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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETEĀ®) | Rosuvastatin /Ezetimibe fixed dose (TREZETEĀ®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose | Drug | Oral Tablets 10 mg/10 mg or 20 mg/10 mg |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joel Rodriguez Saldaña, M.D | Resultados Médicos, desarrollo e Investigación | Principal Investigator |
| Francisco G Padilla Padilla, M.D | Independent | Principal Investigator |
| Ernesto G Cardona MuƱoz, M.D | Independent | Principal Investigator |
| David Cardona Müller, M.D | Independent | Principal Investigator |
| Marcos Ibarra Flores, M.D | Cardiólogos Certificados S.C | Principal Investigator |
| JosƩ A Estrada Suarez, M.D | Independent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Silanes, S.A. de C.V. | Mexico City | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17162426 | Background | Garcia-Garcia G, Aviles-Gomez R, Luquin-Arellano VH, Padilla-Ochoa R, Lepe-Murillo L, Ibarra-Hernandez M, Briseno-Renteria G. Cardiovascular risk factors in the Mexican population. Ren Fail. 2006;28(8):677-87. doi: 10.1080/08860220600936096. | |
| 21346920 | Background | Roth GA, Fihn SD, Mokdad AH, Aekplakorn W, Hasegawa T, Lim SS. High total serum cholesterol, medication coverage and therapeutic control: an analysis of national health examination survey data from eight countries. Bull World Health Organ. 2011 Feb 1;89(2):92-101. doi: 10.2471/BLT.10.079947. Epub 2010 Sep 3. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
| 24603993 | Background | Escobedo-de la Pena J, de Jesus-Perez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish. |
| 30375494 | Background | Adhyaru BB, Jacobson TA. Safety and efficacy of statin therapy. Nat Rev Cardiol. 2018 Dec;15(12):757-769. doi: 10.1038/s41569-018-0098-5. |
| 22442638 | Background | Luvai A, Mbagaya W, Hall AS, Barth JH. Rosuvastatin: a review of the pharmacology and clinical effectiveness in cardiovascular disease. Clin Med Insights Cardiol. 2012;6:17-33. doi: 10.4137/CMC.S4324. Epub 2012 Feb 1. |
| 15531000 | Background | Cheng JW. Rosuvastatin in the management of hyperlipidemia. Clin Ther. 2004 Sep;26(9):1368-87. doi: 10.1016/j.clinthera.2004.09.005. |
| 19436657 | Background | Rubba P, Marotta G, Gentile M. Efficacy and safety of rosuvastatin in the management of dyslipidemia. Vasc Health Risk Manag. 2009;5(1):343-52. doi: 10.2147/vhrm.s3662. Epub 2009 Apr 8. |
| 21267417 | Background | Kones R. Rosuvastatin, inflammation, C-reactive protein, JUPITER, and primary prevention of cardiovascular disease--a perspective. Drug Des Devel Ther. 2010 Dec 9;4:383-413. doi: 10.2147/DDDT.S10812. |
| 25915909 | Background | 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. |
| 17317370 | Background | 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. |
| 36124294 | Derived | 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. |