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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin Initiators |
| ||
| Simvastatin Initiators |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Initiators | Other | Retrospective database analysis no intervention performed. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Low-density Lipoprotein Cholesterol (LDL-C) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Simvastatin |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Evaluable analysis population included all participants who met inclusion criteria. | Posted | Number | Participants | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. As it was a retrospective study, safety data was not analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Simvastatin Initiators | Other | Retrospective database analysis no intervention performed. |
|
| 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). | 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). | 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. | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. |
|
|
|
| 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. | Evaluable analysis population included all participants who met inclusion criteria. | Posted | Number | Participants | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
|
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| Secondary | Low-density Lipoprotein Cholesterol (LDL-C) | 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. | Posted | Mean | Standard Deviation | milligram/deciliter (mg/dL) | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
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| 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. | Evaluable analysis population included all participants who met inclusion criteria. | Posted | Mean | Standard Deviation | mg | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
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| 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). | Evaluable analysis population included all participants who met inclusion criteria. | Posted | Number | Participants | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
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| 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). | Evaluable analysis population included all participants who met inclusion criteria. | Posted | Mean | Standard Deviation | Days | Index date (baseline) up to end of study (28 February 2009) |
|
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|
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| 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. | Evaluable analysis population included all participants who met inclusion criteria. | Posted | Number | Percentage of participants | At least 3 months from the post-index date (baseline) or end of study (28 February 2009) |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| High dose |
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