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

Medical condition to be studied

Dyslipidaemia
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

323
Study design details

Main study objective

to estimate the proportion of patients with mixed dyslipidaemia, initiating Cholib® without prior prescription of simvastatin of the corresponding daily dose (“off-label use”)

Data analysis plan

The statistical analysis will be conducted using SAS® software Version 9.3 for Windows ™ (SAS Institute, North Carolina, USA) and Excel.The statistical unit is the patient. Calculations will be performed on raw data without extrapolation.Continuous variables will be described by the number of valid cases, the number of missing values, mean, standard deviation, median, quartiles (Q1, Q3) and range.Categorical variables will be described as the total number and relative percentage per category.The number of missing data will be indicated, they will not be replaced and not be taken into account for the calculation of the percentages.Confidence intervals of 95% will be calculated for each item, when relevant.Prescribers’ profile will be described per country: age, gender, specialty and region through LTD database.Summaries will be reported at country level. For each analysis period (pre- and post- launch periods) they will be categorized according to the speciality.