Divergence of dose-response with asenapine: a cluster analysis of randomized, double-blind, and placebo control study
| Autor: | Minami Naito, Shuichi Hiraoka, Yoshiteru Takekita, Atsuko Yamamoto, Nobuatsu Aoki, Toshihiko Kinoshita, Yasuhiro Iwama, Tomoyo Yanagida, Chikashi Takano, Yosuke Koshikawa, Haruhiko Ogata, Masaki Kato, Toshiya Funatsuki, Naotaka Sunada |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Hostility Dibenzocycloheptenes Placebo Heterocyclic Compounds 4 or More Rings 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine medicine Clinical endpoint Asenapine Cluster Analysis Humans Antipsychotic Adverse effect Psychiatric Status Rating Scales business.industry Incidence (epidemiology) medicine.disease 030227 psychiatry Psychiatry and Mental health Treatment Outcome Schizophrenia Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery medicine.drug Antipsychotic Agents |
| Zdroj: | CNS spectrums. 27(3) |
| ISSN: | 1092-8529 |
| Popis: | BackgroundDifferences in psychiatric background and dose–response to asenapine in patients with schizophrenia were examined based on efficacy and safety, using data obtained in a double-blind, placebo-controlled trial.MethodsPatients with schizophrenia were classified into three clusters by a cluster analysis based on the Positive and Negative Symptom Scale (PANSS) subscores at baseline, using the data from a 6-week, double-blind, placebo-controlled trial. PANSS Marder factor scores were calculated for each cluster. The efficacy of 10 or 20 mg/day of asenapine on PANSS score was used as the primary endpoint, with the incidence of adverse events evaluated as the secondary endpoint.ResultsA total of 529 asenapine-treated patients were classified into 3 clusters: Cluster-P with the higher scores in positive symptoms, disorganized thoughts, and hostility/excitement, Cluster-N with higher scores in negative symptoms, and Cluster-L with overall lower scores. In Cluster-N and Cluster-L, both 10 and 20 mg/day groups showed significant improvement in PANSS scores, while only the 20 mg/day group showed a significant difference in Cluster-P. Cluster-N and Cluster-L had differences in the incidence of adverse events, but this was not seen in Cluster-P.ConclusionsThe efficacy and safety of asenapine 10 and 20 mg/day differed between the 3 clusters of patients. This suggests that background information regarding baseline psychiatric symptoms may affect the therapeutic response in patients with schizophrenia. |
| Databáze: | OpenAIRE |
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