Atherosclerotic Cardiovascular Disease, Cardiovascular Diseases, Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
High-risk dyslipidemic, Low-density lipoprotein cholesterol, Cardiovascular disease, Lipid modifying therapies, Dyslipidemia, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Brief summary
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.
Detailed description
Suffering from hypercholesterolemia is a major health concern in Europe. Appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. Despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. As this is a non-interventional study, only data from routine clinical practice will be documented.
Interventions
OTHERNon-interventional
This is a non-interventional study.
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Very High Risk and High Risk dyslipidemic patients requiring LMTs * Not simultaneously participating in any interventional study * Providing written informed consent for participation in the study (Informed consent form) * Life expectancy \> 1 year
Exclusion criteria
* Not applicable; non-interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants | Baseline up to 12 months post-enrollment | Blood plasma samples were used to assess LDL-C levels. |
| Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) | Baseline up to 12 months post-enrollment | Clinical events were assessed based on information captured in patient files/medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline up to 12 months post-enrollment | Blood plasma samples were used to assess lipid Protein A levels. |
| Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline up to 12 months post-enrollment | Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels. |
| Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Baseline up to 12 months post-enrollment | The safety outcome measure reports clinical events based on information captured in patient files/medical records. Participants may have reported more than one clinical event associated with any LMT. |
| Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants | Baseline up to 12 months post-enrollment | Blood plasma samples were used to assess hsCRP levels. |
| Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline up to 12 months post-enrollment | Blood plasma samples were used to assess Apolipoprotein B levels. |
Countries
Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom
Participant flow
Recruitment details
A total of 9559 participants were documented in this study (all-documented patients set; APS). Of these 9559 participants, 11 failed screening and 5 were not included due to end of enrollment. A total of 9543 participants were included in the Baseline Analysis Set (BAS) at 580 centers in 14 countries. Of these 9543 participants, a total of 9136 were included in the Full Analysis Set (FAS).
Participants by arm
| Arm | Count |
|---|---|
| High Risk and Very High Risk Dyslipidemic Participants Participants were classified as High and Very High Risk (as assessed by the Framingham risk score for High Risk participants and the SMART score for Very High Risk participants) as well as if previously or newly diagnosed. | 9,543 |
| Total | 9,543 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 153 |
| Overall Study | Lost to Follow-up | 300 |
| Overall Study | No end of study information | 42 |
| Overall Study | Other | 51 |
| Overall Study | Withdrawal of consent by patient | 59 |
Baseline characteristics
| Characteristic | High Risk and Very High Risk Dyslipidemic Participants | — |
|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 306 participants | — |
| Region of Enrollment Belgium | 530 participants | — |
| Region of Enrollment Denmark | 319 participants | — |
| Region of Enrollment Finland | 338 participants | — |
| Region of Enrollment France | 855 participants | — |
| Region of Enrollment Germany | 2289 participants | — |
| Region of Enrollment Ireland | 100 participants | — |
| Region of Enrollment Italy | 2089 participants | — |
| Region of Enrollment Netherlands | 535 participants | — |
| Region of Enrollment Portugal | 120 participants | — |
| Region of Enrollment Spain | 1043 participants | — |
| Region of Enrollment Sweden | 192 participants | — |
| Region of Enrollment Switzerland | 169 participants | — |
| Region of Enrollment United Kingdom | 658 participants | — |
| Sex: Female, Male Female | 2618 Participants | — |
| Sex: Female, Male Male | 6925 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 153 / 9,136 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants
Blood plasma samples were used to assess LDL-C levels.
Time frame: Baseline up to 12 months post-enrollment
Population: Low Density Lipid-Cholesterol (LDL-C) levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants | Baseline | 2.40 mmol/L | Standard Deviation 1.2 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Low Density Lipid-Cholesterol (LDL-C) Levels in High and Very High Risk Cardiovascular Participants | 1 Year | 1.99 mmol/L | Standard Deviation 0.94 |
Primary
Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs)
Clinical events were assessed based on information captured in patient files/medical records.
Time frame: Baseline up to 12 months post-enrollment
Population: Treatment modalities were assessed among participants requiring LMTs with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) | Received any LMT | 8931 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) | Received any statin | 7680 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) | Received any ezetimibe | 2538 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants Utilizing Any Treatment Modality to Manage Plasma Levels of Low Density Lipid-Cholesterol (LDL-C) in High and Very High Risk Participants Requiring Lipid Modifying Therapies (LMTs) | Received any other LMT | 2128 Participants |
Secondary
Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess Apolipoprotein B levels.
Time frame: Baseline up to 12 months post-enrollment
Population: Mean apolipoprotein B levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline | 0.92 g/L | Standard Deviation 0.39 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Apolipoprotein B Levels in High Risk and Very High Risk Dyslipidemic Participants | 1 Year | 0.80 g/L | Standard Deviation 0.34 |
Secondary
Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess ASCVD-modifying cholesterol fragment levels.
Time frame: Baseline up to 12 months post-enrollment
Population: Mean ASCVD-modifying cholesterol levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline: HDL-C | 1.27 mmol/L | Standard Deviation 0.4 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | 1 Year: HDL-C | 1.28 mmol/L | Standard Deviation 0.39 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline: Non-HDL-C | 3.02 mmol/L | Standard Deviation 1.35 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | 1 Year: Non-HDL-C | 2.58 mmol/L | Standard Deviation 1.06 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline: Total Cholesterol | 4.31 mmol/L | Standard Deviation 1.4 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | 1 Year: Total Cholesterol | 3.86 mmol/L | Standard Deviation 1.13 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline: Triglycerides | 1.70 mmol/L | Standard Deviation 1.17 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Atherosclerotic Cardiovascular Disease (ASCVD)-Modifying Cholesterol Fragment Levels in High Risk and Very High Risk Dyslipidemic Participants | 1 Year: Triglycerides | 1.56 mmol/L | Standard Deviation 1.04 |
Secondary
Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess hsCRP levels.
Time frame: Baseline up to 12 months post-enrollment
Population: Mean hsCRP levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants | Baseline | 6.90 mg/L | Standard Deviation 14.8 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Inflammatory High-Sensitive C-Reactive Protein (hsCRP) in High Risk and Very High Risk Dyslipidemic Participants | 1 Year | 4.3 mg/L | Standard Deviation 10.4 |
Secondary
Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants
Blood plasma samples were used to assess lipid Protein A levels.
Time frame: Baseline up to 12 months post-enrollment
Population: Mean lipid protein A levels were assessed in participants with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants | Baseline | 47.97 mg/dL | Standard Deviation 53.87 |
| High Risk and Very High Risk Dyslipidemic Participants | Mean Lipid Protein A Levels in High Risk and Very High Risk Dyslipidemic Participants | 1 Year | 51.24 mg/dL | Standard Deviation 53.47 |
Secondary
Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT
The safety outcome measure reports clinical events based on information captured in patient files/medical records. Participants may have reported more than one clinical event associated with any LMT.
Time frame: Baseline up to 12 months post-enrollment
Population: Clinical events were assessed among participants requiring LMTs with available data in the Full Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients with any clinical event associated with treatment modalities | 423 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients with muscle-associated symptoms | 338 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patient with new-onset and/or worsening of diabetes mellitus | 2 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients with reduced kidney function | 19 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients with neurocognitive impairment | 8 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients with laboratory abnormality/abnormalities | 59 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients with missing event-type | 28 Participants |
| High Risk and Very High Risk Dyslipidemic Participants | Number of Participants With Clinical Events Associated With Treatment Modalities, For Any LMT | Patients without any event | 8508 Participants |