COMMENTARY

Two New General Medicine Trials Neurologists Should Know

Hans-Christoph Diener, MD, PhD

Disclosures

December 02, 2015

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I am Hans-Christoph Diener, a stroke neurologist from the University of Duisburg-Essen in Germany. Today I will discuss two trials that were done in patients in internal medicine but are highly relevant to neurologists as well.

The first[1] is a randomized trial about obstructive sleep apnea syndrome that was published in the New England Journal of Medicine. We all believe that this condition is a risk factor for stroke and recurrent stroke and that these patients should be treated. Investigators included 1325 patients with sleep apnea syndrome who had an ejection fraction of less than 45% and for whom the Apnea-Hypopnea Index showed more than 15 events per hour.

Patients were randomly assigned to adaptive servo-ventilation or medical treatment and were followed for 12 months. The primary endpoint was death, lifesaving cardiovascular interventions, or unplanned hospitalizations for heart failure. The primary endpoint was reached by 54% in the continuous positive airway pressure group and 50.8% in the best medical treatment group, which was not significant. The big surprise was a significant increase in mortality and cardiovascular mortality with a hazard ratio of 1.28 and 1.34. So this trial clearly shows that adaptive servo-ventilation in people with cardiac failure basically has no benefit.

The second study[2]—published on September 17 in the New England Journal of Medicine—is a landmark study because it investigated a new class of drugs, the so-called sodium-glucose cotransporter 2 inhibitors, which act on the kidney in patients with type 2 diabetes (T2D). This new drug empagliflozin—which basically excretes glucose in the kidney—was added to standard care. Investigators randomly assigned 7020 patients with T2D to 3 years of treatment with standard care plus either a placebo or 10 or 25 mg of empagliflozin.

The primary endpoints were nonfatal stroke, nonfatal myocardial infarction (MI), and cardiovascular death.

The primary outcome occurred in 10.5% of the active group and 12.1% in the placebo group, which was added in a hazard ratio of 0.84, which was statistically significant. There was no difference for the endpoints of nonfatal MI and nonfatal stroke, but cardiovascular deaths happened in 3.7% in the active treatment group as compared with 5.9% in the placebo group. This was a 38% relative risk reduction, which was highly significant.

This is a landmark study because it is the first study in about 20 years showing that a new approach to the treatment of T2D is associated with a significant decrease in cardiovascular mortality. This has not been achieved with any other antidiabetic treatment. Most remarkably, this new drug results in a significant reduction in body weight, and it does not lead to increased frequency of severe hypoglycemia. This most likely explains why the mortality was reduced and not increased like in previous trials. We see a lot of patients with diabetes in our stroke unit. We need to know what the best treatments are for our patients if we want to prevent cardiovascular deaths.

Ladies and gentlemen, this a breakthrough in the treatment of T2D.

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