Over the last few years, people living with type 2 diabetes have been reading more and more in the media about their medications and the possible bad things that might happen when they take them. They want to know - are my diabetes drugs safe for my heart? The headlines have been concerning and confusing. Does Lantus® cause cancer? Avandia® causes heart disease! Actos® linked to bladder cancer! Glyburide is associated with more heart disease. It has been a bewildering time! What should we believe? Who is protecting us?
It is important to understand that all drugs go through a rigorous review before being approved for use. Primarily, Health Canada does this for Canada and the Food and Drug Administration(FDA) provides the same for the U.S. Most recently, related to the concerns raised by Avandia®, all diabetes medication new to the market, need to show safety. These are the rules from the FDA, and although this is in the U.S., this decision affects the whole world.
To show safety, clinical trials need to be conducted. Sometimes this is done while the drug is awaiting approval and other times it is after the drug has already been approved. Regardless, all new diabetes drugs are being tested in large, long-term clinical studies in people who are at high risk of heart disease. Using this population allows the studies to be completed in about 4 – 6 years. It would take a lot longer to test these medications in people with diabetes without known heart disease or risk of heart disease.
September has been an exciting month for this reason. The first two studies - SAVOR with saxagliptin or Onglyza® and EXAMINE with alogliptin (currently not available in Canada) - have completed and their findings were presented.
What did we learn? Neither drug has shown any risk of increasing heart disease or stroke in this high-risk population. The studies were different in some ways, such as when people could have had their most recent cardiovascular event (heart attack or stroke), or how many people were studied, and the other things there that we were interested in studying. However, the most important information and the primary reason the studies were being done: are they safe for the heart? Yes they are!
There are also a few important findings about low risk of hypoglycemia (low blood glucose) and ability to control blood sugar levels, but the studies were really not designed to measure this, so these findings are “bonuses”. There will be lots more important information to come from these studies but for now, we can say they do not raise the risk for heart attack or stroke! So yes they are safe for your heart.
Stay tuned…there are about 10 more studies to come in the next 5- 7 years. We will be learning a lot more about protecting your heart!