scholarly journals Cardiovascular Adverse Reactions During Antipsychotic Treatment: Results of AMSP, A Drug Surveillance Program Between 1993 and 2013

2019 ◽  
Vol 23 (2) ◽  
pp. 67-75 ◽  
Author(s):  
Michaela-Elena Friedrich ◽  
Dietmar Winkler ◽  
Anastasios Konstantinidis ◽  
Wolfgang Huf ◽  
Rolf Engel ◽  
...  

Abstract 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.

2019 ◽  
Vol 8 (3) ◽  
pp. 207-212
Author(s):  
Saeed S. Shafti ◽  
Alireza Memarie ◽  
Masomeh Rezaie ◽  
Masomeh Hamidi

Background: Neuroleptic malignant syndrome is a life-threatening complication that can occur anytime during antipsychotic treatment. Objective: The present assessment has probed the incidence and clinical profile of neuroleptic malignant syndrome among a sample of non-western psychiatric patients and compared with the available data in the literature with regard to prevalence and other associated clinical physiognomies. Methods: As a retrospective, record-based evaluation, all cases with diagnosis of neuroleptic malignant syndrome during the last sixty-two months, after ruling out other imaginable differential diagnoses, like encephalitis, meningitis and serotonin syndrome, entered the present investigation. Clinical diagnosis, was in essence also based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. The assessment of independent variables was analyzed by ‘Compression of proportions’. Statistical significance is, defined as p value ≤0.05. Results: Among 19814 psychiatric patients, during a sixty-two months’ period, eighteen cases received the diagnosis of neuroleptic malignant syndrome. The most prevalent symptom was fever, which was observed in 100% of cases. Also, there was no significant difference between the first generation versus second-generation antipsychotics. Neuroleptic malignant syndrome was meaningfully more prevalent among male patients suffering from schizophrenia. Similarly, it was significantly more widespread amid 18-65 years old agegroup. Conclusion: While no significant difference was found between first-generation as opposed to second-generation antipsychotics, neuroleptic malignant syndrome was significantly more prevalent among young and male patients suffering from schizophrenia.


2007 ◽  
Vol 41 (10) ◽  
pp. 1593-1603 ◽  
Author(s):  
Leslie L Citrome ◽  
Richard IG Holt ◽  
Woodie M Zachry ◽  
Jerry D Clewell ◽  
Paul A Orth ◽  
...  

Background: Type 2 diabetes mellitus has been reported during antipsychotic treatment. Objective: To quantify the potential risk of treatment-emergent diabetes mellitus among patients receiving antipsychotic medications. Methods: The MEDLINE and Psychinfo databases were searched using the key words antipsychotic (including individual drug names), diabetes, risk, and incidence for all English-language articles published between 1966 and 2005. Risk calculations were performed using data obtained from pharmacoepidemiologic studies that met the following criteria: (1) cohort design, (2) determination of preexisting diabetes, (3) inclusion of antipsychotic monotherapy as an exposure variable, and (4) comparison with exposure to first-generation antipsychotics. Studies meeting these criteria were used to calculate incidence, attributable risk between agents, and number needed to harm. Results: A total of 25 observational pharmacoepidemiologic studies were found comparing antipsychotics on the outcome of diabetes mellitus. Sufficient information was provided in 15 of the reports to be able to estimate attributable risk, Attributable risk for individual second-generation antipsychotics relative to first-generation antipsychotics ranged from 53 more to 46 fewer new cases of diabetes per 1000 patients. Little observable difference was noted between the individual second-generation antipsychotics versus first-generation antipsychotics on this outcome. However, few of the studies controlled for body weight, race or ethnicity, or the presence of diabetogenic medications. None adjusted for familial history of diabetes, levels of physical activity, or diet, as this information is not usually available in the databases used in pharmacoepidemiologic studies. Conclusions: Based on the published pharmacoepidemiologic reports reviewed, the avoidance of diabetes as an outcome cannot be predictably achieved with precision by choice of a second- versus a first-generation antipsychotic. Risk management for new-onset diabetes requires the assessment of established risk factors such as family history, advancing age, non-white ethnicity, diet, central obesity, and level of physical activity.


2008 ◽  
Vol 192 (6) ◽  
pp. 406-411 ◽  
Author(s):  
M. Smith ◽  
D. Hopkins ◽  
R. C. Peveler ◽  
R. I. G. Holt ◽  
M. Woodward ◽  
...  

