OVERVIEW
Improvement in frequency of SBMs compared to placebo1
- Rapid onset in a majority of patients1
- Continued response to treatment2
- Demonstrated efficacy in adults including those 65 and older2
IMPROVEMENT IN SPONTANEOUS BOWEL MOVEMENT
(SBM) FREQUENCY
SIGNIFICANT IMPROVEMENT IN SPONTANEOUS BOWEL MOVEMENT (SBM) FREQUENCY VS PLACEBO1
Data from the two pivotal 4-week AMITIZA (24 mcg twice daily) Chronic Idiopathic Constipation clinical studies demonstrated that AMITIZA increased the average number of SBMs up to 5.9 at Week 1 vs up to 4.0 for placebo and up to 5.4 at Week 4 vs 3.5 for placebo.1
- SBMs were defined as any bowel movements occurring greater than or equal to 24 hours after the use of rescue medication3
RAPID RELIEF, CONSISTENT RESULTS1
- Rapid relief is defined as onset within 24 hours
- Consistent results in long-term safety studies
- Decreased constipation severity as well as decreased abdominal bloating and abdominal discomfort in 6-month and 12-month safety studies1
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.
CLICK HERE TO SEE IMPORTANT SAFETY INFORMATION BELOW
CONTINUED RESPONSE TO TREATMENT2
In two 4-week Chronic Idiopathic Constipation clinical studies, AMITIZA (24 mcg twice daily) provided continued relief from Chronic Idiopathic Constipation, with up to 71% of those patients who received AMITIZA experiencing relief at Week 4. Relief is defined as ≥ 3 spontaneous bowel movements (SBMs) per week.2
Study 1 and Study 2 were multicenter, double-blind, randomized, placebo-controlled, 4-week studies of patients with Chronic Idiopathic Constipation (patient population: intent to treat, last observation carried forward).
SPONTANEOUS BOWEL MOVEMENT FREQUENCY
PATIENTS 65 YEARS AND OLDER VS THOSE UNDER 65 YEARS2
Pooled secondary subpopulation analysis based on data combined from 4-week Pivotal Studies 1 and 2, and one 3-week study, all multicenter, double-blind, randomized, placebo-controlled studies of patients with Chronic Idiopathic Constipation (patient population: intent to treat, last observation carried forward).
IMPROVEMENT IN CONSTIPATION-RELATED SYMPTOMS COMPARABLE IN ELDERLY PATIENTS1
- Average number of weekly SBMs in patients ≥ 65 is 6.1 (n=23) at Week 42
- Average number of SBMs at Week 4: patients ≥ 65 on placebo, 3.2 (n=29); Patients < 65 on AMITIZA, 5.2 (n=204); patients < 65 on placebo, 3.3 (n=209)2
- The efficacy of AMITIZA in the elderly (≥ 65 years of age) subpopulation was consistent with the efficacy in the overall study population. Of the total number of constipated patients treated in the dose-finding, efficacy, and long-term studies of AMITIZA, 15.5% were
≥ 65 years of age, and 4.2% were ≥ 75 years of age1
IN DEPTH
AMITIZA (24 MCG TWICE DAILY) PIVOTAL CHRONIC IDIOPATHIC CONSTIPATION CLINICAL STUDIES1
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 1 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 to 81] years; 88.9% female; 80.8% Caucasian, 9.6% African American, 7.3% Hispanic, 1.5% Asian; 0.9% = 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
AMITIZA (LUBIPROSTONE) (24 MCG TWICE DAILY): SBM FREQUENCY IN BOTH GENDERS WITH CIC2
Patients whose symptoms met modified Rome II criteria were included in these trials:1-3
- Less than 3 SBMs/week for greater than or equal to 6 months
Along with one or more of the following symptoms of constipation: very hard stools for at least a quarter of all bowel movements, sensation of incomplete evacuation following at least a quarter of bowel movements, and straining with defecation at least a quarter of the time.
- The primary endpoint in the randomized controlled studies was the mean weekly spontaneous bowel movement (SBM) frequency at Week 1.1
- Results from randomized controlled trials were pooled for this secondary analysis.2
Results from secondary pooled data analysis of randomized controlled trials (24 mcg twice daily).
*P ≤ 0.05, **P < 0.001, AMITIZA 48 mcg vs placebo.2
REFERENCES
- AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.
- Data on file, Sucampo Pharma Americas, Inc.
- 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.
Please click here for complete Prescribing Information.
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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.
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