Pimavanserin's Positive Impact on Mortality, Concerns Raised Over Lecanemab Patient Death, FDA Clears Zoom RDL Access System


Neurology News Network for the week ending January 7, 2022. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

In a recently published retrospective analysis, pimavanserin, the only FDA-approved therapy for hallucinations and delusions associated with Parkinson disease dementia (PDP), outperformed other atypical antipsychotics on mortality over a 12-month period. The real-world analysis analyzed Medicare claims data on 2892 patients on pimavanserin and 19,083 comparator patients on other atypical antipsychotics such as clozapine, quetiapine, risperidone, olanzapine, aripiprazole, and brexpiprazole, from 2016 to 2019. In the matched cohort, the hazard ratio (HR) for mortality for pimavanserin vs comparator was 0.78 (95% CI, 0.67-0.91), with the lowest time period-specific HRs in the first 180 days. Across the entirety of the study, patients were followed for a total of 11,147 person-years from treatment initiation until death or censoring. Between the 2 groups, the incidence rate (IR) in the pimavanserin group was 18.9 deaths per 100 PY vs 30.4 deaths per 100 PY in the comparator group.

Days before the FDA is expected to make a decision on Eisai and Biogen’s antiamyloid therapy lecanemab, several clinicians raised concerns about the therapy following the death of a treated patient in the phase 3 Clarity AD trial (NCT03887455). Published in the New England Journal of Medicine, the authors concluded that the findings raise the possibility of cerebral hemorrhages and necrotizing vasculopathy associated with tissue plasminogen activator (tPA) infusion in those with cerebrovascular amyloid on lecanemab.In a corresponding response letter, investigators from the trial agreed that this case raises important management issues for patients with Alzheimer disease (AD), particularly those who are homozygous to the apolipoprotein (APOE) ε4. “Although tPA appears to be the proximate cause of death, this was an unusual case, and we understand why the authors want to highlight a potential concern,” Marwan Sabbagh, MD, and Christopher H. van Dyck, MD, authors of the corresponding letter, wrote. Additionally, they noted that there had been previous reports of fatal large intracerebral hemorrhages after tPA in those with cerebral amyloid angiopathy (CAA) in the absence of antiamyloid medications.

The FDA has granted 510(k) clearance to Imperative Care’s Zoom RDL Access System, making it the first radial access platform developed specifically for treating patients with ischemic stroke. Additionally, the company also announced the successful completion of the first-in-human case using Zoom RDL. Zoom RDL, the newest addition to Imperative’s Zoom Stroke Solution, features an extended hydrophilic coating and the longest optimized vessel dilator on the market, allowing for a smooth introduction into the radial artery. The system also includes a large .088-inch lumen for compatibility with large-bore aspiration catheters. Designed to reach the intracranial vasculature, this new approach may allow clinicians to get higher into the brain and closer to the stroke-causing clot, thus improving control throughout the procedure.

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