Tapentadol Prolonged Release in Patients with Chronic low back Pain: Real-World Data from the German Pain eRegistry

Figures & data

Figure 1. Data selection.

PR: Prolonged release.

Table 1. Baseline characteristics (n = 2331 in each group).

	Tapentadol PR	WHO-III PR
Sex (% female)	1285 (55.1%)	1285 (55.1%)
Age (years)	47.8 ± 10.6 (47.3, 48.3)	47.7 ± 10.6 (47.2, 48.2)
Body mass index (kg/m^2)	26.9 ± 4.5 (26.7, 27.1)	27.1 ± 4.6 (26.9, 27.3)
MPSS pain chronicity stage   I (at risk of chronification)   II (chronification)   III (marked chronification)	192 (8.2%) 897 (38.5%) 1242 (53.3%)	197 (8.5%) 893 (38.3%) 1241 (53.2%)
von Korff chronic pain grade   Grade 1   Grade 2   Grade 3   Grade 4	109 (4.7%) 627 (26.9%) 947 (40.6%) 648 (27.8%)	112 (4.8%) 629 (27%) 955 (41%) 635 (27.2%)
Pain duration (days)   >1 year	438.5 ± 387.1 (93–1801) 787 (33.8%)	438.5 ± 387.2 (90–1798) 787 (33.8%)
Pain-treating physicians visited	5.0 ± 1.6 (1–9)	4.9 ± 1.6 (1–9)
Most common LBP diagnoses (ICD-10)   M51.2 Other thoracic, thoracolumbar and lumbosacral intervertebral disc displacement   M54.4 Lumbago with sciatica   M54.1 Radiculopathy	412 (17.7%) 238 (10.2%) 197 (8.5%)	404 (17.3%) 244 (10.5%) 209 (9%)
Patients with co-morbidities   Co-morbidities/patient	1979 (84.9%) 1.7 ± 1.2 (1.6, 1.8)	1981 (85%) 1.7 ± 1.2 (1.6, 1.8)
Individual treatment target (mm; VAS)	21.9 ± 11.8 (21.4, 22.4)	21.9 ± 11.8 (21.4, 22.4)

Data are mean ± SD (95% CI or range) or number of patients (%).

LBP: Low back pain; MPSS: Mainz Pain Staging System [39]; PR: Prolonged release; SD: Standard deviation; VAS: Visual analogue scale (0–100 mm).

Table 2. Previous and concomitant analgesic medications (n = 2331 in each group).

	All treatments documented before index date		Baseline		End of observation
	Tapentadol PR	WHO-III PR	Tapentadol PR	WHO-III PR	Tapentadol PR	WHO-III PR
WHO-I medication	2248 (96.4%)	2253 (96.7%)	2331 (100%)	2331 (100%)	1103 (47.3%)	1658 (71.1%)
WHO-II medication	2056 (88.2%)	2044 (87.7%)	2056 (88.2%)	2056 (88.2%)	146 (6.3%)	727 (31.2%)
Antiepileptics^†   Pregabalin   Gabapentin	557 (23.9%) 377 (16.2%) 178 (7.6%)	563 (24.2%) 382 (16.4%) 178 (7.6%)	504 (21.6%) 252 (10.8%) 177 (7.6%)	504 (21.6%) 254 (10.9%) 177 (7.6%)	193 (8.3%) 112 (4.8%) 68 (2.9%)	537 (23%) 341 (14.6%) 160 (6.9%)
Antidepressants^†   Amitriptyline   Mirtazapine   Duloxetine	1257 (53.9%) 592 (25.4%) 447 (19.2%) 111 (4.8%)	1258 (54%) 597 (25.6%) 445 (19.1%) 114 (4.9%)	802 (34.4%) 315 (13.5%) 82 (3.5%) 259 (11.1%)	802 (34.4%) 312 (13.4%) 83 (3.6%) 260 (11.2%)	274 (11.8%) 105 (4.5%) 27 (1.2%) 105 (4.5%)	660 (28.3%) 262 (11.2%) 61 (2.6%) 266 (11.4%)
Muscle relaxants	1032 (44.3%)	1045 (44.8%)	667 (28.6%)	667 (28.6%)	478 (20.5%)	750 (32.2%)

† Most common medications shown.

Data are number of patients (%).

PR: Prolonged release.

Figure 2. Newly initiated treatment of adjuvant analgesics during the observation period.

PR: Prolonged release.

Figure 3. Change in main effectiveness parameters over the evaluation period.

*p < 0.001 in favor of tapentadol PR.

BL: Baseline; mPDI: Modified pain disability index; PR: Prolonged release; SF: Short form; VAS: Visual analogue scale; W: Week.

Table 3. Mean changes in pain intensity over the evaluation period (n = 2331 in each group).

