Substances for reducing occurrence of major cardiac events comprising red yeast rice extract and omega-3 polyunsaturated fatty acid or derivative thereof

Abstract

Medicaments and therapeutic compositions comprise Red Yeast Rice extract and omega-3 polyunsaturated fatty acids and/or derivatives thereof, e.g., DHA, derivatives of DHA, EPA, derivatives of EPA or mixtures thereof. One source of the fatty acids or derivatives thereof is fish oil. The compositions are useful for lowering cholesterol and/or triglyceride levels in a subject.

1 . A therapeutic composition comprising (1) at least one omega-3 polyunsaturated fatty acid, at least one pharmaceutically acceptable omega-3 polyunsaturated fatty acid derivative or mixtures thereof, and (2) Red Yeast Rice extract. 
     
     
         2 . The therapeutic composition of  claim 1  wherein component (1) comprises EPA, derivatives of EPA, DHA, derivatives of DHA or mixtures thereof. 
     
     
         3 . The therapeutic composition of  claim 2  wherein component (1) comprises derivatives of EPA and derivatives of DHA. 
     
     
         4 . The therapeutic composition of  claim 3  wherein the derivatives of EPA and derivatives of DHA are selected from the group consisting of alkyl esters, glycerides and phospholipids. 
     
     
         5 . The therapeutic composition of  claim 4  wherein the derivatives of EPA and derivatives of DHA are glycerides. 
     
     
         6 . The therapeutic composition of  claim 1  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         7 . The therapeutic composition of  claim 1  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4% total monacolins. 
     
     
         8 . The therapeutic composition of  claim 1  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         9 . The therapeutic composition of  claim 1  wherein component (1) is a mixture comprising about 35 wt. % triglycerides of EPA and about 25 wt. % triglycerides of DHA. 
     
     
         10 . The therapeutic composition of  claim 9  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         11 . The therapeutic composition of  claim 9  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4% total monacolins. 
     
     
         12 . The therapeutic composition of  claim 9  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         13 . The therapeutic composition of  claim 1  wherein component (1) is a mixture comprising at least about 60 wt. % of a combination of EPA and DHA in a weight ratio of EPA:DHA of from about 1.4:1 to about 5:1, wherein the combination is at least about 60% in the triglyceride form of the EPA and DHA and the balance is at least about 80% mono- and di-glycerides. 
     
     
         14 . The therapeutic composition of  claim 13  wherein the combination is at least about 80% in the triglyceride form. 
     
     
         15 . The therapeutic composition of  claim 13  wherein the combination is at least about 90% in the triglyceride form. 
     
     
         16 . The therapeutic composition of  claim 13  wherein the combination is at least about 98% in the triglyceride form. 
     
     
         17 . The therapeutic composition of  claim 16  wherein the combination is at least about 98% in the triglyceride form and the remainder is monoglycerides, diglycerides or both. 
     
     
         18 . The therapeutic composition of  claim 13  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         19 . The therapeutic composition of  claim 13  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4% total monacolins. 
     
     
         20 . The therapeutic composition of  claim 13  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         21 . The therapeutic composition of  claim 13  wherein the combination comprises about 65 wt. % triglycerides of EPA and about 15 wt. % triglycerides of DHA. 
     
     
         22 . The therapeutic composition of  claim 21  wherein the combination is at least about 80% in the triglyceride form. 
     
     
         23 . The therapeutic composition of  claim 21  wherein the combination is at least about 90% in the triglyceride form. 
     
     
         24 . The therapeutic composition of  claim 21  wherein the combination is at least about 98% in the triglyceride form. 
     
     
         25 . The therapeutic composition of  claim 24  wherein the combination is at least about 98% in the triglyceride form and the remainder is monoglycerides, diglycerides or both. 
     
     
         26 . The therapeutic composition of  claim 21  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         27 . The therapeutic composition of  claim 21  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4 wt. % total monacolins. 
     
     
         28 . The therapeutic composition of  claim 21  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         29 . The therapeutic composition of  claim 13  wherein the combination comprises about 75 wt. % triglycerides of EPA and about 15 wt. % triglycerides of DHA. 
     
