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Kits of hydralazine compounds and isosorbide dinitrate and/or isosorbide mononitrate

a technology of hydralazine compounds and isosorbide mononitrate, which is applied in the direction of biocide, drug composition, cardiovascular disorder, etc., can solve the problems of escalating heath care costs, poor prognosis of heart failure in black patients, and no data at present have examined whether similar differences exist. , to achieve the effect of improving oxygen consumption, preventing mortality, and improving quality of li

Inactive Publication Date: 2008-09-18
NITROMED
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]The present invention provides methods for treating and preventing mortality associated with heart failure, improving oxygen consumption, quality of life and / or exercise tolerance in non-Caucasian patients, preferably black patients, with hypertension by administering a therapeutically effective amount of at least one hydralazine compound or a pharmaceutically acceptable salt thereof, and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, and / or a compound used to treat cardiovascular diseases. The hydralazine compound is preferably hydralazine, or a pharmaceutically acceptable salt thereof, such as hydralazine hydrochloride. The hydralazine compound and the isosorbide dinitrate or isosorbide mononitrate can be administered separately or as components of the same composition.

Problems solved by technology

Heart failure in black patients has been associated with a poorer prognosis than in white patients.
This syndrome is now the leading cause of hospitalization in individuals older than age 65 and is a major contributor to the escalation of heath care costs.
No data at present have examined whether similar differences exist between black patients and white patients with heart failure.

Method used

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  • Kits of hydralazine compounds and isosorbide dinitrate and/or isosorbide mononitrate
  • Kits of hydralazine compounds and isosorbide dinitrate and/or isosorbide mononitrate
  • Kits of hydralazine compounds and isosorbide dinitrate and/or isosorbide mononitrate

Examples

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Statistical Methods

[0068]Baseline measurements were restricted to the test done at the time of randomization. Change in measurements from baseline were compared between black and white patients using t-tests performed for each scheduled follow-up. Kaplan-Meier cumulative mortality curves were plotted to the end of follow-up to describe the trends in mortality over time for black and white patients. Survival curves were compared by the log-rank test. Survival in black and white patients was further analyzed by presence or absence of a history of hypertension.

[0069]In the present invention, an interaction analysis between race and treatment was performed for both V-HeFT I and II, adjusting for baseline imbalances.

[0070]Male patients were screened for participation in the study on the basis of a history of heart failure or documentation of left ventricular enlargement or dysfunction by chest radiography, echocardiography or radionuclide ventriculography. The specific ventricular imagin...

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Abstract

The present invention provides methods of treating and preventing mortality associated with heart failure in an African American patient with hypertension and improving oxygen consumption, quality of life and exercise tolerance by administering a therapeutically effective amount of at least one hydralazine compound and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, or a compound used to treat cardiovascular diseases. In the present invention, the hydralazine compound is preferably hydralazine or a pharmaceutically acceptable salt thereof. Preferred methods of the invention comprise administering hydralazine or a pharmaceutically acceptable salt thereof and isosorbide dinitrate.

Description

RELATED APPLICATIONS[0001]This application is continuation under 35 USC § 120 of U.S. application Ser. No. 10 / 210,113, filed Aug. 2, 2002, allowed, which is a continuation under 35 USC § 120 of U.S. application Ser. No. 09 / 658,261 filed Sep. 8, 2000, issued as U.S. Pat. No. 6,465,463, which claims priority under 35 USC § 119 to U.S. Application No. 60 / 171,102 filed Dec. 16, 1999, and to U.S. Application No. 60 / 152,616 filed Sep. 8, 1999.FIELD OF THE INVENTION[0002]The present invention provides methods of treating and preventing mortality associated with heart failure, improving oxygen consumption, quality of life and / or exercise tolerance in a black patient, with hypertension by administration of a therapeutically effective amount of at least one hydralazine compound or a pharmaceutically acceptable salt thereof, and at least one of isosorbide dinitrate and isosorbide mononitrate, and, optionally, one or more compounds, such as, for example, a digitalis, a diuretic compound, and / or...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K33/00A61K31/502A61K31/55A61K31/351A61K31/403A61K31/4422A61K31/4178A61K31/506A61K31/40A61K31/34A61K31/50A61P9/10
CPCA61K31/34A61K31/50A61K31/502A61K2300/00A61P9/00A61P9/04A61P9/10
Inventor COHN, JAY N.CARSON, PETER
Owner NITROMED
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