Dyslipidemias
Conditions
Keywords
Dyslipidemias, Combine therapy, Lower Cholesterol, Lipids
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.
Interventions
DRUGRosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Oral Tablets 10 mg/10 mg or 20 mg/10 mg
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events presented | 2 months | Describe the frequency and intensity of adverse events presented. |
| Average difference in lipid profile values | Baseline, 2 months | Evaluate the average difference in lipid profile values between at least 2 measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to treatment | 2 months | To assess adherence to treatment with rosuvastatin / ezetimibe fixed-dose combination by pill count. |
| Significant reduction in LDL cholesterol | 2 months | To assess the proportion of subjects who achieved a significant reduction in LDL cholesterol at each concentration of treatment. |
| Percentage of patients who met established goals according to cardiovascular risk | 2 months | 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. |
Countries
Mexico
Outcome results
None listed