Page 68 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Role of saroglitazar in MASH

values. Every participant was interviewed using a series visit, there was an increased level of liver enzymes such
of questionnaires covering demographic characteristics as ALT, AST, and gamma-glutamyl transferase (GGT).
such as age, gender, anthropometric measurement, family Comparisons of pre- and post-treatment values of
history of metabolic disorders or liver disease, current different laboratory parameters including liver enzymes
medications, comprehensive medical history including such as ALT, AST, ALP, and GGT, as well as lipid profile
history of alcohol consumption, and any comorbidities and FibroScan parameters such as LSM and CAP, were
such as diabetes, hypertension, and dyslipidemia. The whole done. After treatment with saroglitazar at 4 mg once-daily
physical examination was performed by a skilled technical dose for 24 weeks, we detected a significant decrease in
assistant. A regular stadiometer was used to measure height, values of ALT (32.97 ± 2.15 U/L; P < 0.001), AST (34.57
and a typical bathroom scale was used to assess weight. The ± 1.65 U/L; P < 0.001), GGT (31.86 ± 2.37 U/L). Mean
BMI was computed using weight in kilograms and height in values of pre-treatment ALT and AST were 93.83 ± 6.16
meters. Baseline demographics of patients were documented, U/L and 76.1 ± 4.1 U/L, respectively, while mean values
including age, gender, height, weight, waist circumference, of post-treatment ALT and AST were 32.97 ± 2.15 U/L
comorbid conditions, and current medicines. and 34.57 ± 1.65 U/L, respectively (both P < 0.001). The
mean values of pre-treatment FibroScan parameters such
Comprehensive medical history was documented, as LSM and CAP were 16.2 ± 1.57 kPa (kilopascal) and
encompassing the individual’s history of alcohol 297.80 ± 37.38 dB/m (decibel/meter), whereas post-
consumption, concurrent medication use, and metabolic treatment mean values were 7.67 ± 0.23 kPa and 264.80
comorbidities such as obesity, hypertension, diabetes ± 6.81 dB/m, respectively (LSM and CAP: P < 0.001 and
mellitus, coronary artery disease, and cerebrovascular P = 0.049, respectively). The average values of pre- and
disease. post-treatment LDL were 122.1 ± 4.84 and 93.51 ± 4.12,
2.5. Statistical analysis respectively (P < 0.001). A significant decrease in values
of LSM and CAP (P < 0.001 and P = 0.049, respectively)
ANOVA test was performed to compare the data collected indirectly showed that there was a marked improvement
before and after treatment, and multiple regression in fibrosis score. The comparison of BMI values between
analysis was used to determine the percent change in ALT, the pre- and post-treatment groups showed no significant
AST, alkaline phosphatase (ALP), bilirubin, BMI, LSM, change (pre- and post-treatment BMI values were
and CAP. The collected data were entered into Microsoft 24.1 ± 3.9 and 24.5 ± 3.05, respectively; P = 0.565).
Excel 2010 for statistical analysis, which was carried out
with the aid of Statistical Package for the Social Sciences It was noticed that saroglitazar, at a once-daily dose
software. Categorical data are presented as proportions, of 4 mg, was safe and well-tolerated because there were
and continuous data are expressed as mean ± SD (for no serious adverse events associated with the medication
parametric data) or median and interquartile range (for that required treatment cessation. All of the 51 patients
non-parametric data). completed the follow-up for 6 months and were included
in the post-treatment data analysis.
3. Results 4. Discussion

A total of 72 individuals were screened for the study. After
excluding 21 patients who met one or more of the outlined The purpose of this trial was to evaluate saroglitazar’s
exclusion criteria, only 51 patients were included in the effectiveness and tolerability in non-diabetic patients with
hepatic inflammation and fibrosis as detected on liver
protocol analysis. Baseline investigations of all 51 patients FibroScan/elastography. This study found that saroglitazar
were conducted. Table 1 displays the basic demographic is safe, tolerable, and effective in the management of
characteristics of the patients.
MASH. Information about saroglitazar’s effectiveness in
All 51 patients who were treated with saroglitazar the Indian population is limited. In this study, liver enzyme
at 4 mg once-daily dose for 24 weeks were followed up and FibroScan parameter improvements before and after
till the end of the study. Out of the sample, 34 patients therapy were compared in non-diabetic individuals with
(72.5%) were male and 17 (27.5%) were female MASH to determine the efficacy of saroglitazar. Based
(male-to-female ratio of 2.6). The mean age of patients was on the widely accepted recommendations that have been
51 ± 13.13 years. The mean value of the fasting blood sugar backed by available evidence, all patients were given 4 mg
level was 92.6 ± 9.7 mg/dL. On baseline investigation, the of saroglitazar. Since this is the first study of its kind in
15
mean value of BMI was 24.1 ± 3.9. LFT and FibroScan India to highlight the potential advantages of saroglitazar,
procedures (two variables, i.e., LSM and CAP, were noted) particularly in non-diabetic MASH, it adds considerably to
were done for the diagnosis of MASH. At the baseline the current medical knowledge. 16

Volume 7 Issue 4 (2024) 4 doi: 10.36922/itps.3560