Changing the treatment paradigm for Parkinson’s disease psychosis with pimavanserin

References

• Fenelon G, Alves G. Epidemiology of psychosis in Parkinson’s disease. J Neurol Sci. 2010;289(1–2):12–17.
   PubMed Web of Science ®Google Scholar
• Taddei RN, Cankaya S, Dhaliwal S, et al. Management of psychosis in Parkinson’s disease: emphasizing clinical subtypes and pathophysiological mechanisms of the condition. Parkinsons Dis. 2017;2017:3256542.
   PubMed Web of Science ®Google Scholar
• Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. What predicts mortality in Parkinson disease?: a prospective population-based long-term study. Neurology. 2010;75(14):1270–1276.
   PubMed Web of Science ®Google Scholar
• Aarsland D, Larsen JP, Tandberg E, et al. Predictors of nursing home placement in Parkinson’s disease: a population-based, prospective study. J Am Geriatr Soc. 2000;48(8):938–942.
   PubMed Web of Science ®Google Scholar
• Aarsland D, Larsen JP, Karlsen K, et al. Mental symptoms in Parkinson’s disease are important contributors to caregiver distress [comparative study]. Int J Geriatr Psychiatry. 1999;14(10):866–874.
   PubMed Web of Science ®Google Scholar
• Llorca PM, Pereira B, Jardri R, et al. Hallucinations in schizophrenia and Parkinson’s disease: an analysis of sensory modalities involved and the repercussion on patients. Sci Rep. 2016;6:38152.
   PubMed Web of Science ®Google Scholar
• Melamed E, Friedberg G, Zoldan J. Psychosis: impact on the patient and family. Neurology. 1999;52(7 Suppl 3):S14–6.
   PubMed Web of Science ®Google Scholar
• Souques A. Rapport sur les syndromes parkinsoniens. Paris, France: Masson: Revue Neurologique; 1921.
   Google Scholar
• Fenelon G, Mahieux F, Huon R, et al. Hallucinations in Parkinson’s disease: prevalence, phenomenology and risk factors. Brain. 2000;123(Pt 4):733–745.
   PubMed Web of Science ®Google Scholar
• Ravina B, Marder K, Fernandez HH, et al. Diagnostic criteria for psychosis in Parkinson’s disease: report of an NINDS, NIMH work group. Mov Disord. 2007;22(8):1061–1068.
   PubMed Web of Science ®Google Scholar
• Mack J, Rabins P, Anderson K, et al. Prevalence of psychotic symptoms in a community-based Parkinson disease sample. Am J Geriatr Psychiatry. 2012;20(2):123–132.
   PubMed Web of Science ®Google Scholar
• Holroyd S, Currie L, Wooten GF. Prospective study of hallucinations and delusions in Parkinson’s disease. J Neurol Neurosurg Psychiatry. 2001;70(6):734–738.
   PubMed Web of Science ®Google Scholar
• Giladi N, Treves TA, Paleacu D, et al. Risk factors for dementia, depression and psychosis in long-standing Parkinson’s disease. J Neural Transm (Vienna). 2000;107(1):59–71.
   PubMed Web of Science ®Google Scholar
• Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year population-based study of psychosis in Parkinson disease. Arch Neurol. 2010;67(8):996–1001.
   PubMedGoogle Scholar
• Lee AH, Weintraub D. Psychosis in Parkinson’s disease without dementia: common and comorbid with other non-motor symptoms. Mov Disord. 2012;27(7):858–863.
   PubMed Web of Science ®Google Scholar
• Vardy ER, Teodorczuk A, Yarnall AJ. Review of delirium in patients with Parkinson’s disease. J Neurol. 2015;262(11):2401–2410.
   PubMed Web of Science ®Google Scholar
• Ffytche DH, Creese B, Politis M, et al. The psychosis spectrum in Parkinson disease. Nat Rev Neurol. 2017;13(2):81–95.
