Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis
Open accessAbstract
BACKGROUND: Nonalcoholic steatohepatitis is a common liver disease that can progress to cirrhosis. Currently, there is no established treatment for this disease. METHODS: We randomly assigned 247 adults with nonalcoholic steatohepatitis and without diabetes to receive pioglitazone at a dose of 30 mg daily (80 subjects), vitamin E at a dose of 800 IU daily (84 subjects), or placebo (83 subjects), for 96 weeks. The primary outcome was an improvement in histologic features of nonalcoholic steatohepatitis, as assessed with the use of a composite of standardized scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis. Given the two planned primary comparisons, P values of less than 0.025 were considered to indicate statistical significance. RESULTS: Vitamin E therapy, as compared with placebo, was associated with a significantly higher rate of improvement in nonalcoholic steatohepatitis (43% vs. 19%, P=0.001), but the difference in the rate of improvement with pioglitazone as compared with placebo was not significant (34% and 19%, respectively; P=0.04). Serum alanine and aspartate aminotransferase levels were reduced with vitamin E and with pioglitazone, as compared with placebo (P<0.001 for both comparisons), and both agents were associated with reductions in hepatic steatosis (P=0.005 for vitamin E and P<0.001 for pioglitazone) and lobular inflammation (P=0.02 for vitamin E and P=0.004 for pioglitazone) but not with improvement in fibrosis scores (P=0.24 for vitamin E and P=0.12 for pioglitazone). Subjects who received pioglitazone gained more weight than did those who received vitamin E or placebo; the rates of other side effects were similar among the three groups. CONCLUSIONS: Vitamin E was superior to placebo for the treatment of nonalcoholic steatohepatitis in adults without diabetes. There was no benefit of pioglitazone over placebo for the primary outcome; however, significant benefits of pioglitazone were observed for some of the secondary outcomes. (ClinicalTrials.gov number, NCT00063622.)
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In the PIVENS trial, 47% with Pioglitazone versus 21% with placebo showed resolution of definite NASH (p = 0.001).
“47% with Pioglitazone versus 21% with Placebo showed a resolution of definite NASH (p = 0.001) [33].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
The Results (Secondary Outcomes) report that steatohepatitis resolved significantly more often with pioglitazone than with placebo (P = 0.001), and the Discussion gives a 47% resolution rate for pioglitazone. The passages in our copy do not give the claimed 21% placebo resolution rate; the 19% placebo figure in Primary Outcome refers to a different measure, histologic improvement. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the PIVENS trial, adverse events in the Vitamin E group were not significantly different compared to Pioglitazone or placebo.
“adverse events in the Vitamin E group were not significantly different compared to Pioglitazone or placebo [33].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
The Results (Secondary Outcomes, Adverse Events) say the distribution of individual adverse events did not differ significantly across the three groups, except for weight gain. The claim omits that exception: the Results also report significant weight gain in the pioglitazone group. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the PIVENS trial, the grade of fibrosis did not improve with Vitamin E.
“However, the grade of fibrosis did not improve [33].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
The Results (Secondary Outcomes) say fibrosis scores were not significantly improved with vitamin E. The Discussion likewise reports no significant improvement in mean fibrosis score after 96 weeks. These passages support a lack of demonstrated improvement, but not the stronger statement that fibrosis did not improve at all. (LLM, conf=0.82)
Experimental — accuracy not yet measuredIn the PIVENS trial, fibrosis was not affected by Pioglitazone treatment.
“Similar to the Vitamin E treatment arm, fibrosis was not affected by Pioglitazone treatment [33].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
The Results (Secondary Outcomes; page not provided) say fibrosis scores were not significantly improved with either pioglitazone or vitamin E. The Discussion likewise reports no significant improvement in mean fibrosis score after 96 weeks. This supports a lack of demonstrated benefit, but “was not affected” overstates the finding by implying that treatment had no effect. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the largest RCT to date, vitamin E supplementation (800 IU daily over 2 years) in individuals with non-diabetic MASH resulted in improvements in both steatosis and disease activity, corroborated by a reduction in liver enzymes.
