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

Completed

• Conditions: Diabetes; Coronary Heart Disease; Peripheral Vascular Disease; Hypercholesterolemia; Cerebrovascular Accident
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00660764
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study Completion: 2005-04
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-13
• Last Update Posted: 2009-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.