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Claims for Patent: 9,233,103

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Claims for Patent: 9,233,103

Title:Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy
Abstract: The present invention relates to methods of treating heartburn in a patient receiving clopidogrel therapy. In another aspect, the present invention relates to methods of preventing gastric bleeding or hemorrhage in patients receiving clopidogrel therapy.
Inventor(s): Lee; Ronald D. (Round Lake Beach, IL)
Assignee: Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:13/411,701
Patent Claims: 1. A method of treating heartburn or erosive esophagitis and at least one second disease state in a patient in need of treatment thereof, the method comprising: a) identifying a patient suffering from heartburn or erosive esophagitis and at least one second disease state, wherein said patient is being treated with or about to be treated with clopidrogel to treat the second disease state; b) preferentially selecting dexlansoprazole from a group of proton pump inhibitors to administer to the patient; and c) concomitantly administering separate dosage forms of clopidogrel and a therapeutically effective amount of dexlansoprazole to said patient in need of treatment thereof; wherein the therapeutically effective amount of dexlansoprazole is a dose of 60 mg.

2. The method of claim 1, wherein the heart burn is heartburn associated with symptomatic non-erosive gastroesophageal reflux disease.

3. The method of claim 1, wherein the administration of the dexlansoprazole to the patient does not inhibit CYP2C19 interactions between the dexlansoprazole and clopidogrel.

4. The method of claim 1, wherein the pharmacological activity of the clopidogrel that is administered is to concomitantly treat the at least one second disease state.

5. The method of claim 1, wherein the at least one second disease state is acute coronary syndrome, peripheral artery disease, myocardial infarction, stroke or a combination thereof.

6. A method of treating heartburn or erosive esophagitis in a patient concomitantly receiving clopidogrel without inhibiting CYP2C19 interactions between the heartburn or esophagitis treatment and clopidogrel in the patient, the method comprising the step of: preferentially administering a therapeutically effective amount of dexlansoprazole to a patient who is concomitantly receiving clopidogrel to treat heartburn or erosive esophagitis, wherein the therapeutically effective amount of dexlansoprazole does not (i) inhibit the pharmacological activity of the clopidogrel; and (ii) inhibit CYP2C19 interactions between the dexlansoprazole and the clopidogrel, wherein the therapeutically effective amount of dexlansoprazole is a dose of 60 mg.

7. The method of claim 6, wherein the heartburn is heartburn associated with symptomatic non-erosive gastroesophageal reflux disease.

8. The method of claim 6, wherein the at least one second disease state is acute coronary syndrome, peripheral artery disease, myocardial infarction, stroke or a combination thereof.

9. The method of claim 1, wherein the treatment of erosive esophagitis comprises healing erosive esophagitis.

10. The method of claim 6, wherein the treatment of erosive esophagitis comprises healing erosive esophagitis.
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