Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy

S. C. Apfel, J. A. Kessler, B. T. Adornato, William J Litchy, C. Sanders, C. A. Rask

Research output: Contribution to journalArticle

252 Citations (Scopus)

Abstract

Background: Preclinical studies have demonstrated that nerve growth factor may prevent or reverse peripheral neuropathy. We have therefore tested the effects of recombinant human nerve growth factor in patients with diabetic polyneuropathy. Methods: A total of 250 patients with symptomatic diabetic polyneuropathy randomly received either placebo or one of two doses of recombinant human nerve growth factor for 6 months. Patients were assessed for symptoms and signs of polyneuropathy before and after treatment. Results: Compared with placebo, recombinant human nerve growth factor led to significant improvement after 6 months of treatment, as measured by the sensory component of the neurologic examination, two quantitative sensory tests, and the impression of most subjects that their neuropathy had improved. Three prospectively identified multiple endpoint analyses indicated improvements in the nerve growth factor treatment groups over the placebo group in all three analyses (p = 0.032; p = 0.008; p = 0.005). Recombinant human nerve growth factor was well tolerated, with injection site discomfort reported as the most frequent adverse event. Conclusions: Recombinant human nerve growth factor appears to be safe and shows preliminary evidence of efficacy in patients with symptomatic diabetic polyneuropathy.

Original languageEnglish (US)
Pages (from-to)695-702
Number of pages8
JournalNeurology
Volume51
Issue number3
StatePublished - Sep 1998
Externally publishedYes

Fingerprint

Diabetic Neuropathies
Nerve Growth Factor
Placebos
Therapeutics
Polyneuropathies
Neurologic Examination
Peripheral Nervous System Diseases
Signs and Symptoms
Injections

ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Apfel, S. C., Kessler, J. A., Adornato, B. T., Litchy, W. J., Sanders, C., & Rask, C. A. (1998). Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy. Neurology, 51(3), 695-702.

Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy. / Apfel, S. C.; Kessler, J. A.; Adornato, B. T.; Litchy, William J; Sanders, C.; Rask, C. A.

In: Neurology, Vol. 51, No. 3, 09.1998, p. 695-702.

Research output: Contribution to journalArticle

Apfel, SC, Kessler, JA, Adornato, BT, Litchy, WJ, Sanders, C & Rask, CA 1998, 'Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy', Neurology, vol. 51, no. 3, pp. 695-702.
Apfel SC, Kessler JA, Adornato BT, Litchy WJ, Sanders C, Rask CA. Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy. Neurology. 1998 Sep;51(3):695-702.
Apfel, S. C. ; Kessler, J. A. ; Adornato, B. T. ; Litchy, William J ; Sanders, C. ; Rask, C. A. / Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy. In: Neurology. 1998 ; Vol. 51, No. 3. pp. 695-702.
@article{7e7d18aef07c472d8475af5c981d21c4,
title = "Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy",
abstract = "Background: Preclinical studies have demonstrated that nerve growth factor may prevent or reverse peripheral neuropathy. We have therefore tested the effects of recombinant human nerve growth factor in patients with diabetic polyneuropathy. Methods: A total of 250 patients with symptomatic diabetic polyneuropathy randomly received either placebo or one of two doses of recombinant human nerve growth factor for 6 months. Patients were assessed for symptoms and signs of polyneuropathy before and after treatment. Results: Compared with placebo, recombinant human nerve growth factor led to significant improvement after 6 months of treatment, as measured by the sensory component of the neurologic examination, two quantitative sensory tests, and the impression of most subjects that their neuropathy had improved. Three prospectively identified multiple endpoint analyses indicated improvements in the nerve growth factor treatment groups over the placebo group in all three analyses (p = 0.032; p = 0.008; p = 0.005). Recombinant human nerve growth factor was well tolerated, with injection site discomfort reported as the most frequent adverse event. Conclusions: Recombinant human nerve growth factor appears to be safe and shows preliminary evidence of efficacy in patients with symptomatic diabetic polyneuropathy.",
author = "Apfel, {S. C.} and Kessler, {J. A.} and Adornato, {B. T.} and Litchy, {William J} and C. Sanders and Rask, {C. A.}",
year = "1998",
month = "9",
language = "English (US)",
volume = "51",
pages = "695--702",
journal = "Neurology",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Recombinant human nerve growth factor in the treatments of diabetic polyneuropathy

AU - Apfel, S. C.

AU - Kessler, J. A.

AU - Adornato, B. T.

AU - Litchy, William J

AU - Sanders, C.

AU - Rask, C. A.

PY - 1998/9

Y1 - 1998/9

N2 - Background: Preclinical studies have demonstrated that nerve growth factor may prevent or reverse peripheral neuropathy. We have therefore tested the effects of recombinant human nerve growth factor in patients with diabetic polyneuropathy. Methods: A total of 250 patients with symptomatic diabetic polyneuropathy randomly received either placebo or one of two doses of recombinant human nerve growth factor for 6 months. Patients were assessed for symptoms and signs of polyneuropathy before and after treatment. Results: Compared with placebo, recombinant human nerve growth factor led to significant improvement after 6 months of treatment, as measured by the sensory component of the neurologic examination, two quantitative sensory tests, and the impression of most subjects that their neuropathy had improved. Three prospectively identified multiple endpoint analyses indicated improvements in the nerve growth factor treatment groups over the placebo group in all three analyses (p = 0.032; p = 0.008; p = 0.005). Recombinant human nerve growth factor was well tolerated, with injection site discomfort reported as the most frequent adverse event. Conclusions: Recombinant human nerve growth factor appears to be safe and shows preliminary evidence of efficacy in patients with symptomatic diabetic polyneuropathy.

AB - Background: Preclinical studies have demonstrated that nerve growth factor may prevent or reverse peripheral neuropathy. We have therefore tested the effects of recombinant human nerve growth factor in patients with diabetic polyneuropathy. Methods: A total of 250 patients with symptomatic diabetic polyneuropathy randomly received either placebo or one of two doses of recombinant human nerve growth factor for 6 months. Patients were assessed for symptoms and signs of polyneuropathy before and after treatment. Results: Compared with placebo, recombinant human nerve growth factor led to significant improvement after 6 months of treatment, as measured by the sensory component of the neurologic examination, two quantitative sensory tests, and the impression of most subjects that their neuropathy had improved. Three prospectively identified multiple endpoint analyses indicated improvements in the nerve growth factor treatment groups over the placebo group in all three analyses (p = 0.032; p = 0.008; p = 0.005). Recombinant human nerve growth factor was well tolerated, with injection site discomfort reported as the most frequent adverse event. Conclusions: Recombinant human nerve growth factor appears to be safe and shows preliminary evidence of efficacy in patients with symptomatic diabetic polyneuropathy.

UR - http://www.scopus.com/inward/record.url?scp=0031752714&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031752714&partnerID=8YFLogxK

M3 - Article

C2 - 9748012

AN - SCOPUS:0031752714

VL - 51

SP - 695

EP - 702

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 3

ER -