“In the largest RCT to date, vitamin E supplementation (800 IU daily over 2 years) in individuals with non-diabetic MASH resulted in improvements in both steatosis and disease activity, which was corroborated by a reduction in liver enzymes.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [372]
The Methods report 247 adults without diabetes randomized to 800 IU of vitamin E daily or other treatment for 96 weeks. The Results report improvements in steatosis and disease activity versus placebo, alongside reduced liver-enzyme levels. The paper describes earlier trials as small but does not establish that this was the largest RCT to date. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Smaller studies have suggested reduction in liver enzymes with vitamin E but there is currently no clear data on fibrosis improvement and no large phase III trial has been performed.
“Smaller studies have suggested reduction in liver enzymes but there is currently no clear data on fi brosis improvement and no large phase III trial has been performed.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [372]
The Results (Secondary Outcomes; page unavailable) report reduced liver-enzyme levels with vitamin E but no significant improvement in fibrosis scores. The claim that no large trial had been performed is not supported: the paper reports its own randomized, placebo-controlled trial of 247 adults. Our copy does not explicitly label that trial phase III. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn several RCTs, pioglitazone has been shown to improve histological features of steatohepatitis, without a clear effect on fibrosis regression even after prolonged (3-year) therapy.
“In several RCTs, pioglitazone, a thiazolidinedione which mainly activates peroxisome proliferator-activated receptor (PPAR) c , has been shown to improve histological features of steatohepatitis, 372,418 -420 without a clear effect on fi brosis regression even after prolonged (3-year) therapy.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [372]
The Results (Secondary Outcomes) report improvements in steatosis and lobular inflammation with pioglitazone, but no significant improvement in fibrosis scores. The Methods and Discussion specify 96 weeks of treatment, not three years, and the primary histologic outcome did not meet the prespecified significance threshold. This trial therefore supports part of the claim, but not its three-year qualifier or, by itself, the reference to several RCTs. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn the PIVENS trial, adverse events were not increased in the Pioglitazone treatment arm, but a significant mean weight gain of +4.7 kg at week 96 was seen.
“Adverse events per se were not increased in the Pioglitazone treatment arm; importantly, however, a significant mean weight gain of +4.7 kg at week 96 was seen [33]”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
In the PIVENS trial, Vitamin E treatment resulted in a significantly higher rate of NASH improvement (43% vs. 19%, p = 0.001) compared with placebo.
“Vitamin E treatment resulted in a significantly higher rate of NASH improvement (43% vs. 19%, p = 0.001) as compared with placebo.”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
In the PIVENS trial, 34% in the Pioglitazone group versus 19% in the placebo group (p = 0.04) showed an improvement in liver histology as defined in the primary outcome.
“34% in the Pioglitazone group versus 19% in the placebo group (p = 0.04) showed an improvement in liver histology as defined in the primary outcome [33].”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
In the PIVENS trial, Pioglitazone did not reach the pre-defined primary study endpoint.
“the PPAR‐y ligand Pioglitazone (30 mg/day) did not reach the pre‐defined primary study endpoint in the PIVENS trial”
From Current treatment of non‐alcoholic fatty liver disease (2022) · cites this paper as [33]
Steatosis does not define the degree of fibrosis nor the progression of NAFLD.
“Steatosis does not define the degree of fibrosis nor the progression of the disease, but reversal of fibrosis is often observed with weight loss of >10% in obese patients with NAFLD.9,10”
From Understanding the cellular interactome of non-alcoholic fatty liver disease (2022) · cites this paper as [9]
Reversal of liver fibrosis is often observed with weight loss of more than 10% in obese patients with NAFLD.
