A serious liver disease called nonalcoholic steatohepatitis, but better known as NASH, may be stopped when some people take the diabetes drug pioglitazone. NASH is a common complication of type 2 diabetes. But a three year long randomized, double-blind, placebo-controlled trial concludes that pioglitazone, sold here as Actos as well as in a generic version, is a safe and effective treatment.
Kenneth Cusi, MD, is the lead author of the study, which the journal Annals of Internal Medicine published online ahead of print. Only the abstract of the study is free online. But a spokesperson for the University of Florida, where Dr. Cusi is a professor of medicine, sent me the full-text.
NASH usually has few or no symptoms, according to the National Institute of Diabetes and Digestive and Kidney Diseases. It is “usually a silent disease.”
Many obese people have NASH
But, as Dr. Cusi wrote in the journal Diabetologia, as many as 30 to 40 percent of obese patients with diabetes have NASH. It “should be suspected in any patient with type 2 diabetes, especially if there are abnormal liver function tests,” other doctors wrote in Diabetes Care. “It should be specifically looked for in all obese patients with Type 2 diabetes.”
NASH can lead to liver failure. My late wife, Catherine Nord, who had type 2 diabetes, had NASH before her liver failed, killing her in March 2007.
NASH cut in half
About 100 people with both NASH and pre-diabetes or type 2 diabetes were in the clinical trial. It found that pioglitazone reduced this fatty liver disease in 58 percent of them. In half of the people in the trial, the drug reduced NASH enough that the researchers concluded it was no longer considered a threat to the liver.
Speaking about pioglitazone, Dr. Cusi said: “The exciting thing is that there is a generic drug that [we knew] prevents the onset of Type 2 diabetes and cardiovascular disease in recent studies. Now, [we know that] it can reduce disease from excess liver fat accumulation and liver inflammation and halt fibrosis that leads to cirrhosis. This will have a lot of long-term benefits for many people with a medication that will be very affordable and is already being used to treat Type 2 diabetes.”
Still, these positive findings don’t come without some concerns. First, Takeda Pharmaceuticals, which developed and markets pioglitazone as Actos, provided the pioglitazone and placebo tablets used in the study.
Of greater concern, however, is the drug’s safety. Eduardo Vilar-Gomez, MD, PhD, of the University of Seville in Spain, and Leon Adams, PhD, of the University of Western Australia, wrote an accompanying editorial about the study that the Annals of Internal Medicine published online ahead of print. Only a preview of its first page is available free online, but Dr. Vilar-Gomez send me a copy of the full text.
“We believe that physicians should consider adding pioglitazone to their toolboxes when facing patients with NASH and diabetes,” the editorial concluded, “but the primary obstacle to the widespread use of pioglitazone remains its safety profile. Thus, treatment should be considered for patients at the greatest risk and should be balanced against the common risk for weight gain and the uncommon risks for fracture and heart failure.”
If you have NASH, you need to talk with your doctor about taking generic pioglitazone or Actos. If Catherine’s doctor had known about the new study and had prescribed Actos to her in time, she could be alive now.
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David Mendosa is a journalist who learned in 1994 that he has Type 2 diabetes, which he now writes about exclusively. He has written thousands of diabetes articles, two books about it, created one of the first diabetes websites, and publishes the monthly newsletter, “Diabetes Update.” His very low-carbohydrate diet, current A1C level of 5.5, and BMI of 19.8 keeps his diabetes in remission without any drugs.