Dyslipidemia
Conditions
Brief summary
This study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.
Interventions
BEHAVIORALLifestyle Changes
Diet, increased physical activity, and weight reduction as per European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology were encouraged in addition to pharmacological measures at the discretion of the treating physician.
DRUGHypolipemics
Pharmacological measures at the discretion of the treating physician and in accordance with the respective authorized label and European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology.
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hyperlipidemic * On therapy for hyperlipidemia for \>=3 months without achieving target lipid values
Exclusion criteria
* Hypersensitivity or intolerance to hypolipemics * Significant myopathy or rhabdomiolysis probably caused by hypolipemics * Uncontrolled endocrine or metabolic disease which is known to affect lipid or lipoprotein values (for example, hypothyroidism and hyperthyroidism)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Target Lipid Values | Baseline and Month 3 | Target total cholesterol value was \<4.5 mmol/L and target low densisty lipoprotein (LDL) value was \<2.5 mmol/L |
| Percentage of Participants With Reduced Cardiovascular Risk | Baseline and Month 3 | Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; \>=17 total points for men, and \>=25 total points for women indicates a \>=30% risk of developing cardiovascular disease. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy. | 1,897 |
| Total | 1,897 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 182 |
| Overall Study | Not meeting all eligibility criteria | 117 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized 30-44 Years | 118 Participants |
| Age, Customized 45-64 Years | 1063 Participants |
| Age, Customized >=65 Years | 716 Participants |
| Sex/Gender, Customized Female | 1042 Participants |
| Sex/Gender, Customized Male | 770 Participants |
| Sex/Gender, Customized Unknown | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,196 |
| serious Total, serious adverse events | 0 / 2,196 |
Outcome results
Primary
Percentage of Participants Achieving Target Lipid Values
Target total cholesterol value was \<4.5 mmol/L and target low densisty lipoprotein (LDL) value was \<2.5 mmol/L
Time frame: Baseline and Month 3
Population: Participants meeting all inclusion and exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants Achieving Target Lipid Values | 46.8 Percentage of participants |
Primary
Percentage of Participants With Reduced Cardiovascular Risk
Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; \>=17 total points for men, and \>=25 total points for women indicates a \>=30% risk of developing cardiovascular disease.
Time frame: Baseline and Month 3
Population: Participants meeting all inclusion and exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants With Reduced Cardiovascular Risk | 51.1 Percentage of participants |