IP Library › Granted Patent US 9,399,026
Granted Patent B2
US 9,399,026 · App. 14/853,374 · Granted Jul 26, 2016

Methods for alleviating statin myopathy

Inventor: Roland W. Winterfield (Hinsdale, IL)
A61K31/19A61K31/22A61K31/366A61K31/40A61K31/405A61K31/4418A61K31/47A61K31/505
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Quick Facts
Patent No.
US 9,399,026
App. No.
14/853,374
Granted
Jul 26, 2016
Kind
B2
Abstract

Disclosed herein are methods and compositions for alleviating side effects of statin administration, such as myopathic or myalgic side effects, short-term memory loss, abnormal liver function, glucose intolerance, hyperglycemia, increased risk for diabetes, or cumulative trauma disorder, comprising administration of β-hydroxy β-methylbutyrate (HMB) to an individual taking a statin. Also disclosed are methods and compositions for alleviating acute rhabdomyolysis comprising administration of HMB. The disclosure further provides uses of HMB in combination with a statin to alleviate side effects of statin administration.

Claims (25)

1. A method for alleviating one or more side effects of statin administration, the method comprising supplementing statin administration with administration of a therapeutically effective amount of β-hydroxy β-methylbutyrate (HMB).

2. The method of claim 1 , wherein the one or more side effects of statin administration are myopathic or myalgic side effects, short-term memory loss, elevated alanine transaminase (ALT) or aspartate transaminase (AST) levels, glucose intolerance, hyperglycemia, increased risk for diabetes, or cumulative trauma disorder.

3. The method of claim 1 , wherein HMB is administered at a dosage of approximately 2.0 to 4.0 grams/day.

4. The method of claim 3 , wherein HMB is administered at a dosage of approximately 3.0 grams/day.

5. The method of claim 4 , wherein HMB is administered at a dosage of approximately 4.0 grams/day.

6. The method of claim 1 , wherein HMB is administered 1 to 5 times per day.

7. The method of claim 6 , wherein HMB is administered 3 times per day.

8. The method of claim 6 , wherein HMB is administered 2 times per day.

9. The method of claim 1 , wherein the statin is atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

10. The method of claim 9 , wherein the statin is rosuvastatin.

11. The method of claim 1 , wherein HMB is administered as calcium HMB monohydrate.

12. The method of claim 1 , wherein HMB is administered as HMB free acid.

13. A pharmaceutical formulation comprising a statin and a statin side effect-alleviating amount of β-hydroxy β-methylbutyrate (HMB).

14. The pharmaceutical formulation of claim 13 , wherein the statin is atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

15. The pharmaceutical formulation of claim 14 , wherein the statin is rosuvastatin.

16. The pharmaceutical formulation of claim 13 , wherein the formulation comprises statin and HMB at a ratio that is approximately 0.001 to 0.1 by weight.

17. The pharmaceutical formulation of claim 13 , wherein the formulation comprises statin and HMB at a ratio that is approximately 0.01 by weight.

18. The pharmaceutical formulation of claim 13 , comprising from about 1.0 gram to about 4.0 grams HMB.

19. The pharmaceutical formulation of claim 13 , wherein HMB is calcium HMB monohydrate.

20. The pharmaceutical formulation of claim 13 , wherein HMB is HMB free acid.

21. A method for treating acute rhabdomyolysis in a patient, the method comprising administering a therapeutically effective amount of β-hydroxy β-methylbutyrate (HMB) to the patient.

22. The method of claim 21 , wherein HMB is administered at a dosage of about 6 grams/day to about 12 grams/day.

23. The method of claim 22 , wherein HMB is administered at a dosage of about 12 grams/day.

24. The method of claim 23 , wherein HMB is HMB free acid.

25. The method of claim 21 , wherein HMB is administered for at least three days.

Continuity (3)
Continuation PCTUS2015023102 · Mar 27, 2015
Provisional Application 61971072 · Mar 27, 2014
Related Publication 20160008304A1 · Jan 14, 2016