Cardiovascular Events Based On Statin Initiation In The Elderly

NCT ID: NCT01304641

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31603 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-02-28

Brief Summary

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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

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

Conditions

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Cardiovascular Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Atorvastatin Initiators

Atorvastatin Initiators

Intervention Type OTHER

Retrospective database analysis no intervention performed.

Simvastatin Initiators

Simvastatin Initiators

Intervention Type OTHER

Retrospective database analysis no intervention performed.

Interventions

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Atorvastatin Initiators

Retrospective database analysis no intervention performed.

Intervention Type OTHER

Simvastatin Initiators

Retrospective database analysis no intervention performed.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A2581188

Identifier Type: -

Identifier Source: org_study_id

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