Naturalistic observational clinical experience of
Transcript
Naturalistic observational clinical experience of
Naturalistic observational clinical experience of inhalable loxapine as acute treatment of agitation P-A. Karlsson1, F. Blanco, Z. Nyman, H. Runge County unit for specialized psychiatry, Öjebyn Piteå, County of Norrbotten, Sweden. 1. Corresponding author: [email protected] OBJECTIVE • Present clinical experience of inhalable loxapine as acute treatment of agitation. • Agitation is a syndrome characterized by excessive motor and verbal activity for which prompt intervention may be needed. • Loxapine is an antipsychotic with D2 and 5HT2A blocking action [1]. • The mean number of psychiatric medicines was 5.2 (range 2-10); clozapine and olanzapine were the most common antipsychotics used. • Before administration of loxapine, another pharmacological treatment had been used in 6 patients without sufficient efficacy. • The mean PEC score before loxapine inhalation was 24, indicating severe agitation in most patients (Fig 1). The PANSS-EC (PEC) SCALE 1 (absent) METHODS 1 • Patients with agitation are characterized with regard to demography, clinical history, diagnosis, and concomitant medication. • The degree of agitation before treatment with inhalable loxapine was assessed by using the PANSS-EC (PEC) scale [2]. • The change from baseline agitation 2 hours post-treatment was assessed by using the Clinical Global Improvement-Impression scale (CGI-I) [3]. • The effect of inhalable loxapine was described from patient´s and staff´s perspective. RESULTS • Data from 13 patients with agitation were reviewed: • 6 with schizophrenia or schizoaffective syndrome • 3 with bipolar disorder • 4 with other psychiatric diagnoses. • The average time since diagnosis was 8 years (range 0.5-25). • Nine patients had one or more co-diagnoses e.g. ADHD (n=5), substance use disorder (n=4). • Some of the patients had been subject to physical restraints for a great number of times in their lives. 7 (extreme) 2 3 13 Gender (Male/Female) 7/6 Age (years), mean (range) 32 (22-54) Time since diagnosis (years), mean (range) 8 (0.5-25) Patients with psychiatric codiagnosis, N 9 4 5 6 7 Symptoms measured: • Poor impulse control • Tension • Hostility • Uncooperativeness • Excitement Max 35 Min 5 Mean 24 Figure 1: The mean PEC score before loxapine inhalation. The PANSS-EC (PEC) scale measures 5 symptoms associated with agitations. Each symptoms is rated on a scale of 1 to 7, and scores are summed. Therefore, total scores can range from 5 (all symptoms absent) to 35 (all symptoms extreme). • 2 hours post loxapine inhalation, the CGI-I assessment demonstrated improvement in 11 patients and no change in 2 patients (fig 2). 85% 15% Table 1: Demographics of participants included in the survey. N P.3.d.083 very much/ much improved minimally improved/ no change Figure 2: Very much or much improved (CGI-I score 1 and 2) was observed by 11 of 13 of the patients (85%). • The staff described the treatment effect as good in 9 patients, inconclusive in 3 patients and as no effect in one patient. • Self-assessment was done by 10 patients of whom 7 reported some treatment effect, which in the staff´s view was partly greater than reported by the patients. • Inhalable loxapine was well tolerated. CONCLUSIONS • In this cohort of markedly ill and hospitalized patients with acute agitation, 9 of 13 patients were diagnosed with schizophrenia, schizoaffective disorder or bipolar disorder. • Inhalation of loxapine demonstrated improvement of the agitation level in 11 patients. • The treatment was well tolerated which is important in these very vulnerable patients. • Inhalable loxapine provides an attractive therapeutic option for acute treatment of patients with agitation. [1] Lesem et al. Rapid acute treatment of agita8on in individuals with schizophrenia: mul8centre, randomised, placebo-‐controlled study of inhaled loxapine,The Bri8sh Journal of Psychiatry. 2011:198, 51–58. [2] Kay SR, et al. The posi8ve and nega8ve syndrome scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261– 276. [3] Berk M, et al: The validity of the CGI severity and improvement scales as measures of clinical effec8veness suitable for rou8ne clinical use. Journal of Evalua8on in Clinical Prac8ce 2008, 14:979-‐983.