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Real-world data so far support pimavanserin trial results


 

REPORTING FROM AAN 2018

– Two studies of real-world use of pimavanserin after its approval in March 2016 for the treatment of Parkinson’s disease–associated psychosis indicate its effectiveness, tolerability, and safety in line with clinical trial results, according to reports presented at the annual meeting of the American Academy of Neurology.

In the first study, 102 patients were prescribed pimavanserin (Nuplazid) during May 2016-March 2018. Of the 88 patients who actually took the drug, 83% had Parkinson’s, and 78% were men. Participants’ mean age was 79 years. Nearly a third had deep brain stimulation.

Jessie Sellers, a nurse practitioner at Vanderbilt University, Nashville, Tenn. Jeff Evans/MDedge News

Jessie Sellers

A majority of patients (n = 49) reported having visual hallucinations alone, and another 37 had both visual hallucinations and delusions. Only two had delusions without hallucinations. For the 72 patients who took pimavanserin for longer than 4 weeks, 63 (88%) reported decreased psychosis symptom, a decrease that did not differ significantly between those with prior antipsychotic use or with deep brain stimulation.

About two-thirds of the patients started taking pimavanserin after failing prior antipsychotic therapy, whereas the other third had not previously taken an antipsychotic. Quetiapine had been used by 91% of previous antipsychotic users, and another 20% had taken clozapine. Other antipsychotics were less commonly used.

There was no consistent strategy implemented for starting pimavanserin: 17 stopped or were advised to stop their other antipsychotic before starting pimavanserin, 15 were told to taper off their other antipsychotic for 1 week or for up to 3 months, and 22 were told to keep taking their other antipsychotic after starting pimavanserin.

The mean treatment duration has been nearly 11 months for the two-thirds of patients who remain on pimavanserin, including 38 who take it alone and another 20 who take it with another antipsychotic.

A total of 10 patients were unable to tolerate pimavanserin because of adverse events, 5 of whom had generalized weakness/gait instability. This adverse event was the only difference in adverse events that was seen from the clinical trials, said lead author Jessie Sellers, a nurse practitioner at Vanderbilt University Medical Center in Nashville, Tenn.

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