a Patients may be counted in more than one row. b See 5.1 for definition. | ||
Effient (%) (N=6741) | Clopidogrel (%) (N=6716) | |
TIMI Major or Minor bleeding | 4.5 | 3.4 |
TIMI Major bleedingb | 2.2 | 1.7 |
Life-threatening | 1.3 | 0.8 |
Fatal | 0.3 | 0.1 |
Symptomatic intracranial hemorrhage (ICH) | 0.3 | 0.3 |
Requiring inotropes | 0.3 | 0.1 |
Requiring surgical intervention | 0.3 | 0.3 |
Requiring transfusion (≥4 units) | 0.7 | 0.5 |
TIMI Minor bleedingb | 2.4 | 1.9 |
a 10-mg Effient maintenance dose | ||||
b 75-mg clopidogrel maintenance dose | ||||
Major/Minor | Fatal | |||
Effienta (%) | Clopidogrelb (%) | Effienta (%) | Clopidogrelb (%) | |
Weight <60 kg (N=308 Effient, N=356 clopidogrel) | 10.1 | 6.5 | 0.0 | 0.3 |
Weight ≥60 kg (N=6373 Effient, N=6299 clopidogrel) | 4.2 | 3.3 | 0.3 | 0.1 |
Age <75 years (N=5850 Effient, N=5822 clopidogrel) | 3.8 | 2.9 | 0.2 | 0.1 |
Age ≥75 years (N=891 Effient, N=894 clopidogrel) | 9.0 | 6.9 | 1.0 | 0.1 |
a Patients may be counted in more than one row. | ||
Effient (%) (N=213) | Clopidogrel (%) (N=224) | |
TIMI Major or Minor bleeding | 14.1 | 4.5 |
TIMI Major bleeding | 11.3 | 3.6 |
Fatal | 0.9 | 0 |
Reoperation | 3.8 | 0.5 |
Transfusion of ≥5 units | 6.6 | 2.2 |
Intracranial hemorrhage | 0 | 0 |
TIMI Minor bleeding | 2.8 | 0.9 |
Effient (%) (N=6741) | Clopidogrel (%) (N=6716) | |
Hypertension | 7.5 | 7.1 |
Hypercholesterolemia/Hyperlipidemia | 7.0 | 7.4 |
Headache | 5.5 | 5.3 |
Back pain | 5.0 | 4.5 |
Dyspnea | 4.9 | 4.5 |
Nausea | 4.6 | 4.3 |
Dizziness | 4.1 | 4.6 |
Cough | 3.9 | 4.1 |
Hypotension | 3.9 | 3.8 |
Fatigue | 3.7 | 4.8 |
Non-cardiac chest pain | 3.1 | 3.5 |
Atrial fibrillation | 2.9 | 3.1 |
Bradycardia | 2.9 | 2.4 |
Leukopenia (<4 x 109 WBC/L) | 2.8 | 3.5 |
Rash | 2.8 | 2.4 |
Pyrexia | 2.7 | 2.2 |
Peripheral edema | 2.7 | 3.0 |
Pain in extremity | 2.6 | 2.6 |
Diarrhea | 2.3 | 2.6 |
a RRR = (1-Hazard Ratio) x 100%. Values with a negative relative risk reduction indicate a relative risk increase. | ||||
Patients with events | From Kaplan-Meier analysis | |||
Effient (%) | Clopidogrel (%) | Relative Risk Reduction (%)a (95% CI) | p-value | |
UA/NSTEMI | N=5044 | N=5030 | ||
CV death, nonfatal MI, or nonfatal stroke | 9.3 | 11.2 | 18.0 (7.3, 27.4) | 0.002 |
CV death | 1.8 | 1.8 | 2.1 (-30.9, 26.8) | 0.885 |
Nonfatal MI | 7.1 | 9.2 | 23.9 (12.7, 33.7) | <0.001 |
Nonfatal Stroke | 0.8 | 0.8 | 2.1 (-51.3, 36.7) | 0.922 |
STEMI | N=1769 | N=1765 | ||
CV death, nonfatal MI, or nonfatal stroke | 9.8 | 12.2 | 20.7 (3.2, 35.1) | 0.019 |
CV death | 2.4 | 3.3 | 26.2 (-9.4, 50.3) | 0.129 |
Nonfatal MI | 6.7 | 8.8 | 25.4 (5.2, 41.2) | 0.016 |
Nonfatal Stroke | 1.2 | 1.1 | -9.7 (-104.0, 41.0) | 0.77 |
Effient | Clopidogrel | ||||
N | % with events | N | % with events | Hazard Ratio (95% CI) | |
Age ≥75 | |||||
Diabetes – yes | 249 | 14.9 | 234 | 21.8 | 0.64 (0.42, 0.97) |
Diabetes – no | 652 | 16.4 | 674 | 15.3 | 1.1 (0.83, 1.43) |
Age <75 | |||||
Diabetes – yes | 1327 | 10.8 | 1336 | 14.8 | 0.72 (0.58, 0.89) |
Diabetes – no | 4585 | 7.8 | 4551 | 9.5 | 0.82 (0.71, 0.94) |
Age ≥75 | |||||
Prior MI – yes | 220 | 17.3 | 212 | 22.6 | 0.72 (0.47, 1.09) |
Prior MI – no | 681 | 15.6 | 696 | 15.2 | 1.05 (0.80, 1.37) |
Age <75 | |||||
Prior MI – yes | 1006 | 12.2 | 996 | 15.4 | 0.78 (0.62, 0.99) |
Prior MI – no | 4906 | 7.7 | 4891 | 9.7 | 0.78 (0.68, 0.90) |
* Identi Dose®, unit dose medication, Lilly | ||||
Features | Strengths | |||
5-mg | 10-mg | |||
Tablet color | yellow | beige | ||
Tablet imprint | 5 | 10 | ||
Tablet imprint | 5121 | 5123 | ||
Presentations and NDC Codes | ||||
Bottles of 30 | 0002-5121-30 | 0002-5123-30 | ||
Blisters ID*24 | 0002-5121-52 | NA | ||
Blisters ID*90 | NA | 0002-5123-77 |
Effient prasugrel hydrochloride tablet, film coated | ||||||||||||||||
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a Patients may be counted in more than one row. b See 5.1 for definition. | ||
Effient (%) (N=6741) | Clopidogrel (%) (N=6716) | |
TIMI Major or Minor bleeding | 4.5 | 3.4 |
TIMI Major bleedingb | 2.2 | 1.7 |
Life-threatening | 1.3 | 0.8 |
Fatal | 0.3 | 0.1 |
Symptomatic intracranial hemorrhage (ICH) | 0.3 | 0.3 |
Requiring inotropes | 0.3 | 0.1 |
Requiring surgical intervention | 0.3 | 0.3 |
Requiring transfusion (≥4 units) | 0.7 | 0.5 |
TIMI Minor bleedingb | 2.4 | 1.9 |
a 10-mg Effient maintenance dose | ||||
b 75-mg clopidogrel maintenance dose | ||||
Major/Minor | Fatal | |||
Effienta (%) | Clopidogrelb (%) | Effienta (%) | Clopidogrelb (%) | |
Weight <60 kg (N=308 Effient, N=356 clopidogrel) | 10.1 | 6.5 | 0.0 | 0.3 |
Weight ≥60 kg (N=6373 Effient, N=6299 clopidogrel) | 4.2 | 3.3 | 0.3 | 0.1 |
Age <75 years (N=5850 Effient, N=5822 clopidogrel) | 3.8 | 2.9 | 0.2 | 0.1 |
Age ≥75 years (N=891 Effient, N=894 clopidogrel) | 9.0 | 6.9 | 1.0 | 0.1 |
a Patients may be counted in more than one row. | ||
Effient (%) (N=213) | Clopidogrel (%) (N=224) | |
TIMI Major or Minor bleeding | 14.1 | 4.5 |
TIMI Major bleeding | 11.3 | 3.6 |
Fatal | 0.9 | 0 |
Reoperation | 3.8 | 0.5 |
Transfusion of ≥5 units | 6.6 | 2.2 |
Intracranial hemorrhage | 0 | 0 |
