About Chronic Idiopathic Constipation in Adults Page

OVERVIEW

Chronic Constipation affects millions of adults in the U.S.¹
Patients with chronic constipation average fewer than 3 bowel movements (BMs) per week^2,3
Patients with chronic constipation may experience abdominal bloating, abdominal discomfort, stool consistency, and straining^2,3

ABOUT CHRONIC IDIOPATHIC CONSTIPATION (CIC)

PREVALENCE OF
CHRONIC CONSTIPATION

Did you know that millions of adults in the U.S. suffer from chronic constipation?¹

HOW CAN YOU IDENTIFY CHRONIC IDIOPATHIC CONSTIPATION?

DEFINITION OF CHRONIC IDIOPATHIC CONSTIPATION

Chronic Idiopathic Constipation is chronic constipation due to an unknown reason. A diagnosis of Chronic Idiopathic Constipation can be made using either the Rome III diagnostic criteria or ACG chronic constipation task force criteria, and ruling out potential secondary causes.^2,3

Rome III diagnostic criteria define functional constipation as constipation occurring for the last 3 months with symptom onset at least 6 months prior to diagnosis with the following characteristics:³

Must include two or more of the following:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three defecations per week
Loose stools are rarely present without the use of laxatives
Insufficient criteria for Irritable Bowel Syndrome

The ACG chronic constipation task force criteria recommends defining chronic constipation using a broader definition than the Rome III diagnostic criteria by encompassing the symptoms most commonly expressed by patients who self-report constipation. According to the ACG chronic constipation task force:²

"Constipation is a symptom-based disorder defined as unsatisfactory defecation and is characterized by infrequent stools, difficult stool passage, or both. Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool, or need for manual maneuvers to pass stool (Grade C Recommendation). Chronic Constipation is defined as the presence of these symptoms for at least 3 months (Grade C recommendation). Available evidence indicates that self-reported constipation is associated with decreased quality of life (Grade C recommendation). Treatment of patients with Chronic Constipation is indicated when the symptoms diminish quality of life. (Grade C recommendation)"

SYMPTOMS OF CHRONIC IDIOPATHIC CONSTIPATION

In addition to infrequent bowel movements, patients with Chronic Idiopathic Constipation may experience:⁴

Abdominal bloating and discomfort
Stool consistency
Straining
Constipation severity

LEARN ABOUT AMITIZA 24 MCG (TWICE DAILY) DOSAGE AND ADMINISTRATION FOR CIC

IN DEPTH

DEFINITION OF CHRONIC IDIOPATHIC CONSTIPATION IN THE AMITIZA CLINICAL TRIALS⁴

The AMITIZA clinical trials used a modified version of the Rome II diagnostic criteria. In the clinical studies, Chronic Idiopathic Constipation was defined as:⁴

Average of < 3 spontaneous bowel movements (SBMs) per week with 1 or more of the following symptoms for at least 6 months:
- 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

REFERENCES

Higgins PDR, Johanson JF. Am J Gastroenterol. 2004;99:750-759.
American College of Gastroenterology Chronic Constipation Task Force. Am J Gastroenterol. 2005;100(Suppl):S5-S21.
Longstreth GF, Thompson WG, Chey WD, et al. Gastroenterology. 2006;130:1480-1491.
AMITIZA [package insert]. Bethesda, MD: Sucampo Pharmaceuticals, Inc.; 2011.

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.

This site is intended for use by U.S. residents only. This site is intended for healthcare professionals.

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.

LUB-03057R1