Methods for alleviating statin myopathy
View Patent ↗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.
1. A pharmaceutical formulation comprising a statin side effect-alleviating amount of β-hydroxy β-methylbutyrate (HMB), or a pharmaceutically acceptable salt thereof, in combination with:
(a) 10 to 80 mg atorvastatin;
(b) 5 to 40 mg rosuvastatin;
(c) 10 to 80 mg pravastatin;
(d) 5 to 80 mg simvastatin;
(e) 10 to 80 mg lovastatin;
(f) 1 to 4 mg pitavastatin; or
(g) 20 to 80 mg fluvastatin;
or a pharmaceutically acceptable salt thereof.
2. The pharmaceutical formulation of claim 1 , which comprises 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin or a pharmaceutically acceptable salt thereof.
3. The pharmaceutical formulation of claim 1 , which comprises 5 mg, 10 mg, 20 mg, or 40 mg rosuvastatin or a pharmaceutically acceptable salt thereof.
4. The pharmaceutical formulation of claim 1 , which comprises 10 mg, 20 mg, 40 mg, or 80 mg pravastatin or a pharmaceutically acceptable salt thereof.
5. The pharmaceutical formulation of claim 1 , which comprises 10 mg, 20 mg, 40 mg, or 80 mg simvastatin or a pharmaceutically acceptable salt thereof.
6. The pharmaceutical formulation of claim 1 , which comprises 10 mg, 20 mg, 40 mg, or 80 mg lovastatin or a pharmaceutically acceptable salt thereof.
7. The pharmaceutical formulation of claim 1 , which comprises 1 mg, 2 mg, or 4 mg pitavastatin or a pharmaceutically acceptable salt thereof.
8. The pharmaceutical formulation of claim 1 , which comprises 20 mg, 40 mg, or 80 mg fluvastatin or a pharmaceutically acceptable salt thereof.
9. The pharmaceutical formulation of any one of claims 1 - 8 , wherein the statin-side effect-alleviating amount of HMB or a pharmaceutically acceptable salt thereof is 4 to 6 grams.
10. The pharmaceutical formulation of claim 9 , wherein the statin-side effect-alleviating amount of HMB or a pharmaceutically acceptable salt thereof is 4 grams.
11. The pharmaceutical formulation of claim 9 , wherein the statin-side effect-alleviating amount of HMB or a pharmaceutically acceptable salt thereof is 6 grams.
12. The pharmaceutical formulation of claim 1 , wherein HMB is calcium HMB monohydrate.
13. The pharmaceutical formulation of claim 1 , wherein HMB is HMB free acid.
14. A method for treating cumulative trauma disorder with myalgia/myositis, repetitive use disorder with micro-traumatic myalgia/myositis, acute or chronic rhabdomyolysis, statin-induced glucose intolerance, or statin-induced short-term memory loss, the method comprising administering to a subject:
(a) a statin side effect-alleviating amount of β-hydroxy β-methylbutyrate (HMB), or a pharmaceutically acceptable salt thereof; and
(b) at least one of:
(i) 10 to 80 mg atorvastatin;
(ii) 5 to 40 mg rosuvastatin;
(iii) 10 to 80 mg pravastatin;
(iv) 5 to 80 mg simvastatin;
(v) 10 to 80 mg lovastatin;
(vi) 1 to 4 mg pitavastatin; or
(vii) 20 to 80 mg fluvastatin;
or a pharmaceutically acceptable salt thereof.
15. The method of claim 14 , comprising administering to a subject 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin or a pharmaceutically acceptable salt thereof.
16. The method of claim 14 , comprising administering to a subject 5 mg, 10 mg, 20 mg, or 40 mg rosuvastatin or a pharmaceutically acceptable salt thereof.
17. The method of claim 14 , comprising administering to a subject 10 mg, 20 mg, 40 mg, or 80 mg pravastatin or a pharmaceutically acceptable salt thereof.
18. The method of claim 14 , comprising administering to a subject 10 mg, 20 mg, 40 mg, or 80 mg simvastatin or a pharmaceutically acceptable salt thereof.
19. The method of claim 14 , comprising administering to a subject 10 mg, 20 mg, 40 mg, or 80 mg lovastatin or a pharmaceutically acceptable salt thereof.
20. The method of claim 14 , comprising administering to a subject 1 mg, 2 mg, or 4 mg pitavastatin or a pharmaceutically acceptable salt thereof.
21. The method of claim 14 , comprising administering to a subject 20 mg, 40 mg, or 80 mg fluvastatin or a pharmaceutically acceptable salt thereof.
22. The method of claim 14 , comprising administering to a subject 4 to 6 grams HMB or a pharmaceutically acceptable salt thereof.
23. The method of claim 22 , comprising administering to a subject 4 grams HMB or a pharmaceutically acceptable salt thereof.
24. The method of claim 22 , comprising administering to a subject 6 grams HMB or a pharmaceutically acceptable salt thereof.
25. The method of claim 14 , wherein HMB is calcium HMB monohydrate.
26. The method of claim 14 , wherein HMB is HMB free acid.