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

NCT00660764 | Completed

• 1 other identifier: 25V07
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia; Coronary Heart Disease; Peripheral Vascular Disease; Cerebrovascular Accident; Diabetes

Keywords

cholesterol; coronary heart disease; rosuvastatin; LDL-C goal; hypercholesterolemia; secondary prevention; primary prevention; CVA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Study Arms (1)

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

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Oral

Also known as: Crestor

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients of practices of General Practioners

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Disease; Peripheral Vascular Diseases; Stroke; Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ingrid van Geel

  CV

  STUDY CHAIR

• Ingeborg Vosjan

  CV

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 17, 2008
• Study Start: May 1, 2003
• Study Completion: April 1, 2005
• Last Updated: March 16, 2009

Record last verified: 2009-03