Updates in Parkinson's, Stroke, and Migraine

Hans-Christoph Diener, MD, PhD


March 05, 2019

This transcript has been edited for clarity.

Dear colleagues, I'm Christoph Diener, a neurologist from the University Duisburg-Essen in Germany. Today I would like to report seven studies published in December 2018.

Let me start with Parkinson's disease. Lancet Neurology published data from the Global Burden of Disease Study on Parkinson's disease between 1990 and 2016.[1] There was a 22% increase in the age-standardized prevalence. In 1990, the worldwide prevalence was about 2.5 million people, and in 2016, 6.1 million. This is not only due to increased age but perhaps has to do with the fact that the disease is better treated and the life expectancy is prolonged.

The second study, the POLAR study, was published in JAMA.[2] This was a study from Australia, investigating the possible benefits of hypothermia in people with severe traumatic brain injury. The study included 511 patients; half of them received hypothermia with a core body temperature between 33°C and 35°C. Patients were included within 72 hours up to 7 days, and the primary outcome was the Glasgow outcomes scale at 6 months. Unfortunately, there was no benefit in terms of functional outcome, mortality, pneumonia, or intracranial hemorrhage. We now have three negative trials on hypothermia in severe traumatic brain injury.

The next two studies deal with migraine. The first study, published in Neurology, investigated one of the CGRP antibodies, galcanezumab, for patients with chronic migraine.[3] This study included 558 patients receiving placebo and 270 patients receiving doses of 120 or 240 mg of galcanezumab. Patients received this treatment once a month subcutaneously, and the primary endpoint was a reduction in migraine across 3 months. The initial number of migraines per month was 19.

Placebo was clearly inferior to galcanezumab, with a decrease of 2.7 migraine days per month compared with 4.6 or 4.8 migraine days with the two doses of galcanezumab. The really good news is that there were basically no adverse events, with an identical number of adverse events for placebo and the active drug. This demonstrates that CGRP antibodies are effective in the treatment of chronic migraine.

The next study, also published in Neurology, reported the outcome of a large, randomized trial with 1856 patients treated with lasmiditan, which is a 5-HT1F receptor agonist that is free of any activity with the blood vessels.[4] This study investigated placebo and two doses of lasmiditan, 100 and 200 mg. The primary endpoint was pain-free status at 2 hours, which was 32% versus 15% for the high dose versus placebo, and 28% versus 15% for the low dose of lasmiditan.

Lasmiditan has both peripheral and central activity in the trigeminal system, which is shown by the adverse event profile exhibiting an increased incidence of dizziness, somnolence, and fatigue. Where does this drug fit in? It probably will be used in the future for patients who have contraindications for triptans, such as severe cerebral and cardiovascular diseases, and a high number of vascular risk factors.

The next study, published in the New England Journal of Medicine, investigated the benefit of the supplementation of vitamin D compared with placebo in 25,871 patients.[5] There was no benefit on cardiovascular diseases, including stroke, and no benefit on the rate of cancer.

The next study, published in the British Medical Journal, is a meta-analysis of three studies that investigated combination antiplatelet therapy compared with monotherapy after high-risk TIA or mild ischemic stroke.[6] The meta-analysis clearly shows the benefit of the combination of clopidogrel and aspirin compared with aspirin monotherapy.

The investigators also advised to use this combination therapy for a time period of 12-21 days only, and to use a loading dose of 300 mg of clopidogrel followed by 75 mg of clopidogrel. The absolute benefit is a reduction in recurrent stroke of 1.9% compared with an increased risk of major bleeds of 0.2%.

The last trial, which was published in Lancet, is the large FOCUS trial .[7] FOCUS was conducted in the United Kingdom and included 3127 patients with stroke (90% ischemic, 10% hemorrhagic). The investigators looked at the possible benefit of fluoxetine 20 mg daily on recovery after stroke compared with placebo.

The primary endpoint was the modified Rankin Scale after 3 months, and there was, unfortunately, no benefit. This fits very well with the TALOS study, which was published 4 weeks ago, demonstrating no benefit of citalopram compared with placebo in more than 600 patients after stroke.[8]

Well, ladies and gentlemen, [I've discussed] seven interesting studies that came out in December 2018. I'm Christoph Diener, a neurologist at the University Duisburg-Essen in Germany. Thank you very much for watching and listening.

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