| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
From the Department of Neurology (Drs. Apfel and Kessler), Albert Einstein College of Medicine, Bronx, NY; Department of Neurology (Dr. Adornato), Stanford University, Palo Alto, CA; Department of Neurology (Dr. Litchy), Health Partners, Minneapolis, MN; and Genentech, Inc. (Drs. Sanders and Rask), South San Francisco, CA.
Address correspondence and reprint requests to Dr Apfel, Kennedy Center, Room 401, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Bronx, NY 10461.
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.
*See the Appendix on page 701 for a list of members of the NGF Study Group.
Supported by Genentech, Inc., South San Francisco, CA.
Received January 20, 1998. Accepted in final form May 15, 1998.
This article has been cited by other articles:
|
|
 |
|
  P. J. Dyck, J. E. Norell, H. Tritschler, K. Schuette, R. Samigullin, D. Ziegler, E. J. Bastyr III, W. J. Litchy, and P. C. O'Brien Challenges in Design of Multicenter Trials: End points assessed longitudinally for change and monotonicity Diabetes Care, October 1, 2007; 30(10): 2619 - 2625. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Kakinoki, S. Sekimoto, S. Yuki, T. Ohgami, M. Sejima, K. Yamagami, and K.-i. Saito Orally Active Neurotrophin-Enhancing Agent Protects Against Dysfunctions of the Peripheral Nerves in Hyperglycemic Animals Diabetes, March 1, 2006; 55(3): 616 - 621. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Gandhi, J. M. Ryals, and D. E. Wright Neurotrophin-3 Reverses Chronic Mechanical Hyperalgesia Induced by Intramuscular Acid Injection J. Neurosci., October 20, 2004; 24(42): 9405 - 9413. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Sasaki, M. B. Chancellor, W. F. Goins, M. W. Phelan, J. C. Glorioso, W. C. de Groat, and N. Yoshimura Gene Therapy Using Replication-Defective Herpes Simplex Virus Vectors Expressing Nerve Growth Factor in a Rat Model of Diabetic Cystopathy Diabetes, October 1, 2004; 53(10): 2723 - 2730. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 D. Ziegler Polyneuropathy in the diabetic patient--update on pathogenesis and management Nephrol. Dial. Transplant., September 1, 2004; 19(9): 2170 - 2175. [Full Text] [PDF]
|
|
|
|
|
|
A. J.M. Boulton, R. A. Malik, J. C. Arezzo, and J. M. Sosenko Diabetic Somatic Neuropathies Diabetes Care, June 1, 2004; 27(6): 1458 - 1486. [Full Text] [PDF]
|
|
|
|
 |
|
 C. Pisano, G. Pratesi, D. Laccabue, F. Zunino, P. Lo Giudice, A. Bellucci, L. Pacifici, B. Camerini, L. Vesci, M. Castorina, et al. Paclitaxel and Cisplatin-Induced Neurotoxicity: A Protective Role of Acetyl-L-Carnitine Clin. Cancer Res., November 15, 2003; 9(15): 5756 - 5767. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Malik Failure to define the pathogenesis and treatment of human diabetic neuropathy The British Journal of Diabetes & Vascular Disease, March 1, 2003; 3(2): 107 - 111. [Abstract] [PDF]
|
|
|
|
 |
|
 J. Sawynok Topical and Peripherally Acting Analgesics Pharmacol. Rev., March 1, 2003; 55(1): 1 - 20. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. R. Goss, W. F. Goins, D. Lacomis, M. Mata, J. C. Glorioso, and D. J. Fink Herpes Simplex-Mediated Gene Transfer of Nerve Growth Factor Protects Against Peripheral Neuropathy in Streptozotocin-Induced Diabetes in the Mouse Diabetes, July 1, 2002; 51(7): 2227 - 2232. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 X.-H. Liu, R. J. Collier, and R. J. Youle Inhibition of Axotomy-induced Neuronal Apoptosis by Extracellular Delivery of a Bcl-XL Fusion Protein J. Biol. Chem., November 30, 2001; 276(49): 46326 - 46332. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. C. Apfel, S. Schwartz, B. T. Adornato, R. Freeman, V. Biton, M. Rendell, A. Vinik, M. Giuliani, J. C. Stevens, R. Barbano, et al. Efficacy and Safety of Recombinant Human Nerve Growth Factor in Patients With Diabetic Polyneuropathy: A Randomized Controlled Trial JAMA, November 1, 2000; 284(17): 2215 - 2221. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. M. Ransohoff and C. Trebst Surprising Pleiotropy of Nerve Growth Factor in the Treatment of Experimental Autoimmune Encephalomyelitis J. Exp. Med., May 8, 2000; 191(10): 1625 - 1630. [Full Text] [PDF]
|
|
|
|
 |
|
 C. B. Nguyen, E. Szönyi, M. D. Sadick, T. E. Hotaling, J.-L. Mendoza-Ramirez, and E. Escandón Stability and Interactions of Recombinant Human Nerve Growth Factor in Different Biological Matrices: In Vitro and In Vivo Studies Drug Metab. Dispos., May 1, 2000; 28(5): 590 - 597. [Abstract] [Full Text]
|
|
|
|
|
|
C. B. Nguyen, L. Harris, E. Szönyi, S. A. Baughman, V. G. Hale, N. O. Dybdal, M. D. Sadick, and E. Escandón Tissue Disposition and Pharmacokinetics of Recombinant Human Nerve Growth Factor after Acute and Chronic Subcutaneous Administration in Monkeys Drug Metab. Dispos., May 1, 2000; 28(5): 598 - 607. [Abstract] [Full Text]
|
|
|
|
 |
|
 S. G. Kernie and L. F. Parada The Molecular Basis for Understanding Neurotrophins and Their Relevance to Neurologic Disease Arch Neurol, May 1, 2000; 57(5): 654 - 657. [Full Text] [PDF]
|
|
|
|
 |
|
 J. C. McArthur, C. Yiannoutsos, D. M. Simpson, B. T. Adornato, E. J. Singer, H. Hollander, C. Marra, M. Rubin, B. A. Cohen, T. Tucker, et al. A phase II trial of nerve growth factor for sensory neuropathy associated with HIV infection Neurology, March 14, 2000; 54(5): 1080 - 1088. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 T. B. Freeman, D. E. Vawter, P. E. Leaverton, J. H. Godbold, R. A. Hauser, C. G. Goetz, and C. W. Olanow Use of Placebo Surgery in Controlled Trials of a Cellular-Based Therapy for Parkinson's Disease N. Engl. J. Med., September 23, 1999; 341(13): 988 - 992. [Full Text]
|
|
|
|
|
|
M. Soilu-Hanninen, P. Ekert, T. Bucci, D. Syroid, P. F. Bartlett, and T. J. Kilpatrick Nerve Growth Factor Signaling through p75 Induces Apoptosis in Schwann Cells via a Bcl-2-Independent Pathway J. Neurosci., June 15, 1999; 19(12): 4828 - 4838. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
J. E. Riggs, S. C. Apfel, W. J. Litchy, J. A. Kessler, C. Sanders, B. T. Adornato, and C. A. Rask Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy Neurology, April 1, 1999; 52(7): 1517 - 1517. [Full Text]
|
|
|
|
 |
|
 Peripheral Neuropathy in HIV Disease AIDS Clinical Care, December 1, 1998; 1998(1201): 1 - 1. [Full Text]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
