Summary: Chronic liver diseases are a major cause of morbidity and mortality worldwide. Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. According to some estimates, it affects 20-40% of the U.S. population. Viral hepatitis and alcoholic liver disease (ALD) are a worldwide problem affecting millions of people. At later stages these liver diseases lead to the formation of fibrosis and cirrhosis, and – in some cases – primary hepatic cancer. Thus, timely and adequate treatment, including hepatoprotector use, plays a huge role in the prevention of these life-threatening conditions.

Aim. To characterize the profile of consecutive outpatients with newly diagnosed or known chronic liver diseases and receiving Essentiale® as adjunctive treatment to standard care under real-life conditions. Other objectives are to identify the prescribing practices of Essentiale® Forte N and other drugs; to evaluate treatment compliance for Essentiale® Forte N under real-life conditions.

Material and methods. This multicenter study (REPAIR) included 64 research centers in five cities of Kazakhstan: Astana, Almaty, Aktobe, Karaganda and Shymkent. The study was conducted in two stages. The first step (i.e. registration) consisted of a profile evaluation of patients treated with Essentiale® Forte N, and of a practice-based study with this drug. Overall, 1,514 patients participated in the study, and data on 1,505 patients were included in the statistical analysis. In the second stage 300 patients were consistently selected. At the second visit each researcher included the first five patients treated with Essentiale® Forte N to assess their adherence to the therapy. All diagnostic and therapeutic procedures were performed in accordance with the approved standard practice guidelines.

Results and discussion. As the study results showed, the problem related to chronic liver diseases is very important. 1,505 patients who met the inclusion criteria were included in the statistical analysis. 1,446 patients (96.1%) completed the study according to its protocol. The average age of the patients was 49.9±11.1 years. 848 patients (56.5%) were female and 652 (43.5%) were male. The first stage of the study consisted of an analysis of the medical history, the initial examination, laboratory and imaging study results. All procedures were performed after the standard examination of patients. The most frequent diagnoses concerning the liver among the enrolled patients were: fatty liver disease (32.2%) and obesity-related diseases (25.8%). Of 300 patients invited to the second visit, 28 patients (9.3%) informed their doctor about long interruptions (lasting more than 1 day), 5 patients (1.7%) about often skipping a dose, 7 patients (2.3%) changed dosage by themselves and 19 patients (6.3%) stopped taking the drug altogether. Thus, 241 (80.3%) completed the full course of treatment and 59 patients (19.7%) did not finish the treatment. 86 of 274 patients (31.4%) with known outcomes fully recovered and 164 (59.9%) experienced significant improvement. Over the entire period of observation, three mild adverse events (AE) were identified.

Conclusion. The results showed that chronic liver diseases continue to be a top social and medical problem. The study allowed to create patient and disease characteristics among patients receiving Essentiale® Forte N as adjunctive treatment to standard care. The obtained data allowed to characterize the treatment prescribed to outpatients suffering from liver disease conditions and to evaluate the compliance to the treatment with Essentiale® Forte N. Most of the patients and physicians were satisfied with the results of the treatment with Essentiale® Forte N.