Citation

Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Neuropsychiatr. Dis. Treat. 2020; 16: 1533-1542.

Copyright

(Copyright © 2020, Dove Press)

DOI

10.2147/NDT.S221242

PMID

unavailable

Abstract

BACKGROUND: Sudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents.

OBJECTIVE: To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables).

METHODS: Data from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed.

RESULTS: In total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M PP1M (172 days [134-222 days])> paliperidone ER (58 days [42-114 days]) and was "not-estimable" in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P<0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P<0.001]).

CONCLUSION: The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence. Clinical trial registration: paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515). © 2020 Mathews et al.

Language: en

Keywords

adult; human; suicide; female; male; Schizophrenia; suicidal ideation; schizophrenia; randomized controlled trial; hospitalization; comparative study; major clinical study; mental disease; controlled study; neuroleptic agent; automutilation; double blind procedure; treatment withdrawal; drug safety; placebo; drug efficacy; drug withdrawal; relapse; drug formulation; Article; treatment duration; drug release; post hoc analysis; Positive and Negative Syndrome Scale; Relapse prevention; paliperidone; medication compliance; Oral paliperidone extended release; Paliperidone palmitate once monthly; Paliperidone palmitate three monthly