Table 2.

Efficacy of tapentadol prolonged release in patients with severe chronic lower back pain with a neuropathic component in phase 3b/4 trials; see text for details of pickup and continuation arms

Trial (comparative period; wks)	Treatment (mg) [no. of pts evaluated for primary endpoint]	Mean change from randomization [mean at randomization] to final evaluation in
		Average pain intensitya (LSM BGD; 95% CI)	Intensity of pain radiating to leg	painDETECT scoreb	NPSI scoreb
Baron et al. [29] (12)	TAP PR 50–250 bid [117]	− 3.7* (− 1.0;  − 1.82, − 0.18)† [7.6]	− 3.9*† [7.5]	− 10.8*† [22]	− 0.35*† [NR]
	OXY/NAL PR 10/5–40/20 bid [112]	− 2.7* [7.6]	− 2.8* [7.6]	− 7.9* [23]	− 0.25* [NR]
	TAP PR pick-up arm [50]	− 3.1* [7.6]	NR [NR]	− 9.0* [22]	NR* [NR]
Baron et al. [30] (8)	TAP PR 500/d [139]	− 1.6** (− 0.066; − 0.57, 0.43)c [6]	− 1.6** [NR]	− 5.8** [18]	− 16.4** [46]
	TAP PR 300/d + PRG [149]	− 1.7** [6]	− 1.9** [NR]	− 6.1** [18]	− 16.7** [46]
	TAP PR 300/d continuation armd [59]	− 5.2** [7.9]	− 5.5** [7.8]	− 15.0** [23]	− 48.8** [63]

OXY/NAL PR maximum dosage also included OXY PR 10 mg bid. For one study [30], some mean values at randomization are estimated from graphs

bid twice daily, d day, LSM BGD least-squares mean between-group difference, NAL naloxone, NPSI Neuropathic Pain Symptom Inventory, NR not reported, NRS 11-point numerical rating scale (0 = no pain; 10 = worst pain imaginable), OXY oxycodone, PR prolonged release, PRG pregabalin 300 mg/d, pts patients, TAP tapentadol

*p <0.001, **p < 0.0001 vs. at randomization (or baseline in the TAP PR continuation arm)

^†p ≤ 0.003 vs. OXY/NAL PR regimen

^aPrimary endpoint (per-protocol pts); average pain intensity in last 3 days rated on NRS. Other endpoints used full analysis set (n = 309 [30] or 256 [29])

^bpainDETECT total score (range 0–38); NPSI total score (range 0–100) [30] or overall feeling score (range 0–1) [29]. Higher scores = more severe pain

^cTAP PR was noninferior to the comparator regimen. Between-group statistical comparisons were not reported for other outcomes

^dValues are mean changes from baseline [mean at baseline] [54]