Cardiovascular, Dyslipidemia
Conditions
Keywords
Dyslipidemia, Cardiovascular, Statin
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.
Interventions
OTHERAtorvastatin Initiators
Retrospective database analysis no intervention performed.
OTHERSimvastatin Initiators
Retrospective database analysis no intervention performed.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-index Cardiovascular (CV) Events | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Per Dose | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 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). |
| Low-density Lipoprotein Cholesterol (LDL-C) | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | — |
| Percentage of Participants Who Adhered to Index Therapy | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 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. |
| Length of Post-index Period | Index date (baseline) up to end of study (28 February 2009) | 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). |
| Mean Dose | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period. | 11,470 |
| Simvastatin Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period. | 20,132 |
| Total | 31,602 |
Baseline characteristics
| Characteristic | Atorvastatin | Simvastatin | Total |
|---|---|---|---|
| Age, Customized 65 to 74 years | 8008 Participants | 13369 Participants | 21377 Participants |
| Age, Customized 75 to 84 years | 2937 Participants | 5790 Participants | 8727 Participants |
| Age, Customized Greater than and equal to (>=) 85 years | 525 Participants | 973 Participants | 1498 Participants |
| Sex: Female, Male Female | 6922 Participants | 12070 Participants | 18992 Participants |
| Sex: Female, Male Male | 4548 Participants | 8062 Participants | 12610 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Population: Evaluable analysis population included all participants who met inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Hazard Ratio for First Cardiovascular (CV) Event | Number of participants with event | 700 Participants |
| Atorvastatin | Hazard Ratio for First Cardiovascular (CV) Event | Number of participants without event | 10770 Participants |
| Simvastatin | Hazard Ratio for First Cardiovascular (CV) Event | Number of participants with event | 1012 Participants |
| Simvastatin | Hazard Ratio for First Cardiovascular (CV) Event | Number of participants without event | 19120 Participants |
p-value: 0.1495% CI: [0.976, 1.192]Regression, Cox
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.
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Population: Evaluable analysis population included all participants who met inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Number of Participants With Post-index Cardiovascular (CV) Events | 700 Participants |
| Simvastatin | Number of Participants With Post-index Cardiovascular (CV) Events | 1012 Participants |
p-value: <0.001Chi-squared
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).
Time frame: Index date (baseline) up to end of study (28 February 2009)
Population: Evaluable analysis population included all participants who met inclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Length of Post-index Period | 519.10 Days | Standard Deviation 251.38 |
| Simvastatin | Length of Post-index Period | 448.41 Days | Standard Deviation 238.11 |
p-value: <0.001t-test, 2 sided
Secondary
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)
Population: Evaluable analysis population included all participants who met inclusion criteria. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Low-density Lipoprotein Cholesterol (LDL-C) | 94.07 milligram/deciliter (mg/dL) | Standard Deviation 24.5 |
| Simvastatin | Low-density Lipoprotein Cholesterol (LDL-C) | 98.03 milligram/deciliter (mg/dL) | Standard Deviation 25.56 |
p-value: <0.001t-test, 2 sided
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.
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Population: Evaluable analysis population included all participants who met inclusion criteria.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atorvastatin | Mean Dose | 19.46 mg | Standard Deviation 15.91 |
| Simvastatin | Mean Dose | 28.36 mg | Standard Deviation 18.6 |
p-value: <0.001t-test, 2 sided
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).
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Population: Evaluable analysis population included all participants who met inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Number of Participants Per Dose | Low dose | 5639 Participants |
| Atorvastatin | Number of Participants Per Dose | Medium dose | 3940 Participants |
| Atorvastatin | Number of Participants Per Dose | High dose | 1891 Participants |
| Simvastatin | Number of Participants Per Dose | High dose | 1020 Participants |
| Simvastatin | Number of Participants Per Dose | Low dose | 12344 Participants |
| Simvastatin | Number of Participants Per Dose | Medium dose | 6768 Participants |
p-value: <0.001Chi-squared
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.
Time frame: At least 3 months from the post-index date (baseline) or end of study (28 February 2009)
Population: Evaluable analysis population included all participants who met inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atorvastatin | Percentage of Participants Who Adhered to Index Therapy | Less than 80 percent | 64.92 Percentage of participants |
| Atorvastatin | Percentage of Participants Who Adhered to Index Therapy | Greater than or equal to 80 percent | 35.08 Percentage of participants |
| Simvastatin | Percentage of Participants Who Adhered to Index Therapy | Less than 80 percent | 57.32 Percentage of participants |
| Simvastatin | Percentage of Participants Who Adhered to Index Therapy | Greater than or equal to 80 percent | 42.68 Percentage of participants |
p-value: <0.001Chi-squared