Cytochrome P-450 Polymorphisms and Response to Clopidogrel

The antiplatelet drug clopidogrel requires activation by cytochrome P-450 (CYP) enzymes. This study shows that CYP polymorphisms that reduce clopidogrel activation result in reduced antiplatelet effect and less clinical benefit in patients with acute coronary syndromes. The antiplatelet drug clopido...

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Published in	The New England journal of medicine Vol. 360; no. 4; pp. 354 - 362
Main Authors	Mega, Jessica L, Close, Sandra L, Wiviott, Stephen D, Shen, Lei, Hockett, Richard D, Brandt, John T, Walker, Joseph R, Antman, Elliott M, Macias, William, Braunwald, Eugene, Sabatine, Marc S
Format	Journal Article
Language	English
Published	Waltham, MA Massachusetts Medical Society 22.01.2009
Subjects	Acute Coronary Syndrome - therapy Adult Angioplasty, Balloon, Coronary Area Under Curve Aryl Hydrocarbon Hydroxylases - genetics Biological and medical sciences Cardiovascular disease Cardiovascular Diseases - epidemiology Cardiovascular Diseases - genetics Combined Modality Therapy Cytochrome P-450 CYP2C19 Drug therapy Female General aspects Genotype Heart attacks Heterozygote Humans Male Medical sciences Mutation Platelet Aggregation - drug effects Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - metabolism Platelet Aggregation Inhibitors - pharmacology Platelet Aggregation Inhibitors - therapeutic use Polymorphism, Genetic Randomized Controlled Trials as Topic Stents Studies Thrombosis - epidemiology Thrombosis - genetics Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Ticlopidine - metabolism Ticlopidine - pharmacology Ticlopidine - therapeutic use Medicine Genetic variability Enzyme Cytochrome P450 Antithrombotic agent Clopidogrel Genotype Thienopyridine derivative Antiplatelet agent Polymorphism
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Abstract	The antiplatelet drug clopidogrel requires activation by cytochrome P-450 (CYP) enzymes. This study shows that CYP polymorphisms that reduce clopidogrel activation result in reduced antiplatelet effect and less clinical benefit in patients with acute coronary syndromes. The antiplatelet drug clopidogrel requires activation by cytochrome P-450 (CYP) enzymes. This study shows that CYP polymorphisms that reduce clopidogrel activation result in reduced antiplatelet effect and less clinical benefit in patients with acute coronary syndromes. Across the spectrum of acute coronary syndromes and in patients undergoing percutaneous coronary interventions (PCI) with stenting, dual antiplatelet therapy with aspirin and clopidogrel, a thienopyridine inhibitor of the platelet P2Y 12 adenosine diphosphate (ADP) receptor, is the standard of care. 1 – 3 However, the pharmacodynamic response to clopidogrel has substantial interpatient variability, 4 – 6 and patients with coronary disease with lesser degrees of platelet inhibition in response to clopidogrel appear to be at increased risk for cardiovascular events. 7 – 10 Clopidogrel is a prodrug that requires biotransformation to an active metabolite by cytochrome P-450 (CYP) enzymes (Figure 1 in the Supplementary Appendix, available . . .
AbstractList	Clopidogrel requires transformation into an active metabolite by cytochrome P-450 (CYP) enzymes for its antiplatelet effect. The genes encoding CYP enzymes are polymorphic, with common alleles conferring reduced function. We tested the association between functional genetic variants in CYP genes, plasma concentrations of active drug metabolite, and platelet inhibition in response to clopidogrel in 162 healthy subjects. We then examined the association between these genetic variants and cardiovascular outcomes in a separate cohort of 1477 subjects with acute coronary syndromes who were treated with clopidogrel in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction (TRITON-TIMI) 38. In healthy subjects who were treated with clopidogrel, carriers of at least one CYP2C19 reduced-function allele (approximately 30% of the study population) had a relative reduction of 32.4% in plasma exposure to the active metabolite of clopidogrel, as compared with noncarriers (P<0.001). Carriers also had an absolute reduction in maximal platelet aggregation in response to clopidogrel that was 9 percentage points less than that seen in noncarriers (P<0.001). Among clopidogrel-treated subjects in TRITON-TIMI 38, carriers had a relative increase of 53% in the composite primary efficacy outcome of the risk of death from cardiovascular causes, myocardial infarction, or stroke, as compared with noncarriers (12.1% vs. 8.0%; hazard ratio for carriers, 1.53; 95% confidence interval [CI], 1.07 to 2.19; P=0.01) and an increase by a factor of 3 in the risk of stent thrombosis (2.6% vs. 0.8%; hazard ratio, 3.09; 95% CI, 1.19 to 8.00; P=0.02). Among persons treated with clopidogrel, carriers of a reduced-function CYP2C19 allele had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events, including stent thrombosis, than did noncarriers. Background Clopidogrel requires transformation into an active metabolite by cytochrome P-450 (CYP) enzymes for its antiplatelet effect. The genes encoding CYP enzymes are polymorphic, with common alleles conferring reduced function. Methods We tested the association between functional genetic variants in CYP genes, plasma concentrations of active drug metabolite, and platelet inhibition in response to clopidogrel in 162 healthy subjects. We then examined the association between these genetic variants and cardiovascular outcomes in a separate cohort of 1477 subjects with acute