Clinical trial NCT01304641: Cardiovascular Events Based On Statin Initiation In The Elderly
Official title: Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular
Dyslipidemia
Keywords: Dyslipidemia
Cardiovascular
Statin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 31603
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Post-index Cardiovascular (CV) Events
timeFrame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
measure: Hazard Ratio for First Cardiovascular (CV) Event
timeFrame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Secondary outcomes:
measure: Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
measure: Mean Dose
timeFrame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
measure: Number of Participants Per Dose
timeFrame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
measure: Length of Post-index Period
timeFrame: Index date (baseline) up to end of study (28 February 2009)
measure: Percentage of Participants Who Adhered to Index Therapy
timeFrame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: