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

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia; Coronary Heart Disease; Peripheral Vascular Disease; Cerebrovascular Accident; Diabetes

Intervention: Rosuvastatin (Drug)

Phase: N/A

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Ingrid van Geel, Study Chair, Affiliation: CV
Ingeborg Vosjan, Study Chair, Affiliation: CV

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.

Clinical Details

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

Study design: Cohort, Prospective

Primary outcome: 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.

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: May 2003
Ending date: February 2006
Last updated: April 24, 2008

Page last updated: June 20, 2008

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