Dyslipidemia
Conditions
Keywords
Statins, Compliance, Dyslipidemia
Brief summary
The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.
Interventions
BEHAVIORALPatient Compliance
Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with dyslipidemia and taking or planning to take statin treatment. * Patients living in the same city of the study center. o Patients aged 18 years and over.
Exclusion criteria
* Patients with severe systemic disease * Patients with alcohol and drug addiction and/or mental disease * Patients nursing or pregnant, or planning to get pregnant during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Were Compliant With Statin Treatment | Month 12 | The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Available Lipid Profiles of Compliant and Non-compliant Participants | Month 12 | Available laboratory measurements of participants were recorded in CRFs. |
| Number of Participants With Reasons of Compliance to Statin Treatment | Month 12 | Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded. |
| Number of Participants With Reasons of Non-compliance to Statin Treatment | Month 12 | Participants were called for a final visit and reasons for non-compliance were recorded. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
This was an observational study evaluating compliance to statin treatment in participants with dyslipidemia. Data available at each visit was recorded in case report forms (CRFs). No laboratory measurements were performed. The gender of 2 subjects was not recorded.
Participants by arm
| Arm | Count |
|---|---|
| Statins Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). | 375 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 107 |
Baseline characteristics
| Characteristic | Statins |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 10.6 |
| Sex/Gender, Customized Female | 186 participants |
| Sex/Gender, Customized Male | 187 participants |
| Sex/Gender, Customized Unknown | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 153 | 4 / 76 | 4 / 44 | 6 / 268 |
| serious Total, serious adverse events | 0 / 153 | 0 / 76 | 0 / 44 | 0 / 268 |
Outcome results
Primary
Percentage of Participants Who Were Compliant With Statin Treatment
The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.
Time frame: Month 12
Population: Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statins | Percentage of Participants Who Were Compliant With Statin Treatment | 86.7 Percentage of participants |
Secondary
Available Lipid Profiles of Compliant and Non-compliant Participants
Available laboratory measurements of participants were recorded in CRFs.
Time frame: Month 12
Population: Primary analysis population, subset of evaluable participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Statins | Available Lipid Profiles of Compliant and Non-compliant Participants | Total cholesterol | 178.94 milligrams per deciliter | Standard Deviation 41.17 |
| Statins | Available Lipid Profiles of Compliant and Non-compliant Participants | Low Density Lipoprotein (LDL) cholesterol | 101.61 milligrams per deciliter | Standard Deviation 33.5 |
| Statins | Available Lipid Profiles of Compliant and Non-compliant Participants | High Density Lipoprotein (HDL) cholesterol | 50.70 milligrams per deciliter | Standard Deviation 14.47 |
| Statins | Available Lipid Profiles of Compliant and Non-compliant Participants | Triglyceride | 137.80 milligrams per deciliter | Standard Deviation 70.24 |
| Non-compliant With Statin Treatment | Available Lipid Profiles of Compliant and Non-compliant Participants | Triglyceride | 156.89 milligrams per deciliter | Standard Deviation 65.32 |
| Non-compliant With Statin Treatment | Available Lipid Profiles of Compliant and Non-compliant Participants | Total cholesterol | 231.59 milligrams per deciliter | Standard Deviation 45.89 |
| Non-compliant With Statin Treatment | Available Lipid Profiles of Compliant and Non-compliant Participants | High Density Lipoprotein (HDL) cholesterol | 53.33 milligrams per deciliter | Standard Deviation 23.76 |
| Non-compliant With Statin Treatment | Available Lipid Profiles of Compliant and Non-compliant Participants | Low Density Lipoprotein (LDL) cholesterol | 156.48 milligrams per deciliter | Standard Deviation 41.22 |
Comparison: Total cholesterolp-value: <0.001t-test, 2 sided
Comparison: LDL cholesterolp-value: <0.001t-test, 2 sided
Comparison: HDL cholesterolp-value: 0.972t-test, 1 sided
Comparison: Triglyceridesp-value: 0.034t-test, 2 sided
Secondary
Number of Participants With Reasons of Compliance to Statin Treatment
Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.
Time frame: Month 12
Population: Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed.
Secondary
Number of Participants With Reasons of Non-compliance to Statin Treatment
Participants were called for a final visit and reasons for non-compliance were recorded.
Time frame: Month 12
Population: Primary analysis population, subset of evaluable participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Can't take drugs regularly due to high drug price | 1 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Lab parameters were normal in final assessment | 11 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Difficulty obtaining prescribed drugs | 8 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Forgot to take drug | 7 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Don't like taking drugs | 9 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Thought it not necessary to take drug | 5 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Was late in taking drug | 1 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Don't think it necesary to take drug continuously | 0 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Don't want to use drugs for a long time | 4 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Experienced adverse events (AEs) | 3 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Think they are useless | 0 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Afraid of becoming an addict | 2 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | I am resting my liver | 0 participants |
| Statins | Number of Participants With Reasons of Non-compliance to Statin Treatment | Other | 9 participants |