Cardiovascular Events Based On Statin Initiation In The Elderly

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Cardiovascular
• Intervention / Treatment: Other: Atorvastatin Initiators; Other: Simvastatin Initiators

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 31603

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study included commercial health plan members and Medicare Advantage Part D enrollees ages 65 years and older with a prescription for atorvastatin or simvastatin filled between 01 July 2006 and 30 November 2008 (subject identification period). The first observed atorvastatin or simvastatin fill during the subject identification period was defined as the index drug and the fill date was defined as the index date. A 12-month period prior to the index date (defined as the pre-index period) was used for identification of comorbid exclusionary conditions. The 12-month period prior to index date was also used for assessment of pre-index patient characteristics. Patients were observed for a minimum of 3 months (following index date) until the earlier of either 1) disenrollment from the health plan or 2) 28 February 2009 (post-index period). The pre- and post-index periods in combination were defined as the analytic period.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atorvastatin Initiators	Other: Atorvastatin Initiators; Retrospective database analysis no intervention performed.
Simvastatin Initiators	Other: Simvastatin Initiators; Retrospective database analysis no intervention performed.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dyslipidemia; Cardiovascular; Statin
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Simvastatin
• Other Study ID Numbers: A2581188