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Sep 04, 2013

Good and Bad News for Diabetes Drugs in Recent Studies

Two clinical trials fail to show cardiovascular benefits from tight blood sugar control using a common class of diabetes drugs.

Patients with diabetes have significantly increased risk for heart disease and can help reduce risk of complications by controlling blood sugar levels. According to studies presented earlier this week at the European Society of Cardiology Congress, a class of drugs that controls blood sugar doesn’t have any cardiovascular benefits and may actually increase risk for heart failure.

These studies—the EXAMINE and SAVOR-TIMI trials—both looked into the safety of DPP-4 drugs, which help strictly control glucose levels and have been approved for the treatment of type 2 diabetes. In the past, similar drugs have been shown to increase cardiovascular risk, and as a result, all new drugs used for glucose control must pass strict safety review to ensure that they don’t negatively impact heart health. Based on study findings, there’s good and bad news when it comes to the safety of DPP-4 diabetes drugs.

The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial tested the safety of the DPP-4 drug alogliptin in patients with type 2 diabetes and a history of heart attack or chronic chest pain. A total of 5,380 patients were enrolled and after following them for up to 40 months, researchers found no cardiovascular risk or benefit associated with the drug compared to the placebo, despite its ability to control glucose.

The second study, the SAVOR-TIMI (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus—Thrombolysis in Myocardial Infarction) trial, looked at the safety of a similar drug called saxagliptin in diabetic patients with high risk or a history of heart disease. After following nearly 16,500 patients for just over two years, researchers found that saxagliptin had no effect on risk for cardiac events. However, they did find that patients taking saxagliptin were significantly more likely to be hospitalized for heart failure than those taking the placebo. 

These findings have garnered much attention because until recently, it was believed that strict glucose control was key to reducing heart disease risk in diabetic patients. But as studies like the EXAMINE and SAVOR-TIMI trials show, drugs that control glucose levels may have no effect on cardiovascular risk or worse, may actually increase risk for heart disease.

It’s clear that more research is needed to better understand the possible risks and benefits associated with DPP-4 drugs. In the meantime, many experts believe that we should focus on addressing specific cardiovascular risk factors in patients with diabetes, instead of trying to achieve intensive blood sugar control. Because although blood sugar control is important to reducing risk of complications from diabetes, we can’t underestimate the importance of addressing other well-known risk factors to reduce heart disease risk.

Questions for You to Consider

  • Why is blood sugar control important for patients with diabetes?
  • Keeping blood glucose levels as close to normal as possible can help prevent or slow the progress of many complications of diabetes. To get tight control, you should pay attention to diet and exercise, keep close track of blood glucose levels, and if you take insulin, closely manage your injection schedule.

  • What are the possible complications of tight blood sugar control?
  • Low blood sugar (hypoglycemia) episodes are a possible complication in people who tightly control their blood sugar by taking insulin or some oral diabetes medicines. Some people who have tight control of their blood sugar may not be able to sense when they have low blood sugar. Some people need to have a higher target blood sugar level because of the danger of low blood sugar. Work with your doctor to set your own target blood sugar range. This will help you achieve the best control possible without having a high risk of hypoglycemia.


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