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Method for treating hyperlipidemiaRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Heterocyclic Carbon Compounds Containing A Hetero Ring Having Chalcogen (i.e., O,s,se Or Te) Or Nitrogen As The Only Ring Hetero Atoms Doai, Hetero Ring Is Six-membered Consisting Of One Nitrogen And Five Carbon Atoms, Polycyclo Ring System Having The Six-membered Hetero Ring As One Of The Cyclos, Bicyclo Ring System Having The Six-membered Hetero Ring As One Of The Cyclos, Quinolines (including Hydrogenated)Method for treating hyperlipidemia description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060046996, Method for treating hyperlipidemia. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] The present invention relates to a method for treating hyperlipidemia, which exhibits an excellent blood cholesterol-lowering action. BACKGROUND ART [0002] Hyperlipidemia is a symptom characterized by the abnormal elevation of lipoprotein levels in blood, particularly cholesterol levels in blood. Hyperlipidemia is known to be closely linked to diseases such as arteriosclerosis and myocardial infarction and its treatment is considered extremely important. [0003] There are a variety of drugs available for the treatment hyperlipidemia or hypercholesterolemia. At present, HMG-CoA reductase inhibitors such as lovastatin, simvastatin, pravastatin, fluvastatin, atorvastatin, rosuvastatin and pitavastatin are most commonly used for its treatment. Of these, pitavastatin ((3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy- -6-heptenoic acid) is known to exhibit a potent HMG-CoA reductase inhibitory action and therefore be useful as an antihyperlipidemic agent (Japanese Patent No. 2569746, U.S. Pat. No. 5,102,888, EP No. 304063). [0004] The blood cholesterol level of patients with hyperlipidemia is lowered by the administration of an HMG-CoA reductase inhibitor. Many patients suffering from hyperlipidemia have a higher blood cholesterol level and their blood cholesterol level is not always possible to fully be lowered by the administration of an HMG-CoA reductase inhibitor. In such a case, treatment with an increased dose of an HMG-CoA reductase inhibitor is not advisable from the viewpoint of safety. [0005] On the other hand, ezetimibe ((3R,4S)-1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4- -(4-hydroxyphenyl)-2-azetidinone) is known as an antihyperlipidemic agent which inhibits absorption of diet-induced and bile-acid-induced cholesterol in the intestinal tract, thus lowering the blood cholesterol level by a mechanism different from that of the HMG-CoA reductase inhibitor (WO95/08532). [0006] The concomitant use of an HMG-CoA reductase inhibitor and ezetimibe was disclosed to be effective for lowering the blood cholesterol level and treatment of atherosclerosis (WO95/08532). The blood cholesterol level lowering action by the coadministration of an HMG-CoA reductase inhibitor and ezetimibe was also reported (Metab. Clin. Exp., 50(10), 1234-1241 (2001)). [0007] The effect brought about by the concomitant use of pitavastatin and ezetimibe on the treatment of hyperlipidemia remains to be seen, however. DISCLOSURE OF THE INVENTION [0008] An object of the present invention is to provide a method for treating hyperlipidemia and hypercholesterolemia, which has an excellent blood cholesterol lowering action. [0009] With the foregoing in view, the present inventors have carried out an extensive investigation, and found that the concomitant use of pitavastatin and ezetimibe brings about a remarkably excellent blood cholesterol level lowering action, so it is very useful for the treatment of hyperlipidemia and hypercholesterolemia. Thus the present invention has been accomplished. [0010] In one aspect of the present invention, there is thus provided a method for treating hyperlipidemia, which comprises administering effective doses of ezetimibe and pitavastatin or a salt or lactone derivative thereof. [0011] In another aspect of the present invention, there is also provided a method for treating hypercholesterolemia, which comprises administering effective doses of ezetimibe and pitavastatin or a salt or lactone derivative thereof. [0012] The methods for treating hyperlipidemia and hypercholesterolemia according to the present invention are effective for the treatment of hyperlipidemia and hypercholesterolemia in that these exhibit excellent action in lowering blood cholesterol level. BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 is a graph showing the blood cholesterol level lowering action brought about by the concomitant use of a calcium salt of pitavastatin and ezetimibe; and [0014] FIG. 2 is a graph showing the blood cholesterol level lowering action brought about by the concomitant use of a calcium salt of atorvastatin and ezetimibe. BEST MODE FOR CARRYING OUT THE INVENTION [0015] Pitavastatin, or salt or lactone derivative thereof (which may hereinafter be called "pitavastatin derivative") to be used in the invention has cholesterol synthesis inhibitory activity based on HMG-CoA reductase inhibition and is known as an antihyperlipidemic agent. Of the pitavastatin derivatives, salts of pitavastatin are preferred, with calcium salt and sodium salt being especially preferred. [0016] Ezetimibe to be used in the invention is known as a medicament exhibiting its effects by inhibiting the cholesterol absorption in the intestine. [0017] According to the present invention, treatment is performed by the coadministration of a pitavastatin derivative and ezetimibe. In the evaluation system using guinea pigs, as will be described later in Examples, the blood cholesterol level is lowered significantly by the concomitant use of the pitavastatin derivative and ezetimibe compared with the single administration of each of them. [0018] In the treatment method of the invention, the dosage form of the pitavastatin derivative and ezetimibe can be selected arbitrarily depending on the purpose of the treatment. Any one of powders, granules, dry syrups, tablets, capsules and injections can be used. Such a dosage form can be prepared by incorporating a pharmaceutically acceptable carrier in the pitavastatin derivative and ezetimibe and adopting a formulation method well known and commonly used in the art. [0019] An orally administrable solid preparation can be obtained by adding an excipient and optionally, a binder, a disintegrant, a lubricant, a coloring agent, a taste corrigent, a smell corrigent and the like, and processing the resulting mixture into tablets, granules, powders or capsules in a conventional manner. As such an additive, those ordinarily accepted in this field can be used. Examples of the excipient include lactose, sodium chloride, glucose, starch, microcrystalline cellulose, and silicic acid; examples of the binder include water, ethanol, propanol, simple syrup, liquefied gelatin, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, shellac, calcium phosphate, and polyvinylpyrrolidone; examples of the disintegrant include agar powder, sodium hydrogencarbonate, sodium lauryl sulfate, and stearic monoglyceride; examples of the lubricant include purified talc, stearate salt, borax, and polyethylene glycol; examples of the coloring agent include .beta.-carotene, yellow iron sesquioxide, and caramel; and examples of the taste corrigent include sucrose and orange peel. Continue reading about Method for treating hyperlipidemia... 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