title: Factors Related to Early Clinical Effects of Quetiapine Extended-Release: A Multinational, Prospective, Observational Study.
abstract: OBJECTIVE
  The first weeks of treatment with antipsychotics are important for the development of their long-term efficacy. The objective of this study was to identify factors related to early clinical effects and quality of life (QoL) improvements with quetiapine extended-release (XR).
  
  
  METHODS
  Six hundred and sixty-five patients starting with quetiapine XR were followed up for 8 weeks (schizophrenia = 153, major depression = 200, bipolar depression = 252, other psychiatric conditions = 60). Clinical effects were assessed by the Clinical Global Impression of Change scale (CGI-C), QoL by the visual analog scale (VAS) of the EQ-5D (QoL-VAS), and adherence by the Moriksy scale. Adverse events were explored: movement disorders by the UKU and Simpson-Angus scales, weight gain by calibrated balances, and diurnal somnolence by the Epworth Somnolence Scale (ESS).
  
  
  RESULTS
  The mean dose of quetiapine XR during follow-up was 195.6 ± 154.8 mg/day. CGI and QoL-VAS scores improved significantly at week 8 by 2.7 ± 0.1 points and 25.1 ± 0.9 points. Adverse events were observed in 34 and 26 % of patients at weeks 4 and 8, respectively. A significant reduction in ESS score was also observed at week 8. Factors independently associated with change in QoL-VAS ≥20 points (n = 292, 43 %) were female gender, more severe disease at baseline, higher antipsychotic dose during follow-up, and improvements in somnolence. Factors independently associated with clinically significant improvement (CGI-C ≥5, n = 610, 93 %) were greater change in QoL-VAS, less frequent movement disorders at baseline, and lack of adverse events during follow-up, especially somnolence.
  
  
  CONCLUSIONS
  Results from this real-setting, large observational study in Central America suggest that disease severity at baseline, gender, antipsychotic dose, and occurrence of adverse reactions has a significant impact on the early clinical effects of quetiapine XR. Clinicaltrials.gov registration number NCT02409823.
authors.affiliation: Clínica de Especialidades Altamira, Managua, Nicaragua.
authors.forename: Luis
authors.initials: L
authors.lastname: Molina
authors.affiliation: Universidad San Carlos de Guatemala, Guatemala, Guatemala.
authors.forename: Byron
authors.initials: B
authors.lastname: Recinos
authors.affiliation: Hospital Juan de Dios de San Pedro, San Pedro, Honduras.
authors.forename: Bezner
authors.initials: B
authors.lastname: Paz
authors.affiliation: Instituto de Salud Mental, Tegucigalpa, Honduras.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Rovelo
authors.affiliation: Colonia Médica, San Salvador, El Salvador.
authors.forename: Fanny Elizabeth
authors.initials: FE
authors.lastname: Elias Rodriguez
authors.affiliation: Clínica de la Conducta, Panama, Panama.
authors.forename: José
authors.initials: J
authors.lastname: Calderón
authors.affiliation: Drugtech, Corporación Farmacéutica Recalcine, San José de Costa Rica, Costa Rica.
authors.forename: Arturo
authors.initials: A
authors.lastname: Arellano
authors.affiliation: Drugtech, Corporación Farmacéutica Recalcine, San José de Costa Rica, Costa Rica.
authors.forename: Santiago
authors.initials: S
authors.lastname: Pomata
authors.affiliation: Pharmacoepidemiology Unit, Etymos Consulting Group, Buenos Aires, Argentina.
authors.forename: María Verónica
authors.initials: MV
authors.lastname: Rey
authors.affiliation: Institute of Cardiology Research (ININCA), University of Buenos Aires, Buenos Aires, Argentina. santiagopl@conicet.gov.ar.|National Research Council (CONICET), Marcelo T. de Alvear 2270, (C1122AAJ), Buenos Aires, Argentina. santiagopl@conicet.gov.ar.
authors.forename: Santiago
authors.initials: S
authors.lastname: Perez-Lloret
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000188:drug therapy*; D011788:Quality of Life; D000069348:Quetiapine Fumarate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy; D012894:Sleep Stages / Q000187:drug effects; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D000069348:Quetiapine Fumarate