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United States Patent (19) 11 Patent Number: 5,019,591 Gardner Et Al

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United States Patent (19) 11 Patent Number: 5,019,591 Gardner Et Al United States Patent (19) 11 Patent Number: 5,019,591 Gardner et al. (45) Date of Patent: May 28, 1991 (54) METHOD FOR TREATING RETINOPATHY Smooth Muscle Histamine Metabolism in Experimental AND OTHER SMALL VESSEL DISORDERS Diabetes," Arteriosclerosis, 2, 142-50 (1982). ASSOCATED WITH DIABETES Hollis, T. M., Kern, J. A., Enea, N. A.; Cosgarea, A.J., "Changes in Plasma Histamine Concentration in the (75) Inventors: Thomas W. Gardner, Franklin; Streptozotocin Diabetic Rat,' Exp. Mol. Pathol, 43, Theodore M. Hollis, State College, 90-6 (1985). both of Pa. Hollis, T. M. Gallik, S. G., Orlidge, A., Yost, J. C.; (73) Assignee: Pennsylvania Research Corporation, "Aortic Endothelial and Smooth Muscle Histamine University Park, Pa. Metabolism, Relationship to Aortic 125I Albumin Ac cumulation in Experimental Diabetes,'Arteriosclerosis, (21) Appl. No.: 312,693 3, 599-606 (1983). 22 Filed: Feb. 17, 1989 Ryan, T. A., Joiner, B. L., Ryan, B. F.; Minitab Student Handbook, First Edition, (1976). 51 Int. Cl. .................... A61K 31/34; A61K 31/135 Carroll, W. C., Hollis, T. M., "Retinal Histamine Syn (52) U.S.C. ..................................... 514/461; 514/648 thesis is Increased in Experimental Diabetes', Invest 58) Field of Search ................................ 514/648, 461 Ophthalmol, Vis. Sci, 29, 1201-04 (1988). 56 References Cited Dull, R. O., Vergis, G. J., Hollis, T. M., "Effect of Chronic Histamine Infusion on the Permeability of the PUBLICATIONS Blood Retinal Barrier,' Fed. Proc. 45, 462 (1986). Chem. Abst, 103:171798r (1985); Akihiro et al. Katora, M. E., Hollis, T. M., “A Simple Fluorometric Dullet al. Fed. Proc. 45,462 (1986). Method for Quantitative Determination of Aortic Pro Hollis, Exp. Mol. Pathol., 431 90-6 (1985). tein Uptake, 'J. Appl. Physiol. 39, 145-9 (1975). Cunha Vaz, J. G., Faria de Abreu, J. R.; Campos, A.J., Primary Examiner-Stanley J. Friedman Figo, G. M.; "Early Breakdown of the Blood Retinal Assistant Examiner-Zohreh A. Fay Barrier in Diabetes,' Br. J. Ophthalmol, 59, 649-56 Attorney, Agent, or Firm-Jones, Day, Reavis & Pogue (1975). Waltman, S. R., Oestrich, C., Krupin, T., Hanish, S., (57) ABSTRACT Ratzan, S., Santiago, J.; Kilo, C., "Quantitative Vitre A method for treating and preventing retinopathy and ous Fluorophotometry, A Sensitive Technique for Mea for treating and preventing other small vessel complica suring Early Breakdown of the Bloodretinal Barrier in tions associated with diabetes which comprises adminis Young Diabetic Patients,” Diabetes, 27, 85-7 (1970). tering a therapeutically effective amount of an antihista Ishibashi, T., Tanaka, K., Taniguchi, Y., "Disruption of mine or a pharmaceutically acceptable derivative Blood-Retinal Barrier in Experimental Diabetic Rats: thereof to a mammal having retinopathy or other small An Electron Microscopic Study,'Exp. Eye, Res, 30, vessel complications associated with diabetes. 401-10 (1980). Orlidge, A., Hollis, T. M., "Aortic Endothelial and 7 Claims, No Drawings 5,019,591 1. 2 leakage, Dull, R. O., Vergis, G. J., Hollis, T. M., "Ef. METHOD FOR TREATING RETNOPATHY AND fect of Chronic Histamine Infusion on the Permeability OTHER SMALL WESSEL DISORDERS of the Blood Retinal Barrier," Fed. Proc. 45,462 (1986). ASSOCATED WITH DABETES It is further known that diabetes mellitus is responsi ble for other small vessel disorders in mammals. Such BACKGROUND OF THE INVENTION other small vessel complications arise in the kidney, 1. Field of the Invention brain (stroke), heart (heart attack), feet (peripheral vas This invention relates to a method for treating and cular disease), skin (skin necrosis), and nerves (periph preventing retinopathy and other small vessel disorders eral neuropathy). associated with diabetes. 10 It is therefore an object of the present invention to 2. Description of the Prior Art provide a method for treating and preventing retino Diabetes mellitus causes retinopathy. Indeed, diabe pathy. tes mellitus causes abnormal blood-ocular barrier per It is a further object of the present invention to pro meability, which subsequently results in diabetic retino vide a method for treating and preventing other small pathy. Nonproliferative phases of this condition are 15 vessel complications which arise in connection with intraretinal, with primary pathogenic processes involv diabetes. ing vascular leakage and vessel occlusion. Employing These and other objects are achieved through the vitreous fluorophotometry, Cunha Vaz et al., Cunha application of a therapeutically effective amount of an Vaz, J. G., Faria de Abreu, J. R., Campos, A.J., Figo, antihistamine, or a pharmaceutically acceptable deriva G. M., "Early Breakdown of the Blood