Education and Awareness Program Targeting the Assessment of Adherence of the Treatment of Dyslipidemia (PRECAVER)

AstraZeneca

Status: Completed

Conditions: Patients With Dyslipidemia

Study type: Observational

Funder types: Industry

Identifiers

NCT00557778

NIS-CBR-CRE-2007/1

Details and patient eligibility

About

Evaluate the benefit (rate of adherence to the treatment), based on the LDL-C reduction in the group that will be exposed to the program of reinforcement of orientation aimed to the patients, compared to the control group, both in previous use of rosuvastatin.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects eligible for the treatment of dyslipidemia with statins according the current guidelines NCEP ATPIII and IV Brazilian Guidelines of Dyslipidemia and Atherosclerosis Prevention.
• Patients with previous use of rosuvastatin for, at least, 15 days and, for no longer than12 months prior to the inclusion in the study.

Exclusion criteria

Pregnancy and childbearing

• History of severe hypersensitivity (including myopathy) to other HMG-CoA reductase inhibitors.
• Subjects with indication of use of cyclosporine and other associations of other lipid lowering drugs.
• Subjects with underlying diseases that may influence lipid levels (i.e. uncontrolled hypothyroidism defined as a Thyroid stimulating hormone (TSH) > 1.5 times upper level of normality (ULN) at Visit 1, AIDS, transplanted subjects, etc).
• History of drug and alcohol abuse.
• Current active liver disease or hepatic failure or elevations in ALT >3 times the ULN.
• Elevation of CPK > 3 times the ULN.
• Elevation in the seric creatinine > 2,0 mg / dL.
• History of malignancy in the last 5 years, except basal cell or squamous cell carcinoma of the skin (women with a history of Cervical dysplasia must be included, unless they have t3 clear consecutive Papanicolaou (Pap) smears , before the entry in the study).
• Any other known clinical condition that, in the opinion of the investigator, may compromise the subject's safety.

Trial design

600 participants in 2 patient groups

1

Description:

Receives treatment with rosuvastatin, according to International and National Guidelines on hypercholesterolemia.

Group 2

Description:

Receives the same treatment as group 1 and information on health improvement, diet and exercises applied to the disease that is being treated. The positive impact of the information upon treatment will be statistically evaluated.