Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1997-09-25
2001-01-16
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C536S007200, C536S007400
Reexamination Certificate
active
06174865
ABSTRACT:
BACKGROUND
1. Technical Field
This invention relates to methods and compositions for treating humans with hypertriglyceridemia using erythromycin compounds.
2. Background Information
Hypertriglyceridemia involves abnormally high concentrations of plasma triglycerides. Although an exact definition of “normal” is impossible, patients with triglyceride concentrations exceeding 150 mg/dL are generally hypertriglyceridemic. Since hypertriglyceridemia may be a risk factor for acute pancreatitis (The National Institutes of Health Consensus Development Panel, Arteriosclerosis 4:296-301 (1984) and Miller el al., Ann. Surg. 190:401-408 (1979)) as well as coronary heart disease (Carlson and Bottiger, Atherosclerosis 39:287-291 (1981)), high triglyceride concentrations require clinical attention. In most cases, non-pharmacologic treatments, such as weight reduction, dietary changes, and alcohol restriction, effectively reduce triglyceride concentrations (Levy et al., Ann. Int. Med. 77:267-294 (1972)). Other patients, however, may require drug therapy.
Pharmacologic treatment of hypertriglyceridemia involves administering drugs, such as fibric acid compounds, that influence lipid metabolism such that triglyceride plasma levels decrease. Specific fibric acid compounds in wide use today include gemfibrozil, fenofibrate, and bezafibrate. Although these drugs appear relatively safe, one major documented side effect is the development of cholesterol gallstones (Coronary Drug Project Research Group, N. Engl. J. Med. 296:1185-1190 (1977)). Further, the first fibric acid drug, clofibrate, may increase the risk of cancer (Report from Committee of Principal Investigators, Br. Heart J. 40:1068-1118 (1978)). These potential side effects, however, rarely warrant discontinued use given the triglyceride-lowering ability of fibric acid drugs as well as their tolerance by most people.
SUMMARY
The present invention relates to treating humans having hypertriglyceridemia by administering erythromycin compounds. In particular, this invention provides a method for reducing triglyceride concentrations by administering erythromycin compounds such as erythromycin, clarithromycin, azithromycin, and troleandomycin.
Using erythromycin compounds to reduce triglyceride levels is particularly beneficial because these compounds are inexpensive, easy to administer, physically tolerable, and effective. In addition, erythromycin compounds reduce low-density lipoprotein (LDL) concentrations as well as increase high-density lipoproteins (HDL) concentrations, both of which can be abnormal in hypertriglyceridemia patients (Klein, U.S. patent application Ser. No. 08/646,062). Since elevated levels of LDL and reduced levels of HDL are risk factors for severe atherosclerosis and coronary heart disease in humans (Holme et al., Arteriosclerosis 1:250-256 (1991)), using erythromycin compounds to reduce plasma triglyceride concentrations is particularly beneficial.
One aspect of this invention relates to reducing plasma triglyceride concentrations in a human by administering an erythromycin compound at doses effective to reduce plasma triglyceride concentrations. Specifically, erythromycin compounds include clarithromycin, troleandomycin, erythromycin, and azithromycin in addition to other derivatives of erythromycin. Further, these erythromycin compounds can be administered orally. Doses can range from about 100 mg/day to about 6,000 mg/day. Alternatively, doses can range from about 1 mg/kg of body weight/day to about 100 mg/kg of body weight/day, preferably from about 5 mg/kg of body weight/day to about 75 mg/kg of body weight/day, more preferably from about 10 mg/kg of body weight/day to about 25 mg/kg of body weight/day, and most preferably about 11 mg/kg of body weight/day or about 22 mg/kg of body weight/day.
Another aspect of this invention relates to treating a human having hypertriglyceridemia by administering an erythromycin compound at doses effective to reduce plasma triglyceride concentrations. Specifically, erythromycin compounds include clarithromycin, troleandomycin, erythromycin, and azithromycin in addition to other derivatives of erythromycin. Further, these erythromycin compounds can be administered orally. Doses can range from about 100 mg/day to about 6,000 mg/day. Alternatively, doses can range from about 1 mg/kg of body weight/day to about 100 mg/kg of body weight/day, preferably from about 5 mg/kg of body weight/day to about 75 mg/kg of body weight/day, more preferably from about 10 mg/kg of body weight/day to about 25 mg/kg of body weight/day, and most preferably about 11 mg/kg of body weight/day or about 22 mg/kg of body weight/day.
Another aspect of this invention relates to treating a human diagnosed with hypertriglyceridemia by administering an erythromycin compound at doses effective to reduce plasma triglyceride concentrations. Specifically, erythromycin compounds include clarithromycin, troleandomycin, erythromycin, and azithromycin in addition to other derivatives of erythromycin. Further, these erythromycin compounds can be administered orally. Doses can range from about 100 mg/day to about 6,000 mg/day. Alternatively, doses can range from about 1 mg/kg of body weight/day to about 100 mg/kg of body weight/day, preferably from about 5 mg/kg of body weight/day to about 75 mg/kg of body weight/day, more preferably from about 10 mg/kg of body weight/day to about 25 mg/kg of body weight/day, and most preferably about 11 mg/kg of body weight/day or about 22 mg/kg of body weight/day.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
Other features and advantages of the invention will be apparent from the following detailed description and from the claims.
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Alan H. Gordon & Associates, P.C.
Peselev Elli
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