Metabolic parameters in patients with schizophrenia during 12-week

treatment with long-acting injectable paliperidone palmitate

M.M. Dumitru1
1
"Fr. I. Rainer "Institute of Anthropology, Bucharest, Romania

BACKGROUND:
Several SGAs are known to be associated with a high risk of metabolic adverse
effects such as weight gain, hyperlipidemia, hyperglycemia [1,2] and increased
cholesterol levels [3] in patients with schizophrenia taking SGAs. Additionally, obese
and overweight patients with schizophrenia are at a higher risk of metabolic
adverse effects than those with normal-weight [4].

In this study was analized the relationship between body mass index (BMI)
and metabolic parameters in patients with schizophrenia treated with longacting injectable paliperidone palmitate (PP) in 12-week study.

METHODS:

Patients with a diagnosis of schizophrenia according to ICD-10 criteria hospitalized

in the Saint Nicolae Psychiatric Hospital during 6 months (september 2015february 2016), aged 18 to 65 years (inclusive), having BMI 15.0 kg/m2 , and a
Positive and Negative Syndrome Scale (PANSS) total score below 120, at baseline
were included. Only patients who received PP continuously from study entry through
study completion were included in data analyses. All adverse events that occured
between the study start and end date were included. Changes in weight, BMI,
glucose, and lipid levels from baseline to endpoint were analyzed using a paired ttest. Was conducted a study that included 64 consecutive patients received PP continuously

from hospitalization and up to 12 weeks and were grouped by baseline BMI (kg/m2):
underweight (BMI <19; n = 4, 6.2%), normal-weight (BMI 19- < 25; n = 22, 34.4%), overweight
(BMI 25-< 30; n = 24, 37.5%) and obese (BMI 30; n = 14, 21.9%). At the end of the study
were analyzed metabolic treatment-emergent adverse events (TEAEs) and changes in related
laboratory results from baseline.
RESULTS:
A total of 64 patients met the criteria for inclusion in this analysis. Majority of
patients were men (62.5%). The baseline demographic and clinical characteristics
were similar across the groups.

Overall mean (SD) dose/month was 70.5 (17.2) mg eq. The mean doses and median duration of
PP exposure were similar among all the BMI-based groups. Occurrences of metabolic TEAEs
overall by group were 0% in underweight groupe, 9.0% (normal-weight), 12.5% (overweight),
and 21.4% (obese). The most common ( 2%) metabolic TEAE were weight gain and elevated
blood levels of glucose and lipids. Mean BMI and weight increased in normal-weight and
overweight groups at study endpoint. The most frequently occurring TEAEs (5% overall) were

insomnia (14%), anxiety (12.5%), worsening of schizophrenia (3.1.%) and psychotic disorders
(4.6%). In this study ware not observed consistent trends for increased metabolic-related
laboratory values by baseline BMI group was observed.

CONCLUSION:
This study demonstrate that the occurrences of metabolic-related TEAEs is associated with
greater BMI status in patients with schizophrenia treated with long-acting injectable paliperidone
palmitate; and were not observed consistent trends in metabolic-related laboratory values.

Keywords: Body mass index, Metabolic, Paliperidone, Schizophrenia, Weight

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64 pacienti were grouped by baseline BMI (kg/m2): underweight (BMI <19; n = 4, 6.2%), normalweight (BMI 19- < 25; n = 22, 34.4%), overweight (BMI 25- < 30; n = 24, 37.5%) and obese (BMI 30; n =
14, 21.9%)

40 barbati 62.5%
4-0

22- 2 patients Occurrences of metabolic TEAEs

24- 3 patients Occurrences of metabolic TEAEs
14- 3 patients Occurrences of metabolic TEAEs