Table 5.

Summary of linaclotide efficacy outcomes in Study 302⁴⁹, ⁵⁹

	Placebo, n = 403	Linaclotide, 290 μg, n = 401	P value
Co-primary endpoints
12-week abdominal pain/discomfort responder	38.5%	54.1%	<0.0001
12-week IBS degree-of-relief responder	16.6%	39.4%	<0.0001
Additional responder analyses
26-week abdominal pain/discomfort responder	36.0%	53.6%	<0.0001
26-week IBS degree-of-relief responder	16.9%	37.2%	<0.0001
12-week sustained abdominal pain/discomfort responder	38.0%	53.6%	<0.0001
12-week sustained IBS degree-of-relief responder	15.6%	36.7%	<0.0001
26-week sustained abdominal pain/discomfort responder	33.3%	51.9%	<0.0001
26-week sustained IBS degree-of-relief responder	14.1%	33.2%	<0.0001
Change from baseline to Week 12 in:
CSBM frequency rate	0.7	2.2	<0.0001
Stool consistency (BSFS)	0.6	1.9	<0.0001
Severity of straining	−0.7	−1.2	<0.0001
SBM frequency	1.3	4.0	<0.0001
Bloating	−1.0	−1.9	<0.0001
Abdominal pain	−1.1	−1.9	<0.0001
Abdominal discomfort	−1.1	−1.9	<0.0001
Abdominal fullness	−1.1	−2.0	<0.0001
Abdominal cramping	−1.1	−1.8	<0.0001
IBS-QoL	11.0	17.3	<0.0001
EQ-5D Utility Index score	0.05	0.09	<0.001
EQ-5D Visual Analogue Scale score	4.7	7.0	<0.01

BSFS, Bristol Stool Formation Scale; CSBM, complete spontaneous bowel movement; EQ-5D, EuroQoL-5 dimensions; IBS, irritable bowel syndrome; NS, not significant; QoL, quality of life; SBM, spontaneous bowel movement.