Effect of rosiglitazone on serum liver biochemistries in diabetic patients with normal and elevated baseline liver enzymes

Naga Chalasani, Evgenia Teal, Stephen D. Hall

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Abstract

OBJECTIVES: Thiazolidinediones (TZD) are recommended to be used cautiously in diabetics with mild elevations in liver enzymes and not to be used in those with alanine aminotransferase >2.5 upper limit normal (ULN). However, studies are not adequate that evaluated the risk of TZD hepatotoxicity in diabetics with elevated liver enzymes. We conducted a study to test if diabetics with elevated liver enzymes have increased risk for hepatotoxicity from rosiglitazone (only TZD available on our formulary). METHODS: This study consisted of two cohorts of patients prescribed rosiglitazone since January 2000. Cohort 1: 210 diabetics with elevated baseline liver enzymes (aspartate aminotransferase (AST) >40 IU/L and/or alanine aminotransferase (ALT) >35 IU/L) who received rosiglitazone, and cohort 2: 628 diabetics with normal liver enzymes who received rosiglitazone. Elevations in liver biochemistries over a 12-month period after initiating rosiglitazone were characterized into mild to moderate or severe elevations and into "Hy's rule" based on published criteria. RESULTS: Compared to cohort 2, patients in cohort 1 did not have higher incidence of mild to moderate (10% vs 6.6%, p = 0.2) or severe elevations (0.9% vs 0.6%, p = 0.9) in liver biochemistries. Similarly, the incidence of liver biochemistry abnormalities meeting the Hy's Rule was statistically not different between the two cohorts (0% vs 0.3%, p = 0.9). The frequency of discontinuing rosiglitazone therapy during the follow-up was similar between cohorts 1 and 2 (8.6% vs 8.1%, p = 1.0). CONCLUSIONS: These results suggest that diabetics with elevated baseline liver enzymes do not have a higher risk of hepatotoxicity from rosiglitazone than those with normal enzymes.

Original languageEnglish
Pages (from-to)1317-1321
Number of pages5
JournalAmerican Journal of Gastroenterology
Volume100
Issue number6
DOIs
StatePublished - Jun 2005

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rosiglitazone
Biochemistry
Liver
Enzymes
Serum
Thiazolidinediones
Alanine Transaminase
Formularies
Incidence

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Effect of rosiglitazone on serum liver biochemistries in diabetic patients with normal and elevated baseline liver enzymes. / Chalasani, Naga; Teal, Evgenia; Hall, Stephen D.

In: American Journal of Gastroenterology, Vol. 100, No. 6, 06.2005, p. 1317-1321.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVES: Thiazolidinediones (TZD) are recommended to be used cautiously in diabetics with mild elevations in liver enzymes and not to be used in those with alanine aminotransferase >2.5 upper limit normal (ULN). However, studies are not adequate that evaluated the risk of TZD hepatotoxicity in diabetics with elevated liver enzymes. We conducted a study to test if diabetics with elevated liver enzymes have increased risk for hepatotoxicity from rosiglitazone (only TZD available on our formulary). METHODS: This study consisted of two cohorts of patients prescribed rosiglitazone since January 2000. Cohort 1: 210 diabetics with elevated baseline liver enzymes (aspartate aminotransferase (AST) >40 IU/L and/or alanine aminotransferase (ALT) >35 IU/L) who received rosiglitazone, and cohort 2: 628 diabetics with normal liver enzymes who received rosiglitazone. Elevations in liver biochemistries over a 12-month period after initiating rosiglitazone were characterized into mild to moderate or severe elevations and into {"}Hy's rule{"} based on published criteria. RESULTS: Compared to cohort 2, patients in cohort 1 did not have higher incidence of mild to moderate (10{\%} vs 6.6{\%}, p = 0.2) or severe elevations (0.9{\%} vs 0.6{\%}, p = 0.9) in liver biochemistries. Similarly, the incidence of liver biochemistry abnormalities meeting the Hy's Rule was statistically not different between the two cohorts (0{\%} vs 0.3{\%}, p = 0.9). The frequency of discontinuing rosiglitazone therapy during the follow-up was similar between cohorts 1 and 2 (8.6{\%} vs 8.1{\%}, p = 1.0). CONCLUSIONS: These results suggest that diabetics with elevated baseline liver enzymes do not have a higher risk of hepatotoxicity from rosiglitazone than those with normal enzymes.",
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AU - Teal, Evgenia

AU - Hall, Stephen D.

