Efficacy and safety of naldemedine according to the type of coadministered laxatives
| (A) Naldemedine only (n=33) | (B) Naldemedine and MgO (n=36) | (C) Naldemedine and another laxative other than MgO (n=11) | (D) Naldemedine, MgO and another laxative (n=13) | P value (A vs B) | P value (A vs C) | P value (A vs D) | |
| Defecation counts before administration (times/day), mean±SD | 0.33±0.60 | 0.31±0.67 | 0.45±0.82 | 0.46±0.66 | 0.997* | 0.926* | 0.899* |
| Defecation counts on day 1 (times/day), mean±SD | 0.66±0.75 (n=32) | 0.60±0.65 (n=35) | 1.55±1.51 (n=11) | 2.54±3.20 (n=13) | 0.998* | 0.202* | <0.001* |
| Average daily defecation counts on days 1–7 (times/day), mean±SD | 0.79±0.46 | 0.80±0.44 | 1.09±0.43 | 1.56±1.38 | 0.999* | 0.428* | 0.002* |
| Change in daily defecation counts during the first 7 days compared with before naldemedine administration (times/day), mean±SD | 0.45±0.63 | 0.49±0.69 | 0.64±1.00 | 1.10±1.75 | 0.997* | 0.906* | 0.097* |
| Incidence of diarrhoea, n (%) | 4 (12.1) | 7 (19.4) | 6 (54.5) | 8 (61.5) | 0.310† | 0.008† | 0.001† |
*Dunnett’s test.
†χ2 for independence test.
MgO, magnesium oxide.