Pharmaceutical formulations of potassium atp channel openers and uses thereof

Abstract

Provided are immediate or prolonged administration of certain potassium ATP (K ATP ) channel openers to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving K ATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of K ATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are method of co-administering K ATP channel openers with other drugs to treat diseases of humans and animals.

1 .- 20 . (canceled) 
     
     
         21 . A method of preventing the transition to diabetes of a prediabetic individual, comprising administering to the individual a pharmaceutical formulation comprising a therapeutically effective amount of diazoxide no more than two times per 24 hours. 
     
     
         22 . The method of  claim 21  wherein said administering is once per 24 hours. 
     
     
         23 . The method of  claim 21 , wherein the pharmaceutical formulation is a controlled release formulation and the controlled release occurs over a time period of 8-24 hours following administration. 
     
     
         24 . The method of  claim 21 , wherein between 100 and 200 mg of diazoxide is administered per dose. 
     
     
         25 . The method of  claim 21 , wherein between 200 and 300 mg of diazoxide is administered per dose. 
     
     
         26 . The method of  claim 21 , wherein between 300 and 500 mg of diazoxide is administered per dose. 
     
     
         27 . A method of restoring normal glucose tolerance to a diabetic individual comprising administering to the individual a therapeutically effective amount of diazoxide. 
     
     
         28 . The method of  claim 27  wherein said administering is once per 24 hours. 
     
     
         29 . The method of  claim 27 , wherein the pharmaceutical formulation is a controlled release formulation and the controlled release occurs over a time period of 8-24 hours following administration. 
     
     
         30 . The method of  claim 27 , wherein between 100 and 200 mg of diazoxide is administered per dose. 
     
     
         31 . The method of  claim 27 , wherein between 200 and 300 mg of diazoxide is administered per dose. 
     
     
         32 . The method of  claim 27 , wherein between 300 and 500 mg of diazoxide is administered per dose. 
     
     
         33 . A method of treating dyslipidemia or impaired glucose tolerance in an individual treated with an anti-psychotic drug, comprising administering to the individual a therapeutically effective amount of diazoxide. 
     
     
         34 . The method of  claim 33  wherein said administering is once per 24 hours. 
     
     
         35 . The method of  claim 33 , wherein the pharmaceutical formulation is a controlled release formulation and the controlled release occurs over a time period of 8-24 hours following administration. 
     
     
         36 . The method of  claim 33 , wherein between 100 and 200 mg of diazoxide is administered per dose. 
     
     
         37 . The method of  claim 33 , wherein between 200 and 300 mg of diazoxide is administered per dose. 
     
     
         38 . The method of  claim 33 , wherein between 300 and 500 mg of diazoxide is administered per dose.