Efficacy, cardiac safety and tolerability of sertindole:: a drug surveillance

被引:18
|
作者
Pezawas, L
Quiner, S
Moertl, D
Tauscher, J
Barnas, C
Küfferle, B
Wolf, R
Kasper, S
机构
[1] Univ Vienna, Dept Gen Psychiat, A-1090 Vienna, Austria
[2] Univ Vienna, Dept Cardiol, A-1090 Vienna, Austria
关键词
atypical antipsychotics; neuroleptics; schizophrenia; sertindole; QT-interval;
D O I
10.1097/00004850-200015040-00003
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Sertindole is a novel atypical antipsychotic, which has shown efficacy in the treatment of positive and negative symptoms of schizophrenia in phase II and III studies. Furthermore, these studies have demonstrated tolerability and a favourable side-effect profile. In contrast to classical antipsychotics, sertindole was not associated with extrapyramidal symptoms (EPS). We report drug surveillance data in 34 comorbid and comedicated sertindole treated patients suffering from different psychotic disorders. The drug surveillance consisted of two distinct phases: inpatient treatment and outpatient follow-up. Clinical global impression (severity and improvement of illness), psychotic symptoms, side-effects, and blood parameters have been carefully documented. With special respect to cardiac safety electrocardiograms (ECGs) have been recorded twice (during sertindole treatment and during treatment with an antipsychotic different from sertindole). Recommended EGG-parameters for assessment of the proarrhythmic risk of a drug have been calculated (QTc-, QTc(2)-interval; QT-, QTc-dispersion). The majority of patients (n = 29) have been treated previously with several typical and/or atypical antipsychotics. We observed a clinical response to sertindole treatment in 29 patients (85%). Both positive and negative symptoms improved with sertindole and no severe side-effects have been documented. EPS occurred at placebo level. A mean QTc-interval prolongation of 19.7 ms (4.7%) has been detected. None of the patients developed clinical or electrocardiographic evidence of cardiac dysrhythmia during sertindole treatment, or other clinical evidence of cardiac abnormalities. In summary, sertindole did show efficacy for positive and negative symptoms together with a favourable side-effect profile. No evidence for an increased proarrhythmic risk has been found. Int Clin Psychopharmacol 15:207-214 (C) 2000 Lippincott Williams & Wilkins.
引用
收藏
页码:207 / 214
页数:8
相关论文
共 50 条
  • [41] Oxcarbazepine: Efficacy, safety, and tolerability in the treatment of mania
    Lande, RG
    INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE, 2004, 8 (01) : 37 - 40
  • [42] Efficacy, safety, and tolerability of quetiapine in patients with schizophrenia
    Nasrallah, HA
    Tandon, R
    JOURNAL OF CLINICAL PSYCHIATRY, 2002, 63 : 12 - 20
  • [43] Linezolid safety, tolerability and efficacy to treat multidrug- and extensively drug-resistant tuberculosis
    Villar, M.
    Sotgiu, G.
    D'Ambrosio, L.
    Raymundo, E.
    Fernandes, L.
    Barbedo, J.
    Diogo, N.
    Lange, C.
    Centis, R.
    Migliori, G. B.
    EUROPEAN RESPIRATORY JOURNAL, 2011, 38 (03) : 730 - 733
  • [44] Comparison of the efficacy, safety, and tolerability of the FDC of telmisartan
    Wander, Gurpreet S.
    Ram, Bhim
    Sonkar, Satyendra Kumar
    Manjunath, C. N.
    Kamath, Padmanabh
    Sreenivasamurthy, L.
    Balamurugan, R.
    Rao, S. S. V. V. Narasinga
    Roy, Debabrata
    Bachubhai, Prajapati Vipulkumar
    Manjula, S.
    Kumar, M. Krishna
    INDIAN HEART JOURNAL, 2024, 76 (03) : 159 - 166
  • [45] A Systematic Review of Efficacy, Safety, and Tolerability of Duloxetine
    Rodrigues-Amorim, Daniela
    Olivares, Jose Manuel
    Spuch, Carlos
    Rivera-Baltanas, Tania
    FRONTIERS IN PSYCHIATRY, 2020, 11
  • [46] Clinical experience with dolutegravir: efficacy, safety, tolerability
    Furtado, Isabel
    Valdoleiros, Sofia R.
    Fragoso, Joana
    Vasconcelos, Olga
    Goncalves, Maria Joao
    Sarmento-Castro, Rui
    HIV & AIDS REVIEW, 2022, 21 (01): : 10 - 16
  • [47] Expert opinion on sonidegib efficacy, safety and tolerability
    Villani, Alessia
    Fabbrocini, Gabriella
    Costa, Claudia
    Ocampo-Garza, Sonia Sofia
    Lallas, Aimilios
    Scalvenzi, Massimiliano
    EXPERT OPINION ON DRUG SAFETY, 2021, 20 (08) : 877 - 882
  • [48] Real world efficacy, tolerability and safety of ubrogepant
    Chiang, C.
    Arca, K. N.
    Dunn, R. B.
    Girardo, M. E.
    Quillen, J. K.
    Dodick, D. W.
    Starling, A. J.
    HEADACHE, 2021, 61 : 139 - 140
  • [49] Real World Efficacy, Tolerability and Safety of Ubrogepant
    Chiang, Chia-Chun
    Arca, Karissa
    Dunn, Rachel
    Girardo, Marlene
    Quillen, Jaxon
    Dodick, David
    Starling, Amaal
    NEUROLOGY, 2021, 96 (15)
  • [50] Bowel preparation for colonoscopy : Efficacy, tolerability and safety
    Martens, Pieter
    Bisschops, Raf
    ACTA GASTRO-ENTEROLOGICA BELGICA, 2014, 77 (02) : 249 - 255