Importance of Long-Acting Injectable Antipsychotic Preparation, Administration, and Injection Site Tolerability: A Focus on Paliperidone Palmitate Once-Every-6-Months Formulation

Table 2

Investigator evaluation of injection sites during the double-blind phase.

Patients, n (%)	PP6M						PP3M
	Baseline, n = 478			End point, n = 477			Baseline, n = 224			End point, n = 223
	Total	High dose	Moderate dose	Total	High dose	Moderate dose	Total	High dose	Moderate dose	Total	High dose	Moderate dose
Erythema/redness
N	478	248	230	477	248	229	224	118	106	223	118	105
Absent	473 (99.0)	245 (98.8)	228 (99.1)	476 (99.8)	247 (99.6)	229 (100)	222 (99.1)	117 (99.2)	105 (99.1)	222 (99.6)	117 (99.2)	105 (100)
Mild	5 (1.0)	3 (1.2)	2 (0.9)	1 (0.2)	1 (0.4)	0	2 (0.9)	1 (0.8)	1 (0.9)	1 (0.4)	1 (0.8)	0
Induration/swelling
n	478	248	230	477	248	229	224	118	106	223	118	105
Absent	469 (98.1)	242 (97.6)	227 (98.7)	475 (99.6)	247 (99.6)	228 (99.6)	220 (98.2)	116 (98.3)	104 (98.1)	222 (99.6)	117 (99.2)	105 (100)
Mild	9 (1.9)	6 (2.4)	3 (1.3)	2 (0.4)	1 (0.4)	1 (0.4)	4 (1.8)	2 (1.7)	2 (1.9)	1 (0.4)	1 (0.8)	0
Tenderness
n	478	248	230	477	248	229	224	118	106	223	118	105
Absent	425 (88.9)	218 (87.9)	207 (90.0)	474 (99.4)	246 (99.2)	228 (99.6)	207 (92.4)	111 (94.1)	96 (90.6)	221 (99.1)	117 (99.2)	104 (99.0)
Mild	48 (10.0)	28 (11.3)	20 (8.7)	3 (0.6)	2 (0.8)	1 (0.4)	16 (7.1)	6 (5.1)	10 (9.4)	2 (0.9)	1 (0.8)	1 (1.0)
Moderate	5 (1.0)	2 (0.8)	3 (1.3)	—	—	—	1 (0.4)	1 (0.8)	0	—	—	—

Note. PP3M, paliperidone palmitate once-every-3-months; PP6M, paliperidone palmitate once-every-6-months.