New and Noteworthy Information—June 2016
Compared with the standard dose of t-PA (0.9 mg/kg), a low dose (0.6 mg/kg) is associated with slightly reduced rates of bleeding and mortality, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Using a two-by-two quasi-factorial open-label design, researchers randomly assigned 3,310 patients who were eligible for thrombolytic therapy to low-dose IV t-PA or the standard dose. At 90 days, 53.2% of participants in the low-dose group had died or had disability, compared with 51.1% of participants in the standard-dose group. Major symptomatic intracerebral hemorrhage occurred in 1.0% of the participants in the low-dose group and in 2.1% of the participants in the standard-dose group. Fatal events occurred within seven days in 0.5% and 1.5% of participants, respectively.
Triptans and dihydroergotamine (DHE) are not associated with acute or subacute ischemic vascular events in the abortive treatment of basilar migraine or hemiplegic migraine, according to a study published online ahead of print April 8 in Headache. A retrospective chart review of 80 patients with basilar migraine or hemiplegic migraine who received acute abortive treatment with either triptans or DHE was conducted at four headache centers to assess the frequency of ischemic vascular events after administration. No stroke or myocardial infarction was reported. In the triptan group, five patients reported adverse effects that included gastrointestinal upset, rash, neck dystonia, nightmares, and flushing. In the DHE group, five patients had adverse events that included chest tightness, dystonic reaction, transient asymptomatic anterior T wave inversion, and agitation.
The FDA has approved Fycompa (perampanel) CIII oral suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and of primary generalized tonic-clonic seizures in patients with epilepsy age 12 and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation. The approval of Fycompa CIII oral suspension was based on a study that demonstrated bioequivalence between a single dose of perampanel oral suspension and a single dose of perampanel tablet when administered under fasted conditions in healthy subjects. Fycompa is an oral medication and the only FDA-approved noncompetitive AMPA receptor antagonist. Its most common side effects include dizziness, sleepiness, headache, tiredness, and irritability. Eisai, headquartered in Woodcliff Lake, New Jersey, markets the drug.
In patients with acute ischemic stroke or transient ischemic attack, ticagrelor is not superior to aspirin in reducing the rate of stroke, myocardial infarction, or death at 90 days, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Included in this study were 13,199 patients with nonsevere ischemic stroke or high-risk transient ischemic attack who had not received IV or intra-arterial thrombolysis and who had not had a cardioembolic stroke. During 90 days of treatment, a primary end point event (ie, stroke, myocardial infarction, or death) occurred in 442 of the 6,589 patients treated with ticagrelor, versus 497 of the 6,610 patients treated with aspirin. Ischemic stroke occurred in 385 patients treated with ticagrelor and in 441 patients treated with aspirin.
Physicians differ substantially when giving prognoses and treatment recommendations for patients with intracerebral hemorrhage, according to a study published online ahead of print April 15 in Neurology. A written survey with two intracerebral hemorrhage scenarios was completed by 742 practicing neurologists and neurosurgeons. Physician predictions of 30-day mortality varied widely, as did treatment recommendations. Responses encompassed the full range of options for each case. No physician demographic or personality characteristics were associated with treatment recommendations. Providing a prognostic score changed treatment recommendations, and the effect differed across cases. When the prognostic score suggested a 0% chance of functional independence, the likelihood of treatment limitations was increased, compared with no prognostic score. Conversely, if the score suggested a 66% chance of independence, treatment limitations were less likely.
Mitoxantrone slightly increases the overall incidence of malignancies and significantly increases the risk of leukemia and colorectal cancer, according to a study published online ahead of print May 11 in Neurology. Researchers retrospectively examined all mitoxantrone-treated patients with multiple sclerosis seen between 1994 and 2007 at one hospital. They collected follow-up information on medically confirmed malignancies, life status, and cause of death, as of 2010. The incidence ratio of malignancy was 1.50. The standardized incidence ratio of colorectal cancer was 2.98, and that of acute myeloid leukemia, 10.44. Higher age at treatment initiation was a risk factor, but neither cumulative mitoxantrone dose, treatment with other immunosuppressive drugs, nor sex was. In all, 55 patients died. Twelve deaths resulted from a malignancy, and 43 from other causes.
