Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)

Study Overview
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Brief Summary
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In an observational multi-centre study (HEROS), the effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who had not been treated with cholesterol lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.

Official Title
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Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)

Conditions
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Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, Cerebrovascular Accident, Diabetes

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C 3.2 mmol/l. According to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention. The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca Exclusion Criteria: Patients with symptoms of myalgia, myopathy or liver function insufficiency (including raised serum transaminases) which bear a causal relation to the treatment with statins, patients with familiar dyslipidemia and/or patients with contra-indications for treatment with rosuvastatin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 eligible for the study were patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C ≥ 3.2 mmol/l. Patients were aged ≥ 18 years and ≤ 70 years (men) and ≤ 75 years (women), according to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention. The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca | Drug: Rosuvastatin<br>* Oral<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who hadn't been treated with cholesterol lowering drugs in the past 3 months. |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, coronary heart disease, rosuvastatin, LDL-C goal, hypercholesterolemia, secondary prevention, primary prevention, CVA