   PubMed Web of Science ®Google Scholar
• Poewe W. Psychosis in Parkinson’s disease. Mov Disord. 2003;18(Suppl 6):S80–7.
   PubMed Web of Science ®Google Scholar
• Goldman JG, Holden S. Treatment of psychosis and dementia in Parkinson’s disease. Curr Treat Options Neurol. 2014;16(3):281.
   PubMed Web of Science ®Google Scholar
• Amar BR, Yadav R, Janardhan Reddy YC, et al. A clinical profile of patients with Parkinson’s disease and psychosis. Ann Indian Acad Neurol. 2014;17(2):187–192.
   PubMed Web of Science ®Google Scholar
• Factor SA, McDonald WM, Goldstein FC. The role of neurotransmitters in the development of Parkinson’s disease-related psychosis. Eur J Neurol. 2017;24(10):1244–1254.
   PubMed Web of Science ®Google Scholar
• Kulick CV, Montgomery KM, Nirenberg MJ. Comprehensive identification of delusions and olfactory, tactile, gustatory, and minor hallucinations in Parkinson’s disease psychosis. Parkinsonism Relat Disord. 2018;54:40–45.
   PubMed Web of Science ®Google Scholar
• Barrett MJ, Smolkin ME, Flanigan JL, et al. Characteristics, correlates, and assessment of psychosis in Parkinson disease without dementia. Parkinsonism Relat Disord. 2017;43:56–60.
   PubMed Web of Science ®Google Scholar
• Aarsland D, Larsen JP, Cummins JL, et al. Prevalence and clinical correlates of psychotic symptoms in Parkinson disease: a community-based study. Arch Neurol. 1999;56(5):595–601.
   PubMedGoogle Scholar
• Pagonabarraga J, Martinez-Horta S, Fernandez de Bobadilla R, et al. Minor hallucinations occur in drug-naive Parkinson’s disease patients, even from the premotor phase. Mov Disord. 2016;31(1):45–52.
   PubMed Web of Science ®Google Scholar
• Goetz CG, Pappert EJ, Blasucci LM, et al. Intravenous levodopa in hallucinating Parkinson’s disease patients: high-dose challenge does not precipitate hallucinations. Neurology. 1998;50(2):515–517.
   PubMed Web of Science ®Google Scholar
• Zhu K, van Hilten JJ, Putter H, et al. Risk factors for hallucinations in Parkinson’s disease: results from a large prospective cohort study. Mov Disord. 2013;28(6):755–762.
   PubMed Web of Science ®Google Scholar
• Ffytche DH, Pereira JB, Ballard C, et al. Risk factors for early psychosis in PD: insights from the Parkinson’s progression markers initiative. J Neurol Neurosurg Psychiatry. 2017;88(4):325–331.
   PubMed Web of Science ®Google Scholar
• de Maindreville AD, Fenelon G, Mahieux F. Hallucinations in Parkinson’s disease: a follow-up study. Mov Disord. 2005;20(2):212–217.
   PubMed Web of Science ®Google Scholar
• Pezzoli S, Cagnin A, Bandmann O, et al. Structural and functional neuroimaging of visual hallucinations in Lewy body disease: a systematic literature review. Brain Sci. 2017;7(7).
   PubMed Web of Science ®Google Scholar
• Stahl SM. Parkinson’s disease psychosis as a serotonin-dopamine imbalance syndrome. CNS Spectr. 2016;21(5):355–359.
   PubMed Web of Science ®Google Scholar
• Huot P, Johnston TH, Darr T, et al. Increased 5-HT2A receptors in the temporal cortex of parkinsonian patients with visual hallucinations. Mov Disord. 2010;25(10):1399–1408.
   PubMed Web of Science ®Google Scholar
• Ballanger B, Strafella AP, van Eimeren T, et al. Serotonin 2A receptors and visual hallucinations in Parkinson disease. Arch Neurol. 2010;67(4):416–421.
