Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
Study Details
Study Description
Brief Summary
This retrospective study evaluates the effectiveness and safety of ezetimibe plus statin or ezetimibe plus fenofibrate in dyslipidemic patients that were treated with these dual inhibition lipid lowering regimens as part of their normal standard of care. This study assesses the percentage of patients who achieve LDL-C target goals and also evaluates the patient compliance to treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Retrospective medical chart review
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients patients with dyslipidemia |
Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate
Ezetimibe 10 mg taken daily for 3 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Evaluation of the change in LDL-C levels after treatment [3 months]
Secondary Outcome Measures
- Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C [3 months]
- Assessment of patient compliance by evaluating the length of stay on therapy [3 months]
- Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties [3 months]
- Evaluation of safety and tolerability in patients receiving dual inhibition therapy [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient was > 20 years and < 75 years of age on the index date*
-
Patient diagnosed with dyslipidemia who did not respond adequately based on NCEP ATP III target to previous lipid lowering treatment, and have received dual inhibition therapy, such as ezetimibe plus statins, ezetimibe plus fenofibrate or ezetimibe alone, for at least 3 months
-
Patient has at least one Total Cholesterol and LDL-C measurements at baseline and 3 months after initiating the dual inhibition therapy.
-
Patient has the following records documented in the chart during the data collection period:
-
Medical history and co morbidities (if available)
-
Total Cholesterol and LDL-C. test results before and after initiating the dual inhibition therapy
-
Prescription information of lipid-lowering dual inhibition regimens NOTE: * Index date: the date of initiating dual inhibition therapy
Exclusion Criteria:
-
Patients who do not meet all the inclusion criteria will be excluded from this survey.
-
Patients who were enrolled in other clinical trial observing specific study procedures which deviates from normal practice will not be included in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P05171