JP234 Induced Warfarin Metabolism in Chronic Atrial Fibrillation

Assignment Task

JP234 is a novel, oral antiarrhythmic agent for controlling heart rate in chronic atrial fibrillation. In clinical trials it has been tolerated well and there are no contraindications to its use. It is effective in. doses of 50, 75 or 100 mg once daily, some patients requiring the 100 mg dose. JP234 is metabolised in the liver and has a half-life of about 24 hours. In vitro studies suggest that it is likely to cause induction of CYP3A4 and CYP2C9. It is recommended that patients with· chronic atrial fibrillation should be  anticoagulated to prevent thromboembolism and most patients who will receive JP234 will also be taking warfarin, which is partly metabolised by these cytochrome enzymes.

Part 1 - Study design

Using the four categories below as a template, design a study to investigate the potential of JP234 to induce the metabolism of a single dose of warfarin.

The four categories are:

(1) Title and objectives

(2) Study design

(3) Drug administration and sampling

(4) Criteria for evaluation

Part 2 - Further recommendations

If JP234 causes clinically important enzyme induction at relevant doses, a possible recommendation would be for patients to switch from warfarin to Rivaroxaban, one of the new oral anticoagulants that acts by inhibiting Factor Xa. Discuss briefly whether this recommendation is likely to be
advantageous.

Part 1, sections 2, 3 and 4 and Part 2 are split into marking categories for:

• knowledge and understanding
• reasoning and critical analysis

Each represents half of the total mark for that section.

The level of knowledge and understanding. of the topic demonstrated by the student:

(i) The accuracy, relevancy and comprehensiveness of information included

(ii) The clarity, accuracy and coherency of the scientific concepts described

(iii) The appropriateness, relevancy and diversity of the sources of information/references used

The quality of reasoning and critical analysis used within the report:

(i) The relevancy, appropriateness, and coherency of the overall. 

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