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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660764

Purpose

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.

Condition	Intervention
Hypercholesterolemia Coronary Heart Disease Peripheral Vascular Disease Cerebrovascular Accident Diabetes	Drug: Rosuvastatin

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Heart Diseases Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied. [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Study Start Date:	May 2003
Study Completion Date:	February 2006
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 Oral

Groups/Cohorts

Assigned Interventions

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

Oral

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients of practices of General Practioners

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660764

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Ingrid van Geel	CV
Study Chair:	Ingeborg Vosjan	CV

More Information

Responsible Party:	AstraZeneca ( Elisabeth Björk - Medical Science Director )
Study ID Numbers:	25V07
Study First Received:	April 15, 2008
Last Updated:	April 24, 2008
ClinicalTrials.gov Identifier:	NCT00660764
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by AstraZeneca:

cholesterol
coronary heart disease
rosuvastatin
LDL-C goal

hypercholesterolemia
secondary prevention
primary prevention
CVA

Study placed in the following topic categories:

Cerebral Infarction
Myocardial Ischemia
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Rosuvastatin
Neoplasm Metastasis
Brain Ischemia
Hypercholesterolemia
Dyslipidemias
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Heart Diseases

Hyperlipidemias
Metabolic Diseases
Stroke
Diabetes Mellitus
Vascular Diseases
Central Nervous System Diseases
Ischemia
Coronary Disease
Brain Infarction
Infarction
Metabolic disorder
Coronary Artery Disease
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Nervous System Diseases

Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009