Epilepsy, Stroke, and More Stroke: New Data

Hans-Christoph Diener, MD, PhD


March 03, 2017

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Dear colleagues, I am Christoph Diener, a neurologist from the Department of Neurology at the University of Essen in Germany. Today, I have three papers: One is on epilepsy, and two are on stroke prevention and atrial fibrillation.

Hypothermia and Convulsive Status Epilepticus

Let me start with the paper on epilepsy.[1] This is a study which was done in France. The study recruited 270 patients who had convulsive status epilepticus. The investigators wanted to see whether hypothermia would have an impact on the outcome.

All of these patients were ventilated, and one half of them received hypothermia for 24 hours in a temperature range between 32 and 34°C on top of standard care. The other half of the patients received standard care. The primary endpoint was Glasgow Outcome Scale score at 90 days and mortality.

The bottom line of this neuroprotective study was that there was no difference either in primary or secondary outcomes. There were more adverse events, as you would expect, with hypothermia. Like in stroke, obviously this is not a therapeutic option.

GI Bleeding and Non-Vitamin K Oral Anticoagulants

Let me come to non-vitamin K oral anticoagulants.[2] Many doctors are afraid of gastrointestinal (GI) bleeding with novel oral anticoagulants (NOACs) compared with warfarin. A group from the United Kingdom performed systematic literature research and a meta-analysis on GI bleeding.

They found that 31 studies reported GI bleeding in 287,000 patients. They found no difference between factor Xa inhibitors compared with warfarin, with an odds ratio of 0.78, and also no difference between warfarin and dabigatran, with an odds ratio of 0.88.

If the endpoint was all GI bleeding, not major GI bleeding, the factor Xa inhibitors did slightly better than dabigatran, but this was due to apixaban and edoxaban. For rivaroxaban, there is even an increased risk for GI bleeding compared with dabigatran.

Low-Dose NOAC vs Warfarin in Prevention of Stroke

The third study[3] is from Denmark. Denmark has a marvelous healthcare system where everything is recorded. The investigators looked at patients who received the low dose of NOAC and compared this with warfarin. They found 50,644 patients: 4400 of them received 2 × 2.5 mg of apixaban, 8875 received 2 × 110 mg of dabigatran, and 3476 patients received 15 mg of rivaroxaban. The comparator was 38,893 patients on warfarin. The study was for the prevention of stroke, and the secondary endpoint was major bleeding complications.

After 1 year with low-dose NOAC, apixaban had a higher stroke rate than warfarin. Dabigatran and rivaroxaban had a similar stroke rate. In terms of bleeding complications, this had a lower incidence with dabigatran vs warfarin, and there was no difference for apixaban and rivaroxaban.

Ladies and gentlemen, why is this relevant? If we look at prescription data in Europe and in the United States, there is a clear trend to prescribe low-dose NOACs even in patients who do not qualify. There are clear rules on who should receive a reduced dose—for example, for dabigatran, age above 75 years and compromised kidney function, or for apixaban two out of three criteria, which include reduced body weight, compromised kidney function, and increased risk for bleeding.

I think the belief still is that in people who do not have a clear indication for dose reduction, use the dose that was tested in the randomized trials, or in the case of dabigatran, use the high dose.

Ladies and gentlemen, three interesting new papers: a status epilepticus paper in the New England Journal of Medicine, the risk for GI bleeding with NOACs in Lancet Gastroenterology and Hepatology, and the reduced NOAC dose paper in the British Medical Journal.

I am Christoph Diener, neurologist at the University of Essen in Germany. Thank you for listening and watching.


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