Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors

Study Overview
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Brief Summary
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This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months. All HMG-CoA reductase inhibitors must be prescribed in accordance with SmPCs approved in Croatia. Data collection for each patient will take place at a single visit. The investigator will complete a Case Report Form with the patient's demographics, the presence of the factors for high cardiovascular risk, current treatment, cholesterol values as well as with further treatment decision.

Official Title
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Non-interventional Study to Assess Reaching of Cholesterol Target Values in Patients Treated With 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) Reductase Inhibitors in Croatia

Conditions
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Hypercholesterolaemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who have been treated with one HMG-CoA reductase inhibitor for at least 6 months without changing the dose for the last 4 weeks at least. All patients must sign Informed consent form. Exclusion Criteria: Patients who have not signed the Informed consent form. Patients with contraindication for the treatment with HMG-CoA reductase inhibitors as per SmPC approved in Croatia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with hypercholesterolaemia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 
| Percentage of patients reaching the LDL-C goals, according to the Fourth Joint European Task Force guideline |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline. |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 
| Number of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline. |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 
| Number of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline. |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 
| Percentage of patients reaching the total cholesterol goals, according to the Fourth Joint European Task Force guideline. |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 
| Percentage of patients with high cardiovascular risk reaching the LDL-C goals according to the Fourth Joint European Task Force guideline. |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 
| Percentage of patients with high cardiovascular risk reaching the total cholesterol goals according to the Fourth Joint European Task Force guideline. |  | During the study visit scheduled at least 6 months after HMG-CoA reductase inhibitor has been initiated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, HMG-CoA reductase inhibitor, cardiovascular risk, LDLl