Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
Efficacy and safety of recombinant human nerve growth factor in patients with diabetic polyneuropathy - A randomized controled trial
Autore:
Apfel, SC; Schwartz, S; Adornato, BT; Freeman, R; Biton, V; Rendell, M; Vinik, A; Giuliani, M; Stevens, JC; Barbano, R; Dyck, PJ;
Indirizzi:
Yeshiva Univ Albert Einstein Coll Med, Dept Neurol, Bronx, NY 10461 USA Yeshiva Univ Albert Einstein Coll Med Bronx NY USA 10461 nx, NY 10461 USA Diabet & Glandular Dis Clin, San Antonio, TX USA Diabet & Glandular Dis Clin San Antonio TX USA Clin, San Antonio, TX USA Diabet & Glandular Dis Clin, Palo Alto, CA USA Diabet & Glandular Dis Clin Palo Alto CA USA Dis Clin, Palo Alto, CA USA Beth Israel Deaconess Med Ctr, Dept Neurol, Boston, MA 02215 USA Beth Israel Deaconess Med Ctr Boston MA USA 02215 l, Boston, MA 02215 USA Arkansas Res Program, Little Rock, AR USA Arkansas Res Program Little Rock AR USA Res Program, Little Rock, AR USA Creighton Univ, Sch Med, Creighton Diabet Ctr, Omaha, NE USA Creighton Univ Omaha NE USA Sch Med, Creighton Diabet Ctr, Omaha, NE USA Eastern Virginia Med Sch, Inst Diabet, Norfolk, VA 23501 USA Eastern Virginia Med Sch Norfolk VA USA 23501 abet, Norfolk, VA 23501 USA Univ Pittsburgh, Med Ctr, Div Neuromuscular Dis, Pittsburgh, PA USA Univ Pittsburgh Pittsburgh PA USA Neuromuscular Dis, Pittsburgh, PA USA Mayo Clin, Dept Neurol, Scottsdale, AZ USA Mayo Clin Scottsdale AZ USAMayo Clin, Dept Neurol, Scottsdale, AZ USA Univ Rochester, Dept Neurol, Rochester, NY USA Univ Rochester Rochester NY USA ochester, Dept Neurol, Rochester, NY USA Mayo Clin & Mayo Fdn, Mayo Med Sch, Preipheral Neuropathy Ctr, Rochester, MN 55905 USA Mayo Clin & Mayo Fdn Rochester MN USA 55905 Ctr, Rochester, MN 55905 USA
Titolo Testata:
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
fascicolo: 17, volume: 284, anno: 2000,
pagine: 2215 - 2221
SICI:
0098-7484(20001101)284:17<2215:EASORH>2.0.ZU;2-N
Fonte:
ISI
Lingua:
ENG
Soggetto:
RETROGRADE AXONAL-TRANSPORT; DETECTION THRESHOLDS; FACTOR NGF; NEUROPATHY; SKIN; RATS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
25
Recensione:
Indirizzi per estratti:
Indirizzo: Apfel, SC Yeshiva Univ Albert Einstein Coll Med, Kennedy Ctr 401, 1300 Morris Pk Ave, Bronx, NY 10461 USA Yeshiva Univ Albert Einstein Coll Med 1300 Morris Pk Ave Bronx NY USA 10461
Citazione:
S.C. Apfel et al., "Efficacy and safety of recombinant human nerve growth factor in patients with diabetic polyneuropathy - A randomized controled trial", J AM MED A, 284(17), 2000, pp. 2215-2221

Abstract

Context Nerve growth factor is a neurotrophic factor that promotes the survival of small fiber sensory neurons and sympathetic neurons in the peripheral nervous system. Recombinant human nerve growth factor (rhNGF) has demonstrated efficacy as treatment for peripheral neuropathy in experimental models and phase 2 clinical trials. Objective To evaluate the efficacy and safety of a 12-month regimen of rhNGF in patients with diabetic polyneuropathy. Design Randomized, double-blind, placebo-controlled phase 3 trial conducted from July 1997 through May 1999,Setting Eighty-four outpatient centers throughout the United States. Patients A total of 1019 men and women aged 18 to 74 years with either type 1 or type 2 diabetes and a sensory polyneuropathy attributable to diabetes. Interventions Patients were randomly assigned to receive either rhNGF, 0.1mug/kg (n = 504), or placebo (n = 515) by subcutaneous injection 3 times per week for 48 weeks. Patients were assessed at baseline, 12 weeks, 24 weeks, and 48 weeks. Main Outcome Measures The primary outcome measure was a change in neuropathy between baseline and week 48, demonstrated by the Neuropathy Impairment Score for the Lower Limbs, compared between the 2 groups. Secondary outcomemeasures included quantitative sensory tests using the CASE IV System, theNeuropathy Symptom and Change questionnaire, the Patient Benefit Questionnaire (PBQ), and a global symptom assessment, as well as nerve conduction studies and occurrence of new plantar foot ulcers. Patients also were evaluated for presence of adverse events. Results Among patients who received rhNGF, 418 (83%) completed the regimencompared with 461 (90%) who received placebo. Administration of rhNGF was safe, with few adverse events attributed to treatment apart from injection site pain/ hyperalgesia and other pain syndromes. However, neither the primary end point (P=.25) nor most of the secondary end points demonstrated a significant benefit of rhNGF. Exceptions were the global symptom assessment (P=.03) and 2 of 32 comparisons within the PBQ, which showed a modest but significant benefit of rhNGF (P=.05 for severity of pain in the legs and P=.003 for 6-month symptoms in the feet and legs). Conclusion Unlike previous phase 2 trials, this phase 3 clinical trial failed to demonstrate a significant beneficial effect of rhNGF on diabetic polyneuropathy.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 28/03/20 alle ore 23:27:29