Lipid-Lowering Potency and Tolerability of Generic Rosuvastatin in Bulgarian Patients with High and Very High Risk
Background: Statins are a class of drugs for treatment of dyslipidemias, but they are also known to significantly reduce the cardiovascular morbidity and mortality in patients at high cardiovascular risk. The objective of our study was to assess the lipid-lowering potency and tolerability of generic rosuvastatin ROSWERA®, prescribed to patients at high and very high cardiovascular risk, with or without hypercholesterolemia.
Methods: Forty-five consecutive patients (24 females, 53.3%), mean age 62 years were included in this prospective study. ROSWERA® was prescribed 10 to 20 mg once in the evening for primary prevention of high-risk patients or secondary prevention of patients with an overt cardiovascular disease. Levels of total cholesterol, LDLcholesterol, HDL-cholesterol, triglycerides, transaminases and creatine kinase were examined at baseline and at months 3, 6, 12.
Results: total cholesterol and LDL-cholesterol levels decreased from 6.84 ± 0.89 and 4.44 ± 1.01 mmol/l (baseline) to 5.05 ± 0.37 and 2.77 ± 0.61 mmol/l (month 12) in patients, treated with ROSWERA® 10 mg. The levels of total cholesterol and LDL-cholesterol diminished to 5.30 ± 0.43 and 2.84 ± 0.45 mmol/l at month 12 in patients, receiving ROSWERA® 20 mg. The transaminase and creatine kinase values did not change significantly and no adverse events were reported.
Conclusion: The generic rosuvastatin ROSWERA® at dosage 10 mg and 20 mg daily demonstrated high lipidlowering efficacy and good safety profile in patients at high and very high cardiovascular risk.