OVERVIEW
- Global symptom relief question
- Overall response definition
- Improvement of global IBS-C symptoms1
EFFICACY
IN 2 CLINICAL STUDIES, THE PRIMARY ENDPOINT WAS OVERALL RESPONSE TO THE QUESTION:1
"How would you rate your relief of symptoms over the past week compared to how you felt before you entered the study?"
Global symptoms were defined as:1
- Abdominal discomfort/pain
- Bowel habits
- Other IBS symptoms
Overall response was defined as "monthly response" for at least 2 months in the 3-month study.1
IN AMITIZA CLINICAL STUDIES, IBS WAS DEFINED AS:1
Abdominal pain or discomfort occurring over at least 6 months with 2 or more of the following:
- Relieved with defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in stool form
PATIENTS WERE SUBTYPED AS HAVING IBS-C IF THEY ALSO EXPERIENCED 2 OR 3 OF THE FOLLOWING:1
- < 3 spontaneous bowel movements per week
- > 25% hard stools
- > 25% spontaneous bowel movements associated with straining
IMPROVEMENT OF GLOBAL IBS-C SYMPTOMS
IN DEPTH
AMITIZA (8 MCG TWICE DAILY) PIVOTAL IRRITABLE BOWEL SYNDROME WITH CONSTIPATION CLINICAL STUDIES1
Two double-blinded, placebo-controlled studies of similar design were conducted in patients with IBS-C. IBS was defined as abdominal pain or discomfort occurring over at least 6 months with 2 or more of the following:
- Relieved with defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in stool form
Patients were sub-typed as having IBS-C if they also experienced 2 of 3 of the following:
- < 3 spontaneous bowel movements per week
- > 25% hard stools
- > 25% spontaneous bowel movements associated with straining.
Following a 4-week baseline/washout period, a total of 1,154 patients (mean age 46.6 [range 18-85] years; 91.6% female; 77.4% Caucasian, 13.2% African American, 8.5% Hispanic, 0.4% Asian; 8.3% ≥ 65 years of age) were randomized and received AMITIZA 8 mcg twice daily (16 mcg/day) or placebo twice daily for 12 weeks.
The primary efficacy endpoint was assessed weekly, utilizing the patient's response to a global symptom relief question based on a 7-point, balanced scale:3
- "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits, and other IBS symptoms) over the past week compared to how you felt before you entered the study?"
The primary efficacy analysis was a comparison of the proportion of "overall responders" in each arm. A patient was considered an "overall responder" if the criteria for being designated a "monthly responder" were met in at least 2 of the 3 months on study. A "monthly responder" was defined as a patient who had reported "significantly relieved" for at least 2 weeks of the month or at least "moderately relieved" in all 4 weeks of that month. During each monthly evaluation period, patients reporting "moderately worse" or "significantly worse" relief, an increase in rescue medication use, or those who discontinued due to lack of efficacy were deemed "non-responders."
REFERENCES
- AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.
- Data on file, Sucampo Pharma Americas, Inc.
- Drossman DA, Chey WD, Johanson JF, et al. Aliment Pharmacol Ther. 2009;29:329-341.
Indication
AMITIZA (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ≥ 18 years old.
Important Safety Information
- AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.
- The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.
- Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.
- AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.
- Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.
- In clinical trials of AMITIZA (24 mcg twice daily vs placebo; N=1113 vs N=316) in patients with Chronic Idiopathic Constipation (CIC), the most common adverse reactions (incidence > 4%) were nausea (29% vs 3%), diarrhea (12% vs < 1%), headache (11% vs 5%), abdominal pain (8% vs 3%), abdominal distension (6% vs 2%), and flatulence (6% vs 2%).
- In clinical trials of AMITIZA (8 mcg twice daily vs placebo; N=1011 vs N=435) in patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common adverse reactions (incidence > 4%) were nausea (8% vs 4%), diarrhea (7% vs 4%), and abdominal pain (5% vs 5%).
- Reduce the dosage in CIC patients with moderate and severe hepatic impairment. Reduce the dosage in IBS-C patients with severe hepatic impairment.
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AMITIZA is a trademark of Sucampo Pharmaceuticals, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
©2012 Takeda Pharmaceuticals North America, Inc.
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