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An assessment of injection site reaction and injection site pain of 1‐month and 3‐month long‐acting injectable formulations of paliperidone palmitate
Author(s) -
Kern Sliwa Jennifer,
Savitz Adam,
Nuamah Isaac,
Mathews Maju,
Gopal Srihari,
Elefant Erica,
Najarian Dean,
Alphs Larry
Publication year - 2018
Publication title -
perspectives in psychiatric care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.538
H-Index - 35
eISSN - 1744-6163
pISSN - 0031-5990
DOI - 10.1111/ppc.12267
Subject(s) - paliperidone palmitate , paliperidone , medicine , injection site , anesthesia , clinical endpoint , incidence (geometry) , randomized controlled trial , schizophrenia (object oriented programming) , pharmacology , antipsychotic , physics , psychiatry , optics
Purpose To evaluate injection site reactions and pain following paliperidone palmitate 1‐month (PP1M) and 3‐month (PP3M) administration using safety data of double‐blind (DB), noninferiority study. Methods Patients ( n = 1,429) with schizophrenia, treated with PP1M (50–150 mg‐eq, 17‐week open‐label [OL] phase) were randomized to PP1M or PP3M in 48‐week DB phase. Findings PP1M and PP3M injections were well tolerated. Incidence of induration, redness, and swelling were low in both phases (OL: 9–12%; DB: 7–13%), and were mostly mild in both groups. Mean ( SD ) visual analog scale scores decreased from OL‐baseline (22.0 [21.6]) to DB‐baseline (19.5 [20.6] vs. 18.4 [20.4]) and DB‐endpoint (15.6 [17.9] vs. 15.5 [18.3]). Practice Implications Injection site reactions and pain were low and similar between both treatments, regardless of administration site and dose.