Overview
The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia.
Description
STUDY OBJECTIVES: The aim of study is to evaluate the efficacy and safety of the new generic formulation (rosuvastatin orally disintegrating tablet (SUVARO®ODT) in patients with dyslipidemia. Also, this study is designed to observe patients' preference and adherence for SUVARO®ODT.
HYPOTHESIS: We hypothesized that there will be no difference in LDL-C lowering efficacy of the two formulations (SUVARO®ODT 10-mg or rosuvastatin Immediate-release tablet (IR) 10-mg).
STUDY DESIGN: This is a randomized, multicenter, open-label, two-period crossover study with 112 enrolled patients.
Subjects: Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
Eligibility
Inclusion Criteria:
- Patients with dyslipidemia over 50 years of age who received statin treatmen for at least 2 months
- Written informed consent to participate in the trial
Exclusion Criteria:
- History of previous hypersensitivity reaction to other statins, including rosuvastatin
- patients with acute arterial disease within 3 months
- Uncontrolled Hypertensive Patients defined as SBP ≥180 mm Hg and DBP ≥110 mm Hg, respectively
- Uncontrolled diabetes mellitus (HbA1c > 9%)
- Uncontrolled hypothyroidism defined as TSH >1.5 within the last 6 months
- Taking other lipid lowering agent except statins
- History of statin-induced myopathy, rhabdomyolysis
- Patients with severe hepatic or renal dysfunction
- BMI (body mass index) > 40 kg/m2
- history of galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption