Activating and sedating adverse effects of second-generation antipsychotics in the treatment of schizophrenia and major depressive disorder: Absolute risk increase and number needed to harm

Journal of Clinical Psychopharmacology

Volumn 37, Issue 2, 2017, Pages 138-147

  Citrome, Leslie ^a  

^a NEW YORK MEDICAL COLLEGE   (United States)

Author keywords

akathisia; antipsychotic; major depressive disorder; number needed to harm; schizophrenia; sedation; somnolence

Indexed keywords

ARIPIPRAZOLE; ASENAPINE; BREXPIPRAZOLE; CARIPRAZINE; FLUOXETINE PLUS OLANZAPINE; ILOPERIDONE; LURASIDONE; NEUROLEPTIC AGENT; OLANZAPINE; PALIPERIDONE; QUETIAPINE; RISPERIDONE; ZIPRASIDONE;

AGITATION; AKATHISIA; ANXIETY DISORDER; ARTICLE; ATTRIBUTABLE RISK; BEHAVIOR DISORDER; FATIGUE; HUMAN; HYPERSOMNIA; INSOMNIA; MAJOR DEPRESSION; PACKAGING; PRIORITY JOURNAL; RESTLESSNESS; SCHIZOPHRENIA; SEDATION; SOMNOLENCE; TREATMENT OUTCOME; AKATHISIA, DRUG-INDUCED; CONSCIOUS SEDATION; DEPRESSIVE DISORDER, MAJOR; DISORDERS OF EXCESSIVE SOMNOLENCE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; META ANALYSIS; PSYCHOMOTOR AGITATION; SLEEP INITIATION AND MAINTENANCE DISORDERS; STATISTICS AND NUMERICAL DATA;

AKATHISIA, DRUG-INDUCED; ANTIPSYCHOTIC AGENTS; CONSCIOUS SEDATION; DEPRESSIVE DISORDER, MAJOR; DISORDERS OF EXCESSIVE SOMNOLENCE; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FATIGUE; HUMANS; PSYCHOMOTOR AGITATION; SCHIZOPHRENIA; SLEEP INITIATION AND MAINTENANCE DISORDERS;

EID: 85011282367     PISSN: 02710749     EISSN: 1533712X     Source Type: Journal    
DOI: 10.1097/JCP.0000000000000665     Document Type: Article

References (70)

