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Completed

NCT Number: NCT01304641

Cardiovascular Events Based On Statin Initiation In The Elderly

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.

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Key information

Conditions

Cardiovascular Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin Initiators

Other

Retrospective database analysis no intervention performed.

Simvastatin Initiators

Other

Retrospective database analysis no intervention performed.

Primary outcomes

  1. Number of Participants With Post-index Cardiovascular (CV) Events

    Time frame: 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.

  2. Hazard Ratio for First Cardiovascular (CV) Event

    Time frame: 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.

Secondary outcomes

  1. Low-density Lipoprotein Cholesterol (LDL-C)

    Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)

  2. Mean Dose

    Time frame: 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.

  3. Number of Participants Per Dose

    Time frame: 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).

  4. Length of Post-index Period

    Time frame: 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).

  5. Percentage of Participants Who Adhered to Index Therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2011
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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