   PubMed Web of Science ®Google Scholar
• Goetz CG, Fan W, Leurgans S, et al. The malignant course of “benign hallucinations” in Parkinson disease. Arch Neurol. 2006;63(5):713–716.
   PubMedGoogle Scholar
• Goetz CG, Stebbins GT, Ouyang B. Visual plus nonvisual hallucinations in Parkinson’s disease: development and evolution over 10 years. Mov Disord. 2011;26(12):2196–2200.
   PubMed Web of Science ®Google Scholar
• Hinkle JT, Perepezko K, Bakker CC, et al. Onset and remission of psychosis in Parkinson’s disease: pharmacologic and motoric markers. Mov Disord Clin Pract. 2018;5(1):31–38.
   PubMed Web of Science ®Google Scholar
• Perez-Lloret S, Barrantes FJ. Deficits in cholinergic neurotransmission and their clinical correlates in Parkinson’s disease. NPJ Parkinsons Dis. 2016;2:16001.
   PubMed Web of Science ®Google Scholar
• Hawkins T, Berman BD. Pimavanserin: A novel therapeutic option for Parkinson disease psychosis. Neurol Clin Pract. 2017;7(2):157–162.
   PubMedGoogle Scholar
• Zahodne LB, Fernandez HH. Pathophysiology and treatment of psychosis in Parkinson’s disease: a review. Drugs Aging. 2008;25(8):665–682.
   PubMed Web of Science ®Google Scholar
• Zahodne LB, Fernandez HH. Parkinson’s psychosis. Curr Treat Options Neurol. 2010;12(3):200–211.
   PubMed Web of Science ®Google Scholar
• Wand AP, Peisah C. Managing psychosis in Parkinson’s disease without drugs. Neurodegener Dis Manag. 2015;5(4):271–274.
   PubMed Web of Science ®Google Scholar
• Connolly B, Fox SH. Treatment of cognitive, psychiatric, and affective disorders associated with Parkinson’s disease. Neurotherapeutics. 2014;11(1):78–91.
   PubMed Web of Science ®Google Scholar
• By the American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015;63(11):2227–2246.
   PubMed Web of Science ®Google Scholar
• Seppi K, Weintraub D, Coelho M, et al. The Movement Disorder Society evidence-based medicine review update: treatments for the non-motor symptoms of Parkinson’s disease. Mov Disord. 2011;26(Suppl 3):S42–80.
   PubMed Web of Science ®Google Scholar
• Wilby KJ, Johnson EG, Johnson HE, et al. Evidence-based review of pharmacotherapy used for Parkinson’s disease psychosis. Ann Pharmacother. 2017;51(8):682–695.
   PubMed Web of Science ®Google Scholar
• Casey DE, Zorn SH. The pharmacology of weight gain with antipsychotics. J Clin Psychiatry. 2001;62(Suppl 7):4–10.
   PubMed Web of Science ®Google Scholar
• Weintraub D, Simuni T, Caspell-Garcia C, et al. Cognitive performance and neuropsychiatric symptoms in early, untreated Parkinson’s disease. Mov Disord. 2015;30(7):919–927.
   PubMed Web of Science ®Google Scholar
• Parkinson Study Group. Low-dose clozapine for the treatment of drug-induced psychosis in Parkinson’s disease. N Engl J Med. 1999;340(10):757–763.
   PubMed Web of Science ®Google Scholar
• Pollak P, Tison F, Rascol O, et al. Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up. J Neurol Neurosurg Psychiatry. 2004;75(5):689–695.
   PubMed Web of Science ®Google Scholar
• Citrome L, McEvoy JP, Saklad SR. Guide to the management of clozapine-related tolerability and safety concerns. Clin Schizophr Relat Psychoses. 2016;10(3):163–177.
