Clinical Observations of Sertindole in???53 Hospitalised Patients with Psychotic Disorders1

Steinert, Tilman; Hauger, B; Eckardt, Jürgen; Schmid, Peter

doi:10.2165/00044011-200525010-00007

Cited by 5 publications

(6 citation statements)

References 10 publications

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“…41 The favorable profile of sertindole on EPS was confirmed by the meta-analysis of Leucht et al, which showed that sertindole (mean ORs, 0.17-0.2) produced fewer EPS than placebo and almost all other drugs and was preceded in ranking only by clozapine (mean ORs, 0.06-0.40). 73 Overall, however, sertindole (mean ORs, 0.78, 0.61 to 0.98) had significantly higher all-cause discontinuation than other drugs, although more participants withdrew because of the perceived lack of efficacy than because of adverse effects (40% vs 17%). Sertindole caused significant increases in prolactin in the short-term but not in the long-term trials, 39,41,42 along with small increases in plasma glucose, 17 total cholesterol 39,44 and tryglicerides.…”

Section: Adverse Eventsmentioning

confidence: 89%

Efficacy and Safety of Sertindole in Schizophrenia

Zoccali

Bruno

Muscatello

2015

Journal of Clinical Psychopharmacology

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Sertindole is an atypical antipsychotic reintroduced into the European market in 2005 after a reevaluation of its risks and benefits, under the agreement that close electrocardiographic screening would be conducted. It has a high affinity for dopamine D2, serotonin 5-HT2A and 5-HT2C, and α1 adrenergic receptors. Moreover, sertindole shows modest affinity for H1-histaminergic and muscarinic receptors. The pharmacological properties, clinical efficacy, safety, and tolerability of sertindole are covered in this article based on a literature review from 1990 to 2014. Given current available findings, sertindole is at least effective as haloperidol, risperidone, and olanzapine on schizophrenia symptoms. Regarding its efficacy on cognitive symptoms, sertindole effect is supported by both preclinical and clinical studies versus haloperidol and olanzapine; however, its role on cognition needs further clarification. Concerning safety and tolerability issues, sertindole is characterized by a low potential to cause sedation and extrapyramidal symptoms, and by an acceptable metabolic profile; nevertheless, cardiac safety remains a major concern, and the electrocardiographic monitoring should be carried out during treatment to substantially reduce cardiovascular risk. In conclusion, although it has an equivalent profile compared to other antipsychotic drugs, sertindole actually remains a second-line choice for schizophrenic patients intolerant to at least one other antipsychotic agent.

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Section: Adverse Eventsmentioning

confidence: 89%

Efficacy and Safety of Sertindole in Schizophrenia

Zoccali

Bruno

Muscatello

2015

Journal of Clinical Psychopharmacology

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“…44 Antagonism of muscarinic receptors is usually the mechanism for antipsychotic induced dry mouth, but sertindole possesses no affinity for the muscarinic receptor. 50 A more plausible mechanism for sertindole-induced dry mouth is the potent >1 antagonism, which might cause rhinitis and secondary dry mouth due to more breathing through the mouth.…”

Section: Discussionmentioning

confidence: 99%

“…43 The most common adverse effects are nasal congestion, dry ejaculation, and dry mouth. 44 Because a substantial part of clozapine patients does not achieve sufficient response to clozapine, and augmentation with antipsychotics is widely used, despite the limited evidence, we decided to investigate the safety and efficacy of sertindole as an augmenting drug to clozapine. We also hypothesized that sertindole might reduce clozapine-induced hypersalivation due to the occurrence of dry mouth in sertindole-treated patients.…”

mentioning

confidence: 99%

Augmenting Clozapine With Sertindole

Nielsen¹,

Emborg²,

Gydesen³

et al. 2012

Journal of Clinical Psychopharmacology

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Clozapine augmentation with antipsychotic drugs is widely used despite sparse evidence supporting this strategy. Sertindole is a nonsedating atypical antipsychotic drug with low affinity for cholinergic receptors, which makes it potentially suitable for augmentation of clozapine. The study design was a 12-week, double-blind, randomized, placebo-controlled study including patients with International Statistical Classification of Diseases, 10th Revision schizophrenia (F20.0-F20.3) and treated with clozapine for at least 6 months who had not achieved sufficient response. Patients were randomized 1:1 to either sertindole 16 mg or placebo, and assessment was done at baseline and after 6 and 12 weeks. Assessment included the Positive and Negative Syndrome Scale, Clinical Global Impression, Udvalg for Kliniske Undersøgelser, World Health Organization Quality of Life Brief, Drug Attitude Inventory, fasting glucose, lipids, and electrocardiogram. Clozapine augmentation with sertindole was not superior to placebo regarding total score or subscale score of the Positive and Negative Syndrome Scale, Clinical Global Impression, World Health Organization Quality of Life Brief, or Drug Attitude Inventory. No increased adverse effects compared with placebo were found. Four patients randomized to sertindole experienced a significant worsening of psychosis, and 2 of them required psychiatric admission. Metabolic parameters were unchanged during the study, but augmentation of clozapine with sertindole was associated with a 12-millisecond (SD, 20-millisecond) QTc prolongation compared with 0 millisecond (SD, 20 milliseconds) in the placebo group (P < 0.03). Augmentation with sertindole showed no benefits compared with placebo. Psychiatrists should be aware that augmentation might not add any benefits for the patients and in some cases worsen psychosis.

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“…Literatürde sertindol kullanan 53 psikotik hastanin klinik olarak degerlendirildigi bir çali §mada 3 olguda akatizi ve 1 olguda parkinsonizm bildirilmiftir (9). Yine literatürde sertindol kullanan bir hastada okülorjik kriz gelifimi ile ilgili bir olgu sunumu bulunmaktadir (10).…”

Section: Tarti §Maunclassified

Sertindol Tedavisi ile Ortaya Çıkan Geç Diskinezi Olgusu

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2012

npa

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Clinical Observations of Sertindole in???53 Hospitalised Patients with Psychotic Disorders1

Cited by 5 publications

References 10 publications

Efficacy and Safety of Sertindole in Schizophrenia

Efficacy and Safety of Sertindole in Schizophrenia

Augmenting Clozapine With Sertindole

Sertindol Tedavisi ile Ortaya Çıkan Geç Diskinezi Olgusu

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