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

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...

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Bibliographic Details
Published in:Journal of diabetes and its complications 2016-03, Vol.30 (2), p.350-356
Main Authors: Ziegler, Dan, Low, Phillip A, Freeman, Roy, Tritschler, Hans, Vinik, Aaron I
Format: Article
Language:English
Subjects:
Antioxidants - therapeutic use
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - pathology
Diabetic Neuropathies - drug therapy
Diabetic Neuropathies - pathology
Disease Progression
Endocrinology & Metabolism
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prognosis
Remission Induction
Thioctic Acid - therapeutic use
Treatment Outcome
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Summary: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.
ISSN:1056-8727
1873-460X
DOI:10.1016/j.jdiacomp.2015.10.018