Preliminary safety and efficacy profile of prucalopride in the treatment of systemic sclerosis (SSc)-related intestinal involvement: results from the open label cross-over PROGASS study

Table 3 Effect of treatment

Variable	Change with prucalopride^a	Change without treatment^a	Effect size^a	Rating^b	p
Likert GERD	-0.678 ± 0.108	-0.001 ± 0.114	-0.677	NA	7.8*10^-5
Likert constipation	-1.282 ± 0.155	0.135 ± 0.158	-1.417	NA	2.01*10^-7
UCLA GIT 2.0	-0.147 ± 0.061	0.021 ± 0.063	-0.168	Same	0.047
UCLA GIT 2.0 Constipation	-0.672 ± 0.112	0.086 ± 0.115	-0.758	Much better	5.4*10^-5
UCLA GIT 2.0 Subscales
Reflux Bloating Fecal soilage Diarrhea Social activities Emotional wellbeing	-0.409 ± 0.094 -0.418 ± 0.088 -0.097 ± 0.133 0.367 ± 0.093 -0.106 ± 0.11 -0.214 ± 0.093	0.01 ± 0.096 -0.084 ± 0.09 0.074 ± 0.141 0.089 ± 0.097 -0.006 ± 0.112 0.017 ± 0.093	-0.419 -0.334 -0.171 0.277 -0.1 -0.231	Better Better Same Worse Better Same	0.003 0.011 0.38 0.053 0.503 0.051

Change in specific scales and scores used to evaluate gastro-intestinal involvement in the period after treatment (prucalopride) or in the no-treatment 4-week periods. Values presented as estimated marginal mean ± estimated standard error corrected for the number of laxatives. GERD gastroesophageal reflux disease, UCLA GIT University of California Los Angeles gastrointestinal tract questionnaire, NA not available. ^aNegative values indicate improvement. ^bInterpretation of treatment effect size according to [30]

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