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Pharmaceutical composition for prevention or treatment of cardiovascular diseases accompanied by diabetes, including amlodipine, losartan, and rosuvastatin, and composite preparation including the same

A technology of rosuvastatin and amlodipine, which is applied in the fields of cardiovascular system diseases, drug combinations, medical preparations containing active ingredients, etc., can solve the problems of undisclosed diabetes patients such as blood pressure and lipid concentration, and enhance the convenience of medication Sexuality and medication adherence, lower mean diastolic blood pressure, excellent blood pressure normalization effect

Inactive Publication Date: 2020-08-07
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Korean Patent Publication No. 10-2007-0068658 discloses a formulation containing amlodipine and simvastatin, but does not disclose a formulation capable of effectively controlling blood pressure and lipid concentration in a diabetic patient group

Method used

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  • Pharmaceutical composition for prevention or treatment of cardiovascular diseases accompanied by diabetes, including amlodipine, losartan, and rosuvastatin, and composite preparation including the same
  • Pharmaceutical composition for prevention or treatment of cardiovascular diseases accompanied by diabetes, including amlodipine, losartan, and rosuvastatin, and composite preparation including the same
  • Pharmaceutical composition for prevention or treatment of cardiovascular diseases accompanied by diabetes, including amlodipine, losartan, and rosuvastatin, and composite preparation including the same

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0131] Example 1: Selection of Trial Subjects and Administration of Clinical Trial Drugs

[0132] 1. Selection of test subjects

[0133] Trial subjects were selected based on the following selection criteria:

[0134] 1) Adults aged 19 to 75

[0135] 2) Patients who meet the following conditions during the first screening

[0136] ①Blood pressure standard: sitDBP≥90 mm Hg

[0137] ②Lipid standard: LDL-C≤250 mg / dl, TG<400 mg / dl

[0138] 3) Patients who meet the following conditions at the second visit after 4 weeks of therapeutic lifestyle change (TLC)

[0139] ① Blood pressure standard: 80 mm Hg ≤ sitDBP < 110 mm Hg

[0140] ②Lipid criteria: Patients who meet the following conditions when classified into Group A, Group B, and Group C according to cardiovascular disease risk

[0141]

[0142] Coronary Heart Disease (CHD) Risk Factors

[0143] 1) Current smoker

[0144] 2) Taking antihypertensive drugs

[0145] 3) Low HDL-C (

[0146] 4) Early family history of ...

experiment example 1

[0209] Experimental Example 1: Measuring mean sitting systolic blood pressure in a diabetic (DM) patient group compared to a non-diabetic patient group (sitSBP) reduction (mmHg)

[0210] For the group (A5+L100+R20) administered with 5 mg of amlodipine, 100 mg of rosuvastatin and 20 mg of rosuvastatin (experimental group) and the group administered with 5 mg of amlodipine and 100 mg of rosuvastatin (A5+L100 ) (control group 1), the change in mean sitSBP relative to baseline (mmHg) of both was measured after 8 weeks. The experimental group and the control group each included a diabetic patient group and a non-diabetic patient group. The results are shown in Table 1 and figure 1 shown.

[0211] [Table 1]

[0212] a): A5+L100+R20(DM) to A5+L100(DM)

[0213]

[0214] b): A5+L100+R20 (DM) to A5+L100 (non-DM)

[0215] c): A5+L100+R20 (non-DM) to A5+L100 (non-DM)

[0216] as table 1 and figure 1 As shown, the (A5+L100+R20) administration group exhibited a larger change i...

experiment example 2

[0219] Experimental Example 2: Measuring the mean sitting diastolic blood pressure of the diabetic group compared to the non-diabetic group (sitDBP) reduction (mmHg)

[0220] The change from baseline in mean sitDBP (mmHg) was measured after 8 weeks in the group (A5+L100+R20) (experimental group) administered 5 mg amlodipine, 100 mg rosuvastatin, and 20 mg rosuvastatin . The experimental group and the control group each include a diabetic patient group and a non-diabetic patient group. The results are shown in Table 2 and figure 2 shown.

[0221] [Table 2]

[0222]

[0223] a): A5+L100+R20(DM) to A5+L100(DM)

[0224] b): A5+L100+R20 (DM) to A5+L100+R20 (non-DM)

[0225] c): A5+L100+R20 (non-DM) to A5+L100 (non-DM)

[0226] as table 2 and figure 2 As shown, the (A5+L100+R20) administration group exhibited an increase in sitDBP change (mm Hg) after 8 weeks compared to the (A5+L100) administration group. From this result it can be seen that when 5 mg amlodipine, 1...

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PUM

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Abstract

Provided herein are a pharmaceutical composition for the prevention or treatment of a cardiovascular disease accompanied by diabetes, and a composite preparation including the pharmaceutical composition. The pharmaceutical composition includes amlodipine or a pharmaceutically acceptable salt thereof, losartan or a pharmaceutically acceptable salt thereof, and rosuvastatin or a pharmaceutically acceptable salt thereof.

Description

technical field [0001] This application claims the rights of Korean Patent Applications No. 10-2017-0134809 and No. 10-2018-0112376 filed at the Korean Intellectual Property Office on October 17, 2017, and September 19, 2018, respectively. The disclosure of the patent application is hereby incorporated by reference in its entirety. [0002] One or more embodiments are related to the prevention or treatment of cardiovascular disease, and more specifically, to a pharmaceutical composition for the prevention or treatment of cardiovascular disease accompanied by diabetes and a composite compound comprising the pharmaceutical composition A preparation, the pharmaceutical composition comprising amlodipine, rocosolvan and rosuvastatin. Background technique [0003] Cardiovascular disease is one of the leading causes of death and is a multifactorial disease caused by the complex interaction of chronic conditions such as hypertension, dyslipidemia, diabetes and various risk factors ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K31/4178A61K31/505A61K9/20A61K9/48
CPCA61K9/1623A61K9/1635A61K9/1652A61K9/2018A61K9/2027A61K9/2054A61K9/2086A61K31/4178A61K31/4422A61K31/505A61K45/06A61P9/00A61K2300/00A61K9/20A61K9/48
Inventor 丁真儿裵惠宁
Owner HANMI PHARMA
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