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Claims for Patent: 5,902,821

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Claims for Patent: 5,902,821

Title: Use of carbazole compounds for the treatment of congestive heart failure
Abstract:A method of treatment using carvedilol is disclosed, wherein the carvedilol decreases the mortality caused by congestive heart failure in patients. The patients are titrated with low amounts of carvedilol, with the initial titration dosage being only 10 to 30% of the daily maintenance dose.
Inventor(s): Lukas-Laskey; Mary Ann (Rosemont, PA), Ruffolo, Jr.; Robert (Spring City, PA), Shusterman; Neil (Wynnewood, PA), Sponer; Gisbert (Laudenbach, DE), Strein; Klaus (Hemsbach, DE)
Assignee: Boehringer Mannheim Pharmaceuticals Corporation Smith Kline Corporation (Gaithersburg, MD)
Application Number:08/875,603
Patent Claims: 1. A method of decreasing mortality caused by congestive heart failure in a patient in need of such decrease, said method comprising:

administering to said patient first dosages at least daily for a period of from 7 to 28 days, said first dosages each comprising carvedilol,

then administering to said patient second dosages at least daily for a period of from 7 to 28 days, said second dosages each containing carvedilol, and

then administering to said patient third dosages daily for a maintenance period, said third dosages each comprising carvedilol, said third dosages each comprising a daily maintenance dose in the range of from about 10 mg to about 100 mg of carvedilol,

said first dosages each comprising carvedilol in an amount which is 10-30% of said daily maintenance dose,

said second dosages each comprising carvedilol in an amount which is 20-70% of said daily maintenance dose.

2. The method of claim 1, wherein the daily maintenance dose is about 25 mg or about 50 mg.

3. The method of claim 1, further comprising administering to said patient at least one other therapeutic agent selected from the group consisting of angiotensin converting enzyme inhibitors, diuretics and cardiac glycosides.

4. The method of claim 3, wherein the angiotensin converting enzyme inhibitor is selected from the group consisting of captopril, lisinopril, fosinopril, enalapril and pharmaceutically acceptable salts of captopril, lisinopril, fosinopril and enalapril.

5. The method of claim 3, wherein said diuretic is selected from the group consisting of hydrochlorothiazide, torasemide, furosemide, and pharmaceutically acceptable salts of hydrochlorothiazide, torasemide and furosemide.

6. The method of claim 3, wherein said cardiac glycoside is selected from the group consisting of digoxin, .beta.-methyl-digoxin and digitoxin.

7. A method of decreasing mortality caused by congestive heart failure in a patient, said method comprising administering to said patient first dosages once or twice daily, for a period of from 7 to 28 days, said first dosages each comprising carvedilol in an amount of about 3.125 mg or 6.25 mg,

then administering to said patient second dosages once or twice daily, for a period of from 7 to 28 days, said second dosages each comprising carvedilol in an amount of about 12.5 mg, and

then administering to said patient maintenance third dosages once or twice daily, said third dosages each comprising carvedilol in an amount of about 25.0 mg or about 50.0 mg.

8. A method as recited in claim 7, wherein at least one of said first, second and maintenance dosages further comprises at least one other therapeutic agent selected from the group consisting of an angiotensin converting enzyme inhibitor, a diuretic and a cardiac glycoside.

9. A method of treating to decrease mortality resulting from congestive heart failure in a patient in need of such treatment, said method comprising administering to said patient carvedilol, alone or in combination with at least one other therapeutic agent, in unit dosages once or twice daily, for a period of from 7 to 28 days, said unit dosages each comprising a pharmaceutical formulation comprising carvedilol in an amount of about 3.125 mg or about 6.25 mg.

10. A method of treating congestive heart failure in a patient in need of such treatment, said method comprising:

administering to said patient first dosages at least daily for a period of from 7 to 28 days, said first dosages each comprising carvedilol,

then administering to said patient second dosages at least daily for a period of from 7 to 28 days, said second dosages each comprising carvedilol, and

then administering to said patient third dosages daily for a maintenance period, said third dosages each comprising carvedilol, said third dosages each comprising a daily maintenance dose in the range of from about 10 mg to about 100 mg of carvedilol,

said first dosages each comprising carvedilol in an amount which his 10-30% of said daily maintenance dose,

said second dosages each comprising carvedilol in an amount which is 20-70% of said daily maintenance dose.

11. Method of claim 10, wherein carvedilol is administered to the patient once or twice daily.
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