What is the role of rosiglitazone in the treatment of fatty liver disease?

Updated: Apr 12, 2018
  • Author: Emily Tommolino, MD; Chief Editor: BS Anand, MD  more...
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Answer

Rosiglitazone is an antidiabetic agent (thiazolidinedione derivative) that improves glycemic control by improving insulin sensitivity. It is sold both as a single-ingredient product under the brand name Avandia and as combination products under the brand names Avandamet (rosiglitazone with metformin) and Avandaryl (rosiglitazone with glimepiride).

Rosiglitazone was studied for 48 weeks in 30 patients with NASH and was found to yield biochemical as well as histologic improvement. [55] In a randomized, open-label trial, rosiglitazone plus metformin was compared with rosiglitazone plus losartan and with rosiglitazone alone after 48 weeks of therapy in 137 subjects with biopsy-proven NASH; the combination regimens yielded no greater benefit than rosiglitazone alone with respect to histopathology. [56]

The 2007 publication of a meta-analysis raised concerns among patients and healthcare professionals that rosiglitazone was potentially associated with an increased risk of myocardial infarction (MI) and heart-related deaths. [57] A 2010 update of this meta-analysis concluded that the totality of the randomized clinical trials continued to demonstrate increased risk for MI (though not for cardiovascular or all-cause mortality) and that the available findings suggested an unfavorable benefit-to-risk ratio for rosiglitazone. [58]

As of November 18, 2011, the US Food and Drug Administration (FDA) requires that healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities. (See Safety Alert on Avandia [last updated 11/4/2011]).

Patients currently taking rosiglitazone and benefiting from the drug may continue if they choose to do so. Rosiglitazone is available to new patients only if they are unable to achieve glucose control on other medications and are unable to take pioglitazone, the only other thiazolidinedione.


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