Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2002-08-02
2004-08-31
Henley, III, Raymond J. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S470000
Reexamination Certificate
active
06784177
ABSTRACT:
FIELD OF THE INVENTION
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 a compound used to treat cardiovascular diseases.
BACKGROUND OF THE INVENTION
Heart failure in black patients has been associated with a poorer prognosis than in white patients. In diseases such as hypertension, blacks exhibit pathophysiologic differences and respond differently to some therapies than whites.
Congestive heart failure (CEF) is a clinical syndrome involving cardiac and peripheral abnormalities that produce morbidity and shortened life span. 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. Recent reports by Ghali et al (
Arch. Intern. Med.
150:769-773 (1990)) and Alexander et al (
JAMA,
274(13):1037-1042 (1995)) have suggested that black patients may have a greater risk than white patients of developing heart failure that consumes medical resources (Whittle et al.,
N. Engl. J. Med.,
329:621-627 (1993)), and the population-based mortality rate for heart failure has been reported to be significantly higher in blacks (Gillum,
Am. Heart J.,
113: 1043-1045 (1987)).
Vasodilator-Heart Failure Trials (V-HeFT) have been conducted, and the trials' designs and results have been published previously (Cohn et al,
N. Engl. J. Med.,
314:1547-1552 (1986); Cohn et al,
N. Engl. J. Med.
325:303-310 (1991)). V-HeFT I was conducted between 1980 and 1985, prior to the introduction of ACE inhibitor therapy. V-HeFT II was conducted from 1985 to 1990. V-HeFT I and V-HeFT II did not consider the race or ethnic origin of the patients that participated in the studies.
Cardiovascular disease may, however, affect white and black patients differently. For example, hypertension, a major etiology of heart failure in black patients, differs pathophysiologically and in treatment response between racial groups (Gillum,
Hypertension,
1:468-475 (1979)). No data at present have examined whether similar differences exist between black patients and white patients with heart failure.
There is a need in the art for new and more effective compositions and methods for treating and preventing mortality associated with heart failure in black patients with hypertension. The present invention is directed to these, as well as other, important ends.
SUMMARY OF THE INVENTION
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.
These and other aspects of the present invention are described in more detail below.
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Carson Peter
Cohn Jay N.
Hale and Dorr LLP
Henley III Raymond J.
Nitro Med, Inc.
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