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< Practice Enhancement Programs / PRIMULA
Clinical Trial Name:
PRIMULA - Prevalence, Treatment Patterns & Resource Use In Patients with Mixed Dyslipidemia Using Lipid Lowering Agents

Status: enrolling

FDA Clinical Trial number:
observational study; not applicable

Brief description:  
PRIMULA is a retrospective cohort study of high-risk Canadian patients with Dyslipidemia who have received their first lipid-lowering prescription between November 1 2005 and January 1 2007.

Eligibility:  
High-risk patients, 35 years and older with Dyslipidemia include those with (1) a diagnosis of atherosclerotic vascular disease (coronary artery disease, cerebrovascular disease, peripheral arterial disease); (2) diabetes; or (3) with a >=20% 10-year risk of coronary artery disease-related death or nonfatal MI as determined by the Framingham risk score.

Inclusion/exclusion criteria:  
Patients new to statin/LLT therapy; AND At high-risk as defined by CCS Guidelines. Age 35 years and older at Index Date

Patients having the core data set in their medical record and having at least one fasting TC, HDL-C, LDL-C and TG record within the 12 months before and after their Index Date.  

Diagnosis of Dyslipidemia and fasting lipid values defining Dyslipidemia and initiation of treatment with statin/LLT between 12 months and 24 months prior to Enrolment Date.

Continuous treatment with (any) statin/LLT from the Index Date to at least 6 weeks prior to the Enrolment Date.

Sponsor(s):
PRIMULA is supported through research funding to the CHRC from
Merck and Merck Frosst