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Efficacy and Safety of Antioxidant Treatment With α-Lipoic Acid Over 4 Years in Diabetic Polyneuropathy
- Source :
- Diabetes Care. 34:2054-2060
- Publication Year :
- 2011
- Publisher :
- American Diabetes Association, 2011.
-
Abstract
- OBJECTIVE To evaluate the efficacy and safety of α-lipoic acid (ALA) over 4 years in mild-to-moderate diabetic distal symmetric sensorimotor polyneuropathy (DSPN). RESEARCH DESIGN AND METHODS In a multicenter randomized double-blind parallel-group trial, 460 diabetic patients with mild-to-moderate DSPN were randomly assigned to oral treatment with 600 mg ALA once daily (n = 233) or placebo (n = 227) for 4 years. Primary end point was a composite score (Neuropathy Impairment Score [NIS]–Lower Limbs [NIS-LL] and seven neurophysiologic tests). Secondary outcome measures included NIS, NIS-LL, nerve conduction, and quantitative sensory tests (QSTs). RESULTS Change in primary end point from baseline to 4 years showed no significant difference between treatment groups (P = 0.105). Change from baseline was significantly better with ALA than placebo for NIS (P = 0.028), NIS-LL (P = 0.05), and NIS-LL muscular weakness subscore (P = 0.045). More patients showed a clinically meaningful improvement and fewer showed progression of NIS (P = 0.013) and NIS-LL (P = 0.025) with ALA than with placebo. Nerve conduction and QST results did not significantly worsen with placebo. Global assessment of treatment tolerability and discontinuations due to lack of tolerability did not differ between the groups. The rates of serious adverse events were higher on ALA (38.1%) than on placebo (28.0%). CONCLUSIONS Four-year treatment with ALA in mild-to-moderate DSPN did not influence the primary composite end point but resulted in a clinically meaningful improvement and prevention of progression of neuropathic impairments and was well tolerated. Because the primary composite end point did not deteriorate significantly in placebo-treated subjects, secondary prevention of its progression by ALA according to the trial design was not feasible.
- Subjects :
- Advanced and Specialized Nursing
medicine.medical_specialty
business.industry
Endocrinology, Diabetes and Metabolism
medicine.disease
Placebo
Gastroenterology
law.invention
Surgery
Clinical trial
Tolerability
Randomized controlled trial
law
Internal medicine
Diabetes mellitus
Internal Medicine
Clinical endpoint
medicine
Adverse effect
business
Polyneuropathy
Subjects
Details
- ISSN :
- 19355548 and 01495992
- Volume :
- 34
- Database :
- OpenAIRE
- Journal :
- Diabetes Care
- Accession number :
- edsair.doi...........c8291aac39da609c1abd2d54d084b28c