Metabolic syndrome treatment

Abstract

Formulations and methods of providing an orally-active anti-metabolic disease Fixed Dose Combinations (FDC) for use as personalized medicine to treat different components of the Metabolic Syndrome or Insulin resistance syndrome such as Type II diabetes, Hypertension, Hyperlipidemia and Obesity are disclosed. Pharmaceutical compositions of anti-inflammatory centric drug formulations and methods comprising of NSAIDS in general and selective Cox-2 inhibitors in particular and one or more anti-T2DM or anti-hypertensive or anti-hyperlipidemic or anti-obesity drugs formulated to exhibit pre-determined modified release kinetics to achieve therapeutic as well as kinetic synergies are disclosed.

What is claimed is: 
     
         1 . A pharmaceutical formulation for the treatment of metabolic syndrome comprising
 (i) a therapeutically effective amount(s) of an active agent selected from the group consisting of at least one anti-diabetic drug; or   (ii) a therapeutically effective amount of at least one anti-hypertensive drug; or   (iii) a therapeutically effective amount of at least one anti-obesity drug; or   (iv) a therapeutically effective amount of at least one drug for the treatment of hyperlipidemia; or   (v) a combination of any of (i), (ii), (iii), and (iv); and   (vi) a therapeutically effective amount of at least one orally active anti-inflammatory drug.   
     
     
         2 . The pharmaceutical formulation of  claim 1 , comprising a therapeutically effective amount(s) of a drug selected from the group consisting of at least one anti-diabetic drug, an anti-hypertensive drug, and a therapeutically effective amount of at least one orally active anti-inflammatory drug. 
     
     
         3 . The pharmaceutical formulation of  claim 1 , comprising therapeutically effective amounts of at least two drugs selected from the group consisting of at least one an anti-hypertensive drug, at least one anti-diabetic drug, at least one drug for the treatment of hyperlipidemia, at least one anti-obesity drug, and at least one anti-inflammatory drug. 
     
     
         4 . The pharmaceutical formulation of  claim 1 , comprising therapeutically effective amounts of at least one an anti-hypertensive drug, at least one anti-diabetic drug, at least one drug for the treatment of hyperlipidemia, at least one anti-obesity drug, and at least one anti-inflammatory drug. 
     
     
         5 . The pharmaceutical formulation of  claim 1 , wherein the metabolic syndrome is Type II diabetes, comprising therapeutically effective amounts of a combination of one or more anti-inflammatory drug(s) and at least one drug used in the treatment of Type II Diabetes. 
     
     
         6 . The pharmaceutical formulation of  claim 1  wherein the metabolic syndrome is Type II diabetes, comprising a therapeutically effective amount(s) of a drug selected from the group consisting of at least one anti-diabetic drug and a blocker of Renin-Angiotensin System (RAS). 
     
     
         7 . The pharmaceutical formulation of  claim 1  for the treatment of hyperlipidemia, comprising therapeutically effective amounts of a combination of one or more anti-inflammatory drug(s) and one or more drugs selected from the group consisting of a statin, niacin, a fibrate, and combinations of any of the foregoing. 
     
     
         8 . The pharmaceutical formulation of  claim 1  for the treatment of obesity comprising therapeutically effective amounts of a combination of one or more anti-inflammatory drug(s) and one or more drugs selected from the group consisting of an anti-obesity drug, an anti-diabetic drug, and combinations of any of the foregoing. 
     
     
         9 . The pharmaceutical formulation of  claim 1  for the treatment of hypertension, comprising therapeutically effective amounts of one or more drugs selected from the group consisting of a beta blocker, a diuretic, an ACE inhibitor, an Angiotension II Receptor Blocker (ARBs), Calcium channel blocker (CCBs), a central agonist, a peripheral-acting adrenergic blocker, a direct vasodilator, a direct renin inhibitor, and combinations of any of the foregoing; and at least one anti-inflammatory drug. 
     
     
         10 . The pharmaceutical formulation of  claim 1 , which is an oral solid dosage form. 
     
     
         11 . The pharmaceutical formulation of  claim 1 , which is a dosage form selected from the group consisting of an oral dosage form, a parenteral dosage form, a transdermal dosage form, and a nasal dosage form. 
     
     
         12 . The formulation of  claim 1 , wherein at least one of the drugs is in controlled or delayed release form. 
     
     
         13 . A method of treating metabolic syndrome, comprising administering to a human patient having a condition selected from the group consisting of Type II diabetes, Hypertension, Hyperlipidemia and Obesity, a pharmaceutical formulation for the treatment of metabolic syndrome comprising
 (i) a therapeutically effective amount(s) of a drug selected from the group consisting of at least one anti-diabetic drug; or   (ii) a therapeutically effective amount of at least one anti-hypertensive drug; or   (iii) a therapeutically effective amount of at least one anti-obesity drug; or   (iv) a therapeutically effective amount of at least one drug for the treatment of hyperlipidemia; or   (v) a combination of any of (i), (ii), (iii), and (iv); and   (vi) a therapeutically effective amount of at least one orally active anti-inflammatory drug.   
     
     
         14 . The method of  claim 13 , wherein the patient is diabetic or prediabetic, comprising administering a therapeutically effective amount(s) of a drug selected from the group consisting of at least one anti-diabetic drug, a blocker of Renin-Angiotensin System (RAS), and a combination of the foregoing, together with a therapeutically effective amount of at least one orally active anti-inflammatory drug. 
     
     
         15 . The method of  claim 13 , wherein one or more of an ACE inhibitor, an angiotension II receptor blocker (ARBs), a DPPIV inhibitor, at least one anti-diabetic drug, a blocker of Renin-Angiotensin System (RAS), together with a therapeutically effective amount of at least one orally active anti-inflammatory drug, are administered to the patient. 
     
     
         16 . The method  claim 13 , wherein the drugs are administered to the patient on a chronic basis. 
     
     
         17 . The method of  claim 14 , wherein the drugs are administered as personalized medicines to clinically manage Type II diabetes or prediabetes in stratified groups of human patients based on their cardiometabolic risk factor profiles. 
     
     
         18 . The method of  claim 14 , wherein the drugs are administered as personalized medicines to clinically manage Type II diabetes or prediabetes groups of patients stratified for lack of adequate therapeutic efficacy with prior treatments. 
     
     
         19 . The method of  claim 14 , further comprising concomitantly administering insulin to the patient to achieve better blood glucose control. 
     
     
         20 . The method of  claim 14 , wherein dosage is adjusted on the basis of glucose measurements.