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.
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Gen Directorate Hlth, Lisbon, Portugal
Lung Dis Ctr Venda Nova, Amadora, PortugalFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Villar, M.
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Sotgiu, G.
D'Ambrosio, L.
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Fdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, ItalyFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
D'Ambrosio, L.
Raymundo, E.
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Lung Dis Ctr Vila Franca de Xira, Vila Franca De Xira, PortugalFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Raymundo, E.
Fernandes, L.
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Lung Dis Ctr Lumiar, Lisbon, PortugalFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Fernandes, L.
Barbedo, J.
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Lung Dis Ctr Sintra, Sintra, PortugalFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Barbedo, J.
Diogo, N.
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Pulido Valente Hosp, Lisbon, PortugalFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Diogo, N.
Lange, C.
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Res Ctr Borstel, Div Clin Infect Dis, Borstel, GermanyFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Lange, C.
Centis, R.
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Fdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, ItalyFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
Centis, R.
Migliori, G. B.
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Fdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, ItalyFdn S Maugeri, Care & Res Inst, WHO Collaborating Ctr TB & Lung Dis, I-21049 Tradate, Italy
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Dayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Wander, Gurpreet S.
Ram, Bhim
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Indira Gandhi Inst Med Sci, Dept Gen Med, Patna 800014, Bihar, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Ram, Bhim
Sonkar, Satyendra Kumar
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King Georges Med Univ, Dept Med, Lucknow 226003, Uttar Pradesh, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Sonkar, Satyendra Kumar
Manjunath, C. N.
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Sri Jayadeva Inst Cardiovasc Sci & Res, Bangalore 560069, Karnataka, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Manjunath, C. N.
Kamath, Padmanabh
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KMC Hosp, Dept Cardiol, Mangalore 575001, Karnataka, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Kamath, Padmanabh
Sreenivasamurthy, L.
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Life Care Hosp & Res Ctr, Bangalore 560092, Karnataka, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Sreenivasamurthy, L.
Balamurugan, R.
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Kovai Diabet Special Ctr & Hosp, Coimbatore 641009, Tamil Nadu, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Balamurugan, R.
Rao, S. S. V. V. Narasinga
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Govt Med Coll & Govt Gen Hosp Old RIMS, Dept Gen Med, Srikakulam 532001, Andhra Pradesh, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Rao, S. S. V. V. Narasinga
Roy, Debabrata
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Rabindranath Tagore Int Inst Cardiac Sci, Kolkata 700099, West Bengal, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Roy, Debabrata
Bachubhai, Prajapati Vipulkumar
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GCS Med Coll, Hosp & Res Ctr, Dept Gen Med, Ahmadabad 380025, Gujarat, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Bachubhai, Prajapati Vipulkumar
Manjula, S.
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Micro Labs Ltd, Dept Med Serv, Bangalore 560001, Karnataka, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
Manjula, S.
Kumar, M. Krishna
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Micro Labs Ltd, Dept Med Serv, Bangalore 560001, Karnataka, IndiaDayanand Med Coll & Hosp, Dept Cardiol, Ludhiana 141001, Punjab, India
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Univ Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, SpainUniv Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, Spain
Rodrigues-Amorim, Daniela
Olivares, Jose Manuel
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Univ Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, Spain
Serv Galego Saude SERGAS, Dept Psychiat, Hlth Area Vigo, Vigo, Spain
Ctr Invest Biomed Red Salud Mental CIBERSAM, Galicia Sur Hlth Res Inst IISGS, Neurosci Area, Vigo, SpainUniv Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, Spain
Olivares, Jose Manuel
Spuch, Carlos
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Univ Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, SpainUniv Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, Spain
Spuch, Carlos
Rivera-Baltanas, Tania
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Ctr Invest Biomed Red Salud Mental CIBERSAM, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Vigo, SpainUniv Vigo, Galicia Sur Hlth Res Inst IISGS, Translat Neurosci Res Grp, Ctr Invest Biomed Red Salud Mental CIBERSAM, Vigo, Spain
机构:
Univ Naples Federico II, Dept Clin Med & Surg, Dermatol Unit, Naples, ItalyUniv Naples Federico II, Dept Clin Med & Surg, Dermatol Unit, Naples, Italy
Costa, Claudia
Ocampo-Garza, Sonia Sofia
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Univ Autonoma Nuevo Leon, Univ Hosp Dr Jose Eleuterio Gonzalez, Dermatol Dept, Monterrey, MexicoUniv Naples Federico II, Dept Clin Med & Surg, Dermatol Unit, Naples, Italy
Ocampo-Garza, Sonia Sofia
Lallas, Aimilios
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Aristotle Univ Thessaloniki, Dept Dermatol 1, Thessaloniki, GreeceUniv Naples Federico II, Dept Clin Med & Surg, Dermatol Unit, Naples, Italy