Measurements and Results: At 12 months, improvements in nerve functions occurred in patients receiving tolrestat. Compared with baseline values, postural hypotension
decreased by a value of 5.9 mm Hg (95% CI, 1.6 to 8.7); deep-breathing,
maximum/minimum heart rate (expiration/inspiration ratio) increased by
a value of 0.026 (CI, 0.015 to 0.036); and lying-to-standing heart rate
ratio (30:15 ratio) increased by a value of 0.032 (CI, 0.027 to 0.052).
In the placebo group, all test results except postural hypotension
deteriorated. Vibration perception threshold at the malleolus and great
toe of the dominant leg improved in the tolrestat group (−1.4; CI,
−3.69 to −1.09) but tended to worsen in the placebo group during the
study period. No important side effects were detected in either group.
Conclusions: The progression of mild diabetic autonomic and peripheral neuropathy may be halted or even reversed by pharmacologic intervention with the
aldose-reductase inhibitor tolrestat.
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