RESUMO
The observational study was aimed at assessing the effectiveness and tolerability of Heptral (brand of ademetionine 1,4-butane disulfonate) in Indian patients presenting with intrahepatic cholestasis (IHC) due to chronic Non alcoholic liver disease (NALD). The study also aimed at understanding the prescribing practices of physicians as well as the profile of patients being prescribed Heptral. This Prospective observational study included 250 patients across 23 sites in India. The assessments of health-economic parameters, liver biochemistry, signs and symptoms of IHC (fatigue, jaundice, and pruritus) were performed at two visits, i.e., at baseline and after six weeks of Ademetionine treatment. Ademetionine was prescribed as part of the routine medical treatment as per the local label and not as a study intervention. Full analysis set (FAS) population included 244 patients. The mean age was 43.75 +/- 11.14 years and 75.5% (184/244) patients were males. 30.7% (75/244) of FAS population presented with cirrhosis. Concomitant medications were recommended to 44.4% (108/243) patients. Ademetionine treatment resulted in statistically significant reduction (p < 0.0001) in burden of disease parameters (number of days off work and number of visits to doctor), levels of biochemical markers and signs and symptoms of IHC. Physicians had favourable opinion for effectiveness and tolerability of Ademetionine for majority of the patients. Administration of Heptral in patients with NALD and IHC resulted in significant improvement in burden of disease, laboratory markers, signs and symptoms of cholestasis. The treatment was well tolerated.