   PubMedGoogle Scholar
• Martinez-Ramirez D, Okun MS, Jaffee MS. Parkinson’s disease psychosis: therapy tips and the importance of communication between neurologists and psychiatrists. Neurodegener Dis Manag. 2016;6(4):319–330.
   PubMed Web of Science ®Google Scholar
• Weintraub D, Chen P, Ignacio RV, et al. Patterns and trends in antipsychotic prescribing for Parkinson disease psychosis. Arch Neurol. 2011;68(7):899–904.
   PubMedGoogle Scholar
• Hack N, Fayad SM, Monari EH, et al. An eight-year clinic experience with clozapine use in a Parkinson’s disease clinic setting. PLoS One. 2014;9(3):e91545.
   PubMed Web of Science ®Google Scholar
• Fernandez HH, Okun MS, Rodriguez RL, et al. Quetiapine improves visual hallucinations in Parkinson disease but not through normalization of sleep architecture: results from a double-blind clinical-polysomnography study. Int J Neurosci. 2009;119(12):2196–2205.
   PubMed Web of Science ®Google Scholar
• Ondo WG, Tintner R, Voung KD, et al. Double-blind, placebo-controlled, unforced titration parallel trial of quetiapine for dopaminergic-induced hallucinations in Parkinson’s disease. Mov Disord. 2005;20(8):958–963.
   PubMed Web of Science ®Google Scholar
• Shotbolt P, Samuel M, Fox C, et al. A randomized controlled trial of quetiapine for psychosis in Parkinson’s disease. Neuropsychiatr Dis Treat. 2009;5:327–332.
   PubMed Web of Science ®Google Scholar
• Hasnain M, Vieweg WV, Howland RH, et al. Quetiapine, QTc interval prolongation, and torsade de pointes: a review of case reports. Ther Adv Psychopharmacol. 2014;4(3):130–138.
   PubMedGoogle Scholar
• Pagano G, Rengo G, Pasqualetti G, et al. Cholinesterase inhibitors for Parkinson’s disease: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2015;86(7):767–773.
   PubMed Web of Science ®Google Scholar
• Fabbrini G, Barbanti P, Aurilia C, et al. Donepezil in the treatment of hallucinations and delusions in Parkinson’s disease. Neurol Sci. 2002;23(1):41–43.
   PubMed Web of Science ®Google Scholar
• Bergman J, Lerner V. Successful use of donepezil for the treatment of psychotic symptoms in patients with Parkinson’s disease. Clin Neuropharmacol. 2002;25(2):107–110.
   PubMed Web of Science ®Google Scholar
• Sawada H, Oeda T, Kohsaka M, et al. Early use of donepezil against psychosis and cognitive decline in Parkinson’s disease: a randomised controlled trial for 2 years. J Neurol Neurosurg Psychiatry. 2018;89(12):1332–1340.
   PubMed Web of Science ®Google Scholar
• Takaya T, Okamoto M, Yodoi K, et al. Torsades de pointes with QT prolongation related to donepezil use. J Cardiol. 2009;54(3):507–511.
   PubMed Web of Science ®Google Scholar
• Shinozaki K. Shortening of donepezil-induced QTc prolongation with a change in the interacting drug, after electrocardiograph monitoring by community pharmacists: a case report. Yakugaku Zasshi. 2012;132(2):237–241.
   PubMed Web of Science ®Google Scholar
• Igeta H, Suzuki Y, Tajiri M, et al. Cardiovascular pharmacodynamics of donepezil hydrochloride on the PR and QT intervals in patients with dementia. Hum Psychopharmacol. 2014;29(3):292–294.
   PubMed Web of Science ®Google Scholar
• Kitt J, Irons R, Al-Obaidi M, et al. A case of donepezil-related torsades de pointes. BMJ Case Rep. 2015;2015:bcr2015211900.
   Google Scholar
• Reading PJ, Luce AK, McKeith IG. Rivastigmine in the treatment of parkinsonian psychosis and cognitive impairment: preliminary findings from an open trial. Mov Disord. 2001;16(6):1171–1174.
