Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2001-08-23
2004-08-03
Saoud, Christine J. (Department: 1647)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S002600, C530S399000
Reexamination Certificate
active
06770624
ABSTRACT:
BACKGROUND OF THE INVENTION
Heart failure occurs in three to four million individuals annually in the United States, and is a highly important cause of cardiac morbidity and mortality. In about 60% of the patients, the heart failure is secondary to late stage coronary disease, and in most of the remainder it is due to primary myocardial disease in the form of idiopathic dilated cardiomyopathy. Treatment for severe heart failure has improved with the addition of angiotensin converting enzyme (ACE) inhibitors to standard therapy, but despite such treatment the outlook remains poor in symptomatic patients (mortality about 10% per year), and limiting cardiac symptoms often persist. Cardiac transplantation is a definitive therapy for severe heart failure in some individuals, but there is a need for new adjunctive medical therapies to improve functional status and provide a more favorable prognosis. Previous findings in animal models, and a recent study in patients with heart failure, showing favorable effects of growth hormone (GH) suggest that GH treatment may offer such an adjunctive measure. Bunting et al., WO95/28173 disclosed treatment of congestive heart failure by administration of GH. Clark et al., U.S. Pat. No. 5,610,134 disclosed treatment of congestive heart failure by administration of GH and insulin-like growth factor 1 (“IGF1”), with or without an angiotensin II converting enzyme (ACE) inhibitor. However, our studies in animals with heart failure have shown that an ACE inhibitor in high dose may diminish the beneficial effects of GH, including its action to promote a physiologic form of hypertrophy.
SUMMARY OF THE INVENTION
We have now invented a new method for treating heart failure which follows myocardial infarction by administering an angiotensin II (AT
1
) receptor blocker for 8-12 weeks, followed thereafter by administration of a growth hormone for 1-3 weeks.
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Chien Kenneth R.
Ross, Jr. John
Bozicevic Karl
Bozicevic Field & Francis LLP
Saoud Christine J.
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