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 @entity2993 was compared to reference product. In @entity1 with increased low density lipoprotein @entity165 ( @entity11429 ) levels of @entity165 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 @entity11429 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, @entity1 were randomly assigned to receive the generic or the reference @entity2993 for 12 weeks. The initial dose of the drugs was 10 mg or 20 mg depending on the baseline @entity11429 value. After six weeks the dose was increased to 20 mg or 40 mg in @entity1 who had not reached the target @entity11429 value of 2.99 mmol/L. RESULTS: Altogether 117 @entity1 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 @entity11429 (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 @entity2993 , 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 @entity2993 were equally effective in correcting the lipid profile and reducing calculated absolute coronary risk in @entity1 with @entity407 and increased coronary risk. Both treatments were equally well tolerated.

Therapeutic equivalence of the generic and the reference @entity2993 in XXXX with increased coronary risk.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity407 :: ('MESH:D006949', 'Disease') :: ['hyperlipidemia'] @entity2993 :: ('MESH:C065179', 'Chemical') :: ['atorvastatin'] @entity11429 :: ('22796', 'Gene') :: ['LDL-C'] @entity165 :: ('MESH:D002784', 'Chemical') :: ['cholesterol']
@entity1 :: (9606,Species) :: ['patients']
