# US 2013/0158069 A1 · Preventive and/or therapeutic agent for thromboembolism in thromboembolism patient with severe renal impairment

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- Number: US 2013/0158069 A1
- Document ID: US20130158069A1
- Status: Published application
- Kind: A1
- Application number: 13/554,610
- Filed: 2012-07-20
- Published: 2013-06-20
- Earliest claimed: 2011-12-14
- Assignees: Daiichi Sankyo Company, Limited
- Inventors: Tetsuya Kimura; Tomohiko Kumakura; Masaya Tachibana; Chiaki Matsumoto; Kenji Abe
- Web page: https://patentgrep.com/patent/US20130158069A1

## CPC

- A61K 31/444: containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
- A61P 7/02: Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 13/12: of the kidneys
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

It is intended to provide a highly safe, orally administrable preventive and/or therapeutic agent for thrombosis and/or embolism that can be applied to a thrombosis and/or embolism patient with severe renal impairment. The present inventors have found that even for a thrombosis and/or embolism patient with severe renal impairment, use of edoxaban at a dose of 15 mg once a day can effectively prevent thrombosis and/or embolism while avoiding the risk of bleeding. The present inventors have also found that even for a thrombosis and/or embolism patient with severe renal impairment, edoxaban at a dose of 15 mg once a day can effectively prevent thrombosis and/or embolism with safety over a long period.

## Claims

### Claim 1

A method for treating thrombosis and/or embolism in a thrombosis and/or embolism patient with severe renal impairment, comprising administering a therapeutic agent containing 15 mg of edoxaban once a day.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the patient has creatinine clearance of 15 mL/min or higher but lower than 30 mL/min.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the therapeutic agent is administered for at least 15 days continuously and/or intermittently.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the thrombosis and/or embolism is venous thromboembolism or thrombosis and/or embolism attributed to atrial fibrillation.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the venous thromboembolism is venous thromboembolism in a postoperative patient.

### Claim 6 (depends on 4)

The method according to claim 4, wherein the venous thromboembolism is acute venous thromboembolism.

### Claim 7 (depends on 4)

The method according to claim 4, wherein the thrombosis and/or embolism attributed to atrial fibrillation is cerebral infarction, systemic embolism, or stroke attributed to atrial fibrillation.

### Claim 8

A kit for treating thrombosis and/or embolism in a thrombosis and/or embolism patient with severe renal impairment, comprising a pharmaceutical composition containing edoxaban and an instruction to administer the edoxaban at a dose of 15 mg once a day.