Treatment of vascular events using lipid-modifying compositions

Details Treatment of vascular events using lipid-modifying compositions Treatment of vascular events using lipid-modifying compositions

1998-11-10

2001-07-24

Kishore, Gollamudi S. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

C424S422000, C424S434000, C424S436000, C514S568000, C514S506000, C514S510000, C514S569000, C514S570000, C514S824000

Reexamination Certificate

active

06264960

ABSTRACT:

BACKGROUND OF THE INVENTION
Vascular disorders, including heart disease and stroke, persist as a leading cause of death in certain age and ethnic groups. A need exists, therefore, for improved treatments for patients at risk for vascular disorders. In particular, a need exists to reduce the occurrence and/or severity of vascular disorders.
SUMMARY OF THE INVENTION
The invention pertains to methods for treating a patient who is at risk for a vascular event (e.g., cardiovascular or cerebrovascular event) comprising administering to the patient an effective amount of a lipid or cholesterol modifying drug. In particular, the patient is one having a lipid profile with a low High Density Lipoprotein-Cholesterol (HDL-C) and a low Low Density Lipoprotein-Cholesterol (LDL-C). A low HDL-C is less than about 40 mg/dL, and a low LDL-C is less than about 130 mg/dL.
The lipid/cholesterol modifying drug comprises a fibric acid or derivative thereof. Examples of fibric acid or derivatives thereof include gemfibrozil, fenofibrate, bezafibrate, ciprofibrate, clofibrate, clinofibrate, niacin and/or combinations thereof.
The claimed method implicates the treatment of various vascular events that can be characterized by a clot in the vessel (e.g., artery, vein) or narrowing of the vessel. A clot which forms in a vessel can partially or fully block blood flow. Examples of such diseases are a thrombotic disorder, myocardial infarction, angina, stroke, pulmonary embolism, transient ischemic attack, deep vein thrombosis, thrombotic re-occlusion subsequent to a coronary intervention procedure and a disorder in which at least one major coronary artery exhibits greater than 50% stenosis. The treatment reduces the occurrence and/or severity of these vascular events.
The claimed methods result in at least a 10% (e.g., 15% or 20%) reduction of the patient's triglyceride level, and/or at least a 5% (e.g., 7% or 10%) increase in the level of HDL-C.
The claimed invention also embodies methods for preventing a cardiovascular and/or cerebrovascular event in an individual who has a lipid profile comprising a low HDL-C level and a low LDL-C level, comprising administering an effective amount of fibric acid or derivative thereof in a carrier (e.g., a pharmaceutically acceptable carrier). The individual can also be at risk for a cardiovascular and/or cerebrovascular event.
Advantages of the claimed invention include the ability to treat cardiovascular and/or cerebrovascular events with lipid modifying drugs/compositions, especially in patients who already have a low HDL-C and low LDL-C lipid profile. The claimed methods provide an effective way to treat, prevent, and/or reduce the reoccurrence or severity of these cardiovascular and/or cerebrovascular events.


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