Methods for treating hyperuricemia in patients with gout using halofenate or halofenic acid and a second urate-lowering agent
Disclosed herein are pharmaceutical compositions, methods and kits for lowering the serum uric acid level of a subject and for the treatment of a condition associated with elevated serum uric acid levels comprising administering a composition comprising a first urate-lowering agent and a second urate-lowering agent. In some aspects the first urate-lowering agent is (−)-halofenate, (−)-halofenic acid, or a pharmaceutically acceptable salts thereof. In some aspects the second urate-lowering agent is an inhibitor of uric acid production, a uricosuric agent, a uricase, or a pharmaceutically acceptable salt thereof.
1. A method of treating hyperuricemia in a subject with gout, comprising concomitant administration to the subject of a therapeutically effective amount of a first urate-lowering agent that is (−)-halofenate, or (−)-halofenic acid or a pharmaceutically acceptable salt thereof, substantially free from its (+)-enantiomer, and a second urate-lowering agent that is febuxostat.
2. The method of claim 1 , where the first urate-lowering agent is (−)-halofenate.
3. The method of claim 1 , where the first urate-lowering agent is administered at between about 100 mg/day and about 1000 mg/day.
4. The method of claim 1 , where the febuxostat is administered at between about 10 mg/day and about 240 mg/day.
5. The method of claim 2 , where the (−)-halofenate is administered at between about 400 mg/day and about 800 mg/day and the febuxostat is administered at between about 40 mg/day and about 120 mg/day.
6. The method of claim 1 , where the subject is refractory to febuxostat.
7. The method of claim 1 , where the gout is severe gout.
8. The method of claim 1 , where the gout is refractory gout.
9. A method of lowering serum uric acid in a subject with gout, comprising concomitant administration to the subject of a therapeutically effective amount of a first urate-lowering agent that is (−)-halofenate, or (−)-halofenic acid or a pharmaceutically acceptable salt thereof, substantially free from its (+)-enantiomer, and a second urate-lowering agent that is febuxostat.
10. The method of claim 9 , where the first urate-lowering agent is (−)-halofenate.
11. The method of claim 9 , where the first urate-lowering agent is administered at between about 100 mg/day and about 1000 mg/day.
12. The method of claim 9 , where the febuxostat is administered at between about 10 mg/day and about 240 mg/day.
13. The method of claim 10 , where the (−)-halofenate is administered at between about 400 mg/day and about 800 mg/day and the febuxostat is administered at between about 40 mg/day and about 120 mg/day.
14. The method of claim 9 , where the subject is refractory to febuxostat.
15. The method of claim 9 , where the gout is severe gout.
16. The method of claim 9 , where the gout is refractory gout.