coronary syndromes who were treated with clopidogrel in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction (TRITON-TIMI) 38. Results In healthy subjects who were treated with clopidogrel, carriers of at least one CYP2C19 reduced-function allele (approximately 30% of the study population) had a relative reduction of 32.4% in plasma exposure to the active metabolite of clopidogrel, as compared with noncarriers (P<0.001). Carriers also had an absolute reduction in maximal platelet aggregation in response to clopidogrel that was 9 percentage points less than that seen in noncarriers (P<0.001). Among clopidogrel-treated subjects in TRITON-TIMI 38, carriers had a relative increase of 53% in the composite primary efficacy outcome of the risk of death from cardiovascular causes, myocardial infarction, or stroke, as compared with noncarriers (12.1% vs. 8.0%; hazard ratio for carriers, 1.53; 95% confidence interval [CI], 1.07 to 2.19; P=0.01) and an increase by a factor of 3 in the risk of stent thrombosis (2.6% vs. 0.8%; hazard ratio, 3.09; 95% CI, 1.19 to 8.00; P=0.02). Conclusions Among persons treated with clopidogrel, carriers of a reduced-function CYP2C19 allele had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events, including stent thrombosis, than did noncarriers. The antiplatelet drug clopidogrel requires activation by cytochrome P-450 (CYP) enzymes. This study shows that CYP polymorphisms that reduce clopidogrel activation result in reduced antiplatelet effect and less clinical benefit in patients with acute coronary syndromes. The antiplatelet drug clopidogrel requires activation by cytochrome P-450 (CYP) enzymes. This study shows that CYP polymorphisms that reduce clopidogrel activation result in reduced antiplatelet effect and less clinical benefit in patients with acute coronary syndromes. Across the spectrum of acute coronary syndromes and in patients undergoing percutaneous coronary interventions (PCI) with stenting, dual antiplatelet therapy with aspirin and clopidogrel, a thienopyridine inhibitor of the platelet P2Y 12 adenosine diphosphate (ADP) receptor, is the standard of care. 1 – 3 However, the pharmacodynamic response to clopidogrel has substantial interpatient variability, 4 – 6 and patients with coronary disease with lesser degrees of platelet inhibition in response to clopidogrel appear to be at increased risk for cardiovascular events. 7 – 10 Clopidogrel is a prodrug that requires biotransformation to an active metabolite by cytochrome P-450 (CYP) enzymes (Figure 1 in the Supplementary Appendix, available . . .
Author	Mega, Jessica L Antman, Elliott M Sabatine, Marc S Close, Sandra L Walker, Joseph R Brandt, John T Hockett, Richard D Macias, William Wiviott, Stephen D Shen, Lei Braunwald, Eugene
Author_xml	– sequence: 1 givenname: Jessica L surname: Mega fullname: Mega, Jessica L – sequence: 2 givenname: Sandra L surname: Close fullname: Close, Sandra L – sequence: 3 givenname: Stephen D surname: Wiviott fullname: Wiviott, Stephen D – sequence: 4 givenname: Lei surname: Shen fullname: Shen, Lei – sequence: 5 givenname: Richard D surname: Hockett fullname: Hockett, Richard D – sequence: 6 givenname: John T surname: Brandt fullname: Brandt, John T – sequence: 7 givenname: Joseph R surname: Walker fullname: Walker, Joseph R – sequence: 8 givenname: Elliott M surname: Antman fullname: Antman, Elliott M – sequence: 9 givenname: William surname: Macias fullname: Macias, William – sequence: 10 givenname: Eugene surname: Braunwald fullname: Braunwald, Eugene – sequence: 11 givenname: Marc S surname: Sabatine fullname: Sabatine, Marc S
BackLink	http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21055461$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/19106084$$D View this record in MEDLINE/PubMed
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Keywords	Medicine Genetic variability Enzyme Cytochrome P450 Antithrombotic agent Clopidogrel Genotype Thienopyridine derivative Antiplatelet agent Polymorphism
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Snippet	The antiplatelet drug clopidogrel requires activation by cytochrome P-450 (CYP) enzymes. This study shows that CYP polymorphisms that reduce clopidogrel... Clopidogrel requires transformation into an active metabolite by cytochrome P-450 (CYP) enzymes for its antiplatelet effect. The genes encoding CYP enzymes are... Background Clopidogrel requires transformation into an active metabolite by cytochrome P-450 (CYP) enzymes for its antiplatelet effect. The genes encoding CYP...
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SubjectTerms	Acute Coronary Syndrome - therapy Adult Angioplasty, Balloon, Coronary Area Under Curve Aryl Hydrocarbon Hydroxylases - genetics Biological and medical sciences Cardiovascular disease Cardiovascular Diseases - epidemiology Cardiovascular Diseases - genetics Combined Modality Therapy Cytochrome P-450 CYP2C19 Drug therapy Female General aspects Genotype Heart attacks Heterozygote Humans Male Medical sciences Mutation Platelet Aggregation - drug effects Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - metabolism Platelet Aggregation Inhibitors - pharmacology Platelet Aggregation Inhibitors - therapeutic use Polymorphism, Genetic Randomized Controlled Trials as Topic Stents Studies Thrombosis - epidemiology Thrombosis - genetics Ticlopidine - adverse effects Ticlopidine - analogs & derivatives Ticlopidine - metabolism Ticlopidine - pharmacology Ticlopidine - therapeutic use
Title	Cytochrome P-450 Polymorphisms and Response to Clopidogrel
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