There are 16 drugs in 9 different pharmacologic classes that are approved by the FDA for the management of type 2 diabetes because they lower blood sugar and glycosolated hemoglobin levels in the blood. These test are used to diagnosis, monitor and are the baisi to approve new drugs to treat type 2 diabetes.
A recent article in Worst Pills, Best Pills addressed several concerns. Diabetes places people at risk for macrovascular long term complications, but there is no evidence that type 2 diabetes drugs currently on the market reduce these risks. The FDA even requires package inserts to warn prescribers that;
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with any oral anti-diabetes drug.
It should not be assumed that lowering blood sugar levels means that a patient’s diabetes is under control and that in turn reduces the risk of developing complications. The article suggests that this is an inadequate way to determine which drugs should be approved and approval should be based upon the ability of the drug to decrease long term complications as a condition of approval.
The FDA has recently required that manufacturers prove that new type 2 diabetes drugs do not present an unacceptable level of heart risk, but they have not required that the studies be completed prior to marketing.
The article states that one reason that the lifestyle changes, such as proper diet, exercise and weight reduction, are not heavily promoted to prevent and manage type 2 diabetes, amy be that the only one who would profit would be the patient. However, they did advise not to stop taking any diabetes medications without first consulting the prescriber.
Annette Karnash