   PubMed Web of Science ®Google Scholar
• Bullock R, Cameron A. Rivastigmine for the treatment of dementia and visual hallucinations associated with Parkinson’s disease: a case series. Curr Med Res Opin. 2002;18(5):258–264.
   PubMed Web of Science ®Google Scholar
• Rovers JM, Dautzenberg PL, Ter Bruggen JP. Rivastigmine as adjunctive therapy in the therapeutic dilemma for the treatment of hallucinations due to Parkinson disease. Tijdschr Gerontol Geriatr. 2006;37(3):117–120.
   PubMedGoogle Scholar
• Burn D, Emre M, McKeith I, et al. Effects of rivastigmine in patients with and without visual hallucinations in dementia associated with Parkinson’s disease. Mov Disord. 2006;21(11):1899–1907.
   PubMed Web of Science ®Google Scholar
• Seppi K, Ray Chaudhuri K, Coelho M, et al. Update on treatments for nonmotor symptoms of Parkinson’s disease-an evidence-based medicine review. Mov Disord. 2019;34(2):180–198.
   PubMed Web of Science ®Google Scholar
• Hermanowicz N, Alva G, Pagan F, et al. The emerging role of pimavanserin in the management of Parkinson’s disease psychosis. J Manag Care Spec Pharm. 2017;23(6–b Suppl):S2–S8.
   PubMed Web of Science ®Google Scholar
• Acadia Pharmaceuticals. Nuplazid® (pimavanserin) Prescribing Information. San Diego, CA: Acadia Pharmaceuticals Inc; 2018.
   Google Scholar
• Amara AW, Chahine LM, Caspell-Garcia C, et al. Longitudinal assessment of excessive daytime sleepiness in early Parkinson’s disease. J Neurol Neurosurg Psychiatry. 2017;88(8):653–662.
   PubMed Web of Science ®Google Scholar
• Hacksell U, Burstein ES, McFarland K, et al. On the discovery and development of pimavanserin: a novel drug candidate for Parkinson’s psychosis. Neurochem Res. 2014;39(10):2008–2017.
   PubMed Web of Science ®Google Scholar
• Kitten AK, Hallowell SA, Saklad SR, et al. Pimavanserin: a novel drug approved to treat Parkinson’s disease psychosis. Innov Clin Neurosci. 2018;15(1–2):16–22.
   PubMedGoogle Scholar
• Cummings J, Isaacson S, Mills R, et al. Pimavanserin for patients with Parkinson’s disease psychosis: a randomised, placebo-controlled phase 3 trial. Lancet. 2014;383(9916):533–540.
   PubMed Web of Science ®Google Scholar
• Voss T, Bahr D, Cummings J, et al. Performance of a shortened Scale for Assessment of Positive Symptoms for Parkinson’s Disease Psychosis. Parkinsonism Relat Disord. 2013;19(3):295–299.
   PubMed Web of Science ®Google Scholar
• Howard R, Phillips P, Johnson T, et al. Determining the minimum clinically important differences for outcomes in the DOMINO trial. Int J Geriatr Psychiatry. 2011;26(8):812–817.
   PubMed Web of Science ®Google Scholar
• Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, and interpretation. J Exp Psychol Gen. 2012;141(1):2–18.
   PubMed Web of Science ®Google Scholar
• Meltzer HY, Mills R, Revell S, et al. Pimavanserin, a serotonin(2A) receptor inverse agonist, for the treatment of parkinson’s disease psychosis. Neuropsychopharmacology. 2010;35(4):881–892.
   PubMed Web of Science ®Google Scholar
• Isaacson S, Azulay J, Ferreira J, et al. Long-term effectiveness of pimavanserin in PD psychosis: data from 2 open-label studies [poster 149 presented at 19th International Congress of Parkinson’s Disease and Movement Disorders]. Mov Disord. 2015;30(Suppl. 1):S57–S9.
