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

Oleh:

Tesfaye, Solomon ; Tandan, Rup ; Bastyr, Edward J. ; Skljarevski, Vladimir ; Price, Karen L.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Diabetes Care vol. 30 no. 10 (Oct. 2007), page 2626.
Topik: 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

Ketersediaan

Perpustakaan FK Nomor Panggil: D05.K.2007.04 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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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.

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