THE KARDIOKANON STUDY: A WAY TO SETTLE THE SUBJECT OF CLINICAL EQUIVALENCE OF GENERIC AND ORIGINAL DRUGS

Abstract

Aim. To compare two therapies based on the use of original or generic drugs in patients with stable ischemic heart disease (IHD). Material and methods. Patients (n=120), aged 40–72 (58.7±7.7) years, 93 men and 27 women, with stable angina, functional class (FC) II (n=117, 97.5%) and III (n=3, 2.5%), were included in the multi-center open randomized study with parallel groups. Patients were randomized into 2 groups: group 1 (n=59) received therapy with original drugs only , and group 2 (n=61) — with generics ones only. Efficacy of the therapies was evaluated by the rate of achievement of target blood pressure (BP<130/80 mm Hg), heart rate (HR=55–60 beat per minute) and cholesterol of low density lipoprotein (LDL<70 mg% or 1.8 mmol/l), as well as by the degree of reduction in the angina attacks rate, the need in short-acting nitrates, and the angina FC. Treatment duration was 12 weeks. Results. After randomization both groups of patients were comparable by the main clinical indicators. The rates of target levels achievement were the following in group 1 vs group 2, respectively: for BP - 54 vs 44%, p=0.08; for HR - 51 vs 53%, р=0.66; LDL cholesterol - 27.7 vs 9.9% of patients, p=0.002. There were no significant differences between original and generic drugs effects on the angina pectoris symptoms dynamics, as well as their influence on glucose, bilirubin, creatinine, alanine and asparagine transaminases, and creatine phosphokinase blood levels dynamics. The original and generic drugs prescription rates, a total number of prescribed drugs and prescribed doses were comparable in both groups at the end of the study. Three patients dropped out of the trial, the frequency of adverse events was 3.4% in group 1 and 11.5% — in group 2 (p=0.09). Conclusion. Generic drugs with proven bioequivalence, used in the KARDIOKANON study , demonstrated their clinical equivalence to original drugs. The use of these drugs in patients with stable IHD may provide efficacy and quality of therapy comparable with these in original drugs.