John Hopton for redOrbit.com – Your Universe Online
2014 has been a pretty positive year for stories about diabetes treatment, and it ends with the news that an important drug for patients with type 2 diabetes could be safe to use even after they are diagnosed with mild to moderate kidney disease. The current Food and Drug Administration (FDA) advice is to suspend use after diagnosis of kidney disease.
Metformin has been used in the United States to lower blood sugar in people with type 2 diabetes for 20 years, and is now the most widely used treatment for type 2. However, FDA guidelines have long stated that if a patient is diagnosed with mild to moderate kidney disease then metformin should be discontinued. A new study has called that advice into question, and if the FDA amends its guidance as a result then the drug could be made available to more than 2.5 million Americans living with type 2 diabetes.
According to a new, systematic review of the literature published by Yale investigators in the Journal of the American Medical Association (JAMA), the risk of metformin resulting in the serious condition lactic acidosis in patients with mild to moderate kidney disease is extremely low–comparable to the risk in those who did not take metformin.
Yale professor of medicine Dr Silvio E. Inzucchi and colleagues at Yale, the University of Texas Southwestern Medical Center, and Aston University in the United Kingdom conducted a systematic review of published research to assess the risk of lactic acidosis with metformin in diabetes patients with mild to moderate kidney disease.
“What we found is that there is essentially zero evidence that this is risky,” said Inzucchi, who is also medical director of the Yale Diabetes Center. “The drug could be used safely, so long as kidney function is stable and not severely impaired.”
The researchers have recommended that the FDA implement a change, pointing out that patients who had previously received great benefit from using metformin were being denied it unnecessarily upon diagnosis of kidney disease of any severity.
“They hit a certain age, their kidney function starts to decline, and the first thing most doctors do is to stop metformin,” Inzucchi said. “What invariably happens next is their diabetes goes out of control. Other drugs may be substituted, but they are usually not generic products like metformin, and so are more expensive and may also have more side effects.”
Inzucchi noted that many health professionals are already aware that the risk of kidney problems due to metformin use is small in the face of the drug’s significant benefits, and are overlooking FDA advice presently. One hundred diabetes experts in the US have backed the group’s recommendation that FDA guidelines be updated.
“Many in the field know that metformin can be used cautiously in patients who have mild to moderate kidney problems,” Inzucchi explained. “Most specialists do this all the time.”
In the case of severe kidney disease, Inzucchi acknowledges that although reduced dosage and careful monitoring may allow limited use of metformin, the desired opening up of regulation that applies to mild to moderate patients is not applicable at this time.
The news comes in the same twelve months that saw Google announce that it is working on smart contact lenses to help diabetics monitor blood sugar levels, the proposal of a less problematic alternative to daily insulin injections for type 2 patients, and a potential cure for type 1 after a stem cell research breakthrough. The stem cell research was inspired by a Harvard professor who wanted to find a cure for his son and daughter who both have type 1 diabetes.
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