Method of Safely and Effectively Treating and Preventing Secondary Hyperparathyroidism in Chronic Kidney Disease
AssigneeProventiv Therapeutics, LLC
InventorCharles W. Bishop
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Abstract
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 Din a patient by administering 25-hydroxyvitamin D3 with or without 25-hydroxyvitamin D2 and, as necessary, 1,25-dihydroxyvitamin D2 as a Vitamin D hormone replacement therapy.
Claims20
A method of treating and preventing secondary hyperparathyroidism in a patient suffering from chronic kidney disease, comprising increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the patient by administering 25-hydroxyvitamin D3 and optionally 25-hydroxyvitamin D2, wherein 25-hydroxyvitamin D3 is the predominant prohormone in circulation.
A method of concurrently lowering or maintaining plasma iPTH levels, increasing or maintaining serum calcium levels, maintaining serum phosphorous levels, increasing or maintaining serum 25-hydroxyvitamin D, or increasing or maintaining serum 1,25-dihydroxyvitamin D levels in a human patient diagnosed with early stage CKD, comprising administering to the patient, 25-hydroxyvitamin D3 and optionally 25-hydroxyvitamin D2 and, further optionally as necessary, 1,25-dihydroxyvitamin D2, such that the blood concentrations of 25-hydroxyvitamin D in the patient are increased to and maintained at or above 30 ng/mL, with 25-hydoxyvitamin D3 being the predominant prohormone, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for 1,25-dihydroxyvitamin D.
A method of reducing the risk of over suppression of plasma iPTH levels in a patient undergoing treatment for elevated levels of plasma iPTH, or maintenance/prevention therapy for secondary hyperparathyroidism, comprising administering 25-hydroxyvitamin D3 and optionally 25-hydroxyvitamin D2 and, further optionally, as necessary, 1,25-dihydroxyvitamin D2, so that the blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL, with 25-hydoxyvitamin D3 being the predominant prohormone, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patient's normal historical physiological range for 1,25-dihydroxyvitamin D, and elevated plasma iPTH levels are decreased or controlled while avoiding an abnormally low bone turnover rate.
A method of treatment, comprising proactively administering 25-hydroxyvitamin D3 and/or Vitamin D3, optionally concurrently with administration of 25-hydroxyvitamin D2, and/or Vitamin D2, to an early stage CKD patient having the potential to develop secondary hyperparathyroidism due to Vitamin D insufficiency or deficiency.
Dependencies are inferred from the claim text.