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(12) Patent Application Publication (10) Pub. No.: US 2005/0054731A1 Folli Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2005/0054731A1 Folli Et Al US 2005.0054731A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0054731A1 Folli et al. (43) Pub. Date: Mar. 10, 2005 (54) MULTI-SYSTEM THERAPY FOR DIABETES, Publication Classification THE METABOLIC SYNDROME AND OBESITY (51) Int. Cl." ...................... A61K 31/535; A61K 31/155 (76) Inventors: Franco Folli, Milano (IT); Paolo Manfredi, New York, NY (US); (52) U.S. Cl. .............................................................. 514/635 Gilbert Gonzales, New York, NY (US) Correspondence Address: (57) ABSTRACT WOOD, HERRON & EVANS, L.L.P. 2700 Carew Tower A multi-System therapy which is adapted to treat diabetes, 441 Wine St. metabolic Syndrome and obesity includes a hypoglycemic Cincinnati, OH 45202 (US) agent, a lipid lowering agent, a blood pressure lowering (21) Appl. No.: 10/868,227 agent and, preferably, an anti-platelet agent. The composi tion can further include various vitamins and Supplements (22) Filed: Jun. 15, 2004 Such as Vitamin B6, vitamin B12, arginin, a folate and other Vitamins and minerals. Preferably, the hypoglycemic agent Related U.S. Application Data is a biguanide hypoglycemic agent without any additional hypoglycemic agent, making the composition Suitable for (60) Provisional application No. 60/501,226, filed on Sep. treatment of individuals who are not hyperglycemic as well 8, 2003. as those who are hyperglycemic. US 2005/0054731 A1 Mar. 10, 2005 MULTI-SYSTEM THERAPY FOR DIABETES, THE 0009 Those people suffering from diabetes generally are METABOLIC SYNDROME AND OBESTY treated with a number of different agents, in particular hypoglycemic agents, blood pressure medication, as well as RELATED APPLICATION cholesterol-lowering drugs. It is common to use multiple different drugs to treat Type II Diabetes. Several drug 0001. This application is related to Provisional U.S. combinations have been produced. Patent Application Ser. No. 60/501,226, filed on Sep. 9, 2003, the disclosure of which is incorporated herein in its 0010. Such drug combinations are disclosed in Ikeda U.S. entirety by reference. Pat. No. 5,952,356, Adjei U.S. Pat. No. 6,524,621, Chaudhari U.S. pending application 2003/0219482 A1, Jaen BACKGROUND OF THE INVENTION et al U.S. application 2002/0037928A1; Fine et al U.S. Pat. No. 6,376,594, Pierson U.S. Pat. No. 6,693,094, Whitcomb 0002) Obesity, the Metabolic Syndrome (also referred to U.S. Pat. No. 6,011,049, Sahoetal U.S. Pat. No. 6,645,997; as Syndrome X), and Type II Diabetes Mellitus, are very Chungi U.S. Pat. No. 6,669,955; and Luskey U.S. Pat. No. much interrelated. Type II Diabetes Mellitus is caused by a 6,646,004. Further, Liang et al U.S. Pat. No. 6,576.256 combination of defective insulin Secretion and insulin resis discloses a combination of a cholesterol-lowering agent, a tance. This results in elevated blood Sugar, elevated blood renin-angiotensin System inhibitor and aspirin. Sethi et al preSSure, increased blood lipids and obesity. This determines U.S. Pat. No. 6,489,345 discloses a combination of E micro and macro Vascular disease with cardiovascular acci Vitamins and hypoglycemic drug, and Doebbner et al U.S. dents, renal insufficiencies, neuropathy, blindneSS and higher Pat. No. 5,847,008 discloses a variety of combinations with incidences of infections. Over 120 million people worldwide acetyl phenols. Other pending applications include 2003/ suffer from diabetes, and 90% of these are Type II Diabetes. O149111; 2003/0114469; 2003/0149111; and 2003/0158090. Eighty percent of those with diabetes are obese. This has an enormous economic impact in addition to the obvious per 0011 Many of these combinations do not include a Sonal impact on those Suffering from this disease. hypoglycemic agent. Further, others will include hypogly cemic agents which are unsuitable for treatment of Meta 0003) The Metabolic Syndrome is characterized by indi bolic Syndrome or obesity. The biguanides are used to treat viduals having abdominal obesity, high triglycerides, low diabetes, and can also be useful in treating obesity and HDL cholesterol, high blood pressure and high fasting Syndrome X. However, other hypoglycemic agent Such as glucose levels. A diagnosis of Metabolic Syndrome is made the Sulfonylureas, the alpha glucosidase inhibitors, the gli when three or more of these factors are established. It is taZones, and the meglitinides will actually induce hypogly believed that as many as 25% of the general population in cemia in patients who are not Suffering from Type II the United States suffer from Metabolic Syndrome. In addi Diabetes. Biguanides have been combined with these other tion to being a direct cause of death, those Suffering from hypoglycemic agents for treatment of