EFFICACY

Effective relief from the bothersome symptoms of CIC

LINZESS was evaluated in 3 CIC clinical trials of more than 2400 patients1

In the CIC trials:

  • Significantly more patients treated with LINZESS were overall complete spontaneous bowel movement (CSBM) responders* than placebo-treated patients
  • LINZESS patients experienced more frequent and complete bowel movements that were easier to pass with less straining when compared to placebo-treated patients
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Improved frequency

In the chronic constipation (CIC) trials, LINZESS improved CSBM frequency at week 12 by an average of ~1.5 more CSBMs than placebo.1,*

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Improved straining

LINZESS improved the amount of straining (time pushing or physical effort to pass stool) with bowel movements vs placebo.1

CIC efficacy smooth stool CIC efficacy smooth stool CIC efficacy smooth stool

Improved stool consistency

LINZESS improved stool consistency vs placebo.1

*A CSBM overall responder was defined as a patient who had 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 12 weeks.1

LINZESS was studied in 3 phase 3, double-blind, placebo-controlled, randomized, multicenter clinical trials for the management of symptoms in 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

In Trials 3 and 4, adult men and women were required to meet modified Rome II criteria for functional constipation†; patients reported <3 CSBMs and ≤6 SBMs per week during the 2-week baseline period.

Patients in Trials 3 and 4 were, on average, 48 years old (range 18-85 years), with 89% female, 76% white, 22% black, and 10% Hispanic.

One phase 3 clinical trial (Trial 5) that compared LINZESS 72 mcg vs placebo

  • Trial designs were identical for the first 12 weeks. Trial 3 included a 4‐week randomized withdrawal period

For Trial 5, all patients met modified Rome III criteria for functional constipation.

†Patients reported one of the following symptoms for at least 12 weeks, which need not be consecutive, in the preceding 12 months: straining in more than 25% of bowel movements, lumpy or hard stools in more than 25% of bowel movements, sensation of incomplete evacuation in more than 25% of bowel movements.

LINZESS helped CIC patients improve the frequency of CSBMs, the consistency of stool, and the straining to pass stool when compared to placebo