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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
SUMMARIES FOR PATIENTS
Liver Damage in a Person Taking the Diabetes Drug Pioglitazone
19 March 2002 | Volume 136 Issue 6 | Page I65
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians-American Society of Internal Medicine.
The summary below is from the full report titled "Mixed Hepatocellular–Cholestatic Liver Injury after Pioglitazone Therapy." It is in the 19 March 2002 issue of Annals of Internal Medicine (volume 136, pages 449-452). The authors are LD May, JH Lefkowitch, MT Kram, and DE Rubin. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians–American Society of Internal Medicine.
What is the problem and what is known about it so far?
Diabetes affects the body's ability to handle sugars, resulting in high blood levels of sugar (glucose). Over time, high blood sugar leads to such complications as blindness, kidney failure, and heart disease. The goal of diabetes treatment is to keep blood sugar levels normal to prevent these complications. The thiazolidinediones are a newer class of diabetes drugs that can help keep blood sugar normal. Unfortunately, the first two approved drugs in this class, troglitazone and rosiglitazone, can cause liver damage in some people. The newest drug in this class, pioglitazone, is thought to be less likely to lead to liver problems than the other two drugs.
Why did the researchers do this particular study?
The authors report a case of liver damage that they observed in a patient taking the drug pioglitazone.
Who was studied?
A 49-year-old man who was taking pioglitazone, 30 mg daily, for treatment of diabetes.
How was the study done?
The authors reviewed the medical records for this patient.
What did the researchers find?
After taking 15 mg of pioglitazone daily for 4 months and 30 mg daily for 2 months, the patient developed abdominal pain, nausea, loss of appetite, and weight loss. Results of blood tests, including tests of liver function, were normal. He developed high blood sugar, and his doctors increased the daily pioglitazone dose to 45 mg. Several days later, the patient noticed that the whites of his eyes were turning yellow and his bowel movements were light in color. He had another set of liver function tests, which showed liver damage. Pioglitazone was stopped, but he continued to take his other medications. Extensive tests revealed no other potential causes of liver damage, and a biopsy of the liver showed changes compatible with drug-related liver damage. The patient's symptoms gradually improved, and results of liver tests became normal 6 weeks after the pioglitazone was stopped.
What were the limitations of the study?
This report includes only one patient, and it is impossible to know for sure whether it was the pioglitazone that was responsible for his liver damage. This report tells us nothing about how common this complication is or whether certain types of patients are more likely to develop complications.
What are the implications of the study?
Liver damage may occur in patients who take pioglitazone. Patients who are taking this drug should have periodic blood tests to check liver function. If patients develop new symptoms while taking pioglitazone, they should contact their doctors.
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  K. G. Tolman, V. Fonseca, A. Dalpiaz, and M. H. Tan Spectrum of Liver Disease in Type 2 Diabetes and Management of Patients With Diabetes and Liver Disease Diabetes Care, March 1, 2007; 30(3): 734 - 743. [Full Text] [PDF]
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 H. A. Spiller and T. S. Sawyer Toxicology of oral antidiabetic medications Am. J. Health Syst. Pharm., May 15, 2006; 63(10): 929 - 938. [Abstract] [Full Text] [PDF]
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 T. M. Baughman, R. A. Graham, K. Wells-Knecht, I. S. Silver, L. O. Tyler, M. Wells-Knecht, and Z. Zhao METABOLIC ACTIVATION OF PIOGLITAZONE IDENTIFIED FROM RAT AND HUMAN LIVER MICROSOMES AND FRESHLY ISOLATED HEPATOCYTES Drug Metab. Dispos., June 1, 2005; 33(6): 733 - 738. [Abstract] [Full Text] [PDF]
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 K. G. Tolman, V. Fonseca, M. H. Tan, and A. Dalpiaz Narrative Review: Hepatobiliary Disease in Type 2 Diabetes Mellitus Ann Intern Med, December 21, 2004; 141(12): 946 - 956. [Abstract] [Full Text] [PDF]
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 T. R Marcy, M. L Britton, and S. M Blevins Second-Generation Thiazolidinediones and Hepatotoxicity Ann. Pharmacother., September 1, 2004; 38(9): 1419 - 1423. [Abstract] [Full Text] [PDF]
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 C. J. Glueck, A. Moreira, N. Goldenberg, L. Sieve, and P. Wang Pioglitazone and metformin in obese women with polycystic ovary syndrome not optimally responsive to metformin Hum. Reprod., August 1, 2003; 18(8): 1618 - 1625. [Abstract] [Full Text] [PDF]
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 W. M. Lee Drug-Induced Hepatotoxicity N. Engl. J. Med., July 31, 2003; 349(5): 474 - 485. [Full Text] [PDF]
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J. Sahi, C. B. Black, G. A. Hamilton, X. Zheng, S. Jolley, K. A. Rose, D. Gilbert, E. L. LeCluyse, and M. W. Sinz Comparative Effects of Thiazolidinediones on in Vitro P450 Enzyme Induction and Inhibition Drug Metab. Dispos., April 1, 2003; 31(4): 439 - 446. [Abstract] [Full Text] [PDF]
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N. Kaplowitz, J. H. Lewis, and P. B. Watkins Did This Drug Cause My Patient's Hepatitis? Ann Intern Med, January 21, 2003; 138(2): 159 - 159. [Full Text] [PDF]
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D. W. Nierenberg Did This Drug Cause My Patient's Hepatitis? Ann Intern Med, January 21, 2003; 138(2): 159 - 160. [Full Text] [PDF]
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A. G. Pinto, O. W. Cummings, and N. Chalasani Severe but Reversible Cholestatic Liver Injury after Pioglitazone Therapy Ann Intern Med, November 19, 2002; 137(10): 857 - 857. [Full Text] [PDF]
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 R. K. Campbell and J. White Counseling Patients With Type 2 Diabetes and Insulin Resistance in the Outpatient Setting The Diabetes Educator, November 1, 2002; 28(6): 938 - 957. [PDF]
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Correction: Mixed Hepatocellular-Cholestatic Liver Injury after Pioglitazone Therapy Ann Intern Med, May 7, 2002; 136(9): 711 - 711. [Full Text] [PDF]
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 Another Thiazolidinedione Can Cause Liver Injury Journal Watch (General), March 26, 2002; 2002(326): 1 - 1. [Full Text]
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D. W. Nierenberg "Did This Drug Cause My Patient's Hepatitis?" and Related Questions Ann Intern Med, March 19, 2002; 136(6): 480 - 483. [Full Text] [PDF]
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