Cardiovascular Events Based On Statin Initiation In The Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01304641
First received: February 24, 2011
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Cardiovascular
Dyslipidemia
Other: Atorvastatin Initiators
Other: Simvastatin Initiators

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Mean Dose [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Per Dose [ Time Frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Index date (baseline) up to end of study (28 February 2009) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 31603
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Atorvastatin Initiators Other: Atorvastatin Initiators
Retrospective database analysis no intervention performed.
Simvastatin Initiators Other: Simvastatin Initiators
Retrospective database analysis no intervention performed.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304641

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01304641     History of Changes
Other Study ID Numbers: A2581188
Study First Received: February 24, 2011
Results First Received: January 3, 2012
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Dyslipidemia
Cardiovascular
Statin

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Atorvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014