Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Patent
1994-12-23
1997-01-14
Weddington, Kevin E.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
514312, 514866, 514884, A61K 3147
Patent
active
055940056
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/SE 93/00272 filed Mar. 31, 1993.
GENERAL BACKGROUND
Diabetes mellitus is a disease characterized by physiologic and anatomic abnormalities in many organs, due to vascular abnormalities. However, the most prominent feature of the disease is disturbed glucose metabolism, resulting in hyperglycemia. Diabetes mellitus is usually divided into two major categories: insulin-dependent diabetes mellitus (Type I diabetes), which usually develops in childhood or adolescence and these patients are prone to ketosis and acidosis. The second category of patients (Type lI diabetes) are not insulin dependent and usually manage with diet and oral hypoglycemic therapy. The annual incidence of Type I diabetes ranges from 10 cases/100.000 persons for non-white males to 16 cases/100.000 persons for white males in the United States, with equal incidence between males and females. The prevalence of Type I diabetes for all ages in the United States population is 160 cases/100.000 persons, with a slightly earlier onset for females with peak age of onset at 10-12 years than for males with peak age of onset at 18 years. Genetic background plays a major role in the development of the disease, with 40% concordance for Type I diabetes exhibited by identical twins and increased incidence among family members. Genes associated with increased susceptability to Type I diabetes reside near the major histocompatibility complex on chromosome 6, with more than 90% of persons with Type I diabetes featuring DR3 or DR4 haplotypes or both. Likewise, siblings sharing DR3 or DR4 haplotypes from both parents more often than random develop Type I diabetes (1).
The onset of symptoms in Type I diabetes is usually acute and frequently follows an antecedant vital infection which might be the trigger to a process leading to destruction of the beta cells secondary to autoimmune insulitis. When beta cell destruction reaches the critical point, the patient's reduced insulin levels lead to hyperglycemia with the typical symptomatology of Type I diabetes. At diagnosis approximately 70% of patients with Type I diabetes have antibodies to islet cell cytoplasm i.e. antigens or to components of the islet cell surface. Approximately 15% of patients with Type I diabetes may also show other autoimmune features, such as hypothyroidism, Graves' disease, Addison's disease, myasthenia gravis and pernicious anemia (2). Autopsies of cases with Type I diabetes show a typical lymphocytic infiltration in the pancreatic islets (3).
Treatment of Type I diabetes at present is not satisfactory and the disease leads to serious life-threatening complications that can be only partly overcome with adequate control of insulin levels, which is usually difficult to accomplish in patients with juvenile onset. In addition to the acute diabetic syndrome, chronic manifestations lead to severe arteriosclerosis with microadenopathy affecting the eye with possible early blindness. One in 20 of all Type I diabetes patients becomes blind; about 40% of Type I diabetes develop renal failure, resulting in chronic hemodialisis and/or the need for renal transplantation (4-7). Severe neuropathic changes are also typical for Type I diabetes with many functional disorders associated with sensory, sympathetic and para-sympathetic nerves. Cranial nerve, as well as peripheral nerve, may be involved. Treatment of neuropathy remains unsatisfactory, despite normal control of glucose levels with adequate insulin therapy.
Strokes are twice as frequent, myocardial infarctions are 2-5 times as frequent and cardiovascular accidents are 5-10 times more frequent in patients with Type I diabetes than among non-diabetic counterparts. The prognosis of patients with Type I diabetes who survive acute myocardial infarction is 3 times more grave compared to non-diabetics who survive acute infarction and the same is true for other vascular complications. Severe and uncontrollable arterosclerosis may also be associated with a variety of etiologies involving abnormalities in platelets, clotti
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Woods, Pathogenesis of Systemic Lupus Erythematosus 60: 999-1016 (1986).
Gross David
Slavin Shimon
Weiss Lola
Pharmacia AB
Weddington Kevin E.
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