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Cited by 366

The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.

Long-Term Efficacy of Rosiglitazone in Nonalcoholic Steatohepatitis: Results of the Fatty Liver Improvement by Rosiglitazone Therapy (Flirt 2) Extension Trial

Ratziu, Vlad, Charlotte, Fréderic, Bernhardt, Carole, Giral, Philippe, Halbron, Marine, LeNaour, Gilles, Hartmann-Heurtier, Agnès, Bruckert, Eric, Poynard, Thierry·2010·Hepatology
DOI 10.1002/hep.23270
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Abstract

Short-term trials of glitazones in nonalcoholic steatohepatitis (NASH) yielded controversial histological results. Longer treatment might result in additional improvement. After a 1-year randomized trial, 53 patients underwent a control liver biopsy and were enrolled in an open-label extension trial of rosiglitazone (RSG), 8 mg/day for 2 additional years. In all, 44 completed the extension phase including 40 with a third liver biopsy. Of these, 22 received placebo (PLB) in the randomized phase (PLB-RSG), and 18 RSG (RSG-RSG). During the 2-year extension phase serum insulin decreased by 26%, homeostasis model assessment (HOMA) by 30%, and alanine aminotransferase (ALT) by 24%. However, there was no significant change in the mean NASH activity score (NAS) (3.8 ± 2.11 versus 3.68 ± 1.8), ballooning score, fibrosis stage (1.76 ± 1.18 versus 1.85 ± 1.19), or area of fibrosis by micromorphometry (4.43% ± 0.68 to 5.54% ± 0.68). In the PLB-RSG group steatosis significantly decreased after 2 years of RSG (median decrease of 15%); in the RSG-RSG group, after an initial decline in the first year of 20%, 2 additional years of RSG did not result in further improvement. Likewise, there was no improvement in the NAS score, ballooning, intralobular inflammation, fibrosis stage, or area of fibrosis with 2 additional years of RSG in the RSG-RSG group. Conclusion: Rosiglitazone has a substantial antisteatogenic effect in the first year of treatment without additional benefit with longer therapy despite a maintained effect on insulin sensitivity and transaminase levels. This suggests that improving insulin sensitivity might not be sufficient in NASH and that additional targets of therapy for liver injury should be explored. (Hepatology 2009.)

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Metadata

Authors
Ratziu, V., Charlotte, F., Bernhardt, C., Giral, P., Halbron, M., LeNaour, G., Hartmann-Heurtier, A., Bruckert, E., & Poynard, T.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2010-02
Volume
51
Issue
2
Pages
445-453
ISSN
0270-9139 (ISSN-L)
DOI
10.1002/hep.23270
OpenAlex
W2069412892
Cited by
366
References
5
FWCI
16.45
Type
journal article
Language
en
Open access
closed

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