Assessment of Health Care Professionals’ Knowledge and Behaviour Regarding Prescribing Conditions of Cholib® (fenofibrate and simvastatin fixed combination): A European PASS conducted in Austria, Portugal, Slovenia, Croatia, Greece and Bulgaria

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

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

  SIMVASTATIN

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  401

Study design details

• Main study objective:
  -To estimate the proportion of first Cholib® prescriptions without prior prescription of simvastatin of the corresponding daily dose ("off-label use").
• Outcomes:
  -to estimate the proportion of first prescriptions of FSFC without prior prescription of simvastatin monotherapy of the corresponding daily dose in patients with mixed dyslipidemia,-to describe and categorize the indications for the fenofibrate/simvastatin initiation, differentiating between Cholib® and FSFC to describe demographic and clinical characteristics of patients receiving these drugs.
• Data analysis plan:
  The statistical analysis will be conducted using the SAS® softwareV9.3 on Windows™ (SAS Institute, North Carolina, USA).Results will be presented, overall and at country level per specialty. Continuous variables will be described by the number of valid cases and missing data, mean, standard deviation, median, Q1, Q3, minimum, and maximum. No missing data will be replaced. Categorical variables will be described as the total number and relative percentage per category. Confidence intervals of 95% will be calculated when relevant. Calculations will first be performed on raw data per specialty, and weighted according to the real proportion of targeted physicians in each country to accurately reflect the population the survey seeks to measure. Possible selection bias will be assessed by comparing the distributions of available characteristics (e.g. region, age, gender, type of practice and specialty) between respondent and non-respondent physicians.