Drug usage patterns of Pylera® in France using the national claims reimbursement database (DUS)

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:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, longitudinal study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A02BD08) bismuth subcitrate, tetracycline and metronidazole

  bismuth subcitrate, tetracycline and metronidazole

Population studied

• Short description of the study population:
  The study included subjects with one or more claims of Pylera® in French databases (SNIIRAM and EGB) from the first marketing in France, starting from April 2013 to March 2015. The study also identified several cohorts from Pylera® post-launch, corresponding to patients with a first prescription in the EGB database.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To describe the usage patterns of Pylera® in real-life practice by obtaining the following data: prescribers, patient age, patient gender, dispensed dose and quantity, number of dispensations over the study period, and concomitant medications dispensing (in particular, of all PPIs).
• Outcomes:
  Misuse: dispensation of more than one pack of Pylera at index date or a dispensation of Pylera not preceded by urea breath test (UBT) or endoscopy (within the year before first dispensation) / Normal use / Treatment failure / Treatment of recurrent infection, Concomitant medication, healthcare usage, presence of hospitalisation, duration of treatment as assessed by the number of packs dispensed, each counting for 10 days of treatment, total quantity of bismuth subcitrate dispensed per patient.
• Data analysis plan:
  The statistical analyses will be carried out for each interim report and final report by the Department of Pharmacology according to a documented and approved Statistical Analysis Plan (SAP). The SAP describes the statistical analyses as foreseen at the time of planning the study. For each report, statistical analysis will be performed after each database extraction from EGB using SAS® software (SAS Institute, last version, North Carolina, USA). Blind double programming will be used for the main outcome measures. Qualitative variables (dichotomous or categorical) will be described in terms of number and frequency. Quantitative variables will be described in terms of mean, standard deviation, median, first and third quartiles. Descriptive statistics of population included in the study, including patient demographics, prescribers, concomitant medication, usage patterns of Pylera® and evolution over time will be carried out.