Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
Global index of safety (GIS): A new instrument to assess drug safety
Autore:
Sacristan, A; Gomez, JC; Badia, X; Kind, P;
Indirizzi:
Lilly SA, Dept Clin Res, Madrid 28108, Spain Lilly SA Madrid Spain 28108Lilly SA, Dept Clin Res, Madrid 28108, Spain Univ York, Ctr Hlth Econ, York YO1 5DD, N Yorkshire, England Univ York York N Yorkshire England YO1 5DD YO1 5DD, N Yorkshire, England Catalan Inst Publ Hlth, Barcelona, Spain Catalan Inst Publ Hlth Barcelona Spain Inst Publ Hlth, Barcelona, Spain
Titolo Testata:
JOURNAL OF CLINICAL EPIDEMIOLOGY
fascicolo: 11, volume: 54, anno: 2001,
pagine: 1120 - 1125
SICI:
0895-4356(200111)54:11<1120:GIOS(A>2.0.ZU;2-Q
Fonte:
ISI
Lingua:
ENG
Soggetto:
BLIND OLANZAPINE TRIAL; SCHIZOPHRENIA; HALOPERIDOL; PLACEBO;
Keywords:
safety; adverse events; antipsychotics; schizophrenia; olanzapine; risperidone; haloperidol;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
12
Recensione:
Indirizzi per estratti:
Indirizzo: Sacristan, A Lilly SA, Dept Clin Res, Avda Ind 30, Madrid 28108, Spain Lilly SA Avda Ind 30 Madrid Spain 28108 Madrid 28108, Spain
Citazione:
A. Sacristan et al., "Global index of safety (GIS): A new instrument to assess drug safety", J CLIN EPID, 54(11), 2001, pp. 1120-1125

Abstract

There is an asymmetry between the extraordinary development of measures and tools aimed at studying the beneficial effects of the drugs and the more limited methods to assess their safety profile. The goal of our study was to develop a global measuring tool to assess drugs' safety. We conducted a survey of Spanish psychiatrists in mental health centers and outpatient treatment units to assess the severity scores that they would assign to a list of the most common adverse events (AEs) that usually occur with antipsychotic treatment. The severity scores were then applied to the list of AEs thatreally occurred along a naturalistic pharmacoepidemiological study on the use of different antipsychotics in the treatment of schizophrenia. The Global Index of Safety (GIS) of the experimental group treated with olanzapine (OLZ) was compared with the GIS of the control group and with the GIS of specific antipsychotics for which the number of treated patients was greater than 100. A total of 194 psychiatrists rated the severity of each AE on a scale of I (insignificant) to 5 (extremely severe). The individual severity was applied to the 2949 schizophrenic patients included in a pharmacoepidemiological study. A GIS was calculated for every group of patients receivingthe same treatments. The GIS of the control group was higher (4.3) than that calculated from the experimental group (2.5) (P < 0.001). The GIS of therisperidone (3.6) and haloperidol (6.0) subgroups were higher than that calculated from the OLZ group (P < 0.001). The development of a GIS may facilitate the comparison of the safety of several drugs and may constitute a very valuable aid for those involved in selecting drugs. (C) 2001 Elsevier Science Inc. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 18/01/20 alle ore 07:31:48