2 • Probe •Vol LXII • No. 3 • May–Aug 2023 Clinical Evidence 1 Liv.52® DS (SYRUP, TABLET) Liv.52 DS is a hepatospecific formulation, designed for the treatment and management of liver disorders. Liv.52 DS has a wide spectrum of therapeutic applications. Liv.52 DS restores the metabolic efficiency of the liver, minimizes damage to the hepatic parenchyma, and accelerates the rate of recovery in various liver disorders such as drug-induced hepatitis. In nonalcoholic steatohepatitis, Liv.52 DS decreases uptake of free fatty acids by hepatocytes, decreases DNA fragmentation through antioxidant activity, and increases urea and albumin secretion. Liv.52® DS in the Management of Statin-Induced Liver Injury Aim To evaluate the efficacy of Liv.52 DS tablet as a hepatoprotective agent in prophylaxis with statin therapy Materials and Methods This open, randomized, comparative, and prospective clinical trial enrolled 50 patients (40 male and 10 female patients; aged 18–70 y) on antihyperlipidemic therapy with statins. Patients with a history of extensive disease that requires hospitalization and pregnant women were excluded from the study. A written informed consent was obtained from all the patients who were included in the study. Patient history was noted, and a thorough clinical examination and symptomatic evaluation were performed. The patients were randomized into 2 groups of 25 each: Liv.52 DS tablet + atorvastatin group and atorvastatin-alone group. The patients were advised to take 1 Liv.52 DS tablet, BID, and 1 atorvastatin tablet (10 mg), BID, for 3 months, based on the groups they were assigned into. All the patients were reviewed every week till the end of the treatment period. The evaluation included clinical examination for general health, body temperature, liver size, skin health, and weight, and subjective signs such as coating of the tongue, loss of appetite, nausea and vomiting, and pain and discomfort in the right hypochondrium. The liver function tests, hemogram, and other biochemical tests were performed at the end of every month for 3 months. The clinical and laboratory evidence of the normal functioning of the liver was considered the primary end point. The changes in the levels of liver function parameters after the treatment were statistically analyzed using repeated measures ANOVA test followed by Dunnett’s multiple comparison post hoc test. The minimum level of significance was fixed at 95% confidence limit, and a 2-sided P value of < .05 was considered significant. Results All the patients completed the trial. At the end of 3 months, a significant increase (P < .01) in the mean values of serum glutamic pyruvic transaminase (SGPT) from 45.87 ± 4.98 to 102.70 ± 12.05 IU/L, serum glutamic oxaloacetic transaminase (SGOT) from 42.70 ± 4.74 to 98.87 ± 12.35 IU/L, and total bilirubin from 0.800 ± 0.026 to 1.022 ± 0.077 g/dL was observed in the atorvastatin-alone group. No such increase in SGPT, SGOT, and total bilirubin
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