Cardiovascular Diseases, Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Hyperlipidemia, Atorvastatin
Brief summary
In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant diseases and cardiovascular risk factor.
Interventions
DRUGAtorvastatin
Atorvastatin, 10- 80 mg, once daily, 6 month treatment
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients, who eligible to sign informed consent; * Patients with indications to lipid lowing therapy, according to local product document. * Patients with CHD and high risk of CV complications (Diabetes Mellitus II, Myocardial Infarction, Heart Failure, Arterial Hypertension, ets) will be included into study; * Patients with LDL levels: \> 3,5 mmol/l
Exclusion criteria
* Individual intolerance of atorvastatin, in accordance to local product document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit | Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit | Month 1 | — |
| Change From Baseline in Lipid Parameters | Month 6 | Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline |
| Percent Change From Baseline in Lipid Parameters | Month 6 | Percent change from baseline calculated as: 100\*(change at Month X)/(baseline value). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lipid Parameters at 1 Month | Month 1 | Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline |
| Percent Change From Baseline in Lipid Parameters at 1 Month | Month 1 | Percent change from baseline calculated as: 100\*(change at Month X)/(baseline value). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily. | 687 |
| Total | 687 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient clinical response | 3 |
| Overall Study | Ongoing | 3 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Atorvastatin |
|---|---|
| Age, Customized Between 18 and 44 years | 35 participants |
| Age, Customized Between 45 and 64 years | 493 participants |
| Age, Customized Greater than or equal to (≥) 65 years | 159 participants |
| High-density lipoprotein (HDL) cholesterol | 48.37 mg/dL STANDARD_DEVIATION 20.14 |
| Low-density lipoprotein (LDL) cholesterol | 179.09 mg/dL STANDARD_DEVIATION 54.19 |
| Sex: Female, Male Female | 283 Participants |
| Sex: Female, Male Male | 404 Participants |
| Total cholesterol | 271.69 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 61.99 |
| Triglycerides | 207.56 mg/dL STANDARD_DEVIATION 145.61 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 687 |
| serious Total, serious adverse events | 0 / 687 |
Outcome results
Primary
Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit
Time frame: Month 6
Population: Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit | 51.52 percentage of participants |
Secondary
Change From Baseline in Lipid Parameters
Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline
Time frame: Month 6
Population: FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Change From Baseline in Lipid Parameters | Change at Month 6 in Total cholesterol, n=593 | -98.06 mg/dL |
| Atorvastatin | Change From Baseline in Lipid Parameters | Change at Month 6 in LDL, n=583 | -76.84 mg/dL |
| Atorvastatin | Change From Baseline in Lipid Parameters | Change at Month 6 in HDL, n=562 | 3.15 mg/dL |
| Atorvastatin | Change From Baseline in Lipid Parameters | Change at Month 6 in Triglycerides, n=585 | -70.57 mg/dL |
Secondary
Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit
Time frame: Month 1
Population: Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure.
Secondary
Percent Change From Baseline in Lipid Parameters
Percent change from baseline calculated as: 100\*(change at Month X)/(baseline value).
Time frame: Month 6
Population: FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Atorvastatin | Percent Change From Baseline in Lipid Parameters | Change at Month 6 in Total cholesterol, n=593 | -33.57 percent change |
| Atorvastatin | Percent Change From Baseline in Lipid Parameters | Change at Month 6 in LDL, n=583 | -40.66 percent change |
| Atorvastatin | Percent Change From Baseline in Lipid Parameters | Change at Month 6 in HDL, n=562 | 14.49 percent change |
| Atorvastatin | Percent Change From Baseline in Lipid Parameters | Change at Month 6 in Triglyceride, n=585 | -23.05 percent change |
Other Pre-specified
Change From Baseline in Lipid Parameters at 1 Month
Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline
Time frame: Month 1
Population: Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.
Other Pre-specified
Percent Change From Baseline in Lipid Parameters at 1 Month
Percent change from baseline calculated as: 100\*(change at Month X)/(baseline value).
Time frame: Month 1
Population: Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.