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Titolo:
Disease status and use of ventilatory support by ALS patients
Autore:
Cedarbaum, JM; Stambler, N;
Indirizzi:
Regeneron Pharmaceut Inc, Clin Affairs, Tarrytown, NY 10591 USA Regeneron Pharmaceut Inc Tarrytown NY USA 10591 , Tarrytown, NY 10591 USA
Titolo Testata:
AMYOTROPHIC LATERAL SCLEROSIS AND OTHER MOTOR NEURON DISORDERS
fascicolo: 1, volume: 2, anno: 2001,
pagine: 19 - 22
SICI:
1466-0822(200103)2:1<19:DSAUOV>2.0.ZU;2-T
Fonte:
ISI
Lingua:
ENG
Soggetto:
AMYOTROPHIC-LATERAL-SCLEROSIS; DETERIORATION; SURVIVAL;
Keywords:
amyotrophic lateral sclerosis; clinical trials; mechanical ventilation;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
8
Recensione:
Indirizzi per estratti:
Indirizzo: Cedarbaum, JM Regeneron Pharmaceut Inc, Clin Affairs, 777 Old Saw Mill River Rd, Tarrytown, NY 10591 USA Regeneron Pharmaceut Inc 777 Old Saw Mill River Rd Tarrytown NY USA 10591
Citazione:
J.M. Cedarbaum e N. Stambler, "Disease status and use of ventilatory support by ALS patients", AMYOTROPH L, 2(1), 2001, pp. 19-22

Abstract

INTRODUCTION: Use of mechanical ventilation (MV), administered either invasively via tracheostomy, or more commonly non-invasively (CPAP, BiPAP), appears to be increasing in ALS. No prospective databases exist that describe the behavior of physicians and patients and the criteria for instituting MVin ALS. METHODS: 387 placebo patients in a Phase III trial of r-metHuBDNF were followed for 9 months. Although the use of MV was not the primary end-point ofthe trial, information was gathered regarding it by cataloging respiratoryadverse events and tracking health resource utilization,RESULTS: 35 of 387 patients utilized My during the trial. Twenty-eight (7%) patients received BiPAP, Seven (2%) were tracheotomized without first receiving BiPAP. Forced vital capacity (NC): BiPAP patients had a mean (+/- SEM) FVC% of 71.8 +/-2.8X and ALSFRS of 27.7 +/-1.0 at baseline; non-BiPAP patients had a mean baseline: FVC% of 88,7 +/-1.0%, and an ALSFRS of 30,3 +/-0.3. Symptom duration at entry was similar for both groups (2.1 +/-0.4 years vs. 2.1 +/-0,1 years). At the time of first use of BiPAP, average FVC% was 47,5 +/-4.0% and ALSFRS score was 22.4 +/-1.5. The range of FVC% at startof BiPAP was 15-87. The nine-month survival was 67.9% for BiPAP patients vs. 86% for non-BiPAP patients. The use of BiPAP varied tremendously among the 38 study sites, with some not employing it at all and others using it inas many as 40% of patients. CONCLUSIONS: Of the 9% of placebo patients who received MV, BiPAP patientswere more rapidly progressing than non-BiPAP patients, and showed a greater eventual mortality rate. Patients began MV at a wide range of values of FVC%, and centers differed in their prescribing practices. Factors influencing BiPAP use are complex, and not strictly related to FVC%.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/04/20 alle ore 13:18:28