Safety and efficacy of duloxetine treatment in older and younger patients with osteoarthritis knee pain: a post hoc, subgroup analysis of two randomized, placebo-controlled trials

Table 3 Treatment-emergent vital sign abnormalities

	Older				Younger
	N*	Placebo n (%)	N*	Duloxetine n (%)	N*	Placebo n (%)	N*	Duloxetine n (%)	Treatment-by-Age Group Interaction p values
PCS Weight gain	92	3 (3.3)	102	0	153	0	128	1 (0.8)	‐‐‐ ^a
PCS Weight loss	92	0	102	6 (5.9)	153	1 (0.7)	128	2 (1.6)	‐‐‐ ^a
Sustained hypertension	84	2 (2.4)	95	1 (1.1)	140	2 (1.4)	121	3 (2.5)	.37
Diastolic hypertension	82	0	91	0	135	1 (0.4)	116	0	‐‐‐ ^a
Systolic hypertension	63	2 (3.2)	78	1 (1.3)	124	2 (1.6)	110	3 (2.7)	.34
Orthostatic hypotension	82	8 (9.8)	98	13 (13.3)	150	8 (5.3)	128	13 (10.2)	.60
Orthostatic tachycardia	93	0	102	0	152	1 (0.7)	136	0	‐‐‐ ^a

^a Treatment-by-age group interaction could not be calculated for diastolic hypertension, PCS weight gain or loss; or for orthostatic tachycardia, because there were 0% values in one or more treatment groups and the model could not fit the data.
Definitions: N*, number of patients at baseline who did not have the abnormality being summarized. PCS (potentially clinically significant) weight gain is ≥7% increase in body weight. PCS (potentially clinically significant) weight loss is ≥5% decrease in body weight. Diastolic hypertension is sitting diastolic blood pressure ≥ 85 mm Hg and increase from baseline of 10 mm Hg for at least 3 consecutive visits. Systolic hypertension is sitting systolic blood pressure ≥ 140 mm Hg and an increase from baseline of 10 mm Hg for at least 3 consecutive visits. Sustained hypertension is having both diastolic and systolic hypertension for at least 3 consecutive visits. Orthostatic hypotension is a decrease of at least 10 mm Hg less than the supine diastolic blood pressure or the standing systolic blood pressure at least 20 mm Hg less than the supine systolic blood pressure. Orthostatic tachycardia is increase of ≥100 beats per minute.

ISSN: 1471-2474