PMID- 10847307
OWN - NLM
STAT- MEDLINE
DCOM- 20000621
LR  - 20190831
IS  - 0160-6689 (Print)
IS  - 0160-6689 (Linking)
VI  - 61
IP  - 5
DP  - 2000 May
TI  - The safety of olanzapine compared with other antipsychotic drugs: results of an 
      observational prospective study in patients with schizophrenia (EFESO Study). 
      Pharmacoepidemiologic Study of Olanzapine in Schizophrenia.
PG  - 335-43
AB  - INTRODUCTION: Results of controlled clinical trials should be confirmed through 
      safety and effectiveness studies in nonselected patient cohorts treated according 
      to routine clinical practice. METHOD: Outpatients with schizophrenia (ICD-10 
      criteria) entered this prospective, naturalistic study when they received a new 
      prescription for an antipsychotic drug. Treatment assignment was based on purely 
      clinical criteria, as the study did not include any experimental intervention. 
      Safety was evaluated through the collection of spontaneous adverse events and a 
      specific questionnaire for extrapyramidal symptoms. Global clinical status was 
      measured through the Clinical Global Impressions-Severity (CGI-S) and the Global 
      Assessment of Functioning (GAF) scales. RESULTS: From the 2967 patients included, 
      2128 patients were treated with olanzapine as monotherapy or combined with other 
      drugs (olanzapine group), and 821 were treated with other antipsychotic drugs as 
      monotherapy or combined with other drugs (control group). There were no 
      statistical differences between treatment groups at baseline regarding age, 
      gender, disease duration, or severity of symptoms. Olanzapine was well tolerated 
      and effective in this study. Overall incidence of adverse events was 
      significantly lower in the olanzapine group compared with the control group (p < 
      .001). Somnolence and weight gain were significantly more frequent in the 
      olanzapine group, and akathisia, dystonia, extrapyramidal syndrome, hypertonia, 
      hypokinesia, and tremor were significantly higher in the control group. Clinical 
      improvement at endpoint, measured through the mean change in the CGI-S and the 
      GAF, was significantly higher in the olanzapine group compared with the control 
      group (p = .004). CONCLUSION: These results show that olanzapine is safe and 
      effective in nonselected schizophrenic outpatients and are consistent with the 
      efficacy and safety profile that olanzapine has shown in previous controlled 
      clinical trials.
FAU - Gomez, J C
AU  - Gomez JC
AD  - Eli Lilly and Company, Madrid, Spain. gomez_juan-carlos@lilly.com
FAU - Sacristan, J A
AU  - Sacristan JA
FAU - Hernandez, J
AU  - Hernandez J
FAU - Breier, A
AU  - Breier A
FAU - Ruiz Carrasco, P
AU  - Ruiz Carrasco P
FAU - Anton Saiz, C
AU  - Anton Saiz C
FAU - Fontova Carbonell, E
AU  - Fontova Carbonell E
LA  - eng
PT  - Clinical Trial
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 12794-10-4 (Benzodiazepines)
RN  - 3G0285N20N (Pirenzepine)
RN  - N7U69T4SZR (Olanzapine)
SB  - IM
CIN - J Clin Psychiatry. 2001 Oct;62(10):828-9. PMID: 11816875
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Ambulatory Care
MH  - Antipsychotic Agents/*adverse effects/therapeutic use
MH  - Basal Ganglia Diseases/chemically induced/epidemiology
MH  - Benzodiazepines
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Humans
MH  - Middle Aged
MH  - Olanzapine
MH  - Pirenzepine/adverse effects/*analogs & derivatives/therapeutic use
MH  - Prospective Studies
MH  - Psychiatric Status Rating Scales/statistics & numerical data
MH  - Schizophrenia/*drug therapy
MH  - Treatment Outcome
EDAT- 2000/06/10 09:00
MHDA- 2000/06/24 11:00
CRDT- 2000/06/10 09:00
PHST- 2000/06/10 09:00 [pubmed]
PHST- 2000/06/24 11:00 [medline]
PHST- 2000/06/10 09:00 [entrez]
AID - 10.4088/jcp.v61n0503 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2000 May;61(5):335-43. doi: 10.4088/jcp.v61n0503.