Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1998-11-18
2002-03-05
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C369S030850, C369S300000, C369S300000
Reexamination Certificate
active
06353009
ABSTRACT:
FIELD OF THE INVENTION
1. Background to the Invention
The present invention relates to a composition and method for the treatment or prevention of hyperuricemia, in which the active agent is an insulin-resistance improving substance, commonly referred to as “insulin sensitivity enhancers”.
2. Background Information
Hyperuricemia is a disease characterized by an abnormally high level of uric acid in the plasma: Plasma is saturated with uric acid at 7.0 mg/dl, and, if the level of uric acid in the blood reaches or exceeds this level because of a metabolic disorder involving uric acid, the resulting condition is called “hyperuricemia”. When the concentration of uric acid in the blood exceeds a certain level, uric acid precipitates as monosodium urate and may deposit in various tissues, such as the cavitas articulare or kidney. This deposition may cause gout, renal disorders or angiopathy. Hyperuricemia may be caused by reduced excretion of uric acid, by its excessive production or by a combination of both. It may also result from other diseases, such as an enzymatic abnormality in the purine metabolism. These are all so-called “primary causes”. Other diseases, such as disorders of the hemocytopoietic organs and renal disorders, and administration of a medicament, such as pyrazinamide or thiazide, may also result in hyperuricemia, and are “so-called secondary causes”.
Examples of diseases caused by hyperuricemia include gout (including acute gouty arthritis and chronic tophaceous arthritis), urinary calculus, hyperuricemic nephropathy (chronic gouty nephropathy, acute hyperuricemic nephropathy) and Lesch-Nyhan syndrome.
Initial treatment of the symptoms of hyperuricemia, particularly gout, may be by the administration of an analgesic agent, such as colchicine, and/or an analgesic anti-inflammatory, such as indomethacin. It is common practice to treat the longer term problem of hyperuricemia by control of the diet, for example by limiting the intake of alcohol or by controlling intake of calories. However, if this dietetic treatment does not work sufficiently well, the disease may be treated by the administration of drugs, for example by the prophylactic administration of an analgesic agent, such as colchicine, or by means of a uric acid excretion stimulator, such as probenecid, sulfinpyrazone, ketophenylbutazone, bucolome or benzbromarone, or a uric acid synthesis inhibitor, such as allopurinol.
In recent years, insulin sensitivity enhancers have been developed for the prevention or treatment of diabetes. The term “insulin sensitivity enhancer” as used herein means a compound which can bring about an improvement in the impaired action of insulin in spite of the existence of endogenous insulin. A wide range of compounds is embraced by the term “insulin sensitivity enhancer”. Typical examples include various thiazolidinedione compounds, oxazolidinedione compounds, isoxazolidinedione compounds and oxadiazolidinedione compounds. They are described, for example, in: WO 94/01433 (=Japanese Patent Application Kokai No. Hei 6-80667), Japanese Patent Application Kokai No. Hei 4-69383, WO 92/02520 (=Japanese Language Kokai Publication (PCT) No. Hei 6-500538), WO 91/07107 (=Japanese Patent Application Kokai No. Hei 3-170478=Japanese Patent Publication No. Hei 7-8862), U.S. Pat. No. 5,132,317 (=Japanese Patent Application Kokai No. Hei 3-90071), U.S. Pat, No. 4,897,405 (=Japanese Patent Application Kokai No. Hei 2-292272), WO 89/08651 (=Japanese Patent Application Kokai No. Hei 1-272574), U.S. Pat. Nos. 5,061,717, 5,120,754, 5,223,522 (=Japanese Patent Application Kokai No. Hei 1-272573), U.S. Pat. Nos. 5,002,953, 5,194,443, 5,232,925, 5,260,445 (=Japanese Patent Application Kokai No. Hei 1-131169), U.S. Pat. No. 4,918,091 (=Japanese Patent Application Kokai No. Sho 64-13076), U.S. Pat. Nos. 4,897,393, 4,948,900 (=Japanese Patent Application Kokai