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

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose

• Registration Number: NCT04862962
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

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.

Study Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-28
• Study Start: 2021-09-30
• Primary Completion: 2022-01-15
• Status Verified: 2022-02
• Study Completion: 2022-02-15
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)	Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose	Rosuvastatin /Ezetimibe fixed dose (TREZETE®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Laboratorio Silanes, S.A. de C.V.; 🇲🇽 Mexico City, Mexico