Objective assessment of metabolic monitoring in patients treated with Seroquel® or Seroquel® XR/quetiapine fumarate: use of IMS Disease Analyzer to assess physician behaviour in the UK and Germany

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  QUETIAPINE FUMARATE

Population studied

• Short description of the study population:
  Patients aged 18 and over with diagnoses of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR/quetiapine fumarate during the calendar periods 13 February - 31 August 2012 seen by general practitioners or psychiatrists in Germany and patients seen by general practitioners in the UK during the period 11 January 2012 - 31July 2012.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Schizophrenia, bipolar disorder or major depressive disorder patients
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  Determine whether physicians in the UK and Germany performmonitoring of patients treated with quetiapine fumurate and quetiapine fumarate XL/XR using select lab tests, measurements and counseling during encounters with patients and to document the proportion of physician encounters within the study sample where patient monitoring is performed.
• Outcomes:
  The proportion of physician encounters where the following patient monitoring is performed: counseling patients on healthy lifestyle improvements, recording patient weight at initiation of treatment & during on-going treatment, and monitoring of: hyperlipidemia, signs and symptoms of hyperglycemia, and worsening of glucose control in patients with or at risk for diabetes mellitus
• Data analysis plan:
  Age and risk factor adjusted proportion of patients receiving each metabolic monitoring test/assessment in each country UK and Germany is derived including confidence intervals (95%) associated with the proportions observed. In evaluating patient encounters meeting certainmonitoring characteristics, physician or physician practice is considered.A determination is made as to whether adjustment for any of the following factors is required (for factors with relatively complete ascertainment, > 60%): use of other antipsychotics in addition to quetiapine fumurate in past 6 months, overweight (from physician record based upon BMI > 25), age (50+), female gender, relevant family history, high blood pressure, high cholesterol, and history of cardiovascular disease (in past 12 months), previous lipid panel or blood glucose testing (in the past 12 months).

Documents

Study results

D1443C00128 Clinical Study Report

Study publications

Brody R.S., Liss C.L., Wray H., Iovin R., Michaylira C., Muthutantri, A., Damst…