QUALITY OF LIFE AND COMPLIANCE TO THERAPY IN PATIENTS FOLLOWING SUCCESSFULTRANSLUMINAL CORONARY ANGIOPLASTY, WHO WERE PRESCRIBED FLUVASTATIN EXTENDED RELEASE ADDED TO STANDARD THERAPY. PROTOCOL OF THE OPEN-LABEL OBSERVATIONAL STUDY

Abstract

Aim. To evaluate quality of life changes and compliance to therapy in patients following successful transluminal angioplasty, who have indications for fluvastatin extended release in addition to standard treatment.Material and methods. This is a national observational multicenter study. An inclusion of 60 investigator centers is planned (out-patient medical centers), the total number of patients to be included is 600. Patients (men and women) with coronary heart disease following successful transluminal coronary angioplasty, who were prescribed fluvastatinextended release (Lescol Forte, Novartis) 80 mg once daily will be included in the observation. The following efficacy and safety parameters will be evaluated: quality of life assessed with SF-36 scale before and during treatment; compliance to therapy; adverse events and serious adverse events. Observation period is planned for 6 months. During this period patient is expected to make 4 visits to treating physician. According to the physician’s decision, observation period can be extended to 12 months.Present study status. The study is completed. 524 patients completed the observation, including 116 patients who were followed up for 12 months. There are 414 men (79%) and 110 women (21%) among patients enrolled into the study.

Keywords

• percutaneous transluminal coronary angioplasty
• fluvastatin extended release
• quality of life