Prasugrel (Effient)

Prevents thrombotic cardiovascular events in patients with acute coronary syndromes who undergo percutaneous coronary intervention.

A theienopyridine inhibitor of platelet P2Y12.

In a phase III study TRITRON-TIMI 38 trial revealed treatment with prasugrel (Effient) reduced risk of cardiovascular death, myocardial infarction, or stroke compared with clopidogrel (Plavix).

In a trial of 13,608 patients with acute coronary syndrome treated with percutaneous coronary intervention with 7% assigned to prasugrel experienced subsequent nonfatal MI, compared to 9.1% of patients assigned to clopidogrel.

Patients assigned to prasugrel with aspirin showed 19% relative reduction for cardiovascular death, nonfatal MI, or nonfatal stroke compared with clopidogrel and aspirin.

Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thromolysis in Myocardial Infarction 38 (TRITON-TIMI) indicated Prasugrel reduced cardiovascular deaths, nonfatal myocardial infarction, or nonfatal stroke by 19% compared with clopidogrel (Wiviott WD).

In the above study the majority of benefit was occurred in the first 30 days of follow-up, and Prasugrel was associated with an overall 31% increase in bleeding, 52% increase in life-threatening bleeding, and a 318% increase in fatal bleeding.

For every 1000 patients treated with Prasugrel compared to clopidogrel there are 24 fewer ischemic events at the cost of 30 more bleeding events (Unger EF).

In a double-blind, randomized trial, of 7243 patients under the age of 75 years receiving aspirin, with unstable angina or myocardial infarction without a ST segment elevation who did not undergo revascularization were treated with prasugrel10 mg daily versus clopidogrel 75 mg a day: pasugrel did not significantly reduce the frequency of the primary endpoint, as compared with Clopidogrel and similar risks of bleeding were observed (Roe MT et al).

Increase risk in solid cancers in the TRITON-TIMI 38 study with increased colon and lung cancers (FDA).

Risk reduction was seen as early 3 days and continued for 15 months of the trial.

Patients treated with prasugrel had a 50% decrease in stent-related clot compared to other agents.  The number of deaths and strokes were similar with the drugs, but patients with a history of stroke were more likely to have another stroke while assigned to prasugrel.

Associated with increased risk for serious bleeding events 2.2% compared to clopidogrel 1.7%.

Risk for bleeding with prasugrel was highest in patients age 75 or older and who weighed less than 131 lb and had a previous history of TIA.

Should not be used in patients with active pathological bleeding or history of transient ischemic attack or stroke.

In patients ≥ 75 years of age, use is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered.

Should not be used in patients likely to undergo urgent coronary artery bypass graft surgery.

Use should be discontinued at least seven days prior to any surgery.

Treatment as a single 60 mg oral loading dose and then continued at 10 mg orally once daily.

Patients taking Effient should also take aspirin daily.

Patients weighing < 60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose.

This adenosine diphosphate antiplatelet agent had no significant reduction in pain in the vasoocclusive crises in patients with sickle cell anemia.

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