Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Condition: Hypertriglyceridemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hypertriglyceridemia; Syndrome
Study type: Observational

Summary: 
      This study is a prospective observational program within the frames of which Tricor
      (fenofibrate) is prescribed to patients with hypertriglyceridemia within a routine procedure
      as a part of the combination therapy with statins.
    

Detailed description: 
      Metabolic syndrome is a cluster of interrelated risk factors that leads to metabolic
      dysregulation and atherosclerotic cardiovascular diseases. The increased risk of
      cardiovascular disease in people with metabolic syndrome has been well established by
      observational studies and meta-analyses.

      Strategies to reduce cardiovascular disease (CVD) risk in primary and secondary prevention
      focus on the optimization of low-density lipoprotein-cholesterol (LDL-C) levels. As
      recommended in current guidelines for lowering blood cholesterol, statins in addition to
      lifestyle modifications remain the first-line therapy to reduce LDL-C in patients at CVD
      risk. However, despite optimal reduction of LDL-C with statins and, correction of other
      modifiable risk factors, CVD risk is not eliminated. The source of this residual risk may be
      due to other atherogenic lipid species such as reduced high-density lipoprotein cholesterol
      (HDL-C) and/or raised triglycerides (TG) which are only modestly affected by statin therapy.

      The use of fibrates in the treatment of dyslipidaemia has changed significantly over recent
      years.

      The potential of fibrate-statin combination treatment is discussed in guidelines and by the
      medical community. Fenofibrate treatment usually reduce TG by 40-50%, total cholesterol (TC)
      and LDL-C by 5-20%, as well as small dense LDL by 10-30%.

      While fibrates are generally well tolerated, combination with a statin might increase the
      risk of side effects and potentially that of myopathy. In the ACCORD study, fenofibrate
      coadministered with simvastatin was neither associated with any increase in the incidence of
      myopathy over that observed with simvastatin monotherapy in patients with type 2 diabetes,
      nor pointing out any safety concerns for the coadministration.

      In view of the demonstrated lipid benefit and good safety profile, fenofibrate is suitable
      for add-on therapy with a statin to minimize the CVD residual risk.

      This post-marketing observational study is conducted to assess effectiveness of fenofibrate
      (145 mg daily) as adjuvant therapy to statins administered for 6 months in patients with
      hypertriglyceridemia and metabolic syndrome.
    

Intervention name(s): Tricor (fenofibrate), 145 mg, film-coated tablet
Intervention type(s): Drug
Intervention description(s): Observational study without intervention. Fenofibrate is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
Other intervention name(s): Tricor
Intervention MeSH terms: Fenofibrate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The program will include adult patients with triglycerides > 2,3 mmol/l who are on statins
        and who are primary prescribed fenofibrate (or fenofibrate treatment break is at least 6
        months) in accordance with ordinary physician practice in Russia.

        The decision to prescribe fenofibrate should be made not on the basis of this protocol but
        in accordance with the routine clinical practice and must be clearly separated from the
        decision to include the patient in the program. No additional diagnostic procedures (in
        addition to standard medical care) should be prescribed. The program included a
        questionnaire for patients to assess the quality of life.
      
Keywords: Tricor; fenofibrate; metabolic syndrome; hypertriglyceridemia