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Claims for Patent: 8,026,281

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Claims for Patent: 8,026,281

Title:Treating metabolic syndrome with fenofibrate
Abstract: A method of treating metabolic syndrome in a human diagnosed with metabolic syndrome by administering a therapeutically effective amount of fenofibrate over a treatment period. The results can include identifying a human as not having clinical metabolic syndrome after treatment, as compared to having metabolic syndrome before treatment.
Inventor(s): Doyle, Jr.; Ralph T. (Milford, NJ), Kling; Douglas F. (Parisippany, NJ), Rongen; Roelof M. L. (Caliton, NJ), Rotenberg; Keith S. (Danville, NJ)
Assignee: Lupin Atlantis Holdings, S.A. (Schaffhausen, CH)
Application Number:11/111,971
Patent Claims: 1. A method for treating metabolic syndrome in a human, the method comprising: administering a therapeutically effective amount of fenofibrate to a human having metabolic syndrome, wherein a human has metabolic syndrome if the human has at least three characteristics selected from the group consisting of: (a) a waist circumference greater than 102 cm for men and greater than 88 cm for women; (b) a triglyceride level greater than 150 mg/dl; (c) an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women; (d) a blood pressure greater than or equal to 130/85 mmHG; and (e) a fasting glucose level greater than 110 mg/dl, such that after said administering of fenofibrate the human no longer has at least three characteristics selected from the group consisting of (a), (b), (c), (d), and (e).

2. The method of claim 1, wherein the fenofibrate is administered once daily.

3. The method of claim 1, wherein the fenofibrate is administered orally.

4. The method of claim 1, wherein the fenofibrate is in the form of microgranules.

5. The method of claim 4, wherein the microgranules of fenofibrate are administered in a tablet or capsule composition.

6. The method of claim 5, wherein the tablet or capsule composition is an immediate-release formulation.

7. The method of claim 5, wherein the tablet or capsule composition comprises one or more excipients, and wherein the one or more excipients are one or more members selected from the group consisting of a wetting agent, a surfactant, a hydrosoluble carrier, and a binder.

8. The method of claim 4, wherein the microgranules comprise a neutral core, an active layer, and an outer layer encompassing the active layer and neutral core.

9. The method of claim 1, wherein the therapeutically effective amount of fenofibrate is from about 20 to about 400 mg per day.

10. The method of claim 9, wherein the therapeutically effective amount of fenofibrate is from about 30 to about 300 mg per day.

11. The method of claim 10, wherein the therapeutically effective amount of fenofibrate is from about 40 to about 200 mg per day.

12. The method of claim 1, wherein the fenofibrate is administered once daily for a treatment period of at least two weeks.

13. The method of claim 12, wherein the fenofibrate is administered once daily for a treatment period of at least four weeks.

14. The method of claim 13, wherein the fenofibrate is administered once daily for a treatment period of at least eight weeks.

15. A method of lowering triglycerides and increasing HDL-cholesterol in a human, the method comprising administering a therapeutically effective amount of fenofibrate to said human, wherein said human has a triglyceride level greater than 150 mg/dl and an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women, and wherein said human has at least one characteristic selected from the group consisting of: (a) a waist circumference greater than 102 cm for men and greater than 88 cm for women; (b) a blood pressure greater than or equal to 130/85 mmHG; and (c) a fasting glucose level greater than 110 mg/dl, such that after said administering of fenofibrate the human has a triglyceride level less than 150 mg/dl and an HDL-cholesterol level greater than 40 mg/dl for men and greater than 50 mg/dl for women and no longer has at least one characteristic selected from the group consisting of (a), (b), and (c).

16. The method of claim 15, wherein the fenofibrate is administered once daily.

17. The method of claim 15, wherein the fenofibrate is administered orally.

18. The method of claim 15, wherein the fenofibrate is in the form of microgranules.

19. The method of claim 18, wherein the microgranules of fenofibrate are administered in a tablet or capsule composition.

