In a nutshell
This study examined the effects of saxagliptin (Onglyza) in patients with type 2 diabetes and impaired kidney function. The study concluded that saxagliptin had similar effects regardless of kidney function, but did increase the risk of hospitalization for heart failure.
Some background
High blood glucose (sugar) levels can, over time, damage the nerves, blood vessels, and kidneys. Patients with both type 2 diabetes (T2D) and kidney damage are also at an increased risk of cardiovascular (heart and blood vessel) events, such as heart attack or stroke. It is important to understand how glucose-lowering medications affect cardiovascular outcomes.
Saxagliptin is a glucose-lowering medication that is eliminated from the body by the kidneys. More studies are needed to investigate the safety and effects of saxagliptin in patients with kidney damage.
Methods & findings
The current trial included 16,492 T2D patients at risk of cardiovascular events. Patients were randomly assigned to receive either saxagliptin or placebo (substance with no effect on the body). Kidney function was measured before the start of treatment. Patients were classified as having normal, mildly impaired, moderately impaired or severely impaired kidney function. Patients were followed for an average of 2 years.
Overall, patients with moderate kidney impairment were 2.38 times more likely to be hospitalized for heart failure compared to those with normal kidney function. Patients with severe kidney impairment were 4.59 times more likely.
Saxagliptin did not significantly increase or decrease the risk of cardiovascular events (heart attack, stroke, or death due to cardiovascular disease). In those with mild impairment, the rate of an event was 6.55% in those treated with saxagliptin and 6.28% with placebo. In those with severe impairment, the rate was 14.7% with saxagliptin and 17.2% with placebo. Saxagliptin increased the risk of hospitalization for heart failure in patients with normal, mildly impaired, or moderately impaired kidney function.
Progression of mild and moderate kidney disease was significantly slower in patients treated with saxagliptin compared to placebo. Saxagliptin significantly improved HbA1c levels (average blood glucose over 3 months).
The bottom line
This study concluded that overall the effects of saxagliptin were similar regardless of kidney function. While saxagliptin did not change the risk of cardiovascular outcomes and lowered HbA1c, it did increase the risk of hospitalization due to heart failure.
The fine print
Patients in this trial may have also been treated with other glucose-lowering medications or treatments for cardiovascular disease. These other treatments were not taken into account in this analysis.
This study was funded by AstraZeneca/Bristol-Myers Squibb, the manufacturers of saxagliptin.
Published By :
Diabetes Care
Date :
Dec 31, 2014
