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WARNING PRECAUTIONS
SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term, prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19 supp. 2: 747-830, 1970).
UGDP said that the patients have treated for 5 - 8 years with regime more a dose fixed as tolbutamide (1.5 grammes a day) had a cardiovascular mortality rate about 2-? time it of patients dealt with the only regime. A significant increase in complete mortality was not noticed, but the use of tolbutamide was stopped based on increase in cardiovascular mortality, by restricting opportunity so for study to show an increase in general mortality. In spite of the polemic concerning the interpretation of these results, conclusions of the study of UGDP provide a foundation appropriate to this warning. The patient should be informed about potential risks and advantages of AMARYL (glimepiride bars) and alternative modes of therapy. Although only a medicament in the sulfonylurea class (Tolbutamide) is included in this study, it is careful of an attitude of security to think that this warning can also apply to other medicaments hypoglycemic oral in this class, owing to their close similarities in the mode of action and chemical structure.
