N/A N=31,602

Cardiovascular Events Based On Statin Initiation In The Elderly

Cardiovascular · Dyslipidemia

Bottom Line

View on ClinicalTrials.gov: NCT01304641 ↗

Enrolled (actual)

31,602

Serious AEs

—

Results posted

Apr 2012

Primary outcome: Primary: Number of Participants With Post-index Cardiovascular (CV) Events — 700; 1012 Participants — p=<0.001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Atorvastatin Initiators (Other); Simvastatin Initiators (Other)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Feb 2011

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

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.

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

View full record on ClinicalTrials.gov →

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.