Clinical trial NCT01551784: An Observational Study of Statin Treatment Induced HDL Changes
Official title: An Observational Study of Statin Treatment Induced HDL Changes - Effect on Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Statin treatment
Cardiovascular disease
Statin treatment induced HDL changes and the effect on cardiovascular disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 120000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Time to first occurrence of hospitalization for acute myocardial infarction, unstable angina pectoris or ischemic stroke related to changes in HDL-C
timeFrame: 1st of January 2004 to 31st December 2010
Secondary outcomes:
measure: 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.
timeFrame: 1st of January 2004 to 31st December 2010
measure: 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.
timeFrame: 1st of January 2004 to 31st December 2010
measure: 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
timeFrame: 1st of January 2004 to 31st December 2010
measure: Potential interactions between baseline HDL and HDL increase and other factors like age, gender, treatment and co-morbidity on the primary endpoint
timeFrame: 1st of January 2004 to 31st December 2010
measure: The health economic consequences of increasing HDL-C with statin treatment
timeFrame: 1st of January 2004 to 31st December 2010
Other outcomes:
Locations:
Study officials:
affiliation: Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Uppsala University 751 22 Uppsala Sweden
name: Gunnar Johansson, MD, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
affiliation: Pharmo Institute for Drug Outcomes Research3508 AE UtrechtThe Netherlands
name: Ron Herings, DR, ASSOC PROF
role: PRINCIPAL_INVESTIGATOR
References: