.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,293,728

« Back to Dashboard

Claims for Patent: 8,293,728

Title:Methods of treating hypertriglyceridemia
Abstract: In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
Inventor(s): Manku; Mehar (England, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT)
Assignee: Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:13/349,153
Patent Claims: 1. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who does not receive concurrent lipid altering therapy comprising: administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate, and substantially no docosahexaenoic acid or its esters for a period of 12 weeks to effect a reduction in triglycerides without substantially increasing LDL-C compared to a second subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who has not received the pharmaceutical composition and a concurrent lipid altering therapy.

2. The method of claim 1, wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day.

3. The method of claim 2 wherein, the pharmaceutical composition is present in one or more capsules.

4. The method of claim 1, wherein the subject and the second subject have one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.

5. The method of claim 4, comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting non-HDL-C and a reduction in fasting VLDL-C compared to the second subject.

6. The method of claim 4, comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting triglycerides of at least about 25% compared to the second subject.

7. The method of claim 4, comprising administering to the subject about 4 g of said pharmaceutical composition daily for the period of 12 weeks, to effect a reduction in fasting Lp-PLA2 of at least 10% compared to the second subject.

8. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl who does not receive concurrent lipid altering therapy comprising, administering to the subject, about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate and substantially no docosahexaenoic acid or its esters for a period of 12 weeks to effect a reduction in fasting triglycerides of at least about 15% without substantially increasing LDL-C compared to a second subject having fasting triglyceride of 500 mg/dl to about 1500 who has not received the pharmaceutical composition and concurrent lipid altering therapy.

9. The method of claim 8, wherein the pharmaceutical composition is administered to the subject 1 to 4 times per day.

10. The method of claim 9, wherein the pharmaceutical composition is present in one or more capsules.

11. The method of claim 8, wherein the subject and the second subject have one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.

12. The method of claim 11, comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting non-HDL-C and a reduction in fasting VLDL-C compared to the second subject.

13. The method of claim 8, comprising administering to the subject about 4 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting triglycerides of at least about 25%.

14. The method of claim 11, comprising: administering to the subject about 4 g of the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in fasting Lp-PLA2 of at least 10% compared to the second subject.

15. The method of claim 1, wherein the subject and the second subject consume a Western diet.

16. The method of claim 1, wherein no fatty acid of the pharmaceutical composition, except for ethyl-EPA, comprises more than about 0.6% by weight of all fatty acids combined.

17. The method of claim 8, wherein the subject and the second subject consume a Western diet.

18. The method of claim 8, wherein no fatty acid of the pharmaceutical composition, except for ethyl-EPA, comprises more than about 0.6% by weight of all fatty acids combined.

19. A method of lowering triglycerides in a subject having a fasting baseline triglyceride level of about 500 mg/dl to about 1500 mg/dl, who does not receive a concurrent lipid altering therapy comprising: administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate and substantially no docosahexaenoic acid or its esters for a period of at least 12 weeks that is effective to reduce in a first patient population receiving 4 g per day of said composition without concurrent lipid altering therapy and having said baseline triglyceride level, a median triglyceride level by at least 5% without substantially increasing LDL-C, compared to a median triglyceride level and LDL-C level observed in a second patient population having said baseline triglyceride level who has not received the pharmaceutical composition and concurrent lipid altering therapy.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc