METHOD OF SAFELY AND EFFECTIVELY TREATING AND PREVENTING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE
A method of treating and preventing secondary hyperparathyroidism in CKD by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering 25-hydroxyvitamin D 3 with or without 25-hydroxyvitamin D 2 and, as necessary, 1,25-dihydroxyvitamin D 2 as a Vitamin D hormone replacement therapy.
1 . A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease Stage 3 or Stage 4, comprising administering to the patient an effective amount of 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 to reduce the patient's serum parathyroid hormone level while safely raising or maintaining both serum total 25-hydroxyvitamin D and serum total 1,25-dihydroxyvitamin D, wherein serum 25-hydroxyvitamin D 3 is greater than serum 25-hydroxyvitamin D 2 or serum 25-hydroxyvitamin D 4 , and wherein said 25-hydroxyvitamin D 2 , when administered, is administered in a lesser amount than said 25-hydroxyvitamin D 3 .
2 . The method of claim 1 , comprising administering said 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 such that blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL.
3 . The method of claim 1 , further comprising administering 1,25-dihydroxyvitamin D 2 as a Vitamin D hormone replacement therapy to the patient.
4 . The method of claim 1 , comprising administering said 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 such that blood concentrations of serum total 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for serum total 1,25-dihydroxyvitamin D without causing side effects selected from the group consisting of hypercalcemia, hyperphosphatemia, hypercalciuria and oversuppression of iPTH.
5 . The method of claim 2 , further comprising administering said 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 to maintain blood concentration of 25-hydroxyvitamin D in the patient at a level of at least 30 ng/mL for at least 30 days.
6 . The method of claim 5 , comprising administering said 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 to maintain blood concentration of 25-hydroxyvitamin D in the patient at a level of at least 30 ng/mL for at least 90 days.
7 . The method of claim 1 , wherein the patient's serum parathyroid hormone level is reduced by at least 30%.
8 . The method of claim 1 , wherein the patient is vitamin D insufficient or vitamin D deficient.
9 . The method of claim 1 , wherein the patient's serum parathyroid hormone level is reduced to the target range for the CKD Stage.
10 . The method of claim 4 , wherein said amount of 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 is further effective to maintain serum total 1,25-dihydroxyvitamin D within the patient's normal historical physiological range for at least 30 days.
11 . The method of claim 1 , wherein said amount of 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 is further effective to maintain the patient's serum parathyroid hormone level at a reduced level from baseline level for at least 30 days.
12 . The method of claim 1 , wherein said amount of 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 is further effective to concurrently maintain plasma PTH at a reduced level from baseline level, blood concentration of 25-hydroxyvitamin D at a level of at least 30 ng/mL, and blood concentration of 1,25-dihydroxyvitamin D within the patient's normal historical physiological range for at least 30 days.
13 . A method of treating secondary hyperparathyroidism in a patient suffering from chronic kidney disease Stage 3 or Stage 4, comprising administering to the patient an effective amount of 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 to reduce the patient's serum parathyroid hormone level while safely raising or maintaining both serum total 25-hydroxyvitamin D and serum total 1,25-dihydroxyvitamin D, wherein serum total 25-hydroxyvitamin D is increased to and/or maintained in a range of 30 ng/mL to 90 ng/mL, wherein serum 25-hydroxyvitamin D 3 is greater than serum 25-hydroxyvitamin D 2 or serum 25-hydroxyvitamin D 4 , and wherein said 25-hydroxyvitamin D 2 , when administered, is administered in a lesser amount than said 25-hydroxyvitamin D 3 .
14 . The method according to claim 13 , further comprising administering 1,25-dihydroxyvitamin D 2 as a Vitamin D hormone replacement therapy to the patient.
15 . The method of claim 13 , comprising administering said 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 such that blood concentrations of serum total 1 ,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for serum total 1,25-dihydroxyvitamin D without causing side effects selected from the group consisting of hypercalcemia, hyperphosphatemia, hypercalciuria and oversuppression of iPTH.
16 . The method of claim 13 , further comprising administering said 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 to increase and/or maintain blood concentration of 25-hydroxyvitamin D in the patient in a range of 30 ng/mL to 90 ng/mL for at least 30 days.
17 . The method of claim 13 , wherein the patient's serum parathyroid hormone level is reduced by at least 30%.
18 . The method of claim 13 , wherein the patient is vitamin D insufficient or vitamin D deficient.
19 . The method of claim 13 , wherein the patient's serum parathyroid hormone level is reduced to the target range for the CKD Stage.
20 . The method of claim 13 , wherein said amount of 25-hydroxyvitamin D 3 and optionally 25-hydroxyvitamin D 2 is further effective to maintain the patient's serum parathyroid hormone level at a reduced level from baseline level for at least 30 days.