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Factors That Impact Symptomatic Diabetic Peripheral Neuropathy in Placebo-Administered Patients From Two 1-Year Clinical Trials

¹ Diabetes Research Unit, Royal Hallamshire Hospital, Sheffield, U.K
² University of Vermont, College of Medicine, Burlington, Vermont
³ Lilly Research Laboratories, Indianapolis, Indiana
⁴ Indiana University, Indianapolis, Indiana

Address correspondence and reprint requests to Professor Solomon Tesfaye, Royal Hallamshire Hospital, Q Floor, Room 26, Glossop Road, Sheffield S102JF, U.K. E-mail: solomon.tesfaye{at}sth.nhs.uk

OBJECTIVE—The purpose of this study was to evaluate the change in neuropathy symptoms and disease progression in placebo-administered patients from two 1-year studies in which the impact of ruboxistaurin (RBX) in mild diabetic peripheral neuropathy (DPN) was tested.

RESEARCH DESIGN AND METHODS—Data from 262 placebo-administered patients from two identical phase 3, randomized, double-blind trials were combined and analyzed.

RESULTS—After 1 year, change in the neuropathy impairment score of lower limbs [NIS(LL)] (–0.63 points; P = 0.005), vibration detection threshold (VDT) (–0.42 just noticeable difference units; P = 0.003), and Neuropathy Total Symptom Score-6 (NTSS-6) questionnaire (–3.73 points; P < 0.001) improved, whereas some electrophysiology measures and heart rate deep breathing (HRDB) (–0.78 beats; P = 0.003) worsened compared with baseline values. There was a small but significant worsening of A1C (0.28%; P < 0.001), and a greater percentage of patients were using analgesics at the end of the trials (33.6%; P = 0.003). At 1 year, the change in NTSS-6 directly correlated with changes in NIS(LL) and VDT and inversely correlated with the peroneal nerve conduction velocity. On logistic regression analyses, a 50% reduction in NTSS-6 score was less likely in patients who used antihypertensive or chronic symptom medication at baseline.

CONCLUSIONS—In placebo-administered patients with mild symptomatic DPN, there was a progressive improvement in symptoms over 12 months, whereas nerve conduction studies and HRDB declined, and clinically significant worsening of DPN would require >1 year of observation.

Abbreviations: DPN, diabetic peripheral neuropathy • HRDB, heart rate variation during deep breathing • NIS(LL), neuropathy impairment score of the lower limbs • NCV, nerve conduction velocity • NTSS-6, Neuropathy Total Symptom Score-6 • RBX, ruboxistaurin • VDT, vibration detection threshold

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