Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 31603
- Primary Endpoint
- Hazard Ratio for First Cardiovascular (CV) Event
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Hazard Ratio for First Cardiovascular (CV) Event
Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.
Number of Participants With Post-index Cardiovascular (CV) Events
Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
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.
Secondary Outcomes
- 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(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Percentage of Participants Who Adhered to Index Therapy(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Number of Participants Per Dose(At least 3 months from the post-index date (baseline) or end of study (28 February 2009))
- Length of Post-index Period(Index date (baseline) up to end of study (28 February 2009))