Real-world comorbidities and treatment patterns among patients with non-alcoholic fatty liver disease receiving phosphatidylcholine as adjunctive therapy in Russia

Igor V Maev; Aleksey A Samsonov; Liudmila K Palgova; Chavdar S Pavlov; Elena Shirokova; Kirill M Starostin

doi:10.1136/bmjgast-2019-000307

Real-world comorbidities and treatment patterns among patients with non-alcoholic fatty liver disease receiving phosphatidylcholine as adjunctive therapy in Russia

BMJ Open Gastroenterol. 2019 Aug 18;6(1):e000307. doi: 10.1136/bmjgast-2019-000307. eCollection 2019.

Authors

Igor V Maev¹, Aleksey A Samsonov¹, Liudmila K Palgova², Chavdar S Pavlov³, Elena Shirokova⁴, Kirill M Starostin⁵

Affiliations

¹ Department of Propedeutics of Internal Diseases and Gastroenterology, A. I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia.
² Clinical Research and Educational Center in Gastroenterology and Hepatology, Institute of High Medical Technologies of St Petersburg University, Saint Petersburg, Russia.
³ Scientific Research Department of Innovation therapy, I. M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia.
⁴ Propedeutics of Internal Medicine Department, I. M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia.
⁵ Medical Affairs, Sanofi-Aventis SA, Moscow, Russia.

Abstract

Objective: Previous research conducted in Russia showed that the number of patients with non-alcoholic fatty liver disease (NAFLD) and associated metabolic comorbidities is large. We conducted an observational study to describe the management of NAFLD in patients with metabolic syndrome in Russia.

Design: A total of 2843 adult patients from 174 medical sites across 6 federal districts of Russia with newly diagnosed NAFLD, who had at least one of four comorbidities, namely overweight/obesity, hypertension, type 2 diabetes mellitus, and hypercholesterolaemia, and who received phosphatidylcholine (PPC) as an adjunctive treatment to standard care, were enrolled during 2015-2016.

Results: Overall, 2263 patients (79.6%) had at least two metabolic comorbidities associated with NAFLD; overweight/obesity was the most common comorbidity reported in 2298 patients (80.8%). Simple steatosis was the most frequently identified clinical form of NAFLD, diagnosed in 2128 patients (74.9%). Among hypertensive patients, ACE inhibitors, statins, and sartans were most commonly prescribed. Biguanides were administered in more than half of diabetic patients. In patients with overweight/obesity and hypercholesterolaemia, statins were the most frequently prescribed medications. Almost all patients (2837/2843; 99.8%) were treated with 1.8 g of PPC three times per day. PPC therapy was associated with a 90.5% 6-month compliance rate, high treatment satisfaction, and a favourable safety profile. However, almost 15% of diabetic patients and 40% of overweight/obese patients received no further treatment.

Conclusions: In Russia, patients with newly diagnosed NAFLD represent a population heavily burdened by comorbidities, mainly overweight/obesity and hypercholesterolaemia. A significant part of these patients did not receive a comprehensive pharmacotherapy, highlighting the existing unmet need in the current management of NAFLD patients with metabolic syndrome in Russia.

Keywords: Russia; comorbidities; essential phospholipids; non-alcoholic fatty liver disease; obesity; overweight; phosphatidylcholine.