Cardiovascular Events Based On Statin Initiation In The Elderly

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304641
• Other study ID #: A2581188
• Status: Completed
• Start date: November 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31603
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular
• Dyslipidemia
• Dyslipidemias

Intervention

Other:
• Atorvastatin Initiators
Retrospective database analysis no intervention performed.
• Simvastatin Initiators
Retrospective database analysis no intervention performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Low-density Lipoprotein Cholesterol (LDL-C)		At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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