Method for treating a patient at risk for developing an nsaid-associated ulcer

Abstract

The present disclosure is directed to a method for treating a disease or disorder in a patient at risk of developing an NSAID-associated ulcer by administering to said patient in need thereof a pharmaceutical composition in unit dose form comprising naproxen, or pharmaceutically acceptable salt thereof, and esomeprazole, or pharmaceutically acceptable salt thereof to said at risk patient and thereby decreasing the patient's risk of developing an ulcer.

1 - 63 . (canceled) 
     
     
         64 . A method of reducing the incidence of NSAID associated gastric ulcers, comprising: 
       administering to a patient taking low dose aspirin for cardiovascular prophylaxis a unit dosage form comprising
 a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof, and 
 b) 500 mg of naproxen, or pharmaceutically acceptable salt thereof; 
 
       wherein the unit dose form provides for coordinated release of the esomeprazole and the naproxen, wherein at least a portion of the esomeprazole, or pharmaceutically acceptable salt thereof, is released independent of the pH of the surrounding medium. 
     
     
         65 . The method of  claim 64 , wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1; N HCl at 75 rpm at 37° C.±0.5° C. 
     
     
         66 . The method of  claim 64 , wherein the unit dosage form is administered twice a day. 
     
     
         67 . The method of  claim 66 , wherein the unit dosage form is administered for 1 month. 
     
     
         68 . The method of  claim 66 , wherein the unit dosage form is administered for 3 months. 
     
     
         69 . The method of  claim 66 , wherein the unit dosage form is administered for 6 months. 
     
     
         70 . The method of  claim 64 , wherein the unit dosage form is suitable for oral administration. 
     
     
         71 . The method of  claim 64 , wherein the unit dose form begins to release the naproxen, or a pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is at about 4.0 or greater. 
     
     
         72 . The method of  claim 64 , wherein the unit dose form begins to release the naproxen, or a pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is at about 4.5 or greater. 
     
     
         73 . A method of treating osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or a combination thereof, comprising: 
       administering to a patient taking low dose aspirin for cardiovascular prophylaxis, a unit dosage form comprising:
 a) 20 mg of esomeprazole, or pharmaceutically acceptable salt thereof and 
 b) 500 mg of naproxen, or pharmaceutically acceptable salt thereof; 
 
       wherein the unit dose form provides for coordinated release of the esomeprazole and the naproxen, wherein at least a portion of the esomeprazole, or pharmaceutically acceptable salt thereof, is released independent of the pH of the surrounding medium. 
     
     
         74 . The method of  claim 73 , wherein the unit dosage form releases less than 10% of the naproxen or a pharmaceutically acceptable salt thereof after 2 hours when tested using the USP Paddle Method in 1000 ml of 0.1; N HCl at 75 rpm at 37° C.±0.5° C. 
     
     
         75 . The method of  claim 73 , wherein the unit dosage form is administered twice a day. 
     
     
         76 . The method of  claim 75 , wherein the unit dosage form is administered for 1 month. 
     
     
         77 . The method of  claim 75 , wherein the unit dosage form is administered for 3 months. 
     
     
         78 . The method of  claim 75 , wherein the unit dosage form is administered for 6 months. 
     
     
         79 . The method of  claim 73 , wherein the unit dosage form is suitable for oral administration. 
     
     
         80 . The method of  claim 73 , wherein the unit dose form begins to release the naproxen, or a pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is at about 4.0 or greater. 
     
     
         81 . The method of  claim 73 , wherein the unit dose form begins to release the naproxen, or a pharmaceutically acceptable salt thereof, when the pH of the surrounding medium is at about 4.5 or greater.