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Predictors of improvement and progression of diabetic polyneuropathy following treatment with α-lipoic acid for 4 years in the NATHAN 1 trial.
J Diabetes Complications 2016; 30(2):350-6JD

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.

Authors+Show Affiliations

Institute for Clinical Diabetology, German Diabetes Center at Heinrich Heine University, Leibniz Center for Diabetes Research, Düsseldorf, Germany; Department of Endocrinology and Diabetology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany. Electronic address: dan.ziegler@ddz.uni-duesseldorf.de.Department of Neurology, Mayo Clinic, Rochester, MN, USA.Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.MEDA Pharma GmbH & Co. KG, Bad Homburg, Germany.Department of Medicine, EVMS Strelitz Diabetes Research Center and Neuroendocrine Unit, Eastern Virginia Medical School, Norfolk, VA, USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26651260

Citation

Ziegler, Dan, et al. "Predictors of Improvement and Progression of Diabetic Polyneuropathy Following Treatment With Α-lipoic Acid for 4 Years in the NATHAN 1 Trial." Journal of Diabetes and Its Complications, vol. 30, no. 2, 2016, pp. 350-6.
Ziegler D, Low PA, Freeman R, et al. Predictors of improvement and progression of diabetic polyneuropathy following treatment with α-lipoic acid for 4 years in the NATHAN 1 trial. J Diabetes Complicat. 2016;30(2):350-6.
Ziegler, D., Low, P. A., Freeman, R., Tritschler, H., & Vinik, A. I. (2016). Predictors of improvement and progression of diabetic polyneuropathy following treatment with α-lipoic acid for 4 years in the NATHAN 1 trial. Journal of Diabetes and Its Complications, 30(2), pp. 350-6. doi:10.1016/j.jdiacomp.2015.10.018.
Ziegler D, et al. Predictors of Improvement and Progression of Diabetic Polyneuropathy Following Treatment With Α-lipoic Acid for 4 Years in the NATHAN 1 Trial. J Diabetes Complicat. 2016;30(2):350-6. PubMed PMID: 26651260.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Predictors of improvement and progression of diabetic polyneuropathy following treatment with α-lipoic acid for 4 years in the NATHAN 1 trial. AU - Ziegler,Dan, AU - Low,Phillip A, AU - Freeman,Roy, AU - Tritschler,Hans, AU - Vinik,Aaron I, Y1 - 2015/11/10/ PY - 2015/10/01/received PY - 2015/10/30/revised PY - 2015/10/31/accepted PY - 2015/12/15/entrez PY - 2015/12/15/pubmed PY - 2016/12/15/medline KW - Autonomic function KW - Cardiovascular risk factors KW - Diabetic polyneuropathy KW - Neuropathic impairments KW - α-lipoic acid SP - 350 EP - 6 JF - Journal of diabetes and its complications JO - J. Diabetes Complicat. VL - 30 IS - 2 N2 - 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. SN - 1873-460X UR - https://www.unboundmedicine.com/medline/citation/26651260/Predictors_of_improvement_and_progression_of_diabetic_polyneuropathy_following_treatment_with_α_lipoic_acid_for_4_years_in_the_NATHAN_1_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1056-8727(15)00437-7 DB - PRIME DP - Unbound Medicine ER -