1. Emsley R, Chiliza B, Asmal L, et al. The nature of relapse in schizophrenia. BMC Psychiatry. 2013;13:50.
2. Muench J, Hamer AM. Adverse effects of antipsychotic medications. Am Fam Physician. 2010;81:617-622.
3. Bruijnzeel D, Suryadevara U, Tandon R. Antipsychotic treatment of schizophrenia: an update. Asian J Psychiatr. 2014;11:3-7.
4. Citrome L. Adjunctive aripiprazole, olanzapine, or quetiapine for major depressive disorder: an analysis of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Postgrad Med. 2010;122: 39-48.
5. Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet. 2013;382:951-962.
6. DibonaventuraM, Gabriel S, Dupclay L, et al. A patient perspective of the impact of medication side effects on adherence: results of a cross-sectional nationwide survey of patients with schizophrenia. BMC Psychiatry. 2012; 12:20.
7. Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf. 2009;4:229-237.
8. Citrome L. Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand. 2008;117:412-419.
9. Citrome L. Relative vs. absolute measures of benefit and risk: what?s the difference? Acta Psychiatr Scand. 2010;121:94-102.
10. Citrome L. Beyond PubMed: searching the grey literature for clinical trial results. Innov Clin Neurosci. 2014;11:42-46.
11. Otsuka Pharmaceutical Company. Abilify® (aripiprazole) tablets, Abilify Discmelt® (aripiprazole) orally disintegrating tablets, Abilify® (aripiprazole) oral solution, Abilify® (aripiprazole) injection for intramuscular use only [prescribing information], revised January 2016. Available at: http://www.otsuka-us.com/Documents/Abilify.PI.pdf. Accessed April 5, 2016.
12. Actavis, Inc. Saphris® (asenapine) sublingual tablets [prescribing information], revised March 2015. Available at: http://pi.actavis.com/data- stream.asp?product-group=1908&p=pi&language=E. Accessed April 5, 2016.
13. Otsuka Pharmaceutical Company. Rexulti®(brexpiprazole) tablets, for oral use [prescribing information], revised August 2015. Available at: http:// www.otsuka-us.com/Products/Documents/Rexulti.PI.pdf. Accessed April 5, 2016.
14. Actavis, Inc. Vraylar? (cariprazine) capsules, for oral use [prescribing information], revised September 2015. Available at: http://pi.actavis.com/ data
15. Vanda Pharmaceuticals Inc. Fanapt® (iloperidone) tablets [prescribing information], revised January 2016. Available at: https://www.fanapt.com/ product/pi/pdf/fanapt.pdf. Accessed April 5, 2016.
16. Sunovion Pharmaceuticals Inc. Latuda (lurasidone hydrochloride) tablets, for oral use [prescribing information], revised July 2013. Available at: http://www.latuda.com/LatudaPrescribingInformation.pdf. Accessed April 5, 2016.
17. Eli Lilly and Company. Zyprexa (olanzapine) tablet for oral use, Zyprexa Zydis (olanzapine) tablet, orally disintegrating for oral use, Zyprexa intramuscular (olanzapine) injection, powder, for solution for intramuscular use [prescribing information], revised July 2015. Available at: http://pi.lilly. com/us/zyprexa-pi.pdf. Accessed April 5, 2016.
18. Eli Lilly and Company. Symbyax (olanzapine and fluoxetine) capsules for oral use [prescribing information], revised January 2015. Available at: http://pi.lilly.com/us/symbyax-pi.pdf. Accessed April 5, 2016.
19. Janssen Pharmaceuticals, Inc. Invega® (paliperidone) extended-release tablets [prescribing information], revised March 2016. Available at: http:// www.invega.com/prescribing-information. Accessed April 5, 2016.
20. AstraZeneca Pharmaceuticals LP. Seroquel XR® (quetiapine fumarate) extended-release tablets, for oral use [prescribing information], revised October 2013. Available at: http://www.azpicentral.com/seroquel-xr/ seroquelxr.pdf. Accessed April 5, 2016.
21. AstraZeneca Pharmaceuticals LP. Seroquel® (quetiapine fumarate) tablets, for oral use [prescribing information], revised October 2013. Available at: http://www.azpicentral.com/seroquel/seroquel.pdf. Accessed April 5, 2016.
22. Janssen Pharmaceuticals, Inc. Risperdal® (risperidone) tablets, for oral use, Risperdal® (risperidone) oral solution, Risperdal® M-TAB® (risperidone) orally disintegrating tablets [prescribing information], revised April 2014. Available at: http://www.janssen.com/us/sites/www-janssen-com-usa/ files/products-documents/risperdal.pdf. Accessed April 5, 2016.
23. Pfizer Inc. Geodon® (ziprasidone HCl) capsules, Geodon® (ziprasidone mesylate) injection for intramuscular use [prescribing information], revised August 2015. Available at: http://labeling.pfizer.com/ShowLabeling.aspx? id=584. Accessed April 5, 2016.
24. Otsuka America Pharmaceutical, Inc. Abilify? (aripiprazole) tablets [prescribing information], revised March 2004. Available at: http://www. accessdata.fda.gov/drugsatfda-docs/label/2004/21436slr006-abilify-lbl. pdf. Accessed April 5, 2016.
25. Eli Lilly and Company. Zyprexa® (olanzapine) [prescribing information]. In: Physicians? Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company, Inc; 2000;1649-1653.
