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Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease

A technology of ETC-1002 and ezetimibe, which can be applied to cardiovascular system diseases, medical preparations containing active ingredients, metabolic diseases, etc., and can solve problems such as negative side effects

Pending Publication Date: 2018-01-02
ESPERION THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, these drugs can also cause negative side effects

Method used

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  • Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
  • Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
  • Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Example 1: ETC-1002 Alone or in Combination with EZE Reduced from Baseline to Week 12 Compared to EZE Monotherapy more LDL-C

[0128] LDL-C reduction was greatest with the combination of ETC-1002 120 mg (43%) or 180 mg (48%) plus EZE (p figure 2 ). After 2 weeks of treatment, LDL-C decreased significantly and stably ( image 3 ). ETC-1002 alone reduced LDL-C by up to 30%, which was significantly greater than that achieved with EZE monotherapy. The greatest mean reduction in LDL-C occurred with ETC-1002 120 mg or 180 mg in combination with EZE, reaching 43% and 48%, respectively. With ETC-1002, EZE, and the combination, LDL-C reductions occurred within 2 weeks of treatment and were maintained throughout the study. LDL-C lowering in statin-intolerant patients appears to be similar to statin-resistant patients. Considering that statin-intolerant patients had a higher baseline risk of cardiovascular disease than statin-resistant patients, 28% vs. 12%, respectively, ...

Embodiment 2

[0129] Example 2: ETC-1002 alone or in combination with EZE reduces more LDL particles than EZE alone count, apolipoprotein B, total cholesterol, and non-HDL-C

[0130] ETC-1002 alone or in combination with EZE reduced significantly more secondary lipid endpoints than EZE alone, including non-HDL-C, total cholesterol, apolipoprotein B, and LDL particle number. ETC-1002 treatment lowered HDL-C (3% to 6% reduction) and raised HDL-C (5% increase) with EZE alone (p<0.0001 to p<0.0001 to p <0.05) (Table 2).

Embodiment 3

[0131] Example 3: Median CRP was reduced by 30% from baseline to Week 12 endpoint with ETC-1002 120 mg, and 40% reduction with ETC-1002 180mg

[0132] The reduction in CRP in the ETC-1002 monotherapy group was significantly greater (p<0.01, both comparisons) than the 10% reduction observed with EZE alone (Table 2).

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Abstract

Disclosed herein are compositions comprising fixed doses of ETC-1002 and Ezetimibe. Also disclosed herein are methods for using fixed doses of ETC-1002 and Ezetimibe. Uses include methods of treatingcardiovascular disease or reducing the risk of cardiovascular disease in a subject. Uses also include methods of treating hypercholesterolemia in a subject.

Description

technical field [0001] The present application relates to methods and compositions useful for treating or reducing the risk of cardiovascular conditions. Statins are the cornerstone of cardiovascular disease prevention and treatment, but statin-related muscle symptoms may occur in 5% to 29% of patients. Muscle symptoms include pain, stiffness, cramps, or weakness, usually without elevated serum creatine kinase (CK), and muscle symptoms are the main manifestations of statin intolerance. The present application relates to a method for treating cardiovascular disease or reducing the risk of cardiovascular disease and a composition comprising fixed doses of ETC-1002 and Ezetimibe for treating cardiovascular disease or reducing the risk of cardiovascular disease . Background technique [0002] Low-density lipoprotein cholesterol (LDL-C) is an established risk factor for cardiovascular disease. However, many patients, such as those with hypercholesterolemia, cannot lower LDL-C ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/194A61K31/397
CPCA61K31/397A61K31/20A61P9/10A61P3/06A61P9/00A61K2300/00A61K31/194A61P43/00
Inventor 罗格·斯科菲尔德·牛顿诺厄·拉班·罗森贝格黛安娜·伊莱恩·麦克杜格尔
Owner ESPERION THERAPEUTICS INC
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