20. The method of claim 19, wherein the tablet or capsule composition is an immediate-release formulation.

21. The method of claim 19, wherein the tablet or capsule composition comprises one or more excipients, and wherein the one or more excipients are one or more members selected from the group consisting of a wetting agent, a surfactant, a hydrosoluble carrier, and a binder.

22. The method of claim 18, wherein the microgranules comprise a neutral core, an active layer, and an outer layer encompassing the active layer and neutral core.

23. The method of claim 15, wherein the therapeutically effective amount of fenofibrate is from about 20 to about 400 mg per day.

24. The method of claim 15, wherein the therapeutically effective amount of fenofibrate is from about 30 to about 300 mg per day.

25. The method of claim 15, wherein the therapeutically effective amount of fenofibrate is from about 40 to about 200 mg per day.

26. The method of claim 15, wherein the fenofibrate is administered once daily for a treatment period of at least two weeks.

27. The method of claim 15, wherein the fenofibrate is administered once daily for a treatment period of at least four weeks.

28. The method of claim 15, wherein the fenofibrate is administered once daily for a treatment period of at least eight weeks.

29. The method of claim 1, wherein the human has: (a) a waist circumference greater than 102 cm for men and greater than 88 cm for women; (b) a triglyceride level greater than 150 mg/dl; and (c) an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women prior to the administration of fenofibrate.

30. The method of claim 1, wherein the human has: (b) a triglyceride level greater than 150 mg/dl; (c) an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women; and (d) a blood pressure greater than or equal to 130/85 mmHG prior to the administration of fenofibrate.

31. The method of claim 1, wherein the human has: (b) a triglyceride level greater than 150 mg/dl; (c) an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women; and (e) a fasting glucose level greater than 110 mg/dl prior to the administration of fenofibrate.

32. The method of claim 29, wherein the human also has a blood pressure greater than or equal to 130/85 mmHG prior to the administration of fenofibrate.

33. The method of claim 29, wherein the human also has a fasting glucose level greater than 110 mg/dl prior to the administration of fenofibrate.

34. A method for treating metabolic syndrome in a human, the method comprising: administering a therapeutically effective amount of fenofibrate to a human having metabolic syndrome, wherein a human has metabolic syndrome if the human has at least three characteristics selected from the group consisting of: (a) a waist circumference greater than 102 cm for men and greater than 88 cm for women; (b) a triglyceride level greater than 150 mg/dl; (c) an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women; (d) a blood pressure greater than or equal to 130/85 mmHG; and (e) a fasting glucose level greater than 110 mg/dl; wherein the fenofibrate is administered as a composition comprising fenofibrate and wherein the composition contains a single surfactant.

35. A method for treating metabolic syndrome in a human, the method comprising: administering a therapeutically effective amount of fenofibrate to a human having metabolic syndrome, wherein a human has metabolic syndrome if the human has at least three characteristics selected from the group consisting of: (a) a waist circumference greater than 102 cm for men and greater than 88 cm for women; (b) a triglyceride level greater than 150 mg/dl; (c) an HDL-cholesterol level less than 40 mg/dl for men and less than 50 mg/dl for women; (d) a blood pressure greater than or equal to 130/85 mmHG; and (e) a fasting glucose level greater than 110 mg/dl; wherein the fenofibrate is administered as a composition comprising granules comprising a neutral core, a layer of fenofibrate surrounding the neutral core, and a layer of hydrosoluble binder surrounding the layer of fenofibrate, wherein the composition contains a single surfactant.

36. The method of claim 34, wherein the surfactant is sodium lauryl sulfate.

37. The method of claim 36, wherein the fenofibrate and sodium lauryl sulfate are present co-micronized.

38. The method of claim 34, wherein after said administering of fenofibrate the human no longer has at least three characteristics selected from the group consisting of (a), (b), (c), (d), and (e).

39. The method of claim 35, wherein the surfactant is sodium lauryl sulfate.

40. The method of claim 35, wherein after said administering of fenofibrate the human no longer has at least three characteristics selected from the group consisting of (a), (b), (c), (d), and (e).
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