Cardiovascular Adverse Reactions During Antipsychotic Treatment: Results of AMSP, A Drug Surveillance Program Between 1993 and 2013.
Adolescent
Adult
Aged
Aged, 80 and over
Antipsychotic Agents
/ adverse effects
Austria
/ epidemiology
Cardiovascular Diseases
/ chemically induced
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Female
Germany
/ epidemiology
Humans
Male
Middle Aged
Product Surveillance, Postmarketing
/ statistics & numerical data
Program Development
Switzerland
/ epidemiology
Young Adult
adverse drug reaction
antipsychotics
cardiovascular
drug surveillance
Journal
The international journal of neuropsychopharmacology
ISSN: 1469-5111
Titre abrégé: Int J Neuropsychopharmacol
Pays: England
ID NLM: 9815893
Informations de publication
Date de publication:
01 02 2020
01 02 2020
Historique:
received:
15
04
2019
revised:
12
08
2019
accepted:
28
08
2019
pubmed:
11
9
2019
medline:
26
11
2020
entrez:
11
9
2019
Statut:
ppublish
Résumé
Cardiovascular diseases are still the leading cause of global mortality. Some antipsychotic agents can show severe cardiovascular side effects and are also associated with metabolic syndrome. This observational study was based on data of AMSP (Arzneimittelsicherheit in der Psychiatrie), a multicenter drug surveillance program in Austria, Germany and Switzerland, that recorded severe drug reactions in psychiatric inpatients. A total of 404 009 inpatients were monitored between 1993 and 2013, whereas 291 510 were treated with antipsychotics either in combination or alone. There were 376 cases of severe cardiovascular adverse reactions reported in the given timespan, yielding a relative frequency of 0.13%. The study revealed that incidence rates of cardiovascular adverse reactions were highest during treatment with ziprasidone (0.35%), prothipendyl (0.32%), and clozapine (0.23%). The lowest rate of cardiovascular symptoms occurred during treatment with promethazine (0.03%) as well as with aripiprazole (0.06%). The most common clinical symptoms were orthostatic collapse and severe hypotonia, sinustachycardia, QTc prolongation, myocarditis, and different forms of arrhythmia. The dosage at the timepoint when severe cardiovascular events occurred was not higher in any of the given antipsychotics than in everyday clinical practice and was in average therapeutic ranges. In terms of subclasses of antipsychotics, no significant statistical difference was seen in the overall frequencies of adverse reactions cases, when first-generation high potency, first-generation low potency, and second-generation antipsychotics were compared. Thirty percent of adverse events among second-generation antipsychotics were induced by clozapine. Our findings on cardiovascular adverse reactions contribute to a better understanding of cardiovascular risk profiles of antipsychotic agents in inpatients.
Sections du résumé
BACKGROUND
Cardiovascular diseases are still the leading cause of global mortality. Some antipsychotic agents can show severe cardiovascular side effects and are also associated with metabolic syndrome.
METHODS
This observational study was based on data of AMSP (Arzneimittelsicherheit in der Psychiatrie), a multicenter drug surveillance program in Austria, Germany and Switzerland, that recorded severe drug reactions in psychiatric inpatients.
RESULTS
A total of 404 009 inpatients were monitored between 1993 and 2013, whereas 291 510 were treated with antipsychotics either in combination or alone. There were 376 cases of severe cardiovascular adverse reactions reported in the given timespan, yielding a relative frequency of 0.13%. The study revealed that incidence rates of cardiovascular adverse reactions were highest during treatment with ziprasidone (0.35%), prothipendyl (0.32%), and clozapine (0.23%). The lowest rate of cardiovascular symptoms occurred during treatment with promethazine (0.03%) as well as with aripiprazole (0.06%). The most common clinical symptoms were orthostatic collapse and severe hypotonia, sinustachycardia, QTc prolongation, myocarditis, and different forms of arrhythmia. The dosage at the timepoint when severe cardiovascular events occurred was not higher in any of the given antipsychotics than in everyday clinical practice and was in average therapeutic ranges. In terms of subclasses of antipsychotics, no significant statistical difference was seen in the overall frequencies of adverse reactions cases, when first-generation high potency, first-generation low potency, and second-generation antipsychotics were compared. Thirty percent of adverse events among second-generation antipsychotics were induced by clozapine.
CONCLUSIONS
Our findings on cardiovascular adverse reactions contribute to a better understanding of cardiovascular risk profiles of antipsychotic agents in inpatients.
Identifiants
pubmed: 31504560
pii: 5556622
doi: 10.1093/ijnp/pyz046
pmc: PMC7093998
doi:
Substances chimiques
Antipsychotic Agents
0
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
67-75Informations de copyright
© The Author(s) 2019. Published by Oxford University Press on behalf of CINP.
Références
Br J Pharmacol. 1997 Mar;120(5):968-74
pubmed: 9138706
J Clin Psychiatry. 2009 Oct;70(10):1340-7
pubmed: 19906339
BMJ. 2005 Feb 26;330(7489):445
pubmed: 15668211
Pharmacopsychiatry. 2004 Mar;37 Suppl 1:S4-11
pubmed: 15052509
Lancet. 2013 Sep 14;382(9896):951-62
pubmed: 23810019
Br Med J. 1969 Mar 1;1(5643):531-6
pubmed: 5764699
CNS Drugs. 2017 Sep;31(9):777-795
pubmed: 28808933
J Pharmacol Exp Ther. 1998 Aug;286(2):788-93
pubmed: 9694935
Ann Pharmacother. 2016 Feb;50(2):89-95
pubmed: 26681444
Schizophr Res. 2005 Dec 1;80(1):19-32
pubmed: 16137860
Expert Opin Drug Metab Toxicol. 2015 Jan;11(1):149-74
pubmed: 25483358
JAMA Psychiatry. 2019 May 1;76(5):499-507
pubmed: 30785608
Am J Public Health Nations Health. 1965 Aug;55:1170-5
pubmed: 14326412
Stat Med. 1993 May 15;12(9):809-24
pubmed: 8327801
Int J Neuropsychopharmacol. 2016 Apr 20;19(4):
pubmed: 26721950
Am J Psychiatry. 2001 Nov;158(11):1774-82
pubmed: 11691681
Psychopharmacology (Berl). 2015 Sep;232(18):3297-308
pubmed: 26231497
Schizophr Res. 2012 Nov;141(2-3):173-8
pubmed: 23010488
Neuropsychiatr Dis Treat. 2019 Jan 25;15:349-355
pubmed: 30774346
J Am Heart Assoc. 2015 Sep 01;4(9):e001666
pubmed: 26330335
Am J Geriatr Pharmacother. 2011 Apr;9(2):120-32
pubmed: 21565711
Am Health Drug Benefits. 2011 Sep;4(5):292-302
pubmed: 25126357
Int J Neuropsychopharmacol. 2014 Oct 31;18(4):
pubmed: 25522416
World J Biol Psychiatry. 2019 Nov;20(9):732-741
pubmed: 30058414
CNS Drugs. 2011 Jun 1;25(6):473-90
pubmed: 21649448
CNS Drugs. 2011 Dec 1;25(12):1035-59
pubmed: 22133326
J Psychiatry Neurosci. 2000 Mar;25(2):154-60
pubmed: 10740988
J Clin Psychiatry. 2017 Sep/Oct;78(8):e905-e912
pubmed: 28406267