     
         30 . The therapeutic composition of  claim 29  wherein the combination is at least about 80% in the triglyceride form. 
     
     
         31 . The therapeutic composition of  claim 29  wherein the combination is at least about 90% in the triglyceride form. 
     
     
         32 . The therapeutic composition of  claim 29  wherein the combination is at least about 98% in the triglyceride form. 
     
     
         33 . The therapeutic composition of  claim 32  wherein the combination is at least about 98% in the triglyceride form and the remainder is monoglycerides, diglycerides or both. 
     
     
         34 . The therapeutic composition of  claim 29  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         35 . The therapeutic composition of  claim 29  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4 wt. % total monacolins. 
     
     
         36 . The therapeutic composition of  claim 29  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         37 . The therapeutic composition of  claim 1  wherein the weight ratio of component (1) to Red Yeast Rice extract is in the range between about 1.4:1 to 2.8:1. 
     
     
         38 . The therapeutic composition of  claim 1  further comprising a dispersing agent. 
     
     
         39 . The therapeutic composition of  claim 38  wherein the dispersant comprises lysine and bamboo. 
     
     
         40 . The therapeutic composition of  claim 1  further comprising a soft gelatin capsule into which component (1), Red Yeast Rice extract and dispersing agent are loaded. 
     
     
         41 . The therapeutic composition of  claim 40  wherein a daily dose of the therapeutic composition is delivered by an integral number of capsules. 
     
     
         42 . The therapeutic composition of  claim 1  wherein a daily dose of the therapeutic composition comprises about 1000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 1200 mg of Red Yeast Rice extract. 
     
     
         43 . The therapeutic composition of  claim 1  wherein a daily dose of the therapeutic composition comprises about 2000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 1200 mg of Red Yeast Rice extract. 
     
     
         44 . The therapeutic composition of  claim 1  wherein a daily dose of the therapeutic composition comprises about 2000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 2400 mg of Red Yeast Rice extract. 
     
     
         45 . The therapeutic composition of  claim 1  wherein a daily dose of the therapeutic composition comprises about 4000 mg of EPA plus DHA and/or derivatives of DHA and 2400 mg of Red Yeast Rice extract. 
     
     
         46 . The therapeutic composition of  claim 1  further comprising an antioxidant. 
     
     
         47 . The therapeutic composition of  claim 46  wherein the antioxidant is chosen from the group consisting of rosemary, vitamin E, astaxanthine, carnitine, ascorbyl palmitate, and tocopherols. 
     
     
         48 . A method of reducing serum cholesterol, triglycerides or both in a subject comprising administering to the subject a dosage comprising (1) at least one omega-3 polyunsaturated fatty acid, at least one pharmaceutically acceptable omega-3 polyunsaturated fatty acid derivative or mixtures thereof, and (2) Red Yeast Rice extract. 
     
     
         49 . The method of  claim 48  wherein component (1) comprises EPA, derivatives of EPA, DHA, derivatives of DHA or mixtures thereof. 
     
     
         50 . The method of  claim 49  wherein component (1) comprises derivatives of EPA and derivatives of DHA. 
     
     
         51 . The method of  claim 50  wherein the derivatives of EPA and derivatives of DHA are selected from the group consisting of alkyl esters, glycerides and phospholipids. 
     
     
         52 . The method of  claim 51  wherein the derivatives of EPA and derivatives of DHA are glycerides. 
     
     
         53 . The method of  claim 48  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         54 . The method of  claim 48  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4% total monacolins. 
     
     
         55 . The method of  claim 48  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         56 . The method of  claim 48  wherein component (1) is a mixture comprising about 35 wt. % triglycerides of EPA and about 25 wt. % triglycerides of DHA. 
     
     
         57 . The method of  claim 56  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         58 . The method of  claim 56  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4% total monacolins. 
     
     
         59 . The method of  claim 56  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         60 . The method of  claim 48  wherein component (1) is a mixture comprising at least about 60 wt. % of a combination of EPA and DHA in a weight ratio of EPA:DHA of from about 1.4:1 to about 5:1, wherein the combination is at least about 60% in the triglyceride form of the fatty acids and the balance is at least about 80% mono- and di-glycerides. 
     
