Methods and compounds for vitamin D therapy
Methods and compositions comprising 1,25-dihydroxyvitamin D 2 are disclosed. A method for lowering or maintaining lowered serum parathyroid hormone in human patients including administering to said patients an effective amount of 1,25-dihydroxyvitamin D 2 to lower or maintain lowered serum parathyroid hormone levels is disclosed. Dosage forms and dosing regimens are also disclosed.
1. A method for safely lowering or maintaining lowered serum intact parathyroid hormone in a human patient, comprising administering to the patient an effective amount of 1,25-dihydroxyvitamin D 2 to lower or maintain lowered serum parathyroid hormone levels without causing substantially increased risk of hypercalcemia or hyperphosphatemia.
2. The method of claim 1 , further comprising concurrently
(a) increasing or maintaining serum calcium levels in the patient;
(b) maintaining serum phosphorous levels in the patient; and
(c) increasing or maintaining serum 1,25-dihydroxyvitamin D levels in the patient by said administration of 1,25-dihydroxyvitamin D 2 .
3. The method according to claim 2 , comprising increasing or maintaining serum calcium levels in the patient in a range of about 8.6 to 10.2 mg/dL by said administration of 1,25-dihydroxyvitamin D 2 .
4. The method according to claim 2 , comprising maintaining phosphorous levels in the patient in a range of 2.5 to 4.5 mg/dL by said administration of 1,25-dihydroxyvitamin D 2 .
5. The method according to claim 2 , comprising increasing serum 1,25-dihydroxyvitamin D levels in the patient to the patient's normal historical physiological range by said administration of 1,25-dihydroxyvitamin D 2 .
6. The method according to claim 2 , comprising maintaining serum 1,25-dihydroxyvitamin D levels in the patient's normal historical physiological range for at least 30 days by said administration of 1,25-dihydroxyvitamin D 2 .
7. The method according to claim 1 , wherein said effective amount is sufficient to lower serum intact parathyroid hormone levels by at least 15%.
8. A method of safely increasing or maintaining blood concentrations of 1,25-dihydroxyvitamin D and maintaining serum calcium and phosphorous levels in a human patient with Chronic Kidney Disease by administering an amount of 1,25-dihydroxyvitamin D 2 to the patient.
9. A method of alleviating one or more symptoms of 1,25-dihydroxyvitamin D deficiency in a human patient with Chronic Kidney Disease, comprising administering an amount of 1,25-dihydroxyvitamin D 2 to the patient such that one or more symptoms of 1,25-dihydroxyvitamin D deficiency are alleviated and serum calcium and phosphorous levels are maintained.
10. The method of claim 9 , wherein said one or more symptoms of 1,25-dihydroxyvitamin D deficiency comprise symptoms of deficiency in the non-classical effects of vitamin D.
11. The method of claim 10 , wherein said administration of 1,25-dihydroxyvitamin D 2 to the patient provides negative endocrine regulation of the renin-angiotensin system in the patient.
12. The method according to claim 1 , wherein the patient has been diagnosed with chronic kidney disease (CKD).
13. The method according to claim 12 , wherein the patient has been diagnosed with hyperparathyroidism secondary to chronic kidney disease (SHPT).
14. The method according to claim 12 , wherein said CKD is Stage 1 or Stage 2 CKD.
15. The method according to claim 12 , wherein said CKD is Stage 3, Stage 4, or Stage 5 CKD.
16. The method according to claim 15 , wherein the amount of amount of 1,25-dihydroxyvitamin D 2 administered is sufficient to reduce serum levels of PTH to 35-70 pg/mL for a Stage 3 CKD patient, to 70-110 pg/mL for a Stage 4 CKD patient, and to 150-300 pg/mL for a Stage 5 CKD patient.
17. The method according to claim 1 , wherein the amount 1,25-dihydroxyvitamin D 2 administered is in a range of 0.1 μg per week to about 100 μg per week.
18. The method according to claim 1 , comprising administering 1,25-dihydroxyvitamin D 2 for at least 30 days.
19. The method according to claim 18 , comprising administering 1,25-dihydroxyvitamin D 2 for at least 2 months.
20. The method according to claim 18 , comprising administering 1,25-dihydroxyvitamin D 2 for at least 6 months.
21. The method according to claim 18 , further comprising avoiding progressive loss of 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D 3 in the patient.