Since 2009, very large, specialized studies on cardiovascular and vascular diseases in people with diabetes have been conducted. The results are extremely positive. They show that the selection of certain diabetes medications can significantly improve the prognosis of cardiovascular and vascular diseases. In addition, surprisingly good results were found with regard to heart muscle weakness (heart failure) and kidney disease (nephropathy).

Every year, new results are published and treatment recommendations are adjusted to reflect the latest findings. Concrete treatment recommendations are derived from these study results on an ongoing, annual basis. These contribute to a decisive improvement in quality of life and survival for people with diabetes.

So-called “Cardiovascular Outcome Trials” (CVOTs)

Why are these studies conducted?

In 2007, a study investigating diabetes treatment with a so-called “glitazone” produced a surprising and alarming result: under certain conditions, the use of this frequently prescribed medication worsened the cardiovascular prognosis of people with diabetes. In response, the U.S. Food and Drug Administration (FDA) made a rapid decision in 2008:

• Every newly approved medication must demonstrate, in a study involving a very large number of people with diabetes (conducted in many countries), that it does not cause harm.
• Participants in these studies receive all medications approved for diabetes treatment as needed.
• One group additionally receives the new medication, while a comparison group receives a placebo.
• At the end of the study, the combined number of heart attacks and strokes, as well as deaths caused by these conditions, is evaluated (the so-called “primary endpoint”).
• Additional outcomes are also assessed (so-called “secondary endpoints”), particularly heart failure, kidney function, and side effects.

Study Results Since 2013: Study Goals Achieved — and Much More!

All substances examined to date have fortunately met the primary study goal: the medications studied are not harmful to people with diabetes (non-inferiority). Completely unexpectedly, however, some medications showed more than just “non-inferiority”: they demonstrated clear advantages compared with the placebo group. Moreover, certain medications significantly improved the risk and prognosis of heart failure and kidney disease. These effects occurred much earlier than expected and were, in part, independent of blood glucose reduction and HbA1c levels.

Inclusion of These Medications in Treatment Recommendations for People with Diabetes

The study results have led to significant changes in treatment recommendations. Whereas the quality of blood glucose control was previously considered the decisive criterion for selecting medications, pre-existing conditions and individual risk profiles are now the determining factors:

1. If cardiovascular damage is already present (heart attack, stroke, peripheral arterial occlusive disease), treatment with the relevant medications should always be initiated—regardless of blood glucose control, including in patients with well-controlled HbA1c levels.
2. If heart failure or kidney disease is present (or if the risk is increased), treatment with the relevant medications should be initiated depending on disease severity—again, regardless of blood glucose control, including in patients with good HbA1c levels.

Use of Blood Glucose–Lowering Medications in Non-Diabetics: The Future Has Begun!

If blood glucose control and HbA1c are not decisive, the question naturally arises as to whether these medications are also effective in non-diabetics. Indeed, three large studies have shown positive results in people without diabetes as well. Certain SGLT-2 inhibitors significantly improve the prognosis of non-diabetic patients with heart failure and kidney disease. In Germany, one SGLT-2 inhibitor has already been approved for the treatment of severe heart failure in non-diabetic patients. Approval for use in people with kidney disease is expected.

Categorised under: Secondary complications
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