AstraZeneca’s Kombiglyze contains saxagliptin, a new diabetes drug that has been linked to increased rates of hospitalization for heart failure and deaths.
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What is Kombiglyze?
Kombiglyze XR is a type-2 diabetes medication made by AstraZeneca. It combines saxagliptin (sold alone as Onglyza) with extended-release metformin, a first-line treatment for diabetes.
Study Links Kombiglyze and 27% Increased Risk of Heart Failure
In February 2014, saxagliptin was linked to a 27% increased risk of hospitalization for heart failure in the SAVOR clinical trial published by the New England Journal of Medicine.
Conclusions were based on nearly 16,500 patients who randomly received a placebo or saxagliptin. After 2.1 years, 3.5% of saxagliptin patients were hospitalized for heart failure, compared to 2.8% of placebo patients.
FDA Concerned About Increased Risk of Death
Soon after this study was published, the FDA announced that it would open a safety investigation. In April 2015, the agency concluded that saxagliptin may significantly raise a patient’s risk of death from all causes, not just heart problems.
What is the problem?
Diabetes is a very serious risk-factor for heart disease, which is why it is so concerning when studies show medications can increase this risk even futher. In fact, people with diabetes have the same risk of heart attack and dying from heart disease as people who have already had heart attacks.
What is Heart Failure?
Heart failure occurs when the heart muscle becomes too weak to effectively pump blood into the body. It is a chronic, progressive disease that worsens as the heart muscle thickens, loses flexibility, and pumps faster.
Symptoms of Heart Failure
- Shortness of breath
- Persistent cough or wheezing
- Edema (fluid accumulation and swelling in tissues)
- Fatigue and weakness
- Nausea and loss of appetite
- Rapid heart rhythm
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