Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate

• Registration Number: NCT00726856
• Lead Sponsor: Organon and Co

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.

Detailed Description

Retrospective medical chart review

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Ezetimibe 10 mg plus statin or ezetimibe 10 mg plus fenofibrate	patients with dyslipidemia

Primary Outcome Measures

Name	Time	Method
Evaluation of the change in LDL-C levels after treatment	3 months

Secondary Outcome Measures

Name	Time	Method
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