Table 1

Efficacy and safety of naldemedine according to the type of coadministered laxatives

Naldemedine only
Naldemedine and MgO
Naldemedine and another laxative other than MgO
Naldemedine, MgO and another laxative
P value
(A vs B)
P value
(A vs C)
P value
(A vs D)
Defecation counts before administration (times/day), mean±SD0.33±0.600.31±0.670.45±0.820.46±0.660.997*0.926*0.899*
Defecation counts on day 1 (times/day), mean±SD0.66±0.75
Average daily defecation counts on days 1–7 (times/day), mean±SD0.79±0.460.80±0.441.09±0.431.56±1.380.999*0.428*0.002*
Change in daily defecation counts during the first 7 days compared with before naldemedine administration (times/day), mean±SD0.45±0.630.49±0.690.64±1.001.10±1.750.997*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.