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N2 - OBJECTIVES: Thiazolidinediones (TZD) are recommended to be used cautiously in diabetics with mild elevations in liver enzymes and not to be used in those with alanine aminotransferase >2.5 upper limit normal (ULN). However, studies are not adequate that evaluated the risk of TZD hepatotoxicity in diabetics with elevated liver enzymes. We conducted a study to test if diabetics with elevated liver enzymes have increased risk for hepatotoxicity from rosiglitazone (only TZD available on our formulary). METHODS: This study consisted of two cohorts of patients prescribed rosiglitazone since January 2000. Cohort 1: 210 diabetics with elevated baseline liver enzymes (aspartate aminotransferase (AST) >40 IU/L and/or alanine aminotransferase (ALT) >35 IU/L) who received rosiglitazone, and cohort 2: 628 diabetics with normal liver enzymes who received rosiglitazone. Elevations in liver biochemistries over a 12-month period after initiating rosiglitazone were characterized into mild to moderate or severe elevations and into "Hy's rule" based on published criteria. RESULTS: Compared to cohort 2, patients in cohort 1 did not have higher incidence of mild to moderate (10% vs 6.6%, p = 0.2) or severe elevations (0.9% vs 0.6%, p = 0.9) in liver biochemistries. Similarly, the incidence of liver biochemistry abnormalities meeting the Hy's Rule was statistically not different between the two cohorts (0% vs 0.3%, p = 0.9). The frequency of discontinuing rosiglitazone therapy during the follow-up was similar between cohorts 1 and 2 (8.6% vs 8.1%, p = 1.0). CONCLUSIONS: These results suggest that diabetics with elevated baseline liver enzymes do not have a higher risk of hepatotoxicity from rosiglitazone than those with normal enzymes.

AB - OBJECTIVES: Thiazolidinediones (TZD) are recommended to be used cautiously in diabetics with mild elevations in liver enzymes and not to be used in those with alanine aminotransferase >2.5 upper limit normal (ULN). However, studies are not adequate that evaluated the risk of TZD hepatotoxicity in diabetics with elevated liver enzymes. We conducted a study to test if diabetics with elevated liver enzymes have increased risk for hepatotoxicity from rosiglitazone (only TZD available on our formulary). METHODS: This study consisted of two cohorts of patients prescribed rosiglitazone since January 2000. Cohort 1: 210 diabetics with elevated baseline liver enzymes (aspartate aminotransferase (AST) >40 IU/L and/or alanine aminotransferase (ALT) >35 IU/L) who received rosiglitazone, and cohort 2: 628 diabetics with normal liver enzymes who received rosiglitazone. Elevations in liver biochemistries over a 12-month period after initiating rosiglitazone were characterized into mild to moderate or severe elevations and into "Hy's rule" based on published criteria. RESULTS: Compared to cohort 2, patients in cohort 1 did not have higher incidence of mild to moderate (10% vs 6.6%, p = 0.2) or severe elevations (0.9% vs 0.6%, p = 0.9) in liver biochemistries. Similarly, the incidence of liver biochemistry abnormalities meeting the Hy's Rule was statistically not different between the two cohorts (0% vs 0.3%, p = 0.9). The frequency of discontinuing rosiglitazone therapy during the follow-up was similar between cohorts 1 and 2 (8.6% vs 8.1%, p = 1.0). CONCLUSIONS: These results suggest that diabetics with elevated baseline liver enzymes do not have a higher risk of hepatotoxicity from rosiglitazone than those with normal enzymes.

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