A European, observational, three-year cohort comparative study on the safety of the fixed-dose combination pravastatin 40 mg/fenofibrate 160 mg (Pravafenix) versus statin alone in real clinical practice (POSE)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multicentric, European, comparative, partly retrospective and prospective, observational study

Study drug and medical condition

• Name of medicine:
  PRAVAFENIX
• Medical condition to be studied:
  Hyperlipidaemia

  Dyslipidaemia

Population studied

• Short description of the study population:
  Adults patients aged 18 years or older treated with pravastatin or with a statin used at standard stable dose in monotherapy followed by general practitioners (GPs), cardiologists, endocrinologists, internists in real clinical practice in three European countries.; Inclusion criteria:; § Adult patients (≥18 years old) currently treated or intended to be treated at time of inclusion with Pravafenix. In case of ongoing therapy at enrolment, treatment with Pravafenix must have started within 12 months prior to ICF signature date.; § Adult patients (≥18 years old) treated by a statin in monotherapy at stable standard dose for at least 3 months (dosage stability should have started within 12 months prior to ICF signature date). The standard dose of statin is defined by NCEP ATP III as the dose required to attain an approximate 30% to 40% reduction of LDL-C levels; i.e. atorvastatin 10 mg, lovastatin 40 mg, pravastatin 40 mg, simvastatin 20-40 mg, fluvastatin 40-80 mg and rosuvastatin 5-10 mg.; ; Exclusion criteria:; § The patients who are participating in other clinical studies concomitantly with this survey will not be included in this study.; § Concomitant lipid lowering therapies with fibrates.; § Patients for which no medical records are available at study treatment initiation.
• 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:
  3000

Study design details

• Main study objective:
  The primary objective is to compare the incidence rate of the main safety endpoints between patients treated by Pravafenix or by a statin in monotherapy in real clinical practice conditions within a three-year follow-up period.
• Outcomes:
  Safety endpoints will include renal and urinary disorders, musculoskeletal and connective disorders, hepatobiliary disorders, cholelithiasis, thromboembolic events, pancreatitis, diabetes mellitus aggravated, blood homocysteine increase, interstitial pneumopathy and phototoxicity. To compare the time to first occurence of the main safety endpoints, the incidence rate of cardiovascular events, the incidence rate of the laboratory abnormalities. To describe the adverse events, the patients characteristics and treatment history, the physicans characteristics, the pattern of use of Pravafenix and the routine risk minimisation.
• Data analysis plan:
  Descriptive analyses for continuous variables such as the mean, its bilateral 95% CI, standard deviation, median, minimum and maximum values will be presented. For categorical variables, the number and the percentage of patients in each category will be specified. The two-sided 95 % CI will be specified for the categorical evaluation criteria. The proportion of patients with at least one occurrence of safety endpoint will be described for each safety endpoint along with the two-sided 95% CI. Time to event (“event-free survival”) will be estimated using the Kaplan Meier method. The cumulative distribution function will be plotted. Comparative analyses For descriptive purpose, characteristics of patients at entry will be compared between the two treatment groups. Adjusted and unadjusted absolute and relative risks will be provided based on incidence rates together with 95% CI.

Documents

Study results

POSE_CSR_SYNOPSIS_ver 1.0