Clinical trial NCT04862962: Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Keywords: Dyslipidemias
Combine therapy
Lower Cholesterol
Lipids
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over 18 years of age (gender indistinct) with dyslipidemia who, at the discretion of thetreating physician have been candidates for treatment with the fixed-dose combination of rosuvastatin-ezetimibe.

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.

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.

Primary outcomes:
measure: Adverse events presented
timeFrame: 2 months
measure: Average difference in lipid profile values
timeFrame: Baseline, 2 months
Secondary outcomes:
measure: Adherence to treatment
timeFrame: 2 months
measure: Significant reduction in LDL cholesterol
timeFrame: 2 months
measure: Percentage of patients who met established goals according to cardiovascular risk
timeFrame: 2 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Laboratorio Silanes, S.A. de C.V.
Study officials:
affiliation: Resultados Médicos, desarrollo e Investigación
name: Joel Rodriguez Saldaña, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Francisco G Padilla Padilla, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Ernesto G Cardona Muñoz, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: David Cardona Müller, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiólogos Certificados S.C
name: Marcos Ibarra Flores, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: José A Estrada Suarez, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Battaggia A, Donzelli A, Font M, Molteni D, Galvano A. Clinical efficacy and safety of Ezetimibe on major cardiovascular endpoints: systematic review and meta-analysis of randomized controlled trials. PLoS One. 2015 Apr 27;10(4):e0124587. doi: 10.1371/journal.pone.0124587. eCollection 2015.
citation: Ballantyne CM, Weiss R, Moccetti T, Vogt A, Eber B, Sosef F, Duffield E; EXPLORER Study Investigators. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol. 2007 Mar 1;99(5):673-80. doi: 10.1016/j.amjcard.2006.10.022. Epub 2007 Jan 4.
citation: Rodriguez-Saldana J, Padilla-Padilla F, Cardona-Munoz EG, Romero-Antonio Y, Arguedas-Nunez MM, Sander-Padilla JG, Martinez-Munoz A, Lugo-Sanchez LA, Rodriguez-Vazquez IC, Gonzalez-Canudas J. Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete(R)) in Dyslipidemia Patients. Cardiol Res Pract. 2022 Sep 10;2022:9464733. doi: 10.1155/2022/9464733. eCollection 2022.