Predictors of improvement and progression of diabetic polyneuropathy following treatment with α-lipoic acid for 4 years in the NATHAN 1 trial

Dan Ziegler, Phillip A. Low, Roy Freeman, Hans Tritschler, Aaron I. Vinik

Research output: Contribution to journalArticlepeer-review

36 Scopus citations

Abstract

Aims We aimed to analyze the impact of baseline factors on the efficacy of α-lipoic acid (ALA) over 4 years in the NATHAN 1 trial. Methods This was a post-hoc analysis of the NATHAN 1 trial, a 4-year randomized study including 460 diabetic patients with mild-to-moderate polyneuropathy using ALA 600 mg qd or placebo. Amongst others, efficacy measures were the Neuropathy Impairment Score of the lower limbs (NIS-LL) and heart rate during deep breathing (HRDB). Results Improvement and prevention of progression of NIS-LL (ΔNIS-LL ≥ 2 points) with ALA vs. placebo after 4 years was predicted by higher age, lower BMI, male sex, normal blood pressure, history of cardiovascular disease (CVD), insulin treatment, longer duration of diabetes and neuropathy, and higher neuropathy stage. Participants treated with ALA who received ACE inhibitors showed a better outcome in HRDB after 4 years. Conclusions Better outcome in neuropathic impairments following 4-year treatment with α-lipoic acid was predicted by normal BMI and blood pressure and higher burden due to CVD, diabetes, and neuropathy, while improvement in cardiac autonomic function was predicted by ACE inhibitor treatment. Thus, optimal control of CVD risk factors could contribute to improved efficacy of α-lipoic acid in patients with higher disease burden.

Original languageEnglish (US)
Pages (from-to)350-356
Number of pages7
JournalJournal of Diabetes and its Complications
Volume30
Issue number2
DOIs
StatePublished - Mar 1 2016

Keywords

  • Autonomic function
  • Cardiovascular risk factors
  • Diabetic polyneuropathy
  • Neuropathic impairments
  • α-lipoic acid

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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