For multiple IBS-D symptom relief,
In adults with IBS-D
Just 2 weeks of XIFAXAN provided significant relief from both abdominal pain and diarrhea1,2*†
TARGET 1 & 21,2†
‡P<0.001 represents pooled data.
†TARGET 1 and 2 study design1,2
Two identical Phase 3, randomized, double-blind, placebo-controlled trials conducted over a 3-month period. A total of 1258 patients meeting Rome II criteria for IBS were to receive XIFAXAN 550 mg (n=624) or placebo (n=634) 3 times a day for 14 days.
Primary endpoint: Adequate relief of IBS signs and symptoms for at least 2 of 4 weeks during the month following 14 days of treatment, with adequate relief defined as a response of “yes” to the weekly Subject Global Assessment (SGA) question: “In regards to your IBS symptoms, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No].”
Primary endpoint results: 41% of patients (254 of 624) in the XIFAXAN 550 mg group, 31% of TARGET 1 placebo group (98 of 314, P=0.01), and 32% of TARGET 2 placebo group (103 of 320, P=0.03) experienced adequate relief of IBS signs and symptoms.
Composite endpoint: ≥30% decrease from baseline in abdominal pain, with a weekly mean stool consistency score of <4 (loose stool) for ≥2 weeks during the month following 2 weeks of treatment.
No rescue medication was allowed in these clinical trials2
XIFAXAN provided significant relief of bloating2
Percentage of BLOATING responders based on weekly responses in
TARGET 1 & 22
§P<0.001 represents pooled data.
Key secondary endpoint: The proportion of subjects who achieved adequate relief of IBS-related bloating (ie, responders) for at least 2 of 4 weeks during the month following 14 days of treatment.2
A bloating responder was defined as a patient who responded “yes” to the weekly question:“In regards to your IBS symptom of bloating, compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No].”2||
||Responses were given during the first 4 weeks of the treatment-free period following 2 weeks of active treatment (primary evaluation period).
XIFAXAN provided significant relief of urgency3
Percentage of URGENCY responders based on weekly responses in
TARGET 1 & 2 in a pooled post hoc analysis3
¶P=0.0003 represents data from pooled post hoc analysis.
Stool frequency (number of bowel movements per day) was assessed as a secondary endpoint, but there was no statistically significant difference between XIFAXAN and placebo.4
- A bowel movement urgency responder was defined as a patient with a ≥30% decrease from baseline in the percentage of days with urgency for at least 2 of 4 weeks during the month following 14 days of treatment. Urgency was determined based on patient response of “yes” to the daily question: “Have you felt or experienced a sense of urgency today? [Yes/No]”3
Short-term therapy.1# Lasting relief
from abdominal pain and diarrhea.1Δ
∆Median of 10 weeks (range of 6 to 24 weeks).1
Just 2 weeks of XIFAXAN provided significant relief from abdominal pain and diarrhea for up to 6 months1#Δ◊
- Primary endpoint: 38% experienced significant improvement in stool consistency and abdominal pain (n=125/328, P<0.05) vs 31% for placebo (n=97/308)1,5
- Median time to symptom recurrence was 10 weeks (range of 6 to 24 weeks)
◊TARGET 3 study design1,5
The primary focus was to assess response to treatment during an 18-week observation phase after initial 4-week follow-up (total of 22 weeks following 2-week treatment). If a patient responded to open-label treatment but later experienced a recurrence, they entered the randomized, double-blind retreatment phase. Randomized patients then received a repeat treatment with either XIFAXAN or placebo.
A responder was defined as a patient experiencing a ≥30% improvement from baseline in the weekly average abdominal pain score (based on daily self-reports) and a ≥50% reduction in the number of days in a week with a daily stool consistency of Bristol Stool Scale type 6 or 7 (mushy or watery) for ≥2 weeks during the month following 2 weeks of treatment.
Recurrence was defined as the return of abdominal pain or lack of stool consistency for 3 weeks of a rolling 4-week period.
After initial relief, recurring symptoms were less severe than baseline1,5a
Change from baseline in mean daily global IBS symptom score during the first and second repeat treatment double-blind phases. Global daily IBS-D symptoms score is based on a 6-question patient assessment related to bowel movement, urgency, pain, bloating, and severity of symptoms.
IBS-D = irritable bowel syndrome with diarrhea