Four trials published in 2018 that may shape neurology practice

• A new treatment option for brain metastases: The usual survival period after brain metastases is 2-4 months. Brain metastasis generally means palliative care. In a study published online August 2018 in the New England Journal of Medicine (N Engl J Med. 2018;379:722-730), nivolumab combined with ipilimumab had clinically meaningful intracranial efficacy, concordant with extracranial activity, in patients with melanoma who had asymptomatic untreated brain metastases. Benefit in intracranial growth of metastases was seen in 57% of patients, 64% of patients did not show any progression of the disease, and the 6-month survival was 80%.

• Gut linked to pathophysiology of Parkinson’s disease: JAMA Neurology provided indirect evidence for role of systemic inflammation in the pathogenesis of Parkinson disease and inflammatory bowel disease in a retrospective cohort study of 144,018 patients with IBD (JAMA Neurol. 2018;75:939-46). Patients with IBD had a 28% higher incidence of Parkinson’s disease. A marked reduction in the incidence of Parkinson’s disease was observed when IBD patients were treated with anti–tumor necrosis factor therapy.

• No beneficial effect of aspirin for prevention of adverse CV events in moderate risk patients: The multicenter ARRIVE study compared the use of aspirin with placebo in more than 12,000 patients with moderate risk of heart disease (10-year risk of coronary heart disease 10-20%) (Lancet. 2018;392:1036-46). No beneficial effects with regard to the primary efficacy endpoint (composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischemic attack) were seen with aspirin after a follow-up period of 60 months.  Gastrointestinal bleeding events (mild) occurred more often with aspirin. Use of aspirin in moderate-risk patients needs to be individualized.

• Major bleeding risks offset primary prevention benefits of aspirin use in patients with diabetes: Aspirin use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease (19% risk reduction) in the ASCENT trial (N Engl J Med. 2018;379:1529-39). Major bleeding events occurred in 314 participants in the aspirin group vs 245 in the placebo group indicating a 30% increase in the risk of major bleeding. So, the absolute benefits were largely counterbalanced by the bleeding hazard. 

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA