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.