Potassium-binding agents for treating hypertension and hyperkalemia

Abstract

The present invention generally relates to methods of treating hypertension (HTN) in patients in need thereof wherein the patient optionally further suffers from chronic kidney disease (CKD) or Type II diabetes mellitus (T2DM). The invention also relates to methods of treating hyperkalemia in a patient in need thereof, wherein the patient suffers from CKD, T2DM or HTN and are optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The invention also relates to methods of treating kidney disease in a patient in need thereof, wherein the patient is optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The methods can comprise administering an effective amount of a potassium-binding agent to the patient to lower the patient's blood pressure and/or increase or stabilize the patient's kidney function.

1 .- 137 . (canceled) 
     
     
         138 . A method of treating hyperkalemia in a human patient in need thereof optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent, the method comprising:
 administering to the human patient a zirconium silicate or a zirconium germinate molecular sieve at a daily dose of between 10 g and 40 g;   wherein the human patient was hyperkalemic before treatment with the zirconium silicate or zirconium germinate molecular sieve; and   wherein the human patient had a decrease in the patient's serum potassium level after 48 hours of treatment with the zirconium silicate or zirconium germinate molecular sieve; and   wherein the human patient was normokalemic after 4 weeks of treatment with the zirconium silicate or zirconium germinate molecular sieve.   
     
     
         139 . The method of  claim 138 , wherein the human patient suffers from chronic kidney disease. 
     
     
         140 . The method of  claim 138 , wherein the zirconium silicate or zirconium germinate molecular sieve is administered three times per day. 
     
     
         141 . The method of  claim 139 , wherein the zirconium silicate or zirconium germinate molecular sieve is administered three times per day. 
     
     
         142 . The method of  claim 138 , wherein the zirconium silicate or zirconium germinate molecular sieve is administered at a daily dose between 15 g and 40 g. 
     
     
         143 . The method of  claim 139 , wherein the zirconium silicate or zirconium germinate molecular sieve is administered at a daily dose between 15 g and 40 g. 
     
     
         144 . The method of  claim 138 , wherein the human patient was being treated with an effective amount of a RAAS agent. 
     
     
         145 . The method of  claim 138 , wherein the zirconium silicate molecular sieve is administered to the patient. 
     
     
         146 . A method of treating hyperkalemia in a human patient suffering from chronic kidney disease in need thereof optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent, the method comprising:
 administering to the human patient a zirconium silicate or a zirconium germinate molecular sieve at a daily dose of between 10 g and 40 g;   wherein the human patient was hyperkalemic before treatment with the zirconium silicate or zirconium germinate molecular sieve;   wherein the human patient was normokalemic after 4 weeks of treatment with the zirconium silicate or zirconium germinate molecular sieve; and   the amount of zirconium silicate or zirconium germinate administered was increased by 5 g daily if patient's serum potassium level was greater than or equal to 5.1 mEq/L or decreased by 5 g daily if the patient's serum potassium level was less than 4.0 mEq/L.   
     
     
         147 . The method of  claim 146 , wherein the zirconium silicate or zirconium germinate molecular sieve is administered once per day. 
     
     
         148 . The method of  claim 147 , wherein the zirconium silicate or zirconium germinate molecular sieve is administered at a daily dose between 15 g and 40 g. 
     
     
         149 . The method of  claim 146 , wherein the zirconium silicate molecular sieve is administered to the patient. 
     
     
         150 . The method of  claim 147 , wherein the zirconium silicate molecular sieve is administered to the patient. 
     
     
         151 . The method of  claim 148 , wherein the zirconium silicate molecular sieve is administered to the patient. 
     
     
         152 . A method of treating hyperkalemia in a human patient in need thereof and optionally treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent, the method comprising:
 administering to the human patient once per day a zirconium silicate molecular sieve at a daily dose of between 10 g and 40 g;   wherein the human patient was hyperkalemic before treatment with the zirconium silicate molecular sieve;   wherein the human patient was normokalemic after 4 weeks of treatment with the zirconium silicate or zirconium germinate molecular sieve; and   the amount of zirconium silicate was increased by 5 g daily if patient's serum potassium level was greater than or equal to 5.1 mEq/L or decreased by 5 g daily if the patient's serum potassium level was less than 4.0 mEq/L.   
     
     
         153 . The method of  claim 152 , wherein the human patient suffers from chronic kidney disease. 
     
     
         154 . The method of  claim 152 , wherein the human patient is being treated with an effective amount of a RAAS agent. 
     
     
         155 . The method of  claim 153 , wherein the human patient is being treated with an effective amount of a RAAS agent. 
     
     
         156 . The method of  claim 152 , wherein the zirconium silicate molecular sieve is administered at a daily dose between 15 g and 40 g. 
     
     
         157 . The method of  claim 153 , wherein the zirconium silicate molecular sieve is administered at a daily dose between 15 g and 40 g. 
     
     
         158 . The method of  claim 154 , wherein the zirconium silicate molecular sieve is administered at a daily dose between 15 g and 40 g.