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(12) Patent Application Publication (10) Pub. No.: US 2005/0182036A1 Kondo Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2005/0182036A1 Kondo Et Al US 2005O182036A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0182036A1 Kondo et al. (43) Pub. Date: Aug. 18, 2005 (54) MEDICINAL COMPOSITION CONTAINING (30) Foreign Application Priority Data AN HMG-COA REDUCTASE INHIBITOR Aug. 2, 2002 (JP)...................................... 2002-225,979 (75) Inventors: Tatsuhito Kondo, Tokyo (JP); Ikuo Sep. 6, 2002 (JP)...................................... 2002-26O719 Takagi, Matsudo-shi (JP); Masato Nakayama, Kitakatsushika-gun (JP); Publication Classification Yasuhiro Torizumi, Ryugasaki-shi (JP) (51) Int. Cl." ......................... A61K 31156; A61K 31/51; Correspondence Address: A61K 31/401; A61K 31/366; FRISHAUF, HOLTZ, GOODMAN & CHICK, A61K 31/225 PC (52) U.S. Cl. ......................... 514/171; 514/423: 514/460; 220 5TH AVE FIL 16 514/548; 514/276 NEW YORK, NY 10001-7708 (US) (73) Assignee: SANKYO COMPANY, LIMITED, (57) ABSTRACT Tokyo (JP) A pharmaceutical composition for promoting the Synthesis of vascular endothelial nitrogen oxide and/or maintaining or (21) Appl. No.: 11/045,400 elevating the concentration of vascular endothelial nitrogen oxide in the blood, or a pharmaceutical composition for (22) Filed: Jan. 27, 2005 improving blood lipids. The pharmaceutical composition Related U.S. Application Data contains an HMG-CoA reductase inhibitor; and gamma ory Zanol, and/or thiamines. For treatment, the components (63) Continuation-in-part of application No. PCT/JP03/ of the composition can be administered together, as a 09835, filed on Aug. 1, 2003. composition, or Separately. US 2005/0182036A1 Aug. 18, 2005 MEDICINAL COMPOSITION CONTAINING AN 0009 Moreover, nitric oxide synthase (NOS) is localized HMG-COA REDUCTASE INHIBITOR not only in the vascular vessels but also in many tissues other than blood vessels, and plays important roles in the 0001. This is a Continuation-in-Part Application of Inter regulation of the cardiovascular System. There are many national Application No. PCT/JP2003/009835 filed Aug. 1, diseases in which NO production is lowered and as such 2003, incorporated by reference herein in its entirety. diseases the following diseases are well known: cardiovas cular diseaseS Such as hypertension, hypercholesterolemia, BACKGROUND OF THE INVENTION atherOSclerosis, ischemic heart disease, cardiac failure, 0002 The present invention relates to a medicinal com thrombosis, and the like; respiratory diseaseS Such as position comprising an HMG-CoA reductase inhibitor and asthma, chronic obstructive pulmonary disease, pulmonary Y-ory Zanol and/or thiamine derivatives, (particularly a hypertension, ARDS (Adult respiratory distress Syndrome), medicinal composition for promoting the production of and the like; diseases of digestive organs Such as hepatopa vascular endothelial nitric oxide and/or maintaining or thy, cirrhosis, gastrointestinal mucous disorders, hyper elevating the concentration of vascular endothelial nitrogen trophic pyloric Stenosis, pancreatitis, and the like; cere oxide in the blood, or a medicinal composition for mitigating brovascular disorderS Such as cerebral ischemia, cerebral blood lipid). infarction, cerebral circulation disorders, Senile dementia, and the like; disorders of the kidney and urinary tract Such 0003. Since old times it has been said that a man is as old as renal dysfunction, impotency, and the like; disorders of as his arteries. Recently, it has been noticed that there is a obstetrics & gynaecology Such as gestational toxicosis, and Significant relationship between decreases in vascular endot the like; infectious and immune diseases, diabetes mellitus, helial nitric oxide (NO) production due to aging and various burn injury, and the like. AS other factors, it has also been diseases frequently observed in elderly individuals. This known that NO production is lowered by certain drugs (see Suggests that vascular aging may be related to decreases of for example, Japanese Patent Publication (Kokai) Number endothelial nitric oxide synthase (eNOS) activity. Hei 10-338637). 