(Updates with early release of third study)
WASHINGTON, June 28 (Reuters) - Two studies released on Monday show GlaxoSmithKline Plc (GSK.L) (GSK.N) diabetes pill Avandia may damage the heart, adding to pressure on U.S. regulators deciding whether the drug should stay on the market. [ID:nN28257505]
But a third study showed that diabetics who took Avandia had a lower risk of heart attack, stroke or death than patients taking drugs of a different type. [ID:nN2880765]
Here are some questions and answers about the issues surrounding Avandia, which is still a blockbuster drug, with $1.2 billion in sales in 2009.
One of the studies was a “meta-analysis” of 56 trials involving people taking Avandia or other diabetes drugs. It found those taking Avandia were 28 percent to 39 percent more likely to have a heart attack, although they were not any more likely to die.
The second study by researchers at the U.S. Food and Drug Administration and the U.S. Centers for Medicare and Medicaid Services compared patients who took Avandia with those who took Takeda Pharmaceutical Co’s (4502.T) Actos, a rival drug in the same class.
They found people taking Avandia had 1.25 times the risk of heart failure compared with those taking Actos, 1.27 times the risk of a stroke and 1.14 times the risk of dying.
The third study, paid for by the U.S. National Institutes of Health, compared patients with diabetes and heart disease taking Avandia plus other types of diabetes drugs with patients simply taking the other drugs. It found that adding Avandia to the mix lowered the risk of heart attack, stroke, or death by 28 percent.
That is just what consumer groups such as Public Citizen and Consumers Union are asking. They have wanted the drug off the market for years, since the first studies suggested that Avandia carried heart risks.
But the third study demonstrates just how difficult it is to show that a drug is dangerous, especially in a disease like diabetes, which is already usually complicated with heart disease and other symptoms as well.
Last week, Germany’s federal joint committee of doctors and health insurers told insurers to stop paying for Avandia.
Members of Congress, including Republican Senator Charles Grassley, Democratic Representative Rosa DeLauro and Senate Finance Committee Chairman Max Baucus, have questioned the FDA’s regulation of Avandia.
GlaxoSmithKline has been fighting to show the drug is safe and FDA officials have also agreed that the data are not clear. The American Diabetes Association rushed out the third study on Monday to help balance the picture and said patients taking Avandia should not just drop it suddenly.
The FDA has scheduled an advisory panel meeting on the heart safety of Avandia on July 13-14. This panel of outside experts could advise FDA to pull the drug from the market, ask to have the current “black box” warning on the label strengthened even more, or call for no action at all.
Some experts suggest there are ways to use Avandia more safely. Earlier this month, Dr. Bernard Zinman of the University of Toronto’s Mount Sinai Hospital said he had found that low doses of Avandia combined with the older diabetes drug metformin can treat diabetes without side effects.
Yes. In May a lawyer involved in some of the suits said Glaxo had settled with nearly 700 people who said they suffered harm because they took Avandia. [ID:nN11123771]
Diabetes is a huge problem globally and is worsening. The World Health Organization estimates that 171 million people globally had diabetes in 2000 and projected that number will nearly double by 2030 to 366 million.
About 90 percent of cases are type-2 diabetes, linked to obesity, poor diet and a lack of exercise, although many people of normal weight also can develop type 2 diabetes.
Diabetes raises the risk of heart disease, stroke, kidney failure and other illnesses. Uncontrolled blood sugar levels can damage the blood vessels, and patients can lose toes, feet and legs to diabetes, while kidneys can fail and damage in the eyes can cause blindness.
Diet and exercise can control diabetes, and many people also take prescription drugs.
Diabetics have 12 classes of drugs to choose from. Avandia, known generically as rosiglitazone, and Actos, known generically as pioglitazone, are in a relatively new class of drugs called thiazolidinediones.
Other new drugs include Merck’s (MRK.N) Januvia and AstraZeneca (AZN.L) and Bristol-Myers Squibb’s (BMY.N) Onglyza. Many other drugs are in clinical trials, attacking diabetes with a variety of approaches.
Older drugs such as metformin and a class known as sulfonylureas are available generically and can also help lower blood sugar. (Reporting by Maggie Fox in Washington; Editing by Susan Heavey, Lisa Von Ahn and Steve Orlofsky)