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- W2034368488 abstract "The safety of tolrestat use in the diabetic patient was demonstrated by data from 14 double-blind and open-label studies conducted in 1,300 patients with diabetic neuropathy; the results were supported by data from earlier bioavailability, pharmacokinetic, and clinical pharmacology trials. There was a generally comparable frequency of complaints in the tolrestat dose groups and placebo groups. In a year-long double-blind study, the only complaint considered to by “possibly” drug-related that occurred with a significantly greater incidence in patients treated with tolrestat than in those on placebo was dizziness. Laboratory test values recorded during the trials supported the positive safety findings of tolrestat. A review of blood urea nitrogen and serum creatinine values did not suggest any potential for tolrestat-induced renal dysfunction. Infrequently, significant elevations in serum hepatic enzyme (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) levels occurred, accounting for 27 of 42 possibly drug-related patient withdrawals following tolrestat administration. On review of these cases, it was concluded that tolrestat may cause hepatocellular damage with coincident elevations in AST and ALT in approximately 2% of patients. Importantly, the abnormalities were reversible after discontinuing the drug, commonly within 8–16 weeks. There was no evidence of a hypersensitivity syndrome in any patient in any study. These results support a favorable safety profile for tolrestat." @default.
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- W2034368488 date "1987-01-01" @default.
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- W2034368488 title "Human safety profile of tolrestat: An aldose reductase inhibitor" @default.
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- W2034368488 doi "https://doi.org/10.1002/ddr.430110208" @default.
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