Monitoring of Compliance with Exenatide Prescribing Guidelines in Canada: Drug Utilisation Study of BYETTA in Canada for 2011-2014

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective database study

Population studied

• Short description of the study population:
  All patients in the IMS Brogan’s LRx database who have been prescribed Byetta in Canada during the analysis period from 2011-2014.
• 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)
• Estimated number of subjects:
  1027

Study design details

• Main study objective:
  To evaluate BYETTA use outside labelling indications in Canada.
• Outcomes:
  The majority of patients were treated with BYETTA in accordance with the Canadian Product Monograph. One-third of patients in the inferred on-label category displayed some off-label behaviour at certain time points, mainly in conjunction with basal insulin
• Data analysis plan:
  This was a retrospective cohort study, with no hypothesis test. Number and proportion of patients were classified in each patient cohort of “inferred on-label”, “off-label” and “inferred off-label”, data were described by study year and gender. Overall off-label use was calculated. Concomitant use of BYETTA with insulin or TZD was further studied. Data on age and gender were obtained based on records documented in the prescription database when a patient initiating a treatment with BYETTA. The patterns and drug classes of concomitant medications were studied and described for each of the three patient cohorts.