Table 3 Studies of metformin to treat nonalcoholic fatty liver disease
From: Diabetes drugs for nonalcoholic fatty liver disease: a systematic review
Author, year country trial name (quality rating) | Population demographics | Interventions (group sizes) duration | Efficacy/effectiveness outcomes | Harms |
|---|---|---|---|---|
A vs. B | A vs. B | |||
Anushiravani, 2019 [22] Iran (good) | Adults with probable NAFLD with or without elevated ALT/AST Age: 47 y % female: 49 Ethnicity: NR BMI, kg/m2: 25.1 vs. 26.1 | A. Metformin 500 mg/d (n = 30) B. Placebo (n = 30) Duration: 3 months | Changes from baseline (P value), between-groups P value: BMI: − 0.6 vs. − 0.7 kg/m2; P = NS ALT: − 10.1 vs. − 0.6; P < 0.001 AST: − 6.4 vs. − 0.9; P < 0.001 | None |
Haukeland, 2009 [15] Norway (fair) | Adults with biopsy-confirmed NAFLD Age: 47.4 y % female: 27.2 Ethnicity, % white: 86.4% BMI, kg/m2: 30.8 Diabetes: 27.3% | A: Metformin 2500 mg/d (3000 mg if weight > 90 kg) (n = 24) B: Placebo (n = 24) Duration: 6 months | Percentage with improvement (P value change from baseline); between-groups P value: Steatosis: 25% (P = 0.10) vs. 38% (P = 0.03); P = 0.052 Fibrosis: 5% (P = 1.00) vs. 17% (P = 0.17); P = 0.36 NAFLD activity score: 20% (P = 0.23) vs. 50% (P = 0.12); P = 0.06 Changes from baseline (P value); between-groups P value: Weight, kg: − 4.3 (P < 0.001) vs. 0.3 (P = 0.45); P < 0.001 BMI: 1.3 (P < 0.001) vs. 0.1 (P = 0.59); P < 0.001 | Serious AEs: NR Withdrawal due to AEs: 2/24 (8.3%) vs. 0/24 (0%) |
Omer, 2010 [20] Turkey (fair) | Adults with type 2 diabetes or impaired glucose tolerance and biopsy-confirmed NAFLD Age: 48.9 y % female: 45.3 Ethnicity: NR BMI, kg/m2: 30.6 Diabetes: NR | A: Metformin 1700 mg/d + rosiglitazone 4 mg/d (n = 22) B: Metformin 1700 mg/d (n = 22) C: Rosiglitazone 4 mg/d (n = 20) Duration: 12 months | Changes from baseline (P value): NAFLD score (n = 10–13): − 3.9 (P = 0.026) vs. 0.7 (P = 0.726) vs. − 2.6 (P = 0.012) AST: − 15.4 (P = 0.01) vs. − 13.0 (P = NS) vs. − 13.2 (P = 0.005) ALT: − 22.7 (P = 0.017) vs. − 16.7 (P = NS) vs. − 36.2 (P < 0.0001) BMI: − 1.3 (P = 0.006) vs. − 3.2 (P = 0.002) vs. − 0.3 (P = NS) | Serious AEs: NR Withdrawal due to AEs: Not adequately reported |
Rana, 2016 [10] India (fair) | Patients with ultrasound diagnosed NAFLD without history of use of insulin sensitizers or hypolipidemic drug use Age: NR Sex: NR Ethnicity: Indian Liver status: AST 55.14 IU/mL; ALT 64.30 (AST and ALT were different at baseline between treatment groups) BMI: 27.95 | A. Metformin (31) B. Rosuvastatin (34) C. Pioglitazone (33) Duration: 24 weeks | Change in ultrasound score (fatty liver) at 24 weeks: our analysis A vs. B: 0.065 vs. − 1.265 (P < 0.001) A vs. C: 0.065 vs. − 0.697 (P < 0.001) Weight change at 24 weeks: our analysis A vs. B: − 4.76 vs. − 4.25 (P = 0.13) A vs. C: − 4.76 vs. 0.03 (P < 0.001) AST change at 24 weeks: our analysis A vs. B: − 14.07 vs. 8.35 (P < 0.001) A vs. C: − 14.07 vs. − 23.73 (P = 0.04) ALT change at 24 weeks: our analysis A vs. B: − 15.55 vs. 8.06 (P < 0.001) A vs. C: − 15.55 vs. − 24.67 (P = 0.13) | NR |
Razavizade, 2013 [14] Iran (fair) | Adults with NAFLD assessed via ultrasonography and predictive formula Age: 35.3 y % female: 15 Ethnicity: NR BMI, kg/m2: 27.7 Diabetes: 7.5% | A: Metformin 1000 mg/d (n = 40) B: Pioglitazone 30 mg/d (n = 40) Duration: 4 months | Changes from baseline (P value), between-groups P value: Liver fat fraction: − 2.53 (P < 0.01) vs. − 3.23 (P < 0.01), P = 0.48 AST: − 10.83 (P < 0.01) vs. − 13.75 (P < 0.01), P = 0.56 ALT: − 21.75 (P < 0.01) vs. − 37.53 (P < 0.01), P = 0.07 Weight, kg: − 2.73 (P < 0.01) vs. − 1.18 (P = 0.04), P = 0.05 | Serious AEs: NR Withdrawal due to AEs: None. |