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High compliance and treatment satisfaction with essential phospholipid treatment of patients with non-alcoholic fatty liver disease


EFSM: 2022;2:220082DOI: 10.52778/efsm.22.0082Publication date: 10.04.2022
Leonid Lazebnik, MD, PhD, Dr. Med. Sci., Chavdar Pavlov, MD, PhD, Dr. Med. Sci., Kirill M Starostin, MD and Branko Popovic, MD

There are numerous randomized controlled studies showing that the intake of essential phospholipids (EPL) can reduce steatosis and improve liver function parameters. Based on these studies EPL are named in several national guidelines as one recommended treatment for non-alcoholic fatty liver disease (NAFLD). A retrospective analysis of three observational studies has now investigated the extent to which compliance and patient satisfaction with EPL treatment correlate with laboratory values and ultrasound parameters a in real-world setting.

High compliance and few treatment discontinuations

Non-alcoholic fatty liver disease (NAFLD) is among the main causes of liver disease [1] and is associated with an increased risk of cancer [2]. Clinical studies and a recent meta-analysis in NAFLD patients have shown that the intake of essential phospholipids (EPL) can reduce liver fat accumulation (steatosis) [3]. EPL are recommended in national guidelines in several countries, including Russia, Latvia, Poland, and China [4–7]. EPL were linked with objective as well as subjective improvements in various studies. A retrospective analysis of three observational studies including 3,384 patients with NAFLD was recently performed to evaluate the extent to which patient compliance and satisfaction with EPL treatment correlate with changes in clinical parameters [2]. During a 12-week period of EPL treatment (600 mg three times daily), 82.2% of patients were compliant, 8.0% gave insufficient information about their treatment compliance (this was assessed as non-compliance), 7.9% reported treatment gaps of more than one day, 1.5% had changed the dosage and 1.8% stated that they had forgotten to take the medication several times. Only 0.3 % of patients reported that they had stopped treatment prematurely; the main reasons for discontinuing treatment were an improvement in well-being (n = 5), individual decision by the patient (n = 1), worsening of a chronic concomitant disease (n = 1), accumulation of pancreatic fluid (n = 1) or unknown (n = 3).

Treatment compliance correlates with positive effects

After 24 weeks (± 1 week) of treatment, compliant patients showed a significant decrease (p < 0.05) in plasma levels of fasting blood glucose, total cholesterol, VLDL and total bilirubin as well as of HbA1c values, compared to non-compliant patients [2]. Furthermore, patients who had complied with the treatment, had significantly better ultrasound parameters (p < 0.001). Male patients, patients with unhealthy lifestyles and/or comorbidities responded more strongly to the EPL therapy [2]. At the end of the 24 weeks of EPL therapy, a significantly higher proportion of compliant patients showed a reduction in symptoms compared to non-compliant patients (91.1 vs. 73.9%; p < 0.0001; Fig. 1A).

High patient satisfaction

A similar relationship was found with regard to the correlation between treatment outcome and clinician and/or patient satisfaction. Of the 634 cases included in the retrospective analysis of treatment satisfaction, almost two-thirds of patients (64.4%) and clinicians (65.9%) were very satisfied with the EPL treatment (10 out of 10 possible points on the satisfaction scale) (Figs. 2A and B). Negative assessments (≤ 4 points) were reported by fewer than 1.5% of clinicians and patients, which provided additional evidence of the positive perception of the EPL treatment. Overall, compliance and patient satisfaction increased together with significant improvements (p < 0.05) in liver enzymes, liver fat content (steatosis) and symptoms after EPL treatment. A significantly higher proportion of patients and/or their clinicians who recorded high or very high values of satisfaction with the treatment, showed symptomatic improvements (reduced number or intensity of symptoms) compared to patients with low or very low satisfaction (p < 0.001; Figs. 1B und C). Treatment compliance and satisfaction therefore correlated with positive effects of EPL on the course of the disease. The strong relationship between treatment compliance and outcome highlights the importance of monitoring the compliance of EPL intake in patients with NAFLD when EPL was prescribed.

Literature

  1. Maev IV, Samsonov AA, et al. 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. Adv Ther 2020;37:4627–40; https://doi.org/10.1007/s12325-020-01493-w.
  2. Ivashkin VT, Maevskaya MV, et al. Correlation of objective endpoints and subjective patient-reported outcomes in NAFLD treatment with essential phospholipids: Real-world data based on pooled analysis of observational studies. Drugs – Real World Outcomes. 2021;8:369–82. https://doi.org/10.1007/s40801-021-00250-x.
  3. Dajani AI, Popovic B. Essential phospholipids for nonalcoholic fatty liver disease associated with metabolic syndrome: A systematic review and network meta-analysis. World J Clin Cases 2020;8(21):5235–49. doi: 10.12998/wjcc.v8.i21.5235. PMID: 33269259; PMCID: PMC7674728.
  4. Derovs A, Pokrotnieks J, Derova J, Laivacuma S, Zeltiņa I, Vīksna L. Society of Digestive Diseases (Latvia). [Clinical practical guidelines for diagnostics, treatment and monitoring of non-alcoholic fatty liver disease]. Nealkohola taukainās aknu slimības diagnostikas, ārstēšanas un novērošanas klīniskās praktiskās rekomendācijas. Rīga: SIA Medicīna un Prese, 2020. 44 p.
  5. Lazebnik LB, Golovanova EV, et al. Non-alcoholic fatty liver disease in adults: clinic, diagnostics, treatment. Guidelines for therapists, third version. Experimental and Clinical Gastroenterology 2021;185(1):4–52. (In Russ.) DOI: 10.31146/1682-8658-ecg-185-1-4-52.
  6. Hartleb M, Wunsch E, Milkiewicz P, et al. Postępowanie z chorymi na niealkoholową stłuszczeniową chorobę wątroby: Zalecenia Polskiej Grupy Ekspertów NAFLD 2019. Med Prakt 2019;10:47–74.
  7. Fan JG, Wei L, Zhuang H, et al. Guidelines of prevention and treatment of nonalcoholic fatty liver disease (2018, China). J Dig Dis 2019;20(4):163–73.

Conflict of interest: K. Starostin and B. Popovic are employees of Sanofi. L. Lazebnik and C. Pavlov declare no conflict of interest.

Disclosures: Medical writing and publication funded by Sanofi.

Affiliation/Correspondence: Leonid Lazebnik, MD, PhD, Dr. Med. Sci., A. I. Evdokimov, Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia, Chavdar Pavlov, MD, PhD, Dr. Med. Sci., I. M. Sechenov First Moscow State Medical University, Ministry of Health of Russia, Moscow, Russian Federation, Kirill M Starostin, MD, Sanofi, Moscow, Russia and Branko Popovic, MD, Sanofi, Industriepark Hoechst, 65926 Frankfurt am Main, Germany
Submission date: 19.11.2021Acceptance date: 11.03.2022Publication date: 10.04.2022
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