Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis

International Journal of Geriatric Psychiatry

Volumn 27, Issue 5, 2012, Pages 472-482

  Dubovsky, Steven L ^a   Frobose, Colleen ^b   Phiri, Phillip ^b   De Greef, Rik ^c   Panagides, John ^b  

^a UNIVERSITY AT BUFFALO   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c NV ORGANON   (Netherlands)

Author keywords

asenapine; older; pharmacokinetics; psychosis; safety; schizophrenia

Indexed keywords

ACETYLSALICYLIC ACID; ASENAPINE; DOCUSATE SODIUM; LISINOPRIL; LORAZEPAM; PARACETAMOL; VALPROIC ACID; ZOLPIDEM;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA; SOMNOLENCE;

AGE FACTORS; AGED; AGED, 80 AND OVER; ANTIPSYCHOTIC AGENTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HETEROCYCLIC COMPOUNDS WITH 4 OR MORE RINGS; HUMANS; MALE; PSYCHOTIC DISORDERS; SCHIZOPHRENIA;

EID: 84859892919     PISSN: 08856230     EISSN: 10991166     Source Type: Journal    
DOI: 10.1002/gps.2737     Document Type: Article

References (28)

1. European Medicines Agency. Sycrest (asenapine). Available at:. [accessed on 28 September 2010 a].
2. Saphris® (asenapine sublingual tablets). Full Prescribing Information, Schering Corporation, a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ, 2010b.
3. Barak Y, Shamir E, Zemishlani H, et al,. 2002. Olanzapine vs. haloperidol in the treatment of elderly chronic schizophrenia patients. Prog Neuropsychopharmacol Biol Psychiatry 26: 1199-1202.
4. Chapel S, Hutmacher MM, Haig G, et al,. 2009. Exposure-response analysis in patients with schizophrenia to assess the effect of asenapine on QTc prolongation. J Clin Pharmacol 49: 1297-1308.
5. Dogterom P, Timmer C, de Greef R, et al,. A phase I study to investigate the safety, tolerability, and pharmacokinetics of single and multiple doses of sublingually administered asenapine in healthy male volunteers. Presented at: American Society for Clinical Pharmacology and Therapeutics 110th Annual Meeting; 3-8 May 2009; Washington, DC.
6. Douglas IJ, Smeeth L., 2008. Exposure to antipsychotics and risk of stroke: self controlled case series study. BMJ 337: a1227.
7. Gareri P, De Fazio P, De Fazio S, et al,. 2006. Adverse effects of atypical antipsychotics in the elderly: a review. Drugs Aging 23: 937-956.
8. Gill SS, Rochon PA, Herrmann N, et al,. 2005. Atypical antipsychotic drugs and risk of ischaemic stroke: population based retrospective cohort study. BMJ 330: 445.
9. Herrmann N, Mamdani M, Lanctot KL,. 2004. Atypical antipsychotics and risk of cerebrovascular accidents. Am J Psychiatry 161: 1113-1115.
10. Hybels CF, Blazer DG,. 2003. Epidemiology of late-life mental disorders. Clin Geriatr Med 19: 663-696.
11. Jeste DV, Alexopoulos GS, Bartels SJ, et al,. 1999. Consensus statement on the upcoming crisis in geriatric mental health: research agenda for the next 2 decades. Arch Gen Psychiatry 56: 848-853.
12. Kane JM, Cohen M, Zhao J, Alphs L, Panagides J,. 2010. Efficacy and safety of asenapine in a placebo-and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol 30: 106-115.
13. Klotz U,. 2009. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev 41: 67-76.
14. Lasser RA, Bossie CA, Zhu Y, et al,. 2004. Efficacy and safety of long-acting risperidone in elderly patients with schizophrenia and schizoaffective disorder. Int J Geriatr Psychiatry 19: 898-905.
15. McIntyre RS, Cohen M, Zhao J, et al,. 2009a. A 3-week, randomized, placebo-controlled trial of asenapine in the treatment of acute mania in bipolar mania and mixed states. Bipolar Disord 11: 673-686.
16. McIntyre RS, Cohen M, Zhao J, et al,. 2009b. Asenapine versus olanzapine in acute mania: a double-blind extension study. Bipolar Disord 11: 815-826.
17. McIntyre RS, Cohen M, Zhao J, et al,. 2010. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord 122: 27-38.
18. Potkin SG, Cohen M, Panagides J,. 2007. Efficacy and tolerability of asenapine in acute schizophrenia: a placebo- and risperidone-controlled trial. J Clin Psychiatry 68: 1492-1500.
19. Prohn M, de Greef HJMM, Chapel S, Kerbusch T,. 2009. Population pharmacokinetics of asenapine in patients with schizophrenia or bipolar disorder Eur Neuropsychopharmacol 19: S542-S543.
20. Rapoport M, Mamdani M, Shulman KI, Herrmann N, Rochon PA,. 2005. Antipsychotic use in the elderly: shifting trends and increasing costs. Int J Geriatr Psychiatry 20: 749-753.
21. Regier DA, Boyd JH, Burke JD Jr, et al,. 1988. One-month prevalence of mental disorders in the United States. Based on five epidemiologic catchment area sites. Arch Gen Psychiatry 45: 977-986.
22. Relling MV, Lin JS, Ayers GD, Evans WE,. 1992. Racial and gender differences in N-acetyltransferase, xanthine oxidase, and CYP1A2 activities. Clin Pharmacol Ther 52: 643-658.
23. Riedel M, Eich FX, Moller HJ,. 2009. A pilot study of the safety and efficacy of amisulpride and risperidone in elderly psychotic patients. Eur Psychiatry 24: 149-153.
24. Sajatovic M, Perez D, Brescan D, Ramirez LF,. 1998. Olanzapine therapy in elderly patients with schizophrenia. Psychopharmacol Bull 34: 819-823.
25. Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R,. 2010. Long-term assessment of asenapine vs. olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry 43: 138-146.
26. Tariot PN, Salzman C, Yeung PP, Pultz J, Rak IW,. 2000. Long-term use of quetiapine in elderly patients with psychotic disorders. Clin Ther 22: 1068-1084.
27. Tzimos A, Samokhvalov V, Kramer M, et al,. 2008. Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Am J Geriatr Psychiatry 16: 31-43.
28. Uchida H, Mamo DC, Mulsant BH, Pollock BG, Kapur S,. 2009. Increased antipsychotic sensitivity in elderly patients: evidence and mechanisms. J Clin Psychiatry 70: 397-405.