Saxagliptin is a drug used for the treatment of type-2 diabetes. The use of saxagliptin and congestive heart failure have been potentially linked, according to a clinical trial known as SAVOR. The randomized SAVOR clinical trial followed participants for approximately two years.

The results of this trial indicated that of 1,000 type-2 diabetes patients at a high-risk level for the development of heart disease that took saxagliptin, 35 would likely experience heart failure.

This figure should be compared to the 28 out of 1,000 patients of the same category not taking the drug for whom this same fate might await. According to an article by The diaTribe Foundation, the data associated with this study reflects a 27% increase in risk of hospitalization for heart failure.

What is Congestive Heart Failure?

When talking about the relationship of using saxagliptin and congestive heart failure, the term heart failure should be defined – it sounds more ominous than perhaps it should. The condition merely reflects a reduced capacity of the heart muscle to pump blood efficiently throughout the body.

Blood flows through the entire circuit of the circulatory system much more slowly, and the heart has a difficult time getting needed oxygen and nutrients to cells.

The heart responds by stretching to hold more blood, and then the chamber walls may gradually thicken and become stiff. The kidneys respond to this reality by retaining fluid rather than releasing it.

Extremities usually swell such as the feet, ankles, calves, hands, and arms as this intracellular fluid excess remains. The extra lymphatic fluid is why it is often called congestive heart failure.

Food and Drug Administration Announces Drug Safety Warning

As results of the SAVOR test linking saxagliptin and congestive heart failure came in, the Food and Drug Administration (FDA) decided to add a warning label to DPP-4 inhibitor drugs like saxagliptin. A drug safety communication announcing this warning label was released in April 2016.

The warning label addresses the potential of taking saxagliptin and congestive heart failure developing as a result. It doesn’t indicate any additional warnings for additional risk of heart attack, stroke or death from heart disease.

The data from SAVOR did not report an increased risk of those conditions. In fact, there were no greater risks noted in these areas than if a type-2 diabetic patient with high risk for heart disease were to take a placebo, according to diaTribe.

It should be also noted that the increased risk is more significant for type-2 diabetic patients with an established medical history of heart or kidney disease.

While the FDA is still investigating the results of the SAVOR study and its implications, it announced to medical providers that extreme caution would be in order with patients falling into this category. It might be prudent to consider other treatment options.

Since the SAVOR study has linked the use of saxagliptin and congestive heart failure, it is good to be on the lookout for symptoms that could indicate this problem might be developing if you or a loved one take this medication:

• Swelling, particularly of the extremities
• Unexplained weight gain
• Difficulty getting a breath
• Frequent bouts of fatigue