	Tapentadol PR			WHO-III PR
	Baseline	End of observation	Change from baseline vs week 12	Baseline	End of observation	Change from baseline vs week 12
Lowest 24-h pain intensity	17.7 ± 18.8 (16.8, 18.6)	7.9 ± 14.7 (7.2, 8.6)	-9.8 ± 15.2 (-55.4%)	17.8 ± 18.6 (16.9, 18.7)	12.2 ± 17 (11.4, 13)	-5.6 ± 16.4 (-31.5%)
Average 24-h pain intensity	46.7 ± 20.7 (45.7, 47.7)	23.5 ± 19.4 (22.6, 24.4)	-23.2 ± 20 (-49.7%)	46.8 ± 21.2 (45.8, 47.8)	33.1 ± 24 (32, 34.2)	-13.7 ± 20.8 (-29.3%)
Highest 24-h pain intensity	73.4 ± 22.7 (72.3, 74.5)	32.4 ± 27.9 (31.3, 33.7)	-41 ± 27.9 (-55.9%)	73.3 ± 22.9 (72.2, 74.4)	47.5 ± 31.4 (46, 49)	-25.8 ± 30 (-35.2%)
Average 24-h pain intensity index	45.9 ± 16.6 (45.1, 46.7)	21.2 ± 18.5 (20.3, 22.1)	-24.7 ± 16.5 (-53.8%)	46 ± 16.8 (45.2, 46.8)	31.1 ± 21.5 (30.1, 32.1)	-14.9 ± 18.9 (-32.4%)
Relative PIX improvement ≥50% vs baseline		1558 (66.8%)			862 (37%)
Attainment of individual treatment target		1470 (63.1%)			1162 (49.8%)

Data are mean mm VAS ± SD (95% CI), mm VAS ± SD (% change) or number of patients (%). All end-of-observation and relative changes from baseline comparisons between treatment groups are in favor of tapentadol PR (p < 0.001). Reduction denotes improvement.

PIX: Pain intensity index; PR: Prolonged release; SD: Standard deviation; VAS: Visual analogue scale.

Figure 4. Change in pain-related impairment of sleep over the observation period.

*p < 0.001 in favor of tapentadol PR.

mPDI: Modified pain disability index; PR: Prolonged release; VAS: Visual analogue scale; W: Week.

Figure 5. Change in pain phenomenology over the observation period.

(A) Mean PDQ7 score. (B) Pain components.

*p < 0.001 in favor of tapentadol PR.

BL: Baseline; PDQ: PainDETECT questionnaire; PR: Prolonged release; W: Week.

Figure 6. Change in bowel function over the observation period.

A BFI reference range of 0–28.8 indicates normal bowel function.

BFI: Bowel function index; BL: Baseline; PR: Prolonged release; VAS: Visual analogue scale; W: Week.

Reproduced with permission from the International Association for the Study of Pain [40].

Table 4. Drug-related adverse events during the 12-week observation period (n = 2331 in each group).

Preferred term	Tapentadol PR	WHO-III PR
Overall	303 (13%)	860 (36.9%)
Constipation	0	373 (16%)
Nausea	45 (1.9%)	191 (8.2%)
Vomiting	19 (0.8%)	69 (3%)
Abdominal pain	36 (1.5%)	11 (0.5%)
Dry mouth	19 (0.8%)	10 (0.4%)
Dizziness	47 (2%)	74 (3.2%)
Headache	73 (3.1%)	55 (2.4%)
Sleep disorder	36 (1.5%)	41 (1.8%)
Daytime sleepiness^†	8 (0.3%)	16 (0.7%)
Confusional state	1 (0.04%)	19 (0.8%)
Drowsiness^†	8 (0.3%)	16 (0.7%)
Fatigue	91 (3.9%)	114 (4.9%)
Hyperhidrosis	28 (1.2%)	28 (1.2%)
Pruritus	10 (0.4%)	28 (1.2%)
Decreased appetite	9 (0.4%)	43 (1.8%)

† Lowest level term, preferred term ‘somnolence.’

Data are number of patients (%).

PR: Prolonged release.

Figure 7. Responder analysis.

The primary end point included the three dimensions: tolerability, effectiveness and safety. A treatment responder had to fulfil the tolerability criterion and the safety criterion plus at least two criteria from the dimension effectiveness.

DRAE: Drug-related adverse event; PR: Prolonged release; QoL: Quality of life.

Schmitt N , GerbershagenHU. The Mainz Staging System (MPSS) for chronic pain. Pain41(Suppl. 5), S484 (1990).

 Google Scholar

Überall MA . Poster presentation at the IASP 2021 Virtual World Congress on Pain: opioid-induced constipation in low back pain routine care with tapentadol.. The International Association for the Study of Pain.

 Google Scholar