A Drug Utilisation Study of Qsiva for Weight Management: A Postmarketing Cohort Database Study in Denmark, Finland, Norway, and Sweden

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

Study drug and medical condition

• Medicinal product name, other:
  Qsiva
• Study drug International non-proprietary name (INN) or common name:
  PHENTERMINE HYDROCHLORIDE

  TOPIRAMATE
• Anatomical Therapeutic Chemical (ATC) code:
  (A08AA51) phentermine and topiramate

  phentermine and topiramate
• Medical condition to be studied:
  Psychiatric symptom

  Cardiovascular symptom

  Obesity

Population studied

• Short description of the study population:
  The study will include all individuals with at least 5 years of available information in the data source before receiving a first dispensing of Qsiva during the study period (Dec 2024 up to Dec 2031 [longest study period for patient inclusion]).
• 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)
• Estimated number of subjects:
  1000

Study design details

• Study design:
  This will be a multi-country, non-interventional cohort study using secondary data to evaluate the effectiveness of risk minimisation measures regarding the risks of cardiovascular and psychiatric conditions among patients prescribed Qsiva.
• Main study objective:
  (1) To describe demographic and baseline characteristics of patients initiating Qsiva; (2) To evaluate Qsiva use inconsistent with specified warnings and precautions and inconsistent with contraindication listed below:; – Qsiva use inconsistent with warnings and precautions:; a) Use in patients with a history of recurrent major depression, bipolar disorder, or psychosis, or in patients with current depression of moderate or worse severity or in patients with suicidal ideation and behaviour; b) Use in patients with a recent myocardial infarction or in other patients at high cardiovascular risk including those with a history of advanced cardiovascular disease (e.g., recent stroke, malignant arrhythmias, congestive heart failure); – Qsiva use inconsistent with contraindication:; a) Use in patients receiving treatment with monoamine oxidase inhibitors (MAOIs); b) Other medicinal products intended for weight loss
• Setting:
  The study is planned to be conducted 4 European countries (Denmark, Finland, Norway, and Sweden) in which Qsiva is approved. National health registers, which collect data from daily practice in the study countries, will be used to study the patient characteristics and prescribing practices in the real world.
• Comparators:
  No comparator.
• Outcomes:
  Patient characteristics, indicators of inappropriate prescribing (e.g., selected cardiovascular conditions and psychiatric conditions, contraindicated medications), indicators of appropriate prescribing (i.e., hypertension and hypertensive heart disease, type 2 diabetes, dyslipidaemia).
• Data analysis plan:
  Exposure to Qsiva will be identified through Anatomical Therapeutic Chemical (ATC) codes based on dispensing prescriptions. Daily dose of Qsiva will be assessed. Characteristics of patients exposed to Qsiva will be assessed at baseline, including demographic variables (e.g., sex, age), lifestyle variables, indicators of inappropriate prescribing (e.g., selected cardiovascular conditions and psychiatric conditions, contraindicated medications), indicators of appropriate prescribing (i.e., hypertension and hypertensive heart disease, type 2 diabetes, dyslipidaemia), other comorbidities, other comedications, and prescriber information. The distributions of all study variables will be calculated and reported. The distribution of characteristics will be calculated and displayed as counts and percentages for categorical variables. For continuous variables, means, standard deviations, medians, first quartiles, third quartiles, first percentile and 99th percentile will be calculated, as appropriate.