Hyperlipidemia
Conditions
Brief summary
It is a prospective observational study. Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased. We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.
Detailed description
Consecutive patient sampling
Interventions
DEVICELipid Self Test
Self test for lipid levels, twice during study period
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 100 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older and able to understand and sign the informed consent form. * Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.
Exclusion criteria
* Patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study. * Patients participating in other clinical trials or non-interventional studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 | Month 12 | Participants with Yes response to a question which stated The self-test have increased my motivation for taking my medication for hyperlipidemia?. The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test. |
| Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12 | Month 12 | Participants with Yes response to a question which stated The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?. |
| Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8 | Week 8 | Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?. |
| Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6 | Month 6 | Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?. |
| Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12 | Month 12 | Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?. |
| Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8 | Week 8 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
| Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6 | Month 6 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
| Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12 | Month 12 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
| Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 | Week 8 | Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
| Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 | Month 6 | Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
| Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 | Month 12 | Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
Countries
Sweden
Participant flow
Pre-assignment details
A total of 259 participants were enrolled in the study, out of which 2 participants were not evaluated due to screening failure.
Participants by arm
| Arm | Count |
|---|---|
| Statins Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months. | 257 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Other | 36 |
| Overall Study | Participant was missing | 1 |
Baseline characteristics
| Characteristic | Statins |
|---|---|
| Age, Continuous | 65.4 Years STANDARD_DEVIATION 9.2 |
| Low-density lipoprotein (LDL) lower than 2.5 millimole/liter (mmol/L) | 30.7 Percentage of participants |
| Positive response on self -estimated treatment compliance | 94.2 Percentage of participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 259 |
| serious Total, serious adverse events | 7 / 259 |
Outcome results
Primary
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Time frame: Month 12
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12 | 51.4 Percentage of participants |
Primary
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Time frame: Month 6
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6 | 8.2 Percentage of participants |
Primary
Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8
LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Time frame: Week 8
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8 | 9.3 Percentage of participants |
Primary
Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12
Participants with Yes response to a question which stated The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?.
Time frame: Month 12
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12 | 54.9 Percentage of participants |
Primary
Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12
Participants with Yes response to a question which stated The self-test have increased my motivation for taking my medication for hyperlipidemia?. The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.
Time frame: Month 12
Population: The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 | 36.2 Percentage of participants |
Primary
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12
Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?.
Time frame: Month 12
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12 | 75.9 Percentage of participants |
Primary
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6
Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?.
Time frame: Month 6
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6 | 61.1 Percentage of participants |
Primary
Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8
Participants with Yes response to a question which stated Have you been taking at least 90% of your medication for hyperlipidemia?.
Time frame: Week 8
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8 | 74.3 Percentage of participants |
Primary
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12
Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Time frame: Month 12
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Statins | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 | Yes | 31.9 Percentage of participants |
| Statins | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 | No | 13.6 Percentage of participants |
Primary
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6
Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Time frame: Month 6
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Statins | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 | Yes | 14.0 Percentage of participants |
| Statins | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 | No | 10.1 Percentage of participants |
Primary
Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8
Participants with Yes or No responses to a question which stated Have you reached your target LDL-cholesterol level?. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.
Time frame: Week 8
Population: The FAS included all enrolled participants who met all inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Statins | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 | Yes | 14.8 Percentage of participants |
| Statins | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 | No | 18.3 Percentage of participants |