Table 3.
Single-component analysis of all six parameters constituting the primary study end point
| Primary endpoint components | OXN (n=128) |
TAP (n=133) |
OR (95% CI) | Significance |
|---|---|---|---|---|
| Efficacy endpoints | ||||
| 1) LBPIX improvement ≥30% at W12 vs BL n | 109 | 111 | 1.137 (0.583–2.218) | P=0.706 |
| Percent (95% CI) | 85.2 (78.0–90.3) | 83.5 (76.2–88.8) | ||
| Average dose; mg MEO; mean (SD) | 112.7 (31.3) | 119.4 (28.5) | P=0.419 | |
| 2) mPDI improvement ≥30% at W12 vs BL n | 100 | 89 | 1.766 (1.015–3.070) | P=0.043 |
| Percent (95% CI) | 78.1 (70.2–84.4) | 66.9 (58.5–74.3) | ||
| Average dose; mg MECl; mean (SD) | 110.4 (35.6) | 118.2 (35.2) | P=0.126 | |
| 3) EQ5D-3L improvement>30% at W12 vs BL n | 98 | 85 | 1.845 (1.074–3.168) | P=0.026 |
| Percent (95% CI) | 76.6 (68.5–83.1) | 63.9 (55.5–71.6) | ||
| Average dose; mg MECl; mean (SD) | 113.5 (33.4) | 124.7 (29.5) | P=0.019 | |
| 1–3) Combined efficacy endpoints n | 74 | 55 | 1.945 (1.188–3.179) | P=0.008 |
| Percent (95% CI) | 57.8 (49.2–66.0) | 41.4 (33.3–49.9) | ||
| Average dose; mg MECl; mean (SD) | 117.6 (31.7) | 124.9 (28.3) | P=0.191 | |
| Safety/tolerability endpoints | ||||
| 4) No TEAE-related treatment discontinuation n | 119 | 123 | 1.075 (0.422–2.739) | P=0.880 |
| Percent (95% CI) | 93.0 (87.2–96.3) | 92.5 (86.7–95.9) | ||
| Average dose; mg MEO; mean (SD) | 109.6 (36.4) | 121.1 (30.6) | P=0.008 | |
| 5) No CNS-side effects n | 117 | 119 | 1.251 (0.546–2.869) | P=0.596 |
| Percent (95% CI) | 91.4 (85.3–95.1) | 89.5 (83.1–93.6) | ||
| Average dose; mg MEQ mean (SD) | 108.4 (37.4) | 120.7 (31.2) | P=0.007 | |
| 6) Normal bowel function (BFI< 28.8) at W12n | 87 | 96 | 0.818 (0.481–1.391) | P=0.457 |
| Percent (95% CI) | 68.0 (59.5–75.4) | 72.2 (64.0–79.1) | ||
| Average dose; mg MEQ; mean (SD) | 104.0 (37.1) | 116.3 (33.6) | P=0.020 | |
| 4–6) Combined safety/tolerability endpoints n | 78 | 86 | 0.853 (0.516–1.409) | P=0.534 |
| Percent (95% CI) | 60.9 (52.3–69.0) | 64.7 (56.2–72.3) | ||
| Average dose; mg MEQ; mean (SD) | 105.3 (36.5) | 118.8 (32.0) | P=0.012 | |
Notes: Data of the upper panel show the absolute (relative) proportion of patients, who presented with a ≥30% improvement (vs baseline) with respect to the LBPIX, pain-related disabilities in daily life (assessed with the mPDI), QOL (assessed with the EQ5D-3L), and the aggregate of all three efficacy parameters. Data of the lower panel show the absolute (relative) proportion of patients, who completed the 12-week treatment observation without any adverse event-related premature discontinuation, who experienced no CNS-related adverse events and, who reported a normal bowel function index at the end of the study), and a combination of all three safety parameters.
Abbreviations: OXN, oxycodone/naloxone; TAP, tapentadol; OR, odds ratio; 95% CI, 95% confidence interval; TEAE, treatment-emergent adverse event; CNS, central nervous system; W12; LBPIX, low back pain intensity index; W12, treatment Week 12 (end of observation); BL, baseline; mPDI, modified pain intensity index; QOL, quality of life; EQ5D-3L, five-dimensional (three-level) European quality-of-life questionnaire; mg, milligram; MEQ, morphine equivalent; SD, standard deviation.