Cardiovascular Events Based On Statin Initiation In The Elderly

Study Overview
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Brief Summary
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The purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific objectives for this project are to: 1) examine the demographic and clinical characteristics of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2) compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin was newly initiated.

Detailed Description
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All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.

Official Title
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Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin

Conditions
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Cardiovascular, Dyslipidemia

Intervention / Treatment
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* Other: Atorvastatin Initiators
* Other: Simvastatin Initiators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 1 fill for atorvastatin or simvastatin (not including combination therapy) between 01 July 2006 and 30 November 2008 Age ≥ 65 years as of the year of index date Continuous enrollment with medical and pharmacy benefits during the analytic period Exclusion Criteria: 1 or more fills for a statin or other dyslipidemia medication in the 12-month pre-index period A pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the 12-month pre-index period Patients with evidence of a cardiovascular event in the 12-month pre-index period. Patients who received both atorvastatin and simvastatin on the index date Patients with unknown gender or region Patients who received dyslipidemia medications other than the index drug within 1 months (30 days) following the index date

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atorvastatin Initiators<br> | Other: Atorvastatin Initiators<br>* Retrospective database analysis no intervention performed.<br>|
| Simvastatin Initiators<br> | Other: Simvastatin Initiators<br>* Retrospective database analysis no intervention performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Post-index Cardiovascular (CV) Events | CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims. | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 
| Hazard Ratio for First Cardiovascular (CV) Event | Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model. | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density Lipoprotein Cholesterol (LDL-C) |  | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 
| Mean Dose | The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims. | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 
| Number of Participants Per Dose | Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg). | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 
| Length of Post-index Period | Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009). | Index date (baseline) up to end of study (28 February 2009) | 
| Percentage of Participants Who Adhered to Index Therapy | Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage. | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, Cardiovascular, Statin