Quality of Life and Functional Outcomes with Tapentadol Prolonged Release in Chronic Musculoskeletal Pain: Post Hoc Analysis

Figures & data

Figure 1. Mean total daily doses over time of tapentadol prolonged release in the 200 to <300 mg, 300 to <400 mg, 400 to <500 mg and ≥500 mg maintenance-dose groups for pooled studies (intent to treat set set who entered maintenance period).

Treatment period of 15 weeks comprising a 3-week titration period and a 12-week maintenance period. Starting dose was 100 mg tapentadol PR in all patients. Analysis of patients in the ITT who entered the maintenance period.

ITT: Intent to treat set; mITT: ITT set who entered maintenance period.

Table 1. Subject demographics categorized by treatment group and WHO steps (intent to treat).

Parameter, baseline	Tapentadol				Oxycodone
	No WHO pretreatment n = 391	WHO step I pretreatment n = 271	WHO step II pretreatment n = 255	WHO step III pretreatment n = 61	No WHO pretreatment n = 453	WHO step I pretreatment n = 250	WHO step II pretreatment n = 238	WHO step III pretreatment n = 58
Age, years, mean (SD)	57.9 (11.82)	58.1 (12.31)	55.3 (11.72)	50.6 (13.92)	57.4 (11.43)	57.6 (13.22)	55.0 (13.14)	54.3 (12.09)
Sex, female, n (%)	247 (63.2)	192 (70.8)	167 (65.5)	33 (54.1)	259 (57.2)	162 (64.8)	140 (58.8)	40 (69.0)
Weight, kg, mean (SD)	91.3 (21.61)	87.6 (22.29)	90.9 (23.31)	95.6 (24.03)	90.9 (21.06)	89.1 (23.03)	92.5 (22.69)	86.8 (17.03)
Height, cm, mean (SD)	168.0 (10.73)	166.3 (9.86)	166.9 (9.88)	171.7 (10.23)	168.4 (10.01)	166.2 (9.46)	167.8 (11.22)	167.3 (10.96)
BMI, kg/m^2, mean (SD)	32.5 (7.91)	31.6 (7.09)	32.6 (7.93)	32.3 (7.40)	32.0 (6.64)	32.2 (7.82)	33.0 (8.03)	31.1 (6.06)
Medical history, n (%) – musculoskeletal	385 (98.5)	268 (98.9)	245 (96.1)	60 (98.4)	445 (98.2)	248 (99.2)	232 (97.5)	57 (98.3)
Pain intensity score, mean (SD)	7.2 (1.27)	7.3 (1.23)	7.6 (1.23)	7.9 (1.24)	7.2 (1.18)	7.3 (1.19)	7.6 (1.27)	7.5 (1.25)
Time since diagnosis, years, median (Q1, Q3)	5.20 (2.22, 10.24)	5.13 (2.60, 10.37)	6.89 (2.77, 13.41)	5.37 (2.69, 15.15)	5.28 (2.35, 10.16)	5.38 (2.30, 10.32)	6.16 (2.68, 10.70)	6.90 (2.05, 15.04)
Prior opioid use, n (%)^†	32 (8.2)	13 (4.8)	232 (91.0)	60 (98.4)	29 (6.4)	13 (5.2)	220 (92.4)	56 (96.6)
Prior nonopioid analgesic use, n (%)	381 (97.4)	268 (98.9)	186 (72.9)	34 (55.7)	436 (96.2)	248 (99.2)	168 (70.6)	36 (62.1)
Reason for dissatisfaction with treatment, n (%) – inadequate analgesia – poor tolerability	389 (99.5) 2 (0.5)	269 (99.3) 2 (0.7)	249 (97.6) 6 (2.4)	57 (93.4) 4 (6.6)	452 (99.8) 1 (0.2)	250 (100) 0	233 (97.9) 5 (2.1)	56 (96.6) 1 (1.7)
SF-36 Mental component summary score, mean (SD)	50.8 (11.6)	50.3 (11.4)	46.8 (12.2)	45.8 (13.6)	50.0 (11.6)	49.1 (11.3)	48.2 (12.7)	45.0 (12.8)
SF-36 Physical component summary score, mean (SD)	28.7 (7.7)	29.6 (8.1)	27.0 (7.6)	26.7 (7.5)	29.3 (7.3)	28.8 (7.6)	28.1 (7.3)	26.2 (6.6)

† During 3 months prior to screening visit.

Q: Quarter; SD: Standard deviation; SF-36: 36-item Short-Form Health Survey.

Figure 2. Changes in SF-36 scores over time during tapentadol prolonged release treatment (doses combined, Intent to treat set who entered maintenance period).

(A) Subdomain scores; (B) summary scores.

SF-36: 36-item Short-Form Health Survey.

Figure 3. Changes in SF-36 summary scale score compared with mean total daily doses over time in tapentadol prolonged release maintenance dose groups (intent to treat set who entered maintenance period).

SF-36: 36-item Short-Form Health Survey; TDD: Total daily dose.

Figure 4. SF-36 score changes at weeks 4, 8 and 12 of the maintenance period and trial end point during tapentadol prolonged release and oxycodone controlled release treatment (doses combined, intent to treat).

Least squares mean from ANCOVA of change from baseline in SF-36 score at the specified week with factors treatment group and pooled site, and covariate baseline score. Missing SF-36 subdomain scores imputed using last observation carried forward over the 15-week treatment period. p-values only shown where point estimate was significantly different from zero.

ANCOVA: Analysis of covariance; Oxy: Oxycodone; SF-36: 36-item Short-Form Health Survey; Tap: Tapentadol.

Figure 5. SF-36 score changes at weeks 4, 8 and 12 of the maintenance period and trial end point during tapentadol prolonged release and oxycodone controlled release treatment according to WHO step class (doses combined, intent to treat).

Least squares mean from ANCOVA for change from baseline in SF-36 score at the specified week with factors treatment group and pooled site and covariate baseline score. Missing SF-36 subdomain scores imputed using last observation carried forward over the 15-week treatment period. p-values only shown where point estimate was significantly different from zero.

ANCOVA: Analysis of covariance; Oxy: Oxycodone; SF-36: 36-item Short-Form Health Survey; Tap: Tapentadol.