Development and validation of a noninvasive prediction model for nonalcoholic steatohepatitis resolution after lifestyle intervention

Vilar‐Gomez, Eduardo; Yasells-Garcia, Ali; Martínez-Pérez, Yadina; Bertot, Luis Calzadilla; Torres-Gonzalez, Ana; Gra-Oramas, Bienvenido; González-Fabián, Licet; Villa-Jiménez, Oscar M.; Friedman, Scott L.; Diago, M.; Romero–Gómez, Manuel

doi:10.1002/hep.28484

Cited by 53 publications

(42 citation statements)

References 49 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It was confirmed that in patients with high ALT levels, canagliflozin not only lowers blood glucose levels, body weight, and insulin levels, but also lowers the levels of liver function parameters such as ALT, AST, and c-GTP. To inhibit the progression of NAFLD, it is important to control body weight, HbA1c, and ALT levels [23,25]. Seko et al reported that a reduction of 30% or more in the baseline ALT level was associated with amelioration of the NAFLD activity score and progression of liver fibrosis in NAFLD patients [22].…”

Section: Discussionmentioning

confidence: 99%

Effects of canagliflozin, an SGLT2 inhibitor, on hepatic function in Japanese patients with type 2 diabetes mellitus: pooled and subgroup analyses of clinical trials

Seko

Sumida

Sasaki³

et al. 2017

J Gastroenterol

View full text Add to dashboard Cite

Background We aimed to investigate the efficacy of canagliflozin (based on its effect on liver function and blood glucose levels) and its safety in high alanine aminotransferase (ALT) patients (ALT [30 U/L). Methods This post hoc analysis of canagliflozin in type 2 diabetes mellitus (T2DM) patients was divided into Study 1 (pooled analysis of 12-and 24-week placebo-controlled, monotherapy studies) and Study 2 (52-week monotherapy/combination therapy study). The canagliflozin 100 mg group data were compared with placebo or baseline ALT subgroup (baseline ALT [30 or B30 U/L) data. The primary endpoint was change in ALT level from baseline. Secondary endpoints were changes in efficacy-related parameters. Adverse events (AEs) were evaluated. Results The mean ALT change at 12 weeks was -10.3 ± 11.7 and -3.2 ± 17.6 U/L in the canagliflozin vs. placebo group in the high ALT subgroup (P = 0.0206); no significant difference was shown in the low ALT subgroup (Study 1). In both ALT subgroups, glycosylated hemoglobin (HbA1c) and body weight were significantly reduced in the canagliflozin vs. placebo group (all P \ 0.0001). The mean change in ALT at 52 weeks was -16.0 ± 18.8 U/L in the high ALT subgroup (P \ 0.0001, Study 2). The incidence of AEs or serious AEs in the high ALT subgroup in the canagliflozin group was similar to that in the placebo group (Study 1) or low ALT subgroup (Studies 1 and 2). Conclusions In T2DM patients with impaired liver function, canagliflozin may improve liver function, reduce HbA1c and body weight, and be well tolerated.

show abstract

Section: Discussionmentioning

confidence: 99%

Effects of canagliflozin, an SGLT2 inhibitor, on hepatic function in Japanese patients with type 2 diabetes mellitus: pooled and subgroup analyses of clinical trials

Seko

Sumida

Sasaki³

et al. 2017

J Gastroenterol

View full text Add to dashboard Cite

show abstract

“…A reduction in NAS (OR, 9.3; 95% CI, 3.4‐25.9; P <.01) and complete resolution of NASH (OR, 7.2, 95% CI, 2.1‐25.1; P <.01), increased the odds of fibrosis regression. Moreover, a recently published algorithm (NASHRES score) for the prediction of NASH resolution after 1 year of lifestyle modification was associated with fibrosis improvement (OR, 7.3; 95% CI, 1.6‐32.2; P <.01). By using a cut‐off ≥69.72 which is related to high probability of NASH resolution, 18 of 21 patients with fibrosis improvement were adequately classified as achieving at least 1‐point of fibrosis reversal (specificity, 94% and PPV, 86%).…”

Section: Resultsmentioning

confidence: 99%

“…Given that NASH resolution was strongly associated to 1‐point fibrosis reversal, we evaluated whether a recently published model of the NASH resolution score could discriminate patients with fibrosis reversal. Interestingly, a cut‐off of NASHRES >69.72 showed a reasonably high PPV (86%) for detecting patients with improved fibrosis …”

Section: Discussionmentioning

confidence: 99%

Serum biomarkers can predict a change in liver fibrosis 1 year after lifestyle intervention for biopsy‐proven NASH

Vilar‐Gomez

Bertot

Friedman

et al. 2017

Liver International

Self Cite

View full text Add to dashboard Cite

show abstract

“…Recently, Vilar-Gomez et al (23,24) reported that weight loss (especially ≥10% weight loss) was highly associated with the level of improvement in the histological features and the resolution of NASH. However, in our study, in the cohort of the construct group, weight loss was observed between each liver biopsy in 3 of 6 patients (50%) [≥10% weight loss was observed in 1 of 6 patients (17%)] with the indolent phenotype.…”

Section: Discussionmentioning

confidence: 99%

New Discriminant Method for Identifying the Aggressive Disease Phenotype of Non-alcoholic Fatty Liver Disease

et al. 2017

View full text Add to dashboard Cite

Objective To detect the aggressive phenotype (AP) of non-alcoholic fatty liver disease (NAFLD) based on the initial laboratory data and clinical characteristics. Methods We enrolled 144 patients with histologically proven NAFLD. For the first analysis, 24 NAFLD patients underwent repeat biopsy to establish a discriminant formula for predicting the AP of NAFLD (D-APN). The AP was defined by NAFLD that had been maintained or progressed to a fibrotic stage beyond stage 2. In the second analysis, we analyzed the distribution of the AP in each stage of disease and the incidence of the PNPLA3 rs738409 GG genotype in AP in 120 other patients. Results After the analysis, the following function was found to discriminate the disease phenotype: z=0.150×body mass index (kg/m2)+0.085×age (years)+1.112×ln (AST) (IU/L)+0.127×ln (m-AST)-12.96. A positive result indicates the AP of NAFLD. The discriminant functions had a positive predictive value of 94% and a negative predictive value of 71%. The distribution of the AP and the incidence of the PNPLA3 GG genotype in the AP in each stage of the disease among the 120 patients were as follows: non-alcoholic fatty liver, 30%/33%; non-alcoholic steatohepatitis (NASH) stage 1, 53%/26%; stage 2, 71%/70%; stage 3, 92%/57%; and stage 4, 93%/64%; there was a significant increase in the incidence of the AP as the disease progressed (p<0.001). Conclusion The new discriminant formula was useful for predicting disease progression potential in NAFLD patients and the incidence of the PNPLA3 GG genotype was elevated according to the distribution of AP.

show abstract

Development and validation of a noninvasive prediction model for nonalcoholic steatohepatitis resolution after lifestyle intervention

Cited by 53 publications

References 49 publications

Effects of canagliflozin, an SGLT2 inhibitor, on hepatic function in Japanese patients with type 2 diabetes mellitus: pooled and subgroup analyses of clinical trials

Effects of canagliflozin, an SGLT2 inhibitor, on hepatic function in Japanese patients with type 2 diabetes mellitus: pooled and subgroup analyses of clinical trials

Serum biomarkers can predict a change in liver fibrosis 1 year after lifestyle intervention for biopsy‐proven NASH

New Discriminant Method for Identifying the Aggressive Disease Phenotype of Non-alcoholic Fatty Liver Disease

Contact Info

Product

Resources

About