“Steatosis does not define the degree of fibrosis nor the progression of the disease, but reversal of fibrosis is often observed with weight loss of >10% in obese patients with NAFLD.9,10”
From Understanding the cellular interactome of non-alcoholic fatty liver disease (2022) · cites this paper as [9]
In the PIVENS phase 3 trial in non-diabetics with NASH, 96 weeks of pioglitazone improved serum transaminases, hepatic steatosis and inflammation, while no significant improvement of fibrosis and NASH was observed, with side effect of weight gain.
“Pioglitazone: PIVENS (phase 3)79; non-diabetics with NASH; 96 weeks of treatment with pioglitazone improved serum transaminases, hepatic steatosis and inflammation, while no significant improvement of fibrosis and NASH was observed. Side effects: weight gain.”
From Novel therapeutic targets for cholestatic and fatty liver disease (2022) · cites this paper as [79]
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- Authors
- Sanyal, A. J., Chalasani, N., Kowdley, K. V., McCullough, A., Diehl, A. M., Bass, N. M., Neuschwander-Tetri, B. A., Lavine, J. E., Tonascia, J., Unalp, A., Van Natta, M., Clark, J., Brunt, E. M., Kleiner, D. E., Hoofnagle, J. H., & Robuck, P. R.
- Affiliations
- Virginia Commonwealth University (US)
- Indiana University Indianapolis (US)
- Virginia Mason Medical Center (US)
- Case Western Reserve University (US)
- Duke University (US)
- University of California, San Francisco (US)
- University of California San Diego (US)
- Johns Hopkins University (US)
- Washington University in St. Louis (US)
- National Cancer Institute (US)
- National Institute of Diabetes and Digestive and Kidney Diseases (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-05-06
- Volume
- 362
- Issue
- 18
- Pages
- 1675-1685
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC2928471
- OpenAlex
- W2062812115
- Cited by
- 3,327
- References
- 33
- Citations by year
- 2026: 138 · 2025: 213 · 2024: 204 · 2023: 206 · 2022: 241 · 2021: 295 · 2020: 290 · 2019: 204 · 2018: 225 · 2017: 196 · 2016: 212 · 2015: 200 · 2014: 187 · 2013: 153 · 2012: 159
- FWCI
- 117.25
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- VCU Scholars Compass (Virginia Commonwealth University) (submittedVersion)
- Funders
- Eli Lilly and Company
- Pfizer
- Gilead Sciences
- Takeda Pharmaceuticals North America
- Teva Pharmaceutical Industries
- Pharmavite
- Cleveland Clinic (UL1RR024989)
- Cleveland Clinic Foundation
- University of Washington (UL1 RR025014)
- Johns Hopkins University
- Case Western Reserve University (UL1RR024989)
- Virginia Commonwealth University
- Saint Louis University
- Intercept Pharmaceuticals
- Astellas Pharma
- Norgine
- National Institutes of Health (UL1TR000448)
- Genentech
- University of California, San Diego
- Johns Hopkins Bloomberg School of Public Health
- School of Medicine, Indiana University
- National Cancer Institute
- National Institute of Diabetes and Digestive and Kidney Diseases (U01DK061730, K24DK002957, U01DK061731, U01DK061713, U01DK061728, U01DK061737, U01DK061732, U01DK061734, U01DK061718, U01DK061738)
- National Center for Research Resources (UL1RR024131, UL1RR024989, M01RR000750, UL1RR025014, M01RR000065, UL1RR024128, M01RR000827)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Keywords
- nonalcoholic steatohepatitis, pioglitazone, vitamin E, thiazolidinediones, liver fibrosis, hepatic steatosis, lobular inflammation, hepatocyte ballooning, transaminases, weight gain, cirrhosis prevention, non-diabetic patients
- MeSH terms
- Pioglitazone, Adult, Transaminases, Antioxidants, Double-Blind Method, Fatty Liver, Female, Humans, Hypoglycemic Agents, Insulin Resistance, Liver, Male, Middle Aged, Vitamin E, Weight Gain, Chi-Square Distribution, Thiazolidinediones, Intention to Treat Analysis
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