Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia

Study Overview
=================
Brief Summary
-----------------
Retrospective, analytical, longitudinal, multicenter study to evaluate the safety of the fixed-dose combination of rosuvastatin / ezetimibe as treatment for patients with dyslipidemia in routine medical practice.

Detailed Description
-----------------
To assess the safety of the fixed-dose combination of rosuvastatin / ezetimibe in subjects older than 18 years of age (gender indistinct) with dyslipidemia who at the discretion have been candidates for treatment with the combination. For the safety analysis, all the research subjects who have taken rosuvastatin / ezetimibe will be considered. The information recorded by the treating physicians in the file will be reviewed and within the case report format (CRF) of all adverse events that occur in the study. The terms originally used in the case report format by the investigators to identify adverse events (AE) will be coded in the analysis stage of Results using the current MEdDRA dictionary. The incidence of AE will be synthesized such as the frequency count and percentage of research subjects with events adverse by organ / system.

Official Title
-----------------
Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years of age. Diagnosis of dyslipidemia. That treatment with the fixed-dose combination of rosuvastatin / ezetimibe is documented. Have security questioning on at least two occasions. Exclusion Criteria: Subjects who has taken any other statins, fibrates, bile acid sequestrants, niacin (> 500 mg) or inhibitors of PCSK9 concomitantly during treatment with rosuvastatin / ezetimibe.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)<br>Rosuvastatin /Ezetimibe fixed dose (TREZETE®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral | Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose<br>* Oral Tablets 10 mg/10 mg or 20 mg/10 mg<br>* Other names: (TREZETE®);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events presented | Describe the frequency and intensity of adverse events presented. | 2 months | 
| Average difference in lipid profile values | Evaluate the average difference in lipid profile values between at least 2 measurements. | Baseline, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment | To assess adherence to treatment with rosuvastatin / ezetimibe fixed-dose combination by pill count. | 2 months | 
| Significant reduction in LDL cholesterol | To assess the proportion of subjects who achieved a significant reduction in LDL cholesterol at each concentration of treatment. | 2 months | 
| Percentage of patients who met established goals according to cardiovascular risk | To identify the percentage of patients who met the established goals according to cardiovascular risk determined by the European Society of Cardiology (ESC) and / or American Heart Association (AHA) / American College of Cardiology (ACC) recommendations. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyslipidemias, Combine therapy, Lower Cholesterol, Lipids