Not an actual patient.
Effective relief from the bothersome symptoms of CIC1
Significantly more adult patients treated with LINZESS were overall CSBM responders* than placebo-treated patients
In Trials 3 and 4, the proportion of patients who were responders to LINZESS 145 mcg was statistically significantly higher than with placebo (Trial 3: 20% [n=217] vs 3% [n=209], respectively; 95% CI: 11%, 22.8%; Trial 4: 15% [n=213] vs 6% [n=215], respectively; 95% CI: 4.2%, 15.7%).
Improved frequency
In the CIC trials, LINZESS improved CSBM frequency at week 12 by an average of ~1.5 more CSBMs than placebo.1,*
Improved straining
LINZESS improved the amount of straining (time pushing or physical effort to pass stool) with bowel movements vs placebo.1
Improved stool consistency
LINZESS improved stool consistency vs placebo.1
In Trial 5, the proportion of patients who were responders to LINZESS 72 mcg was also statistically significantly higher than with placebo (Trial 5: 13% [n=411] vs 5% [n=401], respectively; 95% CI: 4.8%, 12.5%).
*A CSBM overall responder in the CIC trials was defined as having had both 3 or more CSBMs per week and an increase of at least 1 CSBM per week from baseline for 9 or more weeks during the 12-week treatment period. Secondary endpoints included SBM frequency, stool consistency, and amount of straining.
LINZESS was studied in 2 double-blind, placebo-controlled, randomized, multicenter trials (N=642 in Trial 3; N=630 in Trial 4) to evaluate efficacy of linaclotide 145 mcg vs placebo administered orally and 1 double-blind, placebo-controlled, randomized, multicenter trial (N=1,223 in Trial 5) to evaluate efficacy and safety of linaclotide 72 mcg vs placebo administered orally to adult patients with CIC.
- Patients were allowed to continue stable doses of bulk laxatives (eg, fiber) or stool softeners
- Patients were not allowed to take osmotic or stimulant laxatives, bismuth, prokinetic agents, or other drugs to treat CIC
All trial designs were identical through the first 12 weeks, and thereafter differed only in that Trial 3 included a 4-week randomized withdrawal period.
The primary efficacy responder endpoints were based on a patient being a weekly CSBM responder for at least 9 out of the first 12 weeks of treatment. A patient had to have at least 3 CSBMs and an increase of at least 1 CSBM from baseline in a given week for at least 9 weeks out of the 12-week treatment period.
All patients were required to meet the following criteria: Rome II criteria (Trials 3 and 4) or Rome III (Trial 5) for functional constipation, straining during more than 25% of bowel movements, lumpy or hard stools for more than 25% of bowel movements, and a sensation of incomplete evacuation during more than 25% of bowel movements.
CIC, chronic idiopathic constipation; CSBM, complete spontaneous bowel movement; SBM, spontaneous bowel movement.
LINZESS improved CSBM frequency as early as week 1 and throughout the 12-week study1
