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 long-acting 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 2015-february 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 t-test. 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

1.Balf G, Stewart TD, Whitehead R, Baker RA. Metabolic adverse events in patients with mental illness treated with antipsychotics: a primary care perspective. Prim Care Companion J Clin Psychiatry.2008;10(1):15–24. doi: 10.4088/PCC.v10n0104.

2.McIntyre RS, McCann SM, Kennedy SH. Antipsychotic metabolic effects: weight gain, diabetes mellitus, and lipid abnormalities. Can J Psychiatry. 2001;46(3):273–281. 

3.Lindenmayer JP, Czobor P, Volavka J, Citrome L, Sheitman B, McEvoy JP, Cooper TB, Chakos M, Lieberman JA. Changes in glucose and cholesterol levels in patients with schizophrenia treated with typical or atypical antipsychotics. Am J Psychiatry. 2003;160(2):290–296. doi: 10.1176/appi.ajp.160.2.290. 

4.Falissard B, Mauri M, Shaw K, Wetterling T, Doble A, Giudicelli A, De Hert M. The METEOR study: frequency of metabolic disorders in patients with schizophrenia. Focus on first and second generation and level of risk of antipsychotic drugs. Int Clin Psychopharmacol. 2011;26(6):291–302. doi: 10.1097/YIC.0b013e32834a5bf6. 

64 pacienti 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%)

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