   Google Scholar
• Mathis MV, Muoio BM, Andreason P, et al. The US Food and Drug Administration’s perspective on the new antipsychotic pimavanserin. J Clin Psychiatry. 2017;78(6):e668–e73.
   PubMed Web of Science ®Google Scholar
• Difficult choices in treating Parkinson’s disease psychosis [editorial]. Lancet Neurol. 2018;17(7):569.
   PubMed Web of Science ®Google Scholar
• Yasue I, Matsunaga S, Kishi T, et al. Serotonin 2A receptor inverse agonist as a treatment for Parkinson’s disease psychosis: a systematic review and meta-analysis of serotonin 2A receptor negative modulators. J Alzheimers Dis. 2016;50(3):733–740.
   PubMed Web of Science ®Google Scholar
• Citrome L, Norton JC, Chi-Burris K, et al. Pimavanserin for the treatment of Parkinson’s disease psychosis: number needed to treat, number needed to harm, and likelihood to be helped or harmed. CNS Spectr. 2018;23(3):228–238.
   PubMed Web of Science ®Google Scholar
• Nachimuthu S, Assar MD, Schussler JM. Drug-induced QT interval prolongation: mechanisms and clinical management. Ther Adv Drug Saf. 2012;3(5):241–253.
   PubMedGoogle Scholar
• Washington NB, Brahm NC, Kissack J. Which psychotropics carry the greatest risk of QTc prolongation? Current Psychiatry. 2012;11(10):36–39.
   Google Scholar
• Polcwiartek C, Kragholm K, Schjerning O, et al. Cardiovascular safety of antipsychotics: a clinical overview. Expert Opin Drug Saf. 2016;15(5):679–688.
   PubMed Web of Science ®Google Scholar
• Shah AA, Aftab A, Coverdale J. QTc prolongation with antipsychotics: is routine ECG monitoring recommended? J Psychiatr Pract. 2014;20(3):196–206.
   PubMed Web of Science ®Google Scholar
• Ballard C, Isaacson S, Mills R, et al. Impact of current antipsychotic medications on comparative mortality and adverse events in people with Parkinson disease psychosis. J Am Med Dir Assoc. 2015;16(10):898e1–7.
   Web of Science ®Google Scholar
• Mahajan A, Bulica B, Ahmad A, et al. Pimavanserin use in a movement disorders clinic: a single-center experience. Neurol Sci. 2018;39(10):1767–1771.
   PubMed Web of Science ®Google Scholar
• Mills R, Isaacson S, Azulay J-P, et al. Long-term effectiveness of NUPLAZIDTM; (pimavanserin) in PD psychosis: data from 2 open-label studies. Parkinsonism Relat Disord. 2016;22:e92–e3.
   Google Scholar
• Moreno GM, Gandhi R, Lessig SL, et al. Mortality in patients with Parkinson disease psychosis receiving pimavanserin and quetiapine. Neurology. 2018;91(17):797–799.
   PubMed Web of Science ®Google Scholar
• FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson’s disease psychosis [Internet] Silver Spring (MD): FDA Drugs, Drug Safety and Availability; 2018 [updated 2018 Sep 20; cited 2019 May 7]. Available from: https://www.fda.gov/Drugs/DrugSafety/ucm621160.htm
   Google Scholar
• Schrag A, Hovris A, Morley D, et al. Caregiver-burden in Parkinson’s disease is closely associated with psychiatric symptoms, falls, and disability. Parkinsonism Relat Disord. 2006;12(1):35–41.
   PubMed Web of Science ®Google Scholar
• Gomez-Esteban JC, Tijero B, Somme J, et al. Impact of psychiatric symptoms and sleep disorders on the quality of life of patients with Parkinson’s disease. J Neurol. 2011;258(3):494–499.
   PubMed Web of Science ®Google Scholar