Clinical trial NCT00726856: Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
Official title: A Retrospective Survey to Evaluate the Effectiveness and Safety of Dual Inhibition Lipid-lowering Regimen in the Treatment of Dyslipidemic Patients in Normal Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 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

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

Eligibility 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.

Primary outcomes:
measure: Evaluation of the change in LDL-C levels after treatment
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of the percentage of patients who attain their National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III target for LDL-C
timeFrame: 3 months
measure: Assessment of patient compliance by evaluating the length of stay on therapy
timeFrame: 3 months
measure: Comparison of the patient comorbidities among populations gathered from different levels of hospitals and specialties
timeFrame: 3 months
measure: Evaluation of safety and tolerability in patients receiving dual inhibition therapy
timeFrame: 3 months
Other outcomes:
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