An observational study in Cardiovascular and Dyslipidemia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Observational
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.
All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 31,603 is above the median of 600 across 204 observational studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Other: Atorvastatin Initiators
Other: Simvastatin Initiators
Retrospective database analysis no intervention performed.
Retrospective database analysis no intervention performed.
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.
Time frame: 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.
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
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
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
| Milestone | Atorvastatin | Simvastatin |
|---|---|---|
| Started | 11470 | 20132 |
| Completed | 11470 | 20132 |
| Not completed | 0 | 0 |
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.
| Participants | Atorvastatin | Simvastatin |
|---|---|---|
| Number of Participants With Post-index Cardiovascular (CV) Events | 700 | 1012 |
Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.
| Participants | Atorvastatin | Simvastatin |
|---|---|---|
| Number of participants with event | 700 | 1012 |
| Number of participants without event | 10770 | 19120 |
| milligram/deciliter (mg/dL) | Atorvastatin | Simvastatin |
|---|---|---|
| Low-density Lipoprotein Cholesterol (LDL-C) | 94.07 ± 24.50 | 98.03 ± 25.56 |
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.
| mg | Atorvastatin | Simvastatin |
|---|---|---|
| Mean Dose | 19.46 ± 15.91 | 28.36 ± 18.60 |
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).
| Participants | Atorvastatin | Simvastatin |
|---|---|---|
| Low dose | 5639 | 12344 |
| Medium dose | 3940 | 6768 |
| High dose | 1891 | 1020 |
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).
| Days | Atorvastatin | Simvastatin |
|---|---|---|
| Length of Post-index Period | 519.10 ± 251.38 | 448.41 ± 238.11 |
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.
| Percentage of participants | Atorvastatin | Simvastatin |
|---|---|---|
| Less than 80 percent | 64.92 | 57.32 |
| Greater than or equal to 80 percent | 35.08 | 42.68 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atorvastatin | — | — | — |
| Simvastatin | — | — | — |
| Age, Customized(Participants) | Atorvastatin | Simvastatin | Total |
|---|---|---|---|
| 65 to 74 years | 8008 | 13369 | 21377 |
| 75 to 84 years | 2937 | 5790 | 8727 |
| Greater than and equal to (>=) 85 years | 525 | 973 | 1498 |
| Sex: Female, Male(Participants) | Atorvastatin | Simvastatin | Total |
|---|---|---|---|
| Female | 6922 | 12070 | 18992 |
| Male | 4548 | 8062 | 12610 |
No study locations are listed for this record.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.