     
         61 . The method of  claim 60  wherein the combination is at least about 80% in the triglyceride form. 
     
     
         62 . The method of  claim 60  wherein the combination is at least about 90% in the triglyceride form. 
     
     
         63 . The method of  claim 60  wherein the combination is at least about 98% in the triglyceride form. 
     
     
         64 . The method of  claim 63  wherein the combination is at least about 98% in the triglyceride form and the remainder is monoglycerides, diglycerides or both. 
     
     
         65 . The method of  claim 60  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         66 . The method of  claim 60  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4% total monacolins. 
     
     
         67 . The method of  claim 60  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         68 . The method of  claim 60  wherein the combination comprises about 65 wt. % triglycerides of EPA and about 15 wt. % triglycerides of DHA. 
     
     
         69 . The method of  claim 68  wherein the combination is at least about 80% in the triglyceride form. 
     
     
         70 . The method of  claim 68  wherein the combination is at least about 90% in the triglyceride form. 
     
     
         71 . The method of  claim 68  wherein the combination is at least about 98% in the triglyceride form. 
     
     
         72 . The method of  claim 71  wherein the combination is at least about 98% in the triglyceride form and the remainder is monoglycerides, diglycerides or both. 
     
     
         73 . The method of  claim 68  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         74 . The method of  claim 68  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4 wt. % total monacolins. 
     
     
         75 . The method of  claim 68  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         76 . The method of  claim 60  wherein the combination comprises about 75 wt. % triglycerides of EPA and about 15 wt. % triglycerides of DHA. 
     
     
         77 . The method of  claim 76  wherein the combination is at least about 80% in the triglyceride form. 
     
     
         78 . The method of  claim 76  wherein the combination is at least about 90% in the triglyceride form. 
     
     
         79 . The method of  claim 76  wherein the combination is at least about 98% in the triglyceride form. 
     
     
         80 . The method of  claim 79  wherein the combination is at least about 98% in the triglyceride form and the remainder is monoglycerides, diglycerides or both. 
     
     
         81 . The method of  claim 76  wherein said Red Yeast Rice extract comprises at least about 0.1 wt. % monacolin K. 
     
     
         82 . The method of  claim 76  wherein said Red Yeast Rice extract comprises at least about 0.2 wt. % monacolin K and at least about 0.4 wt. % total monacolins. 
     
     
         83 . The method of  claim 76  wherein said Red Yeast Rice extract comprises at least about 0.4 wt. % monacolin K. 
     
     
         84 . The method of  claim 48  wherein the weight ratio of component (1) to Red Yeast Rice extract is in the range between about 1.4:1 to 2.8:1. 
     
     
         85 . The method of  claim 48  further comprising a dispersing agent. 
     
     
         86 . The method of  claim 85  wherein the dispersant comprises lysine and bamboo. 
     
     
         87 . The method of  claim 48  further comprising a soft gelatin capsule into which component (1), Red Yeast Rice extract and dispersing agent are loaded. 
     
     
         88 . The method of  claim 87  wherein a daily dose of the therapeutic composition is delivered by an integral number of capsules. 
     
     
         89 . The method of  claim 48  wherein a daily dose of the therapeutic composition comprises about 1000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 1200 mg of Red Yeast Rice extract. 
     
     
         90 . The method of  claim 48  wherein a daily dose of the therapeutic composition comprises about 2000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 1200 mg of Red Yeast Rice extract. 
     
     
         91 . The method of  claim 48  wherein a daily dose of the therapeutic composition comprises about 2000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 2400 mg of Red Yeast Rice extract. 
     
     
         92 . The method of  claim 48  wherein a daily dose of the therapeutic composition comprises about 4000 mg of EPA and/or derivatives of EPA plus DHA and/or derivatives of DHA and 2400 mg of Red Yeast Rice extract. 
     
     
         93 . The method of  claim 48  further comprising an antioxidant. 
     
     
         94 . The method of  claim 93  wherein the antioxidant is chosen from the group consisting of rosemary, vitamin E, astaxanthine, carnitine, ascorbyl palmitate, and tocopherols.