laxatives > 25% of Fatige 1% 90% of reported BMs during the 12 3 CSBMs and increase of 1 placebo vs. 2% diarrhea events were ≥ ≥ weeks preceding CSBM from baseline during linaclotide mild or moderate in the study, mushy same week for at least 9/12 or severity and only stool (BSFS score 20/26 weeks of treatment period. Sinus congestion 4.5% of of 6) for > 1 SBM Weeks not have to be consecutive. 1% placebo vs. patients or watery, liquid (Weeks 1-12) 5.0% placebo vs. 2% linaclotide discontinued stool 18.0% linaclotide (NNT = 7.7). treatment due to (BSFS of for any (Weeks 1-26) 3.5% placebo vs. diarrhea. 28% of SBM during 15.7% linaclotide (NNT = 8.2). patients reporting baseline period, diarrhea experienced history of surgery Decrease of 30% from baseline in this AE on the first ≥ to remove a average abdominal pain score, 3 day of therapy and ≥ segment of the GI CSBMs and increase of 1 CSBM 76% within first 4 ≥ tract or bariatric from baseline during particular week weeks of treatment. surgery for obesity for at least 9/12 or 20/26 weeks of at any time, history treatment period. (Weeks 1-12) Jadad Quality Rating: of any chronic 3.0% placebo vs. 12.7% linaclotide 5 condition that could (NNT = 10.3). (Weeks 1-26) 2.5% be associated with vs. 12.0% linaclotide (NNT = 10.5) abdominal pain or discomfort and Secondary endpoint: : SBM could confound the frequency after 12 weeks compared trial assessments, to baseline: 1.3 placebo vs. 4.0 abdominal surgery linaclotide within 6 months prior to study, Percentage of patients reporting laxative abuse adequate relief of IBS symptoms for at least 75% of the weeks (9/12 or 20/26): 17.6% placebo vs. 41.9% linaclotide
laxatives > 25% of BMs during the 12 weeks preceding the study, mushy stool (BSFS score of 6) for > 1 SBM or watery, liquid stool (BSFS of for any SBM during baseline period, history of surgery to remove a segment of the GI tract or bariatric surgery for obesity at any time, history of any chronic condition that could be associated with abdominal pain or discomfort and could confound the trial assessments, abdominal surgery within 6 months prior to study, laxative abuse ≥ 3 CSBMs and increase of ≥ 1 CSBM from baseline during same week for at least 9/12 or 20/26 weeks of treatment period. Weeks not have to be consecutive. (Weeks 1-12) 5.0% placebo vs. 18.0% linaclotide (NNT = 7.7). (Weeks 1-26) 3.5% placebo vs. 15.7% linaclotide (NNT = 8.2). Decrease of ≥ 30% from baseline in average abdominal pain score, ≥ 3 CSBMs and increase of ≥ 1 CSBM from baseline during particular week for at least 9/12 or 20/26 weeks of treatment period. (Weeks 1-12) 3.0% placebo vs. 12.7% linaclotide (NNT = 10.3). (Weeks 1-26) 2.5% vs. 12.0% linaclotide (NNT = 10.5) Secondary endpoint: : SBM frequency after 12 weeks compared to baseline: 1.3 placebo vs. 4.0 linaclotide Percentage of patients reporting adequate relief of IBS symptoms for at least 75% of the weeks (9/12 or 20/26): 17.6% placebo vs. 41.9% linaclotide Fatige 1% placebo vs. 2% linaclotide Sinus congestion 1% placebo vs. 2% linaclotide 90% of reported diarrhea events were mild or moderate in severity and only 4.5% of patients discontinued treatment due to diarrhea. 28% of patients reporting diarrhea experienced this AE on the first day of therapy and 76% within first 4 weeks of treatment. Jadad Quality Rating: 5