METHOD OF REDUCING THE LEVEL OF LOW DENSITY LIPOPROTEINS IN THE SERUM OF A PATIENT

Abstract: A method for reducing the level of low density lipoprotein in the serum of a patient without affecting the level of high density lipoprotein which comprises administering to the patient effective amounts of fibroblast interferon.

Description: " Msthod of Reducing the Level of ^- Low Density Lipoproteins in the Serum of a Patient Description 5 Technical Field This invention relates to the medical arts and, more particularly, to an improved method for reducing the level of low density lipoproteins in the serum of a patient. Background Art 10 Serum lipids include free fatty acids, triglycerides, and cholesterol. Cholesterol circulates primarily as a complex of lipid and proteins. These peptides are called lipoproteins. Lipoprotein complexes can be separated, on the basis of density, into chylomicrons, low density lipoproteins, and high 15 density lipoproteins. Serum cholesterol is found primarily in the form of low density and high density lipoproteins. Serum cholesterol level has for some time been considered to be closely related to arteriosclerosis. However, it is only relatively recently that the difference in the effect of 20 high density and low density lipoproteins was noted. It is generally believed that the high density lipoproteins do not contribute to arteriosclerosis and in fact may even have an inhibitory effect on the disease. On the other hand, the level of low density lipoproteins in serum has been correlated 25 with the disease. The distinction between low density lipoproteins and high density lipoproteins is well established among those persons skilled in the art, the dividing line typically being considered a density of 1.063 grams per cubic centimeter. 30 Cantell (New England Journal of Medicine, Vol. 302, pp. 1032-1033, 1980) has reported noting a reduction in circulating high density lipoprotein cholesterol in three patients receiving leukocyte interferon. Naturally this is _ OMPI _ undesirable because of the possible beneficial effect which high density lipoproteins exert in inhibiting arteriosclerosis. Disclosure of Invention Very generally, the method of the invention comprises administering to a patient human fibroblast interferon such as to reduce the level of low density lipoproteins in the patient's serum. Quite unexpectedly, in connecton with the present invention, it has been discovered that unlike leukocyte interferon, fibroblast interferon <jS interferon) does not reduce serum levels of high density lipoproteins. Even more importantly, fibroblast interferon does reduce serum levels of low density lipoproteins. Method of Carrying out the Invention This effect has been demonstrated in the treatment of six female patients. These patients received daily intramuscular injections of human fibroblast interferon. No decrease in high density lipoprotein cholesterol was noted.- However, by the 28th day, total cholesterol levels in the sera of all patients had dropped significantly. Since most of the remaining fraction of total cholesterol is present as low density lipoproteins, such a change indicates a decline in low- density lipoprotein cholesterol resulting from the adminis- tration of fibroblast interferon. The mean total cholesterol level and the low density lipoprotein cholesterol level (LDL) in six patients upon initiation of fibroblast iήterferom administration (0) , upon the 15th day and upon the 30th day were as follows: Study Days Total Cholesterol LDL Cholesterol 0 186 mg/dl 142 15 162 117 30 170 123 OMPI f Dosage levels were 3 to 6 million interferon units depending upon the individual's tolerance for the interferon. In practicing the method of the invention, it is preferred that the administration of the fibroblast interferon 5 be intramuscular and be done in a series of doses over a predetermining period of time. Such doses may be given daily, but periods of from a few hours to a few days between doses may be satisfactory depending upon the patient, the patient's tolerance to the interferon, and the beginning and desired 10 cholesterol levels. Interferon may also be administered intravenously. Since the techniques for measuring cholesterol levels are well known in the art, monitoring can be readily accomplished in order to effect the reduction which the physician treating the patient desires. Dosage levels may be 15 as low as one or a few million units and as high as about 30 million depending upon the interval between dosages. It may be seen, therefore, that the invention provides an effective means of reducing the level of low density lipo¬ proteins in the serum of a patient without affecting the level 20 of high density lipoproteins in the patient's serum. Various modificatons of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are intended to fall within the scope of the appended claims. ?

Claims: Claims 1. A method for reducing the level of low density lipoproteins in the serum of a patient, comprising, administering to the patient human fibroblast interferon. 2. A method according to Claim 1 wherein the interferon is administered intramuscularly. 3. A method according to Claim 1 wherein the interferon is administered in a plurality of doses over a pre¬ determined period of time. 4. A method according to Claim 3 wherein the interferon is administered daily. 5. A method according to claim 3 wherein the dosage level is between 3 million and 6 million units. 6. A method for reducing the level of low desnity lipo- proteins in the serum of a patient, comprising, admin¬ istering a series of doses of human fibroblast interferon • to the patient by intramuscular injection over a pre¬ determined period of time. 7. A method according to Claim 6 wherein the dosage level is between 1 million and 30 million units. 8. A method for treating arteriosclerosis in a patient, comprising, treating said patient so as to lower the level of low density lipoproteins in the patient's serum without lowering the level of high density lipoproteins in the patient's serum. 9. The method of Claim 8 wherein the patient is treated by the administration of human fibroblast interferon.

Inventors: BORDEN ERNEST C, SHRAGO EARL S, BORDEN, ERNEST, C., SHRAGO, EARL, S.
Applicants: WISCONSIN ALUMNI RES FOUND, WISCONSIN ALUMNI RESEARCH FOUNDATION
Application year: 1982
Main classification: A61K45
IPC codes: A61K38