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A New, Non-Invasive Scale for Steatosis Developed Using Real-World Data From Russian Outpatients to Aid in the Diagnosis of Non-Alcoholic Fatty Liver Disease

  • Maev, Igor V.1
  • Samsonov, Alexey A.1
  • Lazebnik, Leonid B.1
  • Golovanova, Elena V.1
  • Pavlov, Chavdar S.2
  • Vovk, Elena I.1
  • Ratziu, Vlad3
  • Starostin, Kirill M.4
  • 1 A. I. Evdokimov, Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia
  • 2 I. M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russia
  • 3 Sorbonne Université and Hôpital Pitié-Salpêtrière Medical School,
  • 4 Department of Medical Affairs, Sanofi, Moscow, Russia
Published Article
Advances in Therapy
Springer Healthcare
Publication Date
Sep 16, 2020
DOI: 10.1007/s12325-020-01493-w
PMID: 32939691
PMCID: PMC7547949
PubMed Central


Introduction The current non-invasive tools for the diagnosis of non-alcoholic fatty liver disease (NAFLD) have methodological limitations. We aimed to develop a non-invasive scale to assist in the diagnosis of NAFLD. To achieve our aim, we conducted a secondary analysis of data from a large observational study conducted in Russia. Methods This retrospective analysis assessed the frequency of NAFLD in the population of patients in the DIREG_L_06725 study, an epidemiological, observational, cross-sectional, multicenter study performed in 50,145 outpatients from 16 Russian cities. Among the cohort of patients diagnosed with NAFLD, we identified factors associated with the risk of NAFLD. To develop a non-invasive tool for diagnosing NAFLD, we also determined the frequency of steatohepatitis. Results Our analysis included 48,297 patients; NAFLD was present in 20,281 patients (42.0%). The majority (64.1%) were women (80.3% post-menopause), and 87% had a body mass index (BMI) > 27.0 kg/m2. We developed a fully non-invasive scale (St-index) that showed a specificity of 91.4% for ruling in steatosis, and a sensitivity of 93.8% for ruling out steatosis. Multivariate regression analyses conducted in the subgroups of patients aged ≥ 12 and < 18 years and those with BMI < 25.0 kg/m2 produced area under the receiver operating characteristic (AUROC) curve values of 0.8243 and 0.7054, respectively. The factors most strongly associated with the development of NAFLD were age > 35 years, presence of type 2 diabetes mellitus, and a waist circumference/height ratio > 0.54. Conclusion Our non-invasive steatosis scale, St-index, can help physicians diagnose NAFLD in high-risk patients in the absence of ultrasound data.

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