METHOD FOR TREATING OR PREVENTING THROMBOSIS USING DABIGATRAN ETEXILATE OR A SALT THEREOF WITH IMPROVED SAFETY PROFILE OVER CONVENTIONAL WARFARIN THERAPY

• US 20120282187A1
• Filed: 07/13/2012
• Published: 11/08/2012
• Est. Priority Date: 11/11/2008
• Status: Abandoned Application

• Current Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Original Assignee: Boehringer Ingelheim International GmbH (C.H. Boehringer Sohn AG & Co. KG)
• Inventors: REILLY, Paul Anthony
• Application Number:
  US13/548,423
• Publication Number:
  US 20120282187A1
• Time in Patent Office: Days
• US Class Current: 424/10.3
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A method for preventing stroke in a patient suffering from atrial fibrillation, wherein the patient has at least one risk factor for major bleeding events, the method comprising administering to the patient 110 mg b.i.d. of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

Claims

1-9. -9. (canceled)

10. A method for reducing error and increasing safety in administering a dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to a patient for (1) prevention of stroke in said patient suffering from atrial fibrillation, wherein the patient has at least one risk factor for major bleeding events, (2) prevention of stroke in a patient having at least one stroke, thrombosis, or embolism risk factor and reduction of risk of a major bleeding event or mortality compared to conventional warfarin therapy, (3) prevention or treatment of thrombosis in said patient, wherein said patient is not suitable for conventional warfarin therapy, or (4) reduction of risk of a major bleeding event, hemorrhagic stroke, intracranial stroke or mortality compared to conventional warfarin therapy in said patient comprising:

(a) confirming that a prescribed capsule contains 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining a unique color-coding of the capsule; and

(b) administering to the patient a capsule of 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

11. The method according to claim 10, further comprising the steps of:

(c) monitoring the patient for bleeding adverse events;

(d) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if no bleeding adverse events occur;

(e) confirming that a prescribed capsule containing a higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the higher dose; and

(f) administering to the patient a capsule of the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

12. The method according to claim 10, further comprising the steps of:

(c) monitoring the patient for bleeding adverse events;

(d) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if bleeding adverse events occur;

(e) confirming that a prescribed capsule containing a lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the lower dose; and

(f) administering to the patient a capsule of the lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

16. The method according to claim 10, wherein the administration is either q.d. or b.i.d.

17. The method according to claim 10, wherein the unique color-coding of the 110 mg dose capsule is a light blue opaque cap and a light blue opaque body.

18. The method according to claim 11, wherein the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, is 150 mg.

19. The method according to claim 18, wherein the unique color-coding of the 150 mg dose capsule is a light blue opaque cap and a cream opaque body.

22. The method according to claim 11, wherein the monitoring occurs over a period of at least 3 months.

13. A method for reducing error and increasing safety in administering a dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to a patient for prevention of stroke in said patient suffering from atrial fibrillation comprising:

(a) determining whether the patient has at least one risk factor for major bleeding events;

(b) prescribing a capsule containing 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to the patient with at least one risk factor for major bleeding events;

(c) confirming that a prescribed capsule contains 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining a unique color-coding of the capsule; and

(d) administering to the patient a capsule of 110 mg of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

14. The method according to claim 13, further comprising the steps of:

(e) monitoring the patient for bleeding adverse events;

(f) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if no bleeding adverse events occur;

(g) confirming that a prescribed capsule containing a higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the higher dose; and

(h) administering to the patient a capsule of the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

15. The method according to claim 13, further comprising the steps of:

(e) monitoring the patient for bleeding adverse events;

(f) modifying the dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, to be administered to a patient if bleeding adverse events occur;

(g) confirming that a prescribed capsule containing a lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, by visually examining color-coding of the capsule, wherein the color-coding of the capsule containing the 110 mg dose is different from the color-coding of the capsule containing the lower dose; and

(h) administering to the patient a capsule of the lower dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof.

20. The method according to claim 13, wherein the risk factor is selected from the group consisting of:

(a) having an age of at least 75 years;

(b) having a history of stroke;

(c) having a history of a transient ischemic attack;

(d) having a history of a thromboembolic event;

(e) having left ventricular dysfunction;

(f) having an age of at least 65 years and having high blood pressure;

(g) having an age of at least 65 years and having diabetes;

(h) having an age of at least 65 years and having coronary artery disease;

(i) having an age of at least 65 years and having peripheral artery disease;

(j) having a history of earlier bleeding events; and

(k) having a reduced creatine clearance less than 80 mL/minute.

21. The method according to claim 13, wherein the step of determining a risk factor is performed through standard or specialized medical procedures.

23. The method according to claim 13, wherein the administration is either q.d. or b.i.d.

24. The method according to claim 13, wherein the unique color-coding of the 110 mg dose capsule is a light blue opaque cap and a light blue opaque body.

25. The method according to claim 14, wherein the higher dose of dabigatran etexilate, optionally in the form of a pharmaceutically acceptable salt thereof, is 150 mg

26. The method according to claim 25 wherein the unique color-coding of the 150 mg dose capsule is a light blue opaque cap and a cream opaque body.

27. The method according to claim 14, wherein the monitoring occurs over a period of at least 3 months.