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

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.

Study Type: Observational

Study Design: Cohort, Prospective

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • 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 Measures

• 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.
  • Time Frame: 2 year
    Safety Issue?: No

Secondary Measures

• Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Ingrid van Geel Study Chair CV  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660764

Study ID Number: 25V07

ClinicalTrials.gov Identifier: NCT00660764

Health Authority: Netherlands: Medical Ethics Review Committee (METC)