Pharmacodynamic Effects of Prasugrel Dosing Regimens in Patients on Maintenance Prasugrel Therapy: Results of a Prospective Randomized Study

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• 作者：Antonio Tello-Montoliu ; MD ; PhD ; Salvatore D. Tomasello ; MD ; José ; Luis Ferreiro ; MD ; Masafumi Ueno ; MD ; Naveen Seecheran ; MD ; Bhaloo Desai ; PhD ; Murali Kodali ; MD ; Ronald K. Charlton ; PhD ; Lyndon C. Box ; MD ; Martin M. Zenni ; MD ; Luis A. Guzman ; MD ; Theodore A. Bass ; MD ; Dominick J. Angiolillo ; MD ; PhD ; ^{dominick.angiolillo@jax.ufl.edu}
• 关键词：percutaneous coronary intervention ; platelet function ; prasugrel
• 刊名：Journal of the American College of Cardiology
• 出版年：2012
• 期刊代码：201_07351097
• 类别：med
• 出版时间：8 May, 2012
• 卷：59
• 期：19
• 页码：1681-1687
• 文件大小：1096 K

摘要

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Objectives

The purpose of this study is to assess the pharmacodynamic effects of different prasugrel dosing regimens in patients on maintenance prasugrel therapy.

Background

There are a growing number of patients on chronic prasugrel therapy regimens, leading to questions about the dosing regimen of prasugrel to administer if percutaneous coronary intervention is required.

Methods

This is a prospective pharmacodynamic study in patients (n = 64) receiving maintenance prasugrel therapy who were randomly allocated to a 10 mg, 30 mg, or 60 mg dose of prasugrel. Pharmacodynamic assessments using multiple assays were conducted at 3 timepoints (baseline and 1 h and 4 h after dosing).

Results

Intragroup comparisons showed that a 60 mg dose reduced the platelet reactivity index (PRI) after 1 h (p = 0.004) and 4 h (p < 0.001, primary endpoint; p = 0.002 between 1 h and 4 h). A 30 mg dose also reduced PRI levels at 1 h (p = 0.006) and 4 h (p < 0.001; p = 0.044 between 1 h and 4 h). A 10 mg dose was associated with modest pharmacodynamic effects. Intragroup comparisons showed similar findings with VerifyNow-P2Y12 and light transmission aggregometry. Intergroup comparisons showed that a 60 mg dose achieved lower PRI levels than 30 mg at 4 h (p = 0.05), and a numerical trend toward better pharmacodynamic effects at 1 h (p = 0.171). Intergroup comparisons were similar with VerifyNow-P2Y12, but not light transmission aggregometry.

Conclusions

For patients on maintenance prasugrel therapy, a 60 mg dosing strategy is associated with faster and higher platelet inhibition compared with lower doses, as assessed by P2Y₁₂ specific assays. (Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy; )