OVERVIEW
- In two 4-week clinical studies, the symptoms evaluated with AMITIZA (24 mcg twice daily) were abdominal bloating, abdominal discomfort, stool consistency, straining, and constipation severity1
- Consistent results in subpopulation analyses for gender, race, and elderly patients (≥ 65 years of age)1
- In 6- to 12-month safety studies, symptoms evaluated were: abdominal bloating, abdominal discomfort, and constipation severity1
IMPROVEMENT IN SIGNS AND SYMPTOMS
Patients suffering from Chronic Idiopathic Constipation may also present with other symptoms besides infrequent bowel movements. When questioned, patients cite straining, passage of hard stools, or difficulty in passing stools.2
IN TWO 4-WEEK STUDIES SYMPTOMS EVALUATED WITH AMITIZA
(24 MCG TWICE DAILY) COMPARED TO PLACEBO WERE:1
- Abdominal bloating
- Abdominal discomfort
- Stool consistency
- Straining
- Constipation severity
Symptom relief is defined as improvement of Chronic Idiopathic Constipation symptoms, including abdominal bloating, abdominal discomfort, stool consistency, straining, and/or constipation severity, in two 4-week clinical studies.1
RESULTS IN LONG-TERM 6- TO 12-MONTH SAFETY STUDIES1
- Decreased constipation severity as well as decreased abdominal bloating and abdominal discomfort in 6-month and 12-month safety studies (24-week to 48-week treatment period)
IN DEPTH
AMITIZA (24 MCG TWICE DAILY) PIVOTAL CHRONIC IDIOPATHIC CONSTIPATION CLINICAL STUDIES
Two double-blinded, 4-week, placebo-controlled studies of identical design were conducted in patients with Chronic Idiopathic Constipation. Chronic Idiopathic Constipation was defined as, on average, fewer than 3 spontaneous bowel movements per week along with one or more of the following symptoms of constipation for at least 6 months prior to randomization:1
- Very hard stools for at least a quarter of all bowel movements
- Sensation of incomplete evacuation following at least a quarter of all bowel movements
- Straining with defecation at least a quarter of the time
Following a 2-week baseline/washout period, a total of 479 patients (mean age 47.2 [range 20-81] years; 88.9% female; 80.8% Caucasian, 9.6% African American, 7.3% Hispanic, 1.5% Asian; 10.9% ≥ 65 years of age) were randomized and received AMITIZA 24 mcg twice daily (48 mcg/day) or placebo twice daily for 4 weeks. The primary endpoint of the studies was spontaneous bowel movement frequency per week at Week 1.1
Spontaneous bowel movements were defined as any bowel movements not occurring within 24 hours of rescue medication use.3
In daily diaries, patients recorded medication administration, use of rescue medications, occurrence of bowel movements, and information regarding stool consistency, straining, and abdominal symptoms.3
REFERENCES
- AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.
- Higgins PDR, Johanson JF. Am J Gastroenterol. 2004;99:750-759.
- Johanson JF, Morton D, Geenen J, Ueno R. Am J Gastroenterol. 2008;103:170-177.
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.
©2011 Takeda Pharmaceuticals North America, Inc.
LUB-03057