TIMI Minor bleeding | 2.8 | 0.9 |
Effient (%) (N=6741) | Clopidogrel (%) (N=6716) | |
Hypertension | 7.5 | 7.1 |
Hypercholesterolemia/Hyperlipidemia | 7.0 | 7.4 |
Headache | 5.5 | 5.3 |
Back pain | 5.0 | 4.5 |
Dyspnea | 4.9 | 4.5 |
Nausea | 4.6 | 4.3 |
Dizziness | 4.1 | 4.6 |
Cough | 3.9 | 4.1 |
Hypotension | 3.9 | 3.8 |
Fatigue | 3.7 | 4.8 |
Non-cardiac chest pain | 3.1 | 3.5 |
Atrial fibrillation | 2.9 | 3.1 |
Bradycardia | 2.9 | 2.4 |
Leukopenia (<4 x 109 WBC/L) | 2.8 | 3.5 |
Rash | 2.8 | 2.4 |
Pyrexia | 2.7 | 2.2 |
Peripheral edema | 2.7 | 3.0 |
Pain in extremity | 2.6 | 2.6 |
Diarrhea | 2.3 | 2.6 |
a RRR = (1-Hazard Ratio) x 100%. Values with a negative relative risk reduction indicate a relative risk increase. | ||||
Patients with events | From Kaplan-Meier analysis | |||
Effient (%) | Clopidogrel (%) | Relative Risk Reduction (%)a (95% CI) | p-value | |
UA/NSTEMI | N=5044 | N=5030 | ||
CV death, nonfatal MI, or nonfatal stroke | 9.3 | 11.2 | 18.0 (7.3, 27.4) | 0.002 |
CV death | 1.8 | 1.8 | 2.1 (-30.9, 26.8) | 0.885 |
Nonfatal MI | 7.1 | 9.2 | 23.9 (12.7, 33.7) | <0.001 |
Nonfatal Stroke | 0.8 | 0.8 | 2.1 (-51.3, 36.7) | 0.922 |
STEMI | N=1769 | N=1765 | ||
CV death, nonfatal MI, or nonfatal stroke | 9.8 | 12.2 | 20.7 (3.2, 35.1) | 0.019 |
CV death | 2.4 | 3.3 | 26.2 (-9.4, 50.3) | 0.129 |
Nonfatal MI | 6.7 | 8.8 | 25.4 (5.2, 41.2) | 0.016 |
Nonfatal Stroke | 1.2 | 1.1 | -9.7 (-104.0, 41.0) | 0.77 |
Effient | Clopidogrel | ||||
N | % with events | N | % with events | Hazard Ratio (95% CI) | |
Age ≥75 | |||||
Diabetes – yes | 249 | 14.9 | 234 | 21.8 | 0.64 (0.42, 0.97) |
Diabetes – no | 652 | 16.4 | 674 | 15.3 | 1.1 (0.83, 1.43) |
Age <75 | |||||
Diabetes – yes | 1327 | 10.8 | 1336 | 14.8 | 0.72 (0.58, 0.89) |
Diabetes – no | 4585 | 7.8 | 4551 | 9.5 | 0.82 (0.71, 0.94) |
Age ≥75 | |||||
Prior MI – yes | 220 | 17.3 | 212 | 22.6 | 0.72 (0.47, 1.09) |
Prior MI – no | 681 | 15.6 | 696 | 15.2 | 1.05 (0.80, 1.37) |
Age <75 | |||||
Prior MI – yes | 1006 | 12.2 | 996 | 15.4 | 0.78 (0.62, 0.99) |
Prior MI – no | 4906 | 7.7 | 4891 | 9.7 | 0.78 (0.68, 0.90) |
* Identi Dose®, unit dose medication, Lilly | ||||
Features | Strengths | |||
5-mg | 10-mg | |||
Tablet color | yellow | beige | ||
Tablet imprint | 5 | 10 | ||
Tablet imprint | 5121 | 5123 | ||
Presentations and NDC Codes | ||||
Bottles of 30 | 0002-5121-30 | 0002-5123-30 | ||
Blisters ID*24 | 0002-5121-52 | NA | ||
Blisters ID*90 | NA | 0002-5123-77 |
Effient prasugrel hydrochloride tablet, film coated | ||||||||||||||||
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