Type II Diabetes. Metabolic Syndrome have a significantly increased risk of Other combination therapies fail to adequately address all of developing Type II Diabetes with all of its complications, as the comorbidities associated with Type II Diabetes with one well as other Serious cardiovascular complications. medicine. Compliance is a critical problem for proper treat 0004 Finally, in the United States, over 61% of the ment of diabetes. Only a fraction of patients with diabetes is population is obese or overweight. Fifty-eight million compliant with prescribed regiments. Individuals required to people are overweight, forty million are characterized as take five or six different pills, either at once or at different times of the day, are less likely to do so. Thus, reducing the obese, and three million are considered morbidly obese. number of pills, or, in other words, combining drugs into a 0005. A somewhat related malady is polycystic ovary Single dosage will greatly improve compliance. Syndrome. Polycystic ovary Syndrome is characterized by anovulation (irregular or absent menstrual periods) and SUMMARY OF THE INVENTION hyperandrogenism (elevated Serum testosterone and andros tenedione). Patients with this syndrome may complain of 0012. The present invention is premised on the realiza abnormal bleeding, infertility, obesity, exceSS hair growth, tion that a combination therapy, that is, a metabolic pill, hair loSS and acne. Insulin resistance, high blood pressure, effective for treatment of diabetes, the Metabolic Syndrome high Serum lipids, increased risk for cardiovascular disease and obesity as well as their complications, is provided by and increased risk of developing Type II Diabetes are also utilizing a combination of a biguanide hypoglycemic agent important features. with a lipid lowering agent, a blood pressure lowering agent, optionally an anti-platelet agent, and optionally a combina 0006 Polycystic ovary syndrome is estimated to affect tion of Vitamins and Supplements which have been shown to about half as many or approximately 10% of women. prevent atherosclerosis and infections. In order to provide a 0007 One of the major biochemical features of polycys Single pharmaceutical that can treat all three of these mala tic ovary Syndrome is insulin resistance accompanied by dies, the hypoglycemic agent cannot be used in combination compensatory hyperinsulinemia (elevated fasting blood with other types of hypoglycemic agents, Such as the alpha insulin levels). Hyperinsulinemia has also been associated glucosidase inhibitors, and the like, because of the risk of with high blood pressure and increased clot formation and inducing hypoglycemia. However, when the pharmaceutical appears to be a major risk factor for the development of heart is designed to treat only Type II Diabetes, additional disease, Stroke and Type II Diabetes. hypoglycemic agents can be employed. 0008. The medical literature suggests that the endocrin 0013 A preferred form of the present invention includes opathy in most patients with polycystic ovary Syndrome can metformin as the hypoglycemic agent, Simvastatin as the be resolved with insulin lowering therapy. cholesterol lowering agent, and a renin-angiotensin System US 2005/0054731 A1 Mar. 10, 2005 inhibitor Such as lisinopril as the blood pressure lowering the renin angiotensin System inhibitors, beta-blockerS Such agent. The preferred anti-platelet agent is aspirin. These may as atenolol, diuretics Such as hydrochlorothiazide, and cal be combined with one or more of the following: a folate, cium channel antagonists, for example, nifedipine. Vitamin B6, B12 and other Supplements Such as asparginin, 0021. The renin angiotensin system inhibitors include beta-carotene, Vitamins A, C, D, E, K, and polyunsaturated ACE inhibitors which inhibit the conversion of angiotensin fatty acids. I to angiotensin II, angiotensin II receptor antagonists and 0.014. The metabolic pill of the present invention can also renin inhibitors. The ACE inhibitors are preferred inhibitors improve the Symptoms of polycystic Ovary Syndrome, of the renin angiotensin Systems for use in the present reduce blood pressure, reduce blood lipids and reduce the invention. The ACE inhibitors include sulfhydryl containing incidence of developing Type II Diabetes and cardiovascular ACE inhibitors including captopril and agents that are complications. Structurally related to captopril Such as fentialpril, pivalopril, Zofenopril, and alacepril. Other ACE inhibitors include the 0.015 The objects and advantages of the present inven dicarboxyl-containing ACE inhibitors including amalopril, tion will be further appreciated in light of the following lisinopril, benaZapril, quinapril, moexipril, ramipril, spira detailed description. pril, perindopril, indolapril, pentopril, and cilaZapril. PhoS
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