PLACID study: A randomized trial comparing the efficacy and safety of inhaled loxapine versus intramuscular aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder.
Por:
San L, Estrada G, Oudovenko N, Montañés F, Dobrovolskaya N, Bukhanovskaya O, Popov M and Vieta E
Publicada:
1 jun 2018
Ahead of Print:
1 may 2018
Resumen:
The aim of the study was to investigate the efficacy and safety of inhaled loxapine compared with the intramuscular (IM) antipsychotic aripiprazole in acutely agitated patients with schizophrenia or bipolar I disorder. PLACID was an assessor-blind, parallel-group trial conducted in 23 centres in the Czech Republic, Germany, Spain, and Russia. Patients (aged 18-65 years) diagnosed with schizophrenia or bipolar I disorder experiencing acute agitation (Clinical Global Impression [CGI]-Severity score = 4) while hospitalized or attending an emergency room were randomized to receive up to two doses of inhaled loxapine 9.1?mg or IM aripiprazole 9.75?mg (= 2?h between doses) during the 24-h study period. The primary efficacy endpoint was time to response (CGI-Improvement score 1 [very much improved] or 2 [much improved]). The primary analysis included randomized patients who provided informed consent (full analysis set [FAS]); the safety analysis included all patients who received study medication. The FAS comprised 357 patients (enrolled December 2, 2014 - October 31, 2016). The between-treatment difference in median time to CGI-Improvement response was 10?min (95% CI 0.0-30.0); p = 0.0005) in favour of inhaled loxapine (median [95% CI]: 50?min [30.0-50.0] vs 60?min [50.0-90.0] with IM aripiprazole); the difference was significant at 10?min (responders: 14% [loxapine] vs 4% [aripiprazole]; p = 0.001). There were no safety issues. Inhaled loxapine reduced agitation faster than IM aripiprazole, supporting its use as a first-line option for managing acute agitation in patients with schizophrenia or bipolar disorder.
Filiaciones:
San L:
Parc Sanitari Sant Joan de Déu, CIBERSAM, Barcelona, Spain
Estrada G:
Ferrer Internacional, S.A., Barcelona, Spain
Oudovenko N:
Ferrer Internacional, S.A., Barcelona, Spain
Montañés F:
Hospital Fundación Alcorcón, Madrid, Spain
Dobrovolskaya N:
City Psychoneurological Dispensary No. 7, Sankt Peterburg, Russia
Bukhanovskaya O:
Treatment and Rehabilitology Scientific Center Phoenix, Rostov on Don, Russia
Popov M:
City Psychiatric Hospital No. 3, Bekhterev Psychoneurological Research Institute, Sankt Peterburg, Russia
Vieta E:
Hospital Clínic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain
Open Access
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