CardiovascularNCT01304641
Cardiovascular Events Based On Statin Initiation In The Elderly
An observational study of Cardiovascular and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular, Dyslipidemia
- What is being tested?
- Atorvastatin Initiators and Simvastatin Initiators
- How many people
- 31,603 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- 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
About this study
Official title: Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
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.
Read the detailed description
All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.
- Conditions
- Cardiovascular, Dyslipidemia
- Being tested
- Atorvastatin Initiators, Simvastatin Initiators
- Keywords
- Dyslipidemia, Cardiovascular, Statin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin InitiatorsOther
Retrospective database analysis no intervention performed.
Simvastatin InitiatorsOther
Retrospective database analysis no intervention performed.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin Initiators | Not described Receives: Other: Atorvastatin Initiators | |
| Simvastatin Initiators | Not described Receives: Other: Simvastatin Initiators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
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.
Measured: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Secondary outcomes (5)
Low-density Lipoprotein Cholesterol (LDL-C)
Measured: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
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.
Measured: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
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).
Measured: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
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).
Measured: Index date (baseline) up to end of study (28 February 2009)
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.
Measured: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304641
- Sponsor's protocol ID
- A2581188
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2011
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
- ClinicalTrials.gov ID
- NCT01304641
- Acronym / sponsor ID
- A2581188
- Conditions
- Cardiovascular, Dyslipidemia
- Keywords
- Dyslipidemia, Cardiovascular, Statin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,603 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Posted 5 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin Initiators | – | Other: Atorvastatin Initiators |
| Simvastatin Initiators | – | Other: Simvastatin Initiators |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin InitiatorsRetrospective database analysis no intervention performed. | Other | Atorvastatin Initiators |
| Simvastatin InitiatorsRetrospective database analysis no intervention performed. | Other | Simvastatin Initiators |
Primary outcome
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.
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.
5 secondary outcomes
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)
Mean Dose
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Number of Participants Per Dose
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Length of Post-index Period
Time frame: Index date (baseline) up to end of study (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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular and Dyslipidemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.