At the International Association of Parkinsonism and Related Disorders (IAPRD) conference in August 2018, Dr Mari discusses why we should not worry that pimavanserin might increase mortality amongst patients with Parkinson’s disease with psychosis.
1. As noted by the FDA, why are the Adverse Event Reporting System (FAERS) data by themselves not an indicator of the safety profile of a drug or biologic? (0:12)
2. In your opinion, has a clear cause-effect relationship between pimavanserin and increased mortality been established? (1:40)
3. How does the mortality rate for patients with Parkinson's disease psychosis (PDP) taking pimavanserin compare to the mortality rate in patients with untreated PDP and those receiving clozapine or off-label quetiapine? (3:04)
4. In your experience, do patients receiving pimavanserin show noticeable improvement in their visual hallucinations, paranoia and other psychotic symptoms? If so, how do you feel this impacts their mortality and/or quality of life? (3:55)
5. Do you think the active engagement with patients and caregivers by specialty pharmacies distributing pimavanserin could impact the frequency of adverse events reported in a chronically ill patient population? (5:25)
Filmed at the XXII World Congress on Parkinson's Diseases and Related Disorders (IAPRD), Lyon, France, August 2018.
Speaker disclosure: Zoltan Mari has received funding from the Michael J. Fox Foundation, the National Parkinson Foundation (now Parkinson’s Foundation), the National Institutes of Health (National Institute of Neurological Disorders and Stroke), Adamas, AbbVie, Allergan, US WorldMeds, Ipsen, Sunovion, and fees for legal consultations. Dr. Mari is also co-founder and Chief Medical Officer of Neuraly, Inc.