To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias

• Study Type: Observational
• Enrollment (Actual): 3270

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan
    • Research Site
  • Hualien, Taiwan
    • Research Site
  • Kaohsiung, Taiwan
    • Research Site
  • Pingtung, Taiwan
    • Research Site
  • Taichung, Taiwan
    • Research Site
  • Tainan, Taiwan
    • Research Site
  • Taipei, Taiwan
    • Research Site
  • Yun-Lin, Taiwan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

based on regular practice and judged by physicians, patients with hyperlipidemia who need to start prescribed with a statin; or to switch from current therapy to a statin, or require dosage adjustment for statin

Description

Inclusion Criteria:

• patients diagnosed with hyperlipidemia
• Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians
• Patients who are willing to participate in this study and who sign an informed consent form

Exclusion Criteria:

• Pregnancy or breast feeding
• Patient are illiterate or unable to fill the questionnaire for any reason
• Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin.
• Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; patients with hyperlipidemia newly initiating a statin; or switched from current therapy to a statin, or require dosage adjustment for statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes on LDL-C, HDL-C, TG, TC	3~6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
ratio for treatment-to-goal	3~6 months
drug compliance	3~6 months
correlation between patient's insight and therapeutic outcome	3~6 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Wen-Ter Lai, MD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 29, 2008
• First Posted (Estimate): July 31, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Statin; LDL-C
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: NIS-CTW-CRE-2007/1