No. Sho 64-56675 =Japanese Patent Publication No. Hei 5-5832), U.S. Pat. No. 4,873,255 (=Japanese Patent Application Kokai No. Sho 64-38090), U.S. Pat. No. 4,703,052 (=Japanese Patent Application Kokai No. Sho 61-271287=Japanese Patent Publication No. Hei 5-86953), U.S. Pat. No. 4,687,777(=Japanese Patent Application Kokai No. Sho 61-267580 =Japanese Patent Publication No. Hei 5-31079), U.S. Pat. No. 4,725,610 (=Japanese Patent Application Kokai No. Sho 61-85372=Japanese Patent Publication No. Hei 5-66956), U.S. Pat. No. 4,572,912 (=Japanese Patent Application Kokai No. Sho 60-51189=Japanese Patent Publication No. Hei 2-31079), U.S. Pat. No. 4,461,902 (=Japanese Patent Application Kokai No. Sho 58-118577=Japanese Patent Publication No. Hei 2-57546), U.S. Pat. Nos. 4,287,200, 4,340,605, 4,438,141, 4,444,779 (=Japanese Patent Application Kokai No. Sho 55-22636=Japanese Patent Publication No. Sho 62-42903), EP 0 708 098A (Japanese Patent Application Kokai No. Hei 9-48779), EP 0 676 398A (=Japanese Patent Application Kokai No. Hei 7-330728), WO 95/18125, EP 0 745 600A, EP 0 332 332A (=Japanese Patent Application Kokai No. Hei 1-272574) and EP 0 604 983A (=Japanese Patent Application Kokai No. Hei 6-247945).
For example, 5-[4-(6-hydroxy-2,5,7,8-tetramethylchroman-2-ylmethoxy)benzyl]-thiazolidine-2,4-dione (which will hereinafter be called “troglitazone”) is a thiazolidine derivative having the ability to enhance the action of insulin and is known for the treatment and/or prevention of diabetes [Fujiwara et al., “Diabetes”, 37, 1459 (1988); Hofmann C. A. et al., “Diabetes Care”, 15, 1075 (1992)]. It has also been reported that the compound has an antioxidant action and is therefore useful as a treatment for insulin-dependent diabetes mellitus (Type I diabetes: IDDM) [“Tonyobyo (Diabetes)”, 37(2), 127-129 (1994)].
It has not, however, previously been reported that any of the above compounds are useful for the treatment or prevention of hypenrnicemia.
There is, for example, a report based on clinical examination values concerning the relationship between the administration of CS-045 (=troglitazone) and uric acid. According to this report, before the administration of troglitazone, the uric acid level is 4.7±1.7, which decreases slightly to 4.4±1.4 after administration. This decrease is within the normal changes to be expected, and there is no suggestion that the administration of troglitazone is effective for the treatment or prevention of hyperuricemia [“Rinsho Iyaku (Clinical Medicine)”, 9, Suppl.3 (July issue), 14 (1993)].
There have also been reports on the relationship between hyperuricemia and insulin resistance. They only suggest the relationship and do not make any suggestion that an insulin sensitivity enhancer is effective for the treatment or prevention of hyperuricemia [“Tonyobyo (Diabetes)”, 40, an extra number, 239, 2P041 (1997), “Sougo Rinsho (Clinic All-round)”, 46(8), 2128-2130 (1997) and “Mebio”, 14(9), 90-96 (1997)].
It has been reported, for example, that 1-(3-bromobenzo[b]furan-2-ylsulfonyl)hydantoin (Japanese Patent Application Kokai No. Hei 6-211657) or benzopyran derivatives (Japanese Patent Application Kokai No. Sho 63-107971), such as ethyl {[5-chloro-3-(2-methylphenyl)-4-oxo-4H-1-benzopyran-7-yl]oxy}acetate, are effective for the prevention and treatment of hyperuricemia, but they are utterly different in structure from the compounds of the present invention.
We have now, most surprisingly, discovered that certain classes of compound which are insulin sensitivity enhancers also have the ability to treat and/or prevent hyperuricemia.
BRIEF SUMMARY OF THE INVENTION
An object of the present invention is to provide a method for the treatment or prevention of hyperuricemia.
A further object of the present invention is to provide a composition for the treatment or prevention of hyperuricemia.
Other objects and advantages of the present inventio
Fujiwara Toshihiko
Horikoshi Hiroyoshi
Iwasaki Koichi
Criares Theodore J.
Frishauf, Holtz Goodman, Langer & Chick, P.C.
Sankyo Company Limited
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