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This article was published at www.annals.org on 21 June 2016.
The full report is titled “Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus. A Randomized Trial.” The authors are K. Cusi, B. Orsak, F. Bril, R. Lomonaco, J. Hecht, C. Ortiz-Lopez, F. Tio, J. Hardies, C. Darland, N. Musi, A. Webb, and P. Portillo-Sanchez.
Pioglitazone for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes. Ann Intern Med. 2016;165:I-15. doi: 10.7326/P16-9018
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Published: Ann Intern Med. 2016;165(5):I-15.
Published at www.annals.org on 21 June 2016
Nonalcoholic steatohepatitis (NASH) is a common chronic liver disease that is found in obese patients with prediabetes or type 2 diabetes. Pioglitazone is a diabetes medication that may be helpful in treating liver disease and some of the metabolic problems found in patients with NASH.
To see whether pioglitazone treatment results in an improvement in liver biopsy results and is a safe treatment for patients with prediabetes or type 2 diabetes and NASH.
101 patients with prediabetes or type 2 diabetes who had a liver biopsy that showed NASH.
Before starting the study, patients had an oral glucose tolerance test to determine whether they had prediabetes or type 2 diabetes. They also had a liver biopsy to see whether NASH was present and how active it was. All of the patients were prescribed a low-calorie diet and were then randomly assigned to receive either pioglitazone or placebo (pills that did not contain active treatment) for 18 months. After 18 months, all of the patients, even those in the placebo group, had the option to be treated with pioglitazone for another 18 months. Liver biopsies were repeated at 18 and 36 months, and blood tests were performed at baseline and 18 months. The researchers monitored the patients and recorded any bad side effects that occurred during the study.
More patients in the pioglitazone group showed improvement in their liver biopsies. In about half of the patients receiving pioglitazone, the liver biopsies no longer showed NASH. The pioglitazone group showed more improvement in fasting blood sugar levels, liver function tests, and triglyceride levels but had a weight gain of about 5.5 pounds compared with the placebo group. No patients developed bladder cancer, osteoporosis, or bone fractures due to osteoporosis.
This study involved 101 patients and was conducted at a single university hospital in the United States. In 2011, while this trial was being conducted, the U.S. Food and Drug Administration released a drug safety warning about a possible risk for bladder cancer with pioglitazone treatment. More recent studies have not found this association. However, as a result of this warning, 11 patients stopped participating in the study during the first 18 months, and another 8 patients withdrew from the second part of the study.
The results of this small trial suggest that 3 years of treatment with pioglitazone was associated with long-term improvements on liver biopsies and metabolic blood tests in patients with prediabetes or type 2 diabetes and NASH.
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Cardiology, Endocrine and Metabolism, Gastroenterology/Hepatology, Diabetes, Coronary Risk Factors.
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