A 40-year-old drug currently in use to treat type 2 diabetes hasn’t been studied as effectively as others for a different disease of the pancreas, which can cause liver failure, writes Carol Lehman-Miller, Medscape correspondent.
Thiazolidinediones, or TZDs for short, are an alternative to traditional diabetes medications. They are a type of an older drug for treating the type 2 diabetes known as insulin-dependent diabetic mellitus, or IDDM.
In an article on Medscape.com, Lehman-Miller explains that “the concern with TZDs has to do with their failure to slow down or reverse the progress of hardening of the arteries, a risk factor for heart attack, stroke and so-called myocardial infarction. In clinical trials, the biggest problem with the drugs appears to be a high incidence of perforation of internal organs, such as the pancreas and the gallbladder.
“While ‘myocardial infarction’ typically means that a person has actually suffered a heart attack,” writes Lehman-Miller, “any type of infarction carries the risk of causing perforation of one of the blood vessels in the heart.
TZDs have been approved by the FDA for use to treat IDDM.
Although more and more people are using TZDs to control their diabetes, no trials have directly evaluated their safety and effectiveness in treating the symptom of pancreatitis in IDDM patients.”
Lehman-Miller notes that the GAIN trial of a TZD known as NEBI-68 did find that the drugs made it easier for patients to reduce the amount of sugar in their blood.
But the available studies on this drug aren’t designed to study its safety and effectiveness in a pancreatitis setting.
“Overall,” Lehman-Miller writes, “the focus on obesogenic behavior, symptoms of diabetes and rates of heart attack and stroke could lead to some important safety questions.”
For a long time, Merck has defended the safety of TZDs because its drugs contain small amounts of fenfluramine, the same chemical as the one that caused a heart attack in a pregnant woman in 1998, she writes.
Merck withdrew the fenfluramine and two other components of the drug Fen-phen in 1997.
Merck’s Merck’s nefendild, the first TZD to go on the market in 2002, was recently turned down by the FDA because of a warning label on it about problems with the pancreas. The panel failed to endorse an ADAPT study of the drug and instead urged the FDA to require more research on safety issues, Lehman-Miller writes.