RT Journal Article
SR Electronic
T1 Tolrestat in the Primary Prevention of Diabetic Neuropathy
JF Diabetes Care
JO Diabetes Care
FD American Diabetes Association
SP 536
OP 541
DO 10.2337/diacare.18.4.536
VO 18
IS 4
A1 Giugliano, Dario
A1 Acampora, Rita
A1 Marfella, Raffaele
A1 Maro, Giosué Di
A1 Rosa, Nicoletta De
A1 Misso, Lucio
A1 Ceriello, Antonio
A1 Quatraro, Antonio
A1 D'Onofrio, Felice
YR 1995
UL http://care.diabetesjournals.org/content/18/4/536.abstract
AB OBJECTIVE To compare the effects of tolrestat and placebo in patients with subclinical diabetic neuropathy. RESEARCH DESIGN AND METHODS Non-insulin-dependent diabetes mellitus (NIDDM) patients with early involvement of the autonomic nervous system were identified by only one pathological (outside the 99% confidence interval of the normal population) squatting test (vagal or sympathetic). Fifty-seven patients entered a randomized, placebo-controlled, double-blind, parallel 52-week study of tolrestat at a dose of 200 mg/day. Cardiovascular reflex tests (squatting vagal and sympathetic tests, pressure gain, deep breathing, lying-to-standing, Valsalva maneuver, and orthostatic hypertension), vibration thresholds, tendon reflexes, and muscle strength were assessed throughout the study. RESULTS At 12 months, nerve function significantly improved in patients receiving tolrestat and deteriorated in patients taking placebo. At baseline, the squatting vagal test was normal in 16 patients in the tolrestat group and in 15 patients in the placebo group. At 12 months, 25 patients taking tolrestat had a normalized squatting test, but only 6 patients taking placebo did (P = 0.02). Vibration perception threshold improved by a value of 6 ± 3 V in the tolrestat group (P < 0.001) and deteriorated by a value of 3 ± 1.8 V (P < 0.001) in the placebo group. CONCLUSIONS Tolrestat may be useful in the primary prevention of diabetic neuropathy.