0004. It has been reported that functional impairment of 0010 Statins are remedies that reduce blood cholesterol the vascular endothelium is Strongly related to pathogenesis levels by inhibiting specifically and competitively HMG and progression of atherosclerosis, which is largely caused CoA reductase in Vivo. In addition to these effects, Statins by decreases in NO production generated by eNOS. Nitric have also been known to promote eNOS activity. However, oxide derived from the vascular wall exhibits Several anti gamma-ory Zanol and thiamines have not been reported as atherosclerotic effects resulting from concomitant vasodila having promoting effects on eNOS activity. Furthermore, tation, inhibition of various factorS Such as platelet coagul there are no data on Synergistic effects of a combination lation, adhesion of blood neutrophils to endothelial cells, treatment using a Statin and a thiamine derivative on the migration and proliferation of vascular Smooth muscle cells, production and/or on maintaining or increasing blood con as well as Suppression of oxidation of LDL, and the like (see centration of vascular endothelial nitric oxide. for example, The Journal of Japanese College of Angiology, 0011 Moreover, it is not known whether a combination Vol. 38 No. 4, 1998 p.215-216). of a Statin and gamma-ory Zanol and/or a thiamine derivative 0005 Since atherosclerosis has been demonstrated to be lowers blood lipids Synergistically. exacerbated by blocking NO Synthesis in animal experi ments, Some direct contribution from NO production seems BRIEF SUMMARY OF THE INVENTION likely in the pathogenesis as well as progression of athero 0012. In light of this background, the present inventors Sclerosis (see for example, Vascular Biology & Medicine, have eagerly Studied pharmacological actions of a combi Vol. 12, No. 2, 2001, p. 189). nation of an HMG-CoA reductase inhibitor and gamma 0006 Since NO produced in endothelial cells exerts ory Zanol and/or a thiamine derivative and found that the various vascular protective actions in humans, these effects production of vascular endothelial nitric oxide was pro may be exploited in therapeutic Strategies designed to main moted and the blood concentration of vascular endothelial tain and/or improve vascular endothelial function. Examples nitric oxide was highly maintained or increased, and blood of known agents that promote eNOS activity include Statins, lipids were mitigated, and completed the present invention. L-arginine, ACE inhibitors, angiotensin II type 1 receptor antagonists, hormones, and Some calcium antagonists. In 0013 The present invention relates to addition, antioxidants Such as Vitamin C, Vitamin E, probu 0014 (1) a medicinal composition comprising an col, and the like have been reported to be beneficial because HMG-CoA reductase inhibitor and gamma-ory Zanol they indirectly promote NO action by preventing inactiva and/or a thiamine derivative as active ingredients. tion of NO (see for example, Japanese pharmacology & 0015. Of the said description, the medicinal compositions Therapeutics, Vol. 29, No. 10, 2001, p. 716). of the present invention include 0007 Furthermore, it has been shown that vitamin C 0016 (2) a medicinal composition according to (1), increases eNOS activity (see for example, Vitamin Vol. 75, comprising one or more HMG-CoA reductase inhibi No.2, 2001, p. 511). torS Selected from the group consisting of pravastatin, 0008. In addition, ginseng, Astragalus root, and Scutel lovastatin, Simvastatin, fluvastatin, rivastatin, atorvas lariae radix of galenical composition in Chinese herbal tatin, pitavastatin, and rosuvastatin as active ingredi medicine have been found to stimulate NO production in entS, blood vessels (see for example, Journal of Traditional Medi 0017 (3) a medicinal composition according to (1), cines, Vol. 11, 1994, p. 102). comprising one or more HMG-CoA reductase inhibi US 2005/0182036A1 Aug. 18, 2005 torS Selected from the group consisting of Simvastatin 0031 (16) a combination therapy of an HMG-CoA and atorvastatin as active ingredients, reductase inhibitor and gamma-ory Zanol and/or a thia 0018 (4) a medicinal composition according to any mine derivative to mitigate blood lipids by administra one Selected from (1) to (3) described above, compris tion of an HMG-CoA reductase inhibitor and gamma ing one or more thiamine derivatives Selected from the ory Zanol and/or a thiamine derivative simultaneously group consisting of thiamine, dicethiamine, octo or separately at certain time intervals, tiamine, cycotiamine, bisibuthiamine, bisbenthiamine, 0032 (17) a combination therapy of an HMG-CoA furSultiamine, proSultiamine, benfotiamine, and phar reductase inhibitor and gamma-ory Zanol and/or a thia macologically acceptable Salts thereof, mine derivative to promote the production of vascular 0019 (5) a medicinal composition according to any endothelial nitric oxide and/or to maintain or increase one selected from (1) to (3) described above, in which blood vascular nitric oxide concentration, the thiamine derivative is benfotiamine, 0033 (18) a combination therapy of an HMG-CoA 0020 (6) a medicinal composition according to any reductase inhibitor and gamma-ory Zanol and/or a thia one Selected from (1) to (5) for promoting the produc mine derivative to mitigate blood lipid levels. tion of vascular endothelial nitric oxide and/or main 0034) Furthermore, the present invention provides taining or increasing blood concentration of vascular endothelial nitric
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