Efficacy and Safety of Antioxidant Treatment With {alpha}-Lipoic Acid Over 4 Years in Diabetic Polyneuropathy: The NATHAN 1 Trial Full Text
Diabetes Care,

Ziegler D et al. – Four–year treatment with α–lipoic acid (ALA) in mild–to–moderate diabetic distal symmetric sensorimotor polyneuropathy (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 subjects, secondary prevention of its progression by ALA according to the trial design was not feasible.

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 four times 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%).

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access Full Text, PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Endocrinology

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Endocrinology Articles

1 Effects of 12 weeks high-dose vitamin D3 treatment on insulin sensitivity, beta cell function, and metabolic markers in patients with type 2 diabetes and vitamin D insufficiency – A double-blind, randomized, placebo-controlled trial Metabolism, July 9, 2014    Clinical Article

2 Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial The Lancet, July 7, 2014    Evidence Based Medicine    Clinical Article

3 Combination therapy with sitagliptin and lansoprazole in patients with recent-onset type 1 diabetes (REPAIR-T1D): 12-month results of a multicenter, randomized, placebo-controlled, phase 2 trial The Lancet Diabetes & Endocrinology, July 21, 2014    Clinical Article

4 Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial The Lancet, July 25, 2014    Evidence Based Medicine    Clinical Article

5 Diabetes mellitus, physical activity, and longevity between the ages of 70 and 90 Journal of the American Geriatrics Society, July 14, 2014    Clinical Article

6 Comparison of repaglinide and metformin versus metformin alone for type 2 diabetes: a meta-analysis of randomized controlled trials Diabetes Research and Clinical Practice, July 10, 2014    Evidence Based Medicine    Clinical Article

7 Can people with type 2 diabetes live longer than people without diabetes? A comparison of all-cause mortality in people initiated with metformin monotherapy or sulfonylurea monotherapy and matched controls without diabetes Diabetes, Obesity and Metabolism, July 11, 2014    Clinical Article

8 Thyroid-stimulating hormone, thyroglobulin, and thyroid hormones and risk of differentiated thyroid carcinoma: The EPIC study Journal of the National Cancer Institute, May 14, 2014    Clinical Article

9 Clinical effectiveness of Novolin® 30R versus Lantus® combined with Glucobay® treatment in elderly patients with type 2 diabetes mellitus controlled by oral hypoglycaemic agents: A randomized study The Journal of International Medical Research, July 3, 2014    Clinical Article

10 Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus sitagliptin in patients with type 2 diabetes and renal impairment: A randomized phase III study Diabetes Care, July 23, 2014    Clinical Article

11 Insulin therapy for type 2 diabetes mellitus JAMA, July 1, 2014    Evidence Based Medicine    Clinical Article

12 Comparing dosing of basal insulin analogues detemir and glargine: Is it really unit-per-unit and dose-per-dose? Annals of Pharmacotherapy, March 12, 2014    Clinical Article

13 Canagliflozin, a sodium glucose co-transporter 2 inhibitor, reduces post-meal glucose excursion in patients with type 2 diabetes by a non-renal mechanism: results of a randomized trial Metabolism, July 9, 2014    Clinical Article

14 Effects of omega-3 fatty acid supplementation on insulin metabolism and lipid profiles in gestational diabetes: Randomized, double-blind, placebo-controlled trial Clinical Nutrition, July 17, 2014    Clinical Article

15 Postprandial glucose-lowering effects of fermented red ginseng in subjects with impaired fasting glucose or type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial Full Text BMC Complementary and Alternative Medicine, July 18, 2014    Free full text    Clinical Article

16 Statins and the risk of diabetes: Evidence from a large population-based cohort study Diabetes Care, July 3, 2014    Clinical Article

17 Barriers to initiating insulin in type 2 diabetes patients: development of a new patient education tool to address myths, misconceptions and clinical realities The Patient - Patient-Centered Outcomes Research, July 15, 2014    Clinical Article

18 Comparison of the effects of slowly and rapidly absorbed carbohydrates on postprandial glucose metabolism in type 2 diabetes mellitus patients: a randomized trial American Journal of Clinical Nutrition, July 17, 2014    Clinical Article

19 Effects of weight loss, weight cycling, and weight loss maintenance on diabetes incidence and change in cardiometabolic traits in the diabetes prevention program Diabetes Care, July 16, 2014    Clinical Article

20 ABC goal achievement predicts microvascular but not macrovascular complications over 6-years in adults with type 1 diabetes: The Coronary Artery Calcification in Type 1 Diabetes Study Journal of Diabetes and its Complications, July 14, 2014    Clinical Article

Indexed Journals in Endocrinology: Endocrinology, Journal of Endocrinology, Clinical Endocrinology, Diabetesmore

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Connect with us, stay current.

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close