Cardiovascular Events Based On Statin Initiation In The Elderly

Completed

• Conditions: Cardiovascular; Dyslipidemia
• Interventions: Other: Simvastatin Initiators; Other: Atorvastatin Initiators

• Registration Number: NCT01304641
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Results First Submitted: 2012-01-03
• Results First Submitted QC: 2012-03-08
• Results First Posted: 2012-04-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31603

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simvastatin Initiators	Simvastatin Initiators	-
Atorvastatin Initiators	Atorvastatin Initiators	-

Primary Outcome Measures

Name	Time	Method
Hazard Ratio for First Cardiovascular (CV) Event	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	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 Outcome Measures

Name	Time	Method
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)	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.
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)	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.
Number of Participants Per Dose	At least 3 months from the post-index date (baseline) or end of study (28 February 2009)	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).
Length of Post-index Period	Index date (baseline) up to end of study (28 February 2009)	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).