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Boh M. 1, Opolski G. 2, Poredos P. 3, Ceska R. 4, Jezovnik M. K. 3
1 Medical Research and Pharmacovigilance, KRKA d. d. Novo mesto, Ljubljana, Slovenia;
2 Department of Cardiology, Medical University of Warsaw, Warsaw, Poland;
3 Department of Vascular Disease, University Medical Centre, Ljubljana, Slovenia;
4 Third Department of Internal Medicine, First School of Medicine, Charles University, Prague, Czech Republic
AIM.Generic drugs are more and more frequently used instead of originators. However, uncertainty exists with respect to therapeutic equivalence of generic product with originator one. Therefore, in this study efficacy and safety of generic atorvastatin was compared to reference product. In patients with increased low density lipoprotein cholesterol (LDL-C) levels of cholesterol and changes of total coronary risk were followed.
METHODS. A randomized, double-blind, multicenter parallel study was carried out in 22 centers. The study included 148 subjects with LDL-C higher than 3 mmol/L and increased coronary risk (>9.5% in 10 years calculated according to PROCAM algorithm). After a four-week placebo run-in period, patients were randomly assigned to receive the generic or the reference atorvastatin for 12 weeks. The initial dose of the drugs was 10 mg or 20 mg depending on the baseline LDL-C value. After six weeks the dose was increased to 20 mg or 40 mg in patients who had not reached the target LDL-C value of 2.99 mmol/L.
RESULTS: Altogether 117 patients have been analysed in the per-protocol analysis. The GA was proven to be equally effective to the reference product as shown by the significantly equal reduction in LDL-C (GA: 37.8%, RA: 38.4%, P=NS) using the non-inferiority statistical analysis. Also other lipid parameters were significantly lowered by both drugs with the exception of HDL-C. Both drugs significantly reduced absolute coronary risk by 13% and 13.3% for the generic and the reference atorvastatin, respectively. Systolic blood pressure was also significantly reduced by approximately 10 mmHg in both study groups. Both products had similar adverse events profile. No cases of therapy withdrawal due to safety were recorded.
CONCLUSION:Both the generic and the reference atorvastatin were equally effective in correcting the lipid profile and reducing calculated absolute coronary risk in patients with hyperlipidemia and increased coronary risk. Both treatments were equally well tolerated.