BackgroundThe increased prevalence of diabetes in schizophrenia is partly attributed to antipsychotic treatment, in particular second-generation antipsychotics, but the evidence has not been systematically reviewed.AimsSystematic review and meta-analysis comparing diabetes risk for different antipsychotics in people with schizophrenia.MethodWe searched MEDLINE, PsycINFO, EMBASE, International Pharmaceutical Abstracts, CINAHL and Web of Knowledge until September 2006. Studies were eligible for inclusion if the design was cross-sectional, case-control, cohort or a controlled trial in individuals with schizophrenia or related psychotic disorders, where second-generation antipsychotics (defined as clozapine, olanzapine, risperidone and quetiapine) were compared with first-generation antipsychotics and diabetes was an outcome. Data were pooled using random effects inverse variance weighted meta-analysis.ResultsOf the studies that met the inclusion criteria (n=14), 11 had sufficient data to include in the meta-analysis. Four of these were retrospective cohort studies. The relative risk of diabetes in patients with schizophrenia prescribed one of the second-generation v. first-generation antipsychotics was 1.32 (95% CI 1.15-1.51). There were insufficient data to include aripiprazole, ziprasidone and amisulpride in this analysis.ConclusionsThere is tentative evidence that the second-generation antipsychotics included in this study are associated with a small increased risk for diabetes compared with firstgeneration antipsychotics in people with schizophrenia. Methodological limitations were found in most studies, leading to heterogeneity and difficulty interpreting data. Regardless of type of antipsychotic, screening for diabetes in all people with schizophrenia should be routine.


2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S313-S314
Author(s):  
Shih-Ku Lin ◽  
An-Nie Chung

Abstract Background Research on Asian Prescription Pattern (REAP) is the largest and the longest lasting international collaborative research in psychiatry in Asia since 2001. At present, four studies on antipsychotics in schizophrenia, two antidepressants, one bipolar disorder and one mood disorder were completed. Previous studies have examined the use of Long-acting Injectable (LAI) antipsychotic in patients with schizophrenia and revealed major differences across countries. The aim of the study is to investigate the prescription trend of LAI antipsychotic use in four REAP schizophrenia surveys. Methods We analyzed the results from four times of REAP studies (AP1 to AP4, 2001, 2004, 2009 and 2016), to compare the trend of LAI prescriptions rates in China, Hong Kong, Japan, Korea, Singapore, and Taiwan, and also the rate of LAI use among 15 Asian countries in AP4. Results A total of 10505 patients were analyzed, with an average rate of 14.6% of patients received LAI antipsychotic treatment. For comparison of AP1 to AP4, there was a wide variation in the rate of LAI use among the six countries, with the highest prescription rate in Singapore (68.1%) and the lowest in Korea (1.6 %). Korean patients received no LAIs treatment in the first two surveys, and the rates in China and Japan were also very low. While in Hong Kong and Singapore, the rates were much higher. In AP4 survey, India, Malaysia, Thailand, Pakistan and Sri Lanka have a higher rate of LAI use, while in Indonesia, Myanmar, the rate is much lower. Vietnam does not use LAI at all. The prescription trend was also diverse, which increased in Korea and Japan and decreased in China, Hong Kong and Singapore. The overall prescription trend of LAI was in decrease. Besides, when analyzing cases with only using second generation antipsychotics, the usage of LAI was increased. Discussion Previous studies identified several factors associated with prescription of LAI, including demographic and clinical characteristics of patients, patients’ and physicians’ attitude towards LAI, availability of LAI, insurance coverage and related cultural factors. The prescription trend of first generation LAI was decreased in most of the six countries; on the other hand, second generation LAI usages maintain steady level and even slightly increased. In conclusion, LAI antipsychotic is still underuse in Asia, especially in some countries such as Korea, China, Japan, Indonesia and Myanmar. Various factors that influenced the prescription rate of LAI antipsychotic should be addressed further.


