Older, cheaper diabetes medications are highly effective and come with far fewer side effects than a pair of drugs that received federal regulators’ most stringent warning last month, according to at least one clinical investigator involved in a new round of research involving both drugs.
Actos and Avandia, medications designed to keep blood sugar under control in people with type 2 diabetes, have been under close scrutiny for several months.
Now, in a separate pair of studies in which researchers pooled existing studies on the two drugs and re-examined the data, findings reveal that even though Actos and Avandia belong to the same chemical class, they have different chemical profiles.
Actos appears to lower the risk of heart attack and stroke, but it still raises the risk of congestive heart failure, the reason last month the Food and Drug Administration required a “black box warning” on the medication’s label.
Rival drug, Avandia, which also must carry the stern cautionary labeling, has even more side effects: It raises the risk of heart attacks and strokes, and increases the likelihood of heart failure.
The new analyses were published in Wednesday’s Journal of the American Medical Association.
“Patients should be taking older, cheaper drugs like metformin, and (newly diagnosed) patients shouldn’t be starting on Avandia or Actos,” said Dr. Sonal Singh, a professor of internal medicine at Wake Forest University, and lead author of the new Avandia research. “These are third-line options. Neither of these drugs should be used.”
Singh found that Avandia increased the risk of heart attack by 42 percent and doubled the risk of heart failure. He also found that Avandia increased the risk of bone fractures in women and caused fluid to increase in patients’ eyes. “Both of the drugs have these side effects,” Singh said.
He said Avandia and Actos run 10 times the daily cost of metformin, which averages about $1.40 per day.
Avandia, a product of GlaxoSmithKline, belongs to the class of medications known as thiazolidinediones, which were introduced in the late 1990s as a innovative way to treat diabetes. The drugs help lower blood sugar but they act on a multitude of metabolic pathways — so many, experts said this week, that scientists have yet to figure out what they are.
Dr. Michael Lincoff of the Cleveland Clinic, author of the Actos study, said that because Actos appears to prevent heart attacks, the drug is still a good choice for patients. Heart attack and stroke risks are substantially elevated in diabetics.
Lincoff added that fluid retention linked to congestive heart failure can be alleviated by giving patients a diuretic.
His study was conducted with a $25,000 grant from Takeda Pharmaceutical Co., the makers of Actos.