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Combination therapy, composition and methods for the treatment of cardiovascular disorders

A technology of composition and mixture, which is applied in combination therapy for the treatment of cardiovascular diseases, in the field of treating these diseases, and can solve problems such as increasing blood sugar

Inactive Publication Date: 2010-03-24
SYNDROMEX LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the combined statin / fibrate treatment modality runs the risk of synergistic rhabdomyolysis, a hallmark side effect of both statins and fibrates [Hodel, Toxicol. Lett. 128:159-168( 2002); Bottorff, Am. J. Cardiol. 97: 27C-31C (2006)]
Similarly, niacin is contraindicated in dyslipidemic insulin-resistant patients due to its glycemic-increasing potency and therefore does not provide an appropriate statin combination therapy modality for dyslipidemic insulin-resistant / diabetic CVD patients

Method used

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  • Combination therapy, composition and methods for the treatment of cardiovascular disorders
  • Combination therapy, composition and methods for the treatment of cardiovascular disorders
  • Combination therapy, composition and methods for the treatment of cardiovascular disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0255] M16ββ reduces triglycerides, increases HDL-C and sensitizes insulin in humans

[0256] Evaluation of clinical and laboratory safety parameters

[0257] Fifteen healthy male volunteers aged 25-52 were treated with different doses of M16ββ for a period ranging from 1 week to 4 weeks. In all subjects, no changes in any clinical (weight, blood pressure, pulse, ECG) and laboratory (hematology, blood chemistry, urinalysis) safety parameters related to the drug were detected, where the parameters were in the treatment They were checked during the course and one month after the treatment.

[0258] The hypolipidemic effect of M16ββ

[0259] Eight non-diabetic patients with dyslipidemia were treated with a placebo maintenance period of 4-5 weeks, followed by a 3-5 month cycle of treatment p.o. with gradually increasing M16ββ doses ranging from 200mg / day to 800mg / day. MEDICA treatment resulted in a significant (mean 55%) decrease in plasma triglycerides, a 13% increase in HDL-C, and a d...

Embodiment 2

[0264] The hypolipidemic effect of Medica 16αα, Medica 16ββ, statins and their combinations in a guinea pig model

[0265] The lipid-lowering activity of the hypolipidemic peroxisome proliferator (HPP) in rats and mice is mediated through the activation of liver PPARα [Hertz, Biochem. Pharmacol. 61: 1057-62 (2001)] . Unlike rats and mice, human liver does not respond to hPPARα [Hertz Toxicol. Lett. 102-103, 85-90 (1998); Cattley Regul. Toxicol Pharmacol. 27: 47-60 (1988)], and HPP is in Lipid-lowering activity in humans is mediated by suppressing the activity of HNF-4α [Hertz (2001) ibid.]. Therefore, it is problematic to screen for HPP in rats and mice in order to develop human drugs for lowering blood lipids. Unlike rats and mice, and similar to humans, guinea pigs do not respond to liver PPARα [Choudhung, Mat. Res. 448:201-12 (2000)]. In contrast to the partial non-response of hamsters to liver PPARα, the non-response of guinea pigs to liver PPARα is clear. In addition, th...

Embodiment 3

[0278] Effects of MEDICA combined with statins on patients with metabolic syndrome with dyslipidemia

[0279] In order to evaluate the lipid-lowering effects of individual M16ββ and M16ββ / statin combinations at different doses, one hundred obese, dyslipidemia, non-diabetic men and one hundred postmenopausal women aged 30-70 years were divided Twenty experimental groups (10 subjects in each group). The criteria for inclusion and exclusion are detailed below (Table 7). Different experimental groups were treated with different concentrations of M16ββ (0, 50, 100, 200 or 400 mg of M16ββ) with statins or without statins. The control group received a placebo. The experimental groups are listed in Table 6. All groups were treated orally with M16ββ or statin / M16ββ combination for 12 weeks, and fasting plasma triglycerides and cholesterol (total, LDL-C, HDL-C, VLDL-C) were measured once every two weeks throughout the study.

[0280] The further metabolic effects of the M16ββ and M16ββ / s...

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Abstract

The present invention relates to a combination therapy for the treatment of cardiovascular disorders. More particularly, the invention relates to compositions combining long-chain optionally substituted amphipatic carboxylates (known as MEDICA drugs) and particularly, M16alphaalpha, M16beltabelta and M18gammagamma, with HMG-CoA reductase inhibitors (known as statins). The compositions of the invention may particularly be used for the treatment of cardiovascular disorders, for elevating HDL-cholesterol levels, decreasing non-HDL-cholesterol and particularly triglycerides, and decreasing insulinresistance in a subject suffering from Metabolic Syndrom or cardiovascular disorders. The invention further provides methods of treatment of such disorders using these combined compositions.

Description

Invention field [0001] The present invention relates to a combination therapy for the treatment of cardiovascular disorders. More particularly, the present invention relates to the combination of an amphiphilic carboxylate whose long chain is optionally substituted with an HMG-CoA reductase inhibitor (3-hydroxy-3-methylglutaryl-CoA reductase inhibitor, known as As statin (statin)) combined together. The composition of the present invention can be used particularly for the treatment of cardiovascular disorders. The invention also provides methods of using these combined compositions to treat these disorders. Background of the invention [0002] Throughout this application, various publications, including U.S. patents, use author and year citations, and patent use numbers. The publications of these publications, patents and patent applications are incorporated into this application by reference in their entirety to more fully describe the technical state related to the present i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/20A61K31/22A61K31/366A61K31/40A61K31/405A61K31/44A61K31/47A61K31/505A61P3/00A61P3/06A61P3/10A61P9/00A61P9/10A61P9/12
CPCA61K31/47A61K31/366A61K31/20A61K31/505A61K31/405A61K31/22A61K31/44A61K45/06A61K31/40A61P1/00A61P19/02A61P25/28A61P27/00A61P29/00A61P3/00A61P3/10A61P35/00A61P3/04A61P3/06A61P37/00A61P37/02A61P7/02A61P7/04A61P9/00A61P9/10A61P9/12A61K2300/00
Inventor 雅各布·巴尔-塔纳
Owner SYNDROMEX LTD