attributable to attenuation of clopidogrel's PK profile. This is characterized by lower plasma levels of Clop-AM over the sampling time course in DM patients compared with non-DM patients and only modestly attributed to altered functional status of the P2Y12 signaling pathway. |
| Author | Darlington, Andrew Ueno, Masafumi Sugidachi, Atsuhiro Guzman, Luis A. Angiolillo, Dominick J. Moser, Brian A. Bass, Theodore A. Jakubowski, Joseph A. Desai, Bhaloo Rollini, Fabiana Franchi, Francesco Tello-Montoliu, Antonio Ferreiro, José Luis |
| Author_xml | – sequence: 1 givenname: Dominick J. surname: Angiolillo fullname: Angiolillo, Dominick J. email: dominick.angiolillo@jax.ufl.edu organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 2 givenname: Joseph A. surname: Jakubowski fullname: Jakubowski, Joseph A. organization: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana – sequence: 3 givenname: José Luis surname: Ferreiro fullname: Ferreiro, José Luis organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 4 givenname: Antonio surname: Tello-Montoliu fullname: Tello-Montoliu, Antonio organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 5 givenname: Fabiana surname: Rollini fullname: Rollini, Fabiana organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 6 givenname: Francesco surname: Franchi fullname: Franchi, Francesco organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 7 givenname: Masafumi surname: Ueno fullname: Ueno, Masafumi organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 8 givenname: Andrew surname: Darlington fullname: Darlington, Andrew organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 9 givenname: Bhaloo surname: Desai fullname: Desai, Bhaloo organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 10 givenname: Brian A. surname: Moser fullname: Moser, Brian A. organization: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana – sequence: 11 givenname: Atsuhiro surname: Sugidachi fullname: Sugidachi, Atsuhiro organization: Daiichi Sankyo Co., Ltd., Tokyo, Japan – sequence: 12 givenname: Luis A. surname: Guzman fullname: Guzman, Luis A. organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida – sequence: 13 givenname: Theodore A. surname: Bass fullname: Bass, Theodore A. organization: University of Florida College of Medicine-Jacksonville, Jacksonville, Florida |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28779776$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/25190236$$D View this record in MEDLINE/PubMed |
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| Copyright | 2014 American College of Cardiology Foundation 2015 INIST-CNRS Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
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| Keywords | PRI DM diabetes mellitus ADP PRP coronary disease ANCOVA MFI PRU CYP VASP Cmax AUC[0-tlast] PGE1 CAD LSM platelets VASP-P ACS Clop-AM PD LD LTA VN PK Endocrinopathy Type 2 diabetes Human Metabolic diseases Patient Cardiovascular disease Coronary heart disease Antiplatelet agent Platelet Antithrombotic agent Clopidogrel Antagonist Circulatory system Thienopyridine derivative Cardiology Biological receptor |
| Language | English |
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| Snippet | Several studies have shown that patients with diabetes mellitus (DM) exhibit an impaired response to clopidogrel. This may contribute to their increased risk... |
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| SubjectTerms | Adult Aged Aspirin - adverse effects Aspirin - therapeutic use Biological and medical sciences Cardiology. Vascular system Cohort Studies Coronary Artery Disease - blood Coronary Artery Disease - complications Coronary Artery Disease - drug therapy coronary disease Coronary heart disease diabetes mellitus Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy Diabetes. Impaired glucose tolerance Dose-Response Relationship, Drug Drug Administration Schedule Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female Follow-Up Studies Heart Humans Male Medical sciences Middle Aged Platelet Aggregation - drug effects Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - therapeutic use Platelet Function Tests platelets Prospective Studies Purinergic P2Y Receptor Antagonists - adverse effects Purinergic P2Y Receptor Antagonists - therapeutic use Reference Values Risk Assessment Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Ticlopidine - therapeutic use Treatment Outcome |
| Title | Impaired Responsiveness to the Platelet P2Y12 Receptor Antagonist Clopidogrel in Patients With Type 2 Diabetes and Coronary Artery Disease |
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