Statin and omega-3 fatty acids for reduction of apo-b levels

Abstract

Methods of utilizing a combined administration or a unit dosage of a combination of an HMG-CoA inhibitor and omega-3 fatty acids for the reduction of apolipoprotein-B levels. The methods are especially useful in the treatment of patients with hypertriglyceridemia or hypercholesterolemia or mixed dyslipidemia, coronary heart disease (CHD), vascular disease, atherosclerotic disease and related conditions, and for the prevention or reduction of cardiovascular, cardiac, and vascular events.

Description

[0001]The present application is a continuation-in-part of U.S. application Ser. No. 11 / 742,292, filed Apr. 30, 2007, and claims priority to provisional patent application Ser. No. 60 / 850,280, filed Oct. 10, 2006, the disclosures of which are hereby incorporated by reference.FIELD OF THE INVENTION[0002]The present invention relates to a method utilizing a combined administration or a unit dosage of a combination of an HMG-CoA inhibitor and omega-3 fatty acids for the reduction of apolipoprotein-B (Apo-B) levels. This method is especially useful in the treatment of patients with hypertriglyceridemia or hypercholesterolemia or mixed dyslipidemia, coronary heart disease (CHD), vascular disease, atherosclerotic disease and related conditions, and for the prevention or reduction of cardiovascular, cardiac, and vascular events.BACKGROUND OF THE INVENTION[0003]In humans, cholesterol and triglycerides are part of lipoprotein complexes in the bloodstream, and can be separated via ultracentri...

AI Technical Summary

Benefits of technology

[0028]There is an unmet need in the art for methods for the increased reduction of Apo-B levels over monotherapy with an HMG-CoA inhibitor alone. This method is especially useful in the treatment of one or more of the following: hyper...

Problems solved by technology

Some types of cardiovascular disease are congenital, but many are acquired later in life and are attributable to unhealthy habits, such as a sedentary lifestyle and smoking.

Some types of CVD can also lead to further heart problems, such as angina, major adverse cardiovascular events (MACEs) and / or major coronary events (MCEs) such as myocardial infarction (MI) or coronary intervention, or even death (cardiac or cardiovascular), which underscores the importance of efforts to treat and prevent CVD.

While the ATP III was not prepared to replace LDL-C as the primary target of lipid therapy, it noted that limited epidemiological and clinical trial evidence supports Apo-B's superiority over LDL-C in risk prediction.

In many patients with hypertriglyceridemia, hypercholesterolemia and / or mixed dyslipidemia, the use of diet and single-drug therapy does not always decrease LDL-C, triglycerides and / or Apo-B levels adequately enough to reach targeted values.

While most of these studies confirm that statins significantly reduce Apo-B levels, most studies also report a lack of significant further reduction of Apo-B levels with added omega-3 fatty acid treatment.

However, the addition of fish oil to pravastatin monotherapy resulted in only a numerical increase in LDL-C levels, which was not statistically significant.

The Grekas et al. study results seem dubious, given that the study did not show a significant reduction in Apo-B levels with pravastatin therapy alone.

Thus, the fact that the Grekas et al. study did not see significant Apo-B reduction with pravastatin makes the study results subject to doubt.

However, the study only compared combination treatment versus fish oil monotherapy, and did not compare combination treatment versus statin monotherapy.