An Observational Study of Statin Treatment Induced HDL Changes (SIRIUS)

An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease

The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease

Detailed Description

An observational study of statin treatment induced HDL changes - effect on cardiovascular disease

• Study Type: Observational
• Enrollment (Actual): 120000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who received a first prescription of a statin (ATC code C10AA) between 1st of January 2004 and 31st of December 2010. Swedish data will be extracted from medical records and national registers and for UK and the Netherlands from central registers.

Description

Inclusion Criteria:

• Started treatment with statins within the observation period (2004-2010)
• The patient must have valid baseline and follow-up measurements for HDL-C and LDL-C.

Exclusion Criteria:

• Malignancy Alcohol abuse/alcohol dependence

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C	1st of January 2004 to 31st December 2010

Secondary Outcome Measures

Outcome Measure	Time Frame
The effect of statin induced changes in HDL-C (per mmol/L) on a composite endpoint including unstable angina pectoris, myocardial infarction, ischemic stroke and all cause mortality.	1st of January 2004 to 31st December 2010
Time to first occurence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke and ischemic heart disease mortality related to changes in HDL-C.	1st of January 2004 to 31st December 2010
The relationships between acquired HDL levels after statin treatment on the primary endpoint and the effect of HDL increase on the primary endpoint for different levels of baseline HDL	1st of January 2004 to 31st December 2010
Potential interactions between baseline HDL and HDL increase and other factors like age, gender, treatment and co-morbidity on the primary endpoint	1st of January 2004 to 31st December 2010
The health economic consequences of increasing HDL-C with statin treatment	1st of January 2004 to 31st December 2010

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Gunnar Johansson, MD, PROFESSOR, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala Sweden; Principal Investigator: Ron Herings, DR, ASSOC PROF, Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: March 5, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 14, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Statin treatment; Statin treatment induced HDL changes and the effect on cardiovascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NIS-CSE-CRE-2011/1