N/A
Completed N=31,602
Cardiovascular Events Based On Statin Initiation In The Elderly
Cardiovascular · Dyslipidemia
Source: ClinicalTrials.gov NCT01304641 ↗
Enrolled (actual)
31,602
Serious AEs
—
Results posted
Apr 2012
Primary outcomePrimary: Number of Participants With Post-index Cardiovascular (CV) Events — 700; 1012 Participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Post-index Cardiovascular (CV) Events |
700; 1012 | <0.001 sig |
| PRIMARY Hazard Ratio for First Cardiovascular (CV) Event |
700; 1012; 10770; 19120 | 0.140 |
| SECONDARY Low-density Lipoprotein Cholesterol (LDL-C) |
94.07; 98.03 | <0.001 sig |
| SECONDARY Mean Dose |
19.46; 28.36 | <0.001 sig |
| SECONDARY Number of Participants Per Dose |
5639; 12344; 3940; 6768; 1891; 1020 | <0.001 sig |
| SECONDARY Length of Post-index Period |
519.10; 448.41 | <0.001 sig |
| SECONDARY Percentage of Participants Who Adhered to Index Therapy |
64.92; 57.32; 35.08; 42.68 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01304641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.