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Factors that impact symptomatic diabetic peripheral neuropathy in placebo-administered patients from two 1-year clinical trials.
Diabetes Care. 2007 Oct; 30(10):2626-32.DC

Abstract

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 > or = 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.

Authors+Show Affiliations

Diabetes Research Unit, Royal Hallamshire Hospital, Q Floor, Room 26, Glossop Road, Sheffield S102JF, UK. solomon.tesfaye@sth.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17623822

Citation

Tesfaye, Solomon, et al. "Factors That Impact Symptomatic Diabetic Peripheral Neuropathy in Placebo-administered Patients From Two 1-year Clinical Trials." Diabetes Care, vol. 30, no. 10, 2007, pp. 2626-32.
Tesfaye S, Tandan R, Bastyr EJ, et al. Factors that impact symptomatic diabetic peripheral neuropathy in placebo-administered patients from two 1-year clinical trials. Diabetes Care. 2007;30(10):2626-32.
Tesfaye, S., Tandan, R., Bastyr, E. J., Kles, K. A., Skljarevski, V., & Price, K. L. (2007). Factors that impact symptomatic diabetic peripheral neuropathy in placebo-administered patients from two 1-year clinical trials. Diabetes Care, 30(10), 2626-32.
Tesfaye S, et al. Factors That Impact Symptomatic Diabetic Peripheral Neuropathy in Placebo-administered Patients From Two 1-year Clinical Trials. Diabetes Care. 2007;30(10):2626-32. PubMed PMID: 17623822.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Factors that impact symptomatic diabetic peripheral neuropathy in placebo-administered patients from two 1-year clinical trials. AU - Tesfaye,Solomon, AU - Tandan,Rup, AU - Bastyr,Edward J,3rd AU - Kles,Keri A, AU - Skljarevski,Vladimir, AU - Price,Karen L, AU - ,, Y1 - 2007/07/10/ PY - 2007/7/12/pubmed PY - 2007/11/14/medline PY - 2007/7/12/entrez SP - 2626 EP - 32 JF - Diabetes care JO - Diabetes Care VL - 30 IS - 10 N2 - 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 > or = 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. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/17623822/Factors_that_impact_symptomatic_diabetic_peripheral_neuropathy_in_placebo_administered_patients_from_two_1_year_clinical_trials_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=17623822 DB - PRIME DP - Unbound Medicine ER -