Effect of Tolrestat on oesophageal transit time and cholecystic motility in type 2 diabetic patients with asymptomatic diabetic neuropathy.

Abstract

The aim of the present study was to investigate the influence of Tolrestat, an aldose-reductase inhibitor, on both oesophageal and cholecystic motility in Type-2 diabetic patients with asymptomatic diabetic neuropathy. Sixty-six patients were randomly assigned to receive Tolrestat 200 mg once daily (33 patients) or were left without specific treatment (33 patients) for 12 months. Efficacy and safety evaluation were done at 4.5 and 12 months by persons blinded to the patient treatment regimen. Scintigraphic evaluation of oesophageal motility showed significant changes in transit time for Tolrestat at 12 months (p < 0.001). There was no significant effect of Tolrestat on cholecystic function in cholecystography, although diabetic patients taking Tolrestat showed a trend toward improvement. The vibration perception threshold at two sites of the dominant leg improved by at least 3 volts in the Tolrestat group and remained unchanged or slightly deteriorated in the control group. Tendon reflexes and blood pressure fall after standing were improved in the Tolrestat group. In conclusion, one-year treatment with Tolrestat significantly improved oesophageal motility and vibration perception in Type-2 diabetic patients with asymptomatic diabetic neuropathy.