26. AstraZeneca Pharmaceuticals LP. Seroquel® (quetiapine fumarate) tablets [prescribing information]. In: Physicians? Desk Reference. 54th ed. Montvale, NJ: Medical Economics Company, Inc.; 2000;562-566.
27. US Food and Drug Administration. Abilify (aripiprazole) tablets. Otsuka Pharmaceutical Co., Ltd. Application no.: 21-436. Approval date: 11/15/2002 [drug approval package]. Available at: http://www.accessdata. fda.gov/drugsatfda-docs/nda/2002/21-436-Abilify.cfm. Accessed April 5, 2016.
28. US Food and Drug Administration. Abilify (aripiprazole) oral tablets. Otsuka Pharmaceutical Development & Commercialization, Inc. Application no.: 021436 s018. Approval date: 11/16/2007 [drug approval package]. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/ nda/2007/021436s018TOC.cfm. Accessed April 5, 2016.
29. US Food and Drug Administration. Saphris (asenapine) tablet. Organon USA Inc. Application no.: 022117. Approval date: 8/13/2009 [drug approval package]. Available at: http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2009/022117s000TOC.cfm. Accessed April 5, 2016.
30. US Food and Drug Administration. REXULTI (brexpiprazole) tablets. Otsuka Pharmaceutical Company, Ltd. Application no.: 205422Orig1s000 and 205422Orig2s000. Approval date: July 10, 2015 [drug approval package] Available at: http://www.accessdata.fda.gov/drugsatfda-docs/ nda/2015/205422s000TOC.cfm. Accessed April 5, 2016.
31. US Food and Drug Administration. Vraylar (cariprazine). Forest Laboratories, LLC. Application no.: 204370 Orig1 and Orig2. Approval date: September 17, 2015 [drug approval package] Available at: http:// www.accessdata.fda.gov/drugsatfda-docs/nda/2015/ 204370Orig2s000TOC.cfm. Accessed April 5, 2016.
32. US Food and Drug Administration. Fanapt (iloperidone) tablets. Vanda Pharmaceuticals. Application no.: 022192. Approval date: 5/06/2009 [drug approval package] Available at: http://www.accessdata.fda.gov/drugsatfda- docs/nda/2009/022192s000TOC.cfm. Accessed April 5, 2016.
33. US Food and Drug Administration. Latuda (lurasidone hydrochloride) tablets. Sunovion Pharmaceuticals, Inc. Application no.: 200603. Approval date: 10/28/2010 [drug approval package] Available at: http://www. accessdata.fda.gov/drugsatfda-docs/nda/2010/200603Orig1s000TOC. cfm. Accessed April 5, 2016.
34. US Food and Drug Administration. Zyprexa (olanzapine). Lilly. NDA 20-592 [approval package]. Available at: http://www.accessdata.fda.gov/ drugsatfda-docs/nda/96/020592-Original-Approval-Pkg%20.pdf. Accessed April 5, 2016.
35. US Food and Drug Administration. SYMBYAX(olanzapine and fluoxetine hydrochloride). Eli Lilly & Company. NDA 21-520/S-012. Approval date: 03/19/2009 [approval package]. Available at: http://www.accessdata.fda. gov/drugsatfda-docs/nda/2009/021520Orig1s012.pdf. Accessed April 5, 2016.
36. US Food and Drug Administration. Invega (paliperidone) extended-release tablets. Janssen. Application no.: 021999. Approval date: 12/19/2006 [drug approval package] Available at: http://www.accessdata.fda.gov/drugsatfda- docs/nda/2006/021999s000-TOC.cfm. Accessed April 5, 2016.
37. US Food and Drug Administration. Seroquel XR extended-release tablets. AstraZeneca Pharmaceuticals LP. Application no.: 022047 s000. Approval date: 5/17/2007 [drug approval package] Available at: http://www. accessdata.fda.gov/drugsatfda-docs/nda/2007/022047s000TOC.cfm. Accessed April 5, 2016.
38. US Food and Drug Administration. Seroquel XR extended-release tablets. AstraZeneca Pharmaceuticals LP. Application no.: NDA 22-047/S-011. Approval date: December 2, 2009 [approval package]. Available at: http:// www.accessdata.fda.gov/drugsatfda-docs/nda/2009/022047Orig1s011. pdf. Accessed April 5, 2016.
39. US Food and Drug Administration. Seroquel/quetiapine fumarate. Zeneca Pharmaceuticals. Application no.: 20639. Approval date: 9/26/1997 [drug approval package] Available at: http://www.accessdata.fda.gov/drugsatfda- docs/nda/97/20639-seroquel-toc.cfm. Accessed April 5, 2016.
40. US Food and Drug Administration. Risperdal (risperidone). Janssen Research. Application no.: 20588/S002 and 20272/S007. Approval date: October 17, 1997 [approval package]. Available at: http://www.accessdata. fda.gov/drugsatfda-docs/nda/97/20588.pdf; http://www.accessdata.fda. gov/drugsatfda-docs/nda/pre96/020272-safety-review.pdf. Accessed April 5, 2016.
41. US Food and Drug Administration. Geodon (Ziprasidone HCI) Capsules. Pfizer Central Research. Application no.: 20-825. Approval date: 2/5/2001 [drug approval package] Available at: http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2001/20-825-Geodan.cfm. Accessed April 5, 2016.
42. US Food and Drug Administration. Briefing Book, July 30, 2009 PDAC, Saphris (asenapine) sublingual tablets. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ PsychopharmacologicDrugsAdvisoryCommittee/UCM173877.pdf. Accessed April 5, 2016.
43. Schering-Plough Research Institute. Briefing Document, July 30, 2009 PDAC, Saphris (asenapine) sublingual tablets. Available at: http://www.fda. gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173876.pdf. Accessed April 5, 2016.