Retinal Barrier 20 tive thereof to a diabetic mammal which substantially in Diabetes,” Br. J. Ophthalmol, 59, 649-56 (1975), prevents or minimizes the occurrence of retinopathy performed one of the earliest studies that indicated dia and other small vessel disorders which typically arise betic patients showed vitreal leakage of sodium fluores from diabetes. cein, whereas nondiabetic individuals did not. Since then, others have observed changes in blood-ocular 25 SUMMARY OF THE INVENTION barrier sodium fluorescein permeability in diabetic hu This invention relates to a method for treating and mans and rats, noting that these changes may occur preventing retinopathy and for treating and preventing before any ophthalmoscopic or angiographic signs of other small vessel complications associated with diabe diabetic retinopathy are present, Waltman, S. R., Oes tes which comprises administering a therapeutically trich, C., Krupin, T., Hanish, S., Ratzan, S., Santiago, 30 effective amount of an antihistamine or a pharmaceuti J., Kilo, C., "Quantitative Vitreous Fluorophotometry. cally acceptable derivative thereof to a mammal having A Sensitive Technique for Measuring Early Breakdown retinopathy or other small vessel complications associ of the Bloodretinal Barrier in Young Diabetic Patients," ated with diabetes. Diabetes, 27, 85-7 (1970), Ishibashi, T., Tanaka, K., Taniguchi, Y., “Disruption of Blood-Retinal Barrier in 35 DETALED DESCRIPTION OF THE Experimental Diabetic Rats: An Electron Microscopic INVENTION Study," Exp. Eye. Res, 30, 401-10 (1980). Causes of blood-ocular leakage in diabetics are still In accordance with one embodiment of the present unresolved, although there is considerable agreement invention, retinopathy and other small vessel disorders that hyperglycemia is an important contributing factor. 40 associated with diabetes mellitus are treated and pre Orlidge and Hollis, Orlidge, A., Hollis, T. M., "Aortic vented by a method which comprises administering to a Endothelial and Smooth Muscle Histamine Metabolism mammal a therapeutically effective amount of an anti in Experimental Diabetes,” Arteriosclerosis, 2, 142-50 histamine or a pharmaceutically acceptable derivative (1982), reported that aortic endothelial and smooth thereof. muscle cell histamine synthesis is increased in strep 45 Antihistamines which can be employed in the process tozotocin diabetic rats. This increase in histamine syn of this invention include any of the many known H-1 thesis was normalized by insulin treatment, as well as by receptor antagonists including without limitation, di treatment with alpha hydrazinohistidine, a relatively phenhydramine, terfenadine, mequitazine, astemizole, specific inhibitor of histidine decarboxylase, Hollis, T. acrivastine, SCH29851, SK&F93944, clemastine, keto M., Gallik, S. G., Orlidge, A., Yost, J. C., "Aortic En 50 tifen, azatadine, oxatomide, azelastine, doxepine, piper dothelial and Smooth Muscle Histamine Metabolism. oxan (933F), 929F, 1571F, mepyramine, chlorphenira Relationship to Aortic 125I Albumin Accumulation in mine, triprolidine, promethazine, as well as any of the Experimental Diabetes," Arteriosclerosis, 3, 599-606 many known H-2 receptor antagonists, including with (1983), hyperglycemic rats treated with alphahy out limitation, burimamide, cinetidine, ranitidine, drazinohistidine also exhibited normal aortic albumin 55 famotidine, nizatidine. Of course, any other known permeability characteristics in contrast to elevated per antihistamines, H-1 receptor antagonists and H-2 recep meability in diabetic rats not given this inhibitor. Plasma tor antagonists may be used as well, as well as any phar histamine concentrations are elevated in diabetic rats, maceutically acceptable variations, derivatives, salts or Hollis, T. M., Kern, J. A., Enea, N.A., Cosgarea, A.J., preparations therefrom. Diphenhydramine and raniti "Changes in Plasma Histamine Concentration in the dine are especially preferred antihistamines. Streptozotocin Diabetic Rat,' Exp. Mol. Pathol, 43, The antihistamines may be administered systemically 90-6 (1985), as is retinal histamine synthesis, Carroll, W. in any convenient form, as well as intravenously or C., Hollis, T. M., “Retinal Histamine Synthesis is In intramuscularly. Systemic application in pill form is creased in the Streptozotocin Diabetic Rat, Invest Oph preferred. thalmol.” Wis Sci, 29, 1201-04 (1988). Finally, chronic 65 The antihistamines should be administered in a thera intravenous histamine infusion in nondiabetic rats raises peutically effective amount, with dosage and regimens their plasma histamine concentrations to those of dia for the application readily ascertainable by one skilled betic animals, thereby increasing blood-ocular albumin in the art. A range of from about 1 mg/kg body mass to 5,019,591 3 4. over 100 mg/kg body mass may be used
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