2020 ◽  
Vol 25 (1) ◽  
pp. 23-32
Author(s):  
Gerd Laux

Für die Therapie schizophrener Erkrankungen sind seit fast 60 Jahren Antipsychotika/Neuroleptika aufgrund ihrer antipsychotischen Wirkung von zentraler Bedeutung. Die Einteilung kann unter verschiedenen Gesichtspunkten erfolgen (chemische Struktur, neuroleptische Potenz, Rezeptorprofil), heute werden üblicherweise unterschieden typische (traditionelle, klassische, konventionelle) Antipsychotika der ersten Generation ‒ »First Generation Antipsychotics« (FGA) ‒ und sog. atypische (»neuere«) Neuroleptika bzw. Antipsychotika der zweiten Generation ‒»Second Generation Antipsychotics« (SGA). Hierzu zählen Aripiprazol, Asenapin, Cariprazin, Clozapin, Olanzapin, Quetiapin, Risperidon, Sertindol und Ziprasidon. Hierbei handelt es sich um keine homogene Gruppe – sowohl neuropharmakologisch (Wirkmechanismus), als auch hinsichtlich klinischem Wirkprofil und dem Nebenwirkungsspektrum bestehen z. T. erhebliche Unterschiede. Neben der Akut-Medikation ist eine Langzeitmedikation bzw. Rezidivprophylaxe mit Antipsychotika für die Rehabilitation vieler schizophrener Patienten im Sinne eines »Stresspuffers« von grundlegender Bedeutung. In Placebo-kontrollierten Studien trat bei Patienten, die über ein Jahr behandelt wurden, bei etwa 30% unter Neuroleptika ein Rezidiv auf, unter Placebo bei mehr als 70%. Für die Langzeitbehandlung bietet sich der Einsatz von Depot-Neuroleptika an, neu entwickelt wurden Langzeit-Depot-Injektionen mit Intervallen von bis zu 3 Monaten. Grundsätzlich ist die niedrigstmögliche (wirksame) Dosis zu verwenden. Im Zentrum der Nebenwirkungen (UAW) standen lange Zeit extrapyramidal-motorische Bewegungsstörungen (EPMS), mit der Einführung von Clozapin und anderen atypischen Antipsychotika der zweiten Generation gewannen andere Nebenwirkungen an Bedeutung. Hierzu zählen Gewichtszunahme, Störungen metabolischer Parameter und ein erhöhtes Risiko für Mortalität und zerebrovaskuläre Ereignisse bei älteren Patienten mit Demenz. Entsprechende Kontrolluntersuchungen sind erforderlich, für Clozapin gibt es aufgrund seines Agranulozytose-Risikos Sonderbestimmungen. Immer sollte ein Gesamtbehandlungsplan orientiert an der neuen S3-Praxisleitlinie Schizophrenie der DGPPN aufgestellt werden, der psychologische und milieu-/sozial-therapeutische Maßnahmen einschließt. Standard ist heute auch eine sog. Psychoedukation, für Psychopharmaka liegen bewährte Patienten-Ratgeber vor.


2009 ◽  
Vol 22 (5) ◽  
pp. 478-488 ◽  
Author(s):  
Ericka L. Breden ◽  
Mei T. Liu ◽  
Stacey R. Dean ◽  
Toyin S. Tofade

In 2007, 5 of the 7 second-generation antipsychotics were listed in the Top 200 Drugs prescribed by retail sales in the United States. Cardiovascular disease is the leading cause of natural death in individuals with schizophrenia. Second-generation antipsychotics have been implicated with metabolic and cardiovascular adverse effects, and it is important for nonpsychiatric practitioners to be familiar with the monitoring parameters recommended for these agents. This article discusses the risk of weight gain, hyperglycemia, hyperlipidemia, hyperprolactinemia, and cardiovascular concerns associated with second-generation antipsychotic agents. It also discusses the proposed mechanisms for each of these adverse effects. Furthermore, it reviews suggested monitoring parameters to help manage cardiovascular disease in this patient population, and to improve the gap that exists between mental health care and physical health care in the schizophrenic population.


2021 ◽  
pp. 000486742110516
Author(s):  
Mark Taylor ◽  
Dante Dangelo-Kemp ◽  
Dennis Liu ◽  
Steve Kisely ◽  
Simon Graham ◽  
...  

Objectives: To evaluate the utilisation and persistence of antipsychotics for the treatment of schizophrenia in Australia. Methods: A retrospective study using the Australian Pharmaceutical Benefits Scheme database of a representative 10% sample. All adults with schizophrenia who were dispensed three or more supplies of oral (including clozapine) or long-acting injectable antipsychotics between 1 June 2015 and 31 May 2020 were included. Persistence time in treatment was evaluated using survival analysis and Cox hazard ratios. Results: In all, 26,847 adults with schizophrenia were studied. Oral second-generation antipsychotics were more frequently dispensed than the other antipsychotic groups studied. Median treatment persistence times were 18.3 months for second-generation antipsychotic long-acting injectables, 10.7 months for oral second-generation antipsychotics and were significantly lower for both formulations of first-generation antipsychotics at 5.2 months (long-acting injectables) and 3.7 months (oral). The median persistence time for clozapine was significantly longer than all other antipsychotics groups. Conclusions: Oral second-generation antipsychotics and second-generation antipsychotic long-acting injectables accounted for over 75% and 13% of all antipsychotics in Australia, respectively. Concerns over medication adherence and subsequent relapse have not translated into increased long-acting injectable usage despite their significantly longer persistence. Clozapine, the single most ‘persistent’ antipsychotic, was only used in 9% of people, although up to a third of all cases are likely to be treatment-resistant. Our data suggest clinicians should give consideration to the earlier use of second-generation antipsychotic long-acting injectables and clozapine, to ameliorate prognosis in schizophrenia.


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