44. US Food and Drug Administration. FDA Background on Zeldox? (ziprasidone hydrochloride capsules), Pfizer, Inc., Psychopharmacological Drugs Advisory Committee, July 19, 2000. Available at: http://www.fda. gov/ohrms/dockets/ac/00/backgrd/3619b1b.pdf. Accessed April 5, 2016.
45. Pfizer. Briefing Document for ZELDOX® CAPSULES (Ziprasidone HCl), FDA Psychopharmacological Drugs Advisory Committee. July 19, 2000. Available at: http://www.fda.gov/ohrms/dockets/ac/00/backgrd/ 3619b1a.pdf. Accessed April 5, 2016.
46. European Medicines Agency. Assessment report, Latuda. International non-proprietary name: lurasidone. Procedure No. EMEA/H/C/002713/0000. 23 January 2014. EMA/113836/2014. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR---Public-assessment-report/human/002713/WC500164684.pdf. Accessed April 5, 2016.
47. Medicines Evaluation Board in the Netherlands. Public Assessment Report, Seroquel XR 50 mg, prolonged release tablets, Seroquel XR 200 mg, prolonged release tablets, Seroquel XR 300 mg, prolonged release tablets, Seroquel XR 400 mg, prolonged release tablets. EU procedure no.: NL/H/0156/08-011/MR. Registration number in the Netherlands: RVG 34625-8. 10 April 2008. Available at: http://db.cbg-meb.nl/mri/par/nlh- 0156-008-009-010-011.pdf. Accessed April 5, 2016.
48. Eli Lilly and Company. Clinical study summary: study F1D-MC-HGAP. Available at: http://www.lillytrials.com/results/Zyprexa.pdf. Accessed April 5, 2016.
49. Eli Lilly and Company. Clinical study summary: study F1D-MC-HGAD. Available at: http://www.lillytrials.com/results/Zyprexa.pdf. Accessed April 5, 2016.
50. Eli Lilly and Company. Clinical study summary: study F1D-MC-HGGA. Available at: http://www.lillytrials.com/results/Symbyax.pdf. Accessed April 5, 2016.
51. Eli Lilly and Company. Clinical study summary: study H6P-MC-HDAO. Available at: http://www.lillytrials.com/results/Symbyax.pdf. Accessed April 5, 2016.
52. Eli Lilly and Company. Clinical study summary: study F1D-MC-HGIE. Available at: http://www.lillytrials.com/results/Symbyax.pdf. Accessed April 5, 2016.
53. Eli Lilly and Company. Clinical study summary: study F1D-MC-HGHZ. Available at: http://www.lillytrials.com/results/Symbyax.pdf. Accessed April 5, 2016.
54. Eli Lilly and Company. Clinical study summary: study F1D-MC-HGFR. Available at: http://www.lillytrials.com/results/Symbyax.pdf. Accessed April 5, 2016.
55. Durgam S, Litman RE, Papadakis K, et al. Cariprazine in the treatment of schizophrenia: a proof-of-concept trial. Int Clin Psychopharmacol. 2016; 31:61-68.
56. DurgamS, Starace A, LiD, et al. An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: a phase II, randomized clinical trial. Schizophr Res. 2014;152:450-457.
57. Durgam S, Cutler AJ, Lu K, et al. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placeboand active-controlled trial. J Clin Psychiatry. 2015;76:e1574-e1582.
58. Kane JM, Zukin S,WangY, et al. Efficacy and safety of cariprazine in acute exacerbation of schizophrenia: results from an international, phase III clinical trial. J Clin Psychopharmacol. 2015;35:367-373.
59. Trivedi MH, Thase ME, Osuntokun O, et al. An integrated analysis of olanzapine/fluoxetine combination in clinical trials of treatment-resistant depression. J Clin Psychiatry. 2009;70:387-396.
60. Bauer M, Pretorius HW, Constant EL, et al. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009;70:540-549.
61. El-Khalili N, Joyce M, Atkinson S, et al. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. Int J Neuropsychopharmacol. 2010;13:917-932.
62. Bauer M, El-KhaliliN, Datto C, et al.Apooled analysis of two randomised, placebo-controlled studies of extended release quetiapine fumarate adjunctive to antidepressant therapy in patients with major depressive disorder. J Affect Disord. 2010;127:19-30.
63. Citrome L, Eramo A, Francois C, et al. Lack of tolerable treatment options for patients with schizophrenia. Neuropsychiatr Dis Treat. 2015;11: 3095-3104.
64. Citrome L. A review of the pharmacology, efficacy and tolerability of recently approved and upcoming oral antipsychotics: an evidence-based medicine approach. CNS Drugs. 2013;27:879-911.
65. Citrome L. New second-generation long-acting injectable antipsychotics for the treatment of schizophrenia. Expert Rev Neurother. 2013;13:767-783.
66. Golder S, Loke YK, Wright K, et al. Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med. 2016;13:e1002127.
67. Lineberry N, Berlin JA, Mansi B, et al. Recommendations to improve adverse event reporting in clinical trial publications: a joint pharmaceutical industry/journal editor perspective. BMJ. 2016;355:i5078.
68. Citrome L. The grey literature is far from drab. Int J Clin Pract. 2016; 70:790.
69. National Institutes of Health, Department of Health and Human Services. Clinical trials registration and results information submission. Final rule. Fed Regist 2016;81:64981-65157.
70. National Institutes of Health. Department of Health and Human Services. NIH policy on the dissemination of NIH-funded clinical trial information. Fed Regist. 2016; 81: 64922-64928.