Understanding IBS-C and CIC

Irritable Bowel Syndrome with Constipation (IBS‑C) and Chronic Idiopathic Constipation (CIC) are prevalent conditions with similar symptoms, including infrequent and incomplete bowel movements.5,15 The disease state and pathophysiology information in this section can be useful when addressing your patients’ needs and determining if LINZESS is the appropriate treatment to manage their symptoms.

Use the buttons below to view the disease state overviews for IBS-C and CIC.



IBS-C disease state overview

IBS-C is one of the 3 subtypes of IBS, a chronic functional gastrointestinal (GI) disorder that arises from an abnormal functioning of the GI tract and not from structural or biochemical abnormalities. The other 2 subtypes of IBS are IBS with diarrhea (IBS-D) and IBS with mixed bowel pattern (IBS-M), which can vary between constipation and diarrhea.14,21

IBS-C is defined as abdominal pain or discomfort that occurs in association with constipation. IBS-C is associated with hard or lumpy stool consistency in at least 25% of bowel movements, and loose or watery stool consistency in less than 25% of bowel movements. In IBS-C, symptoms are chronically present.14,21

In an Internet-based survey,* adult IBS-C sufferers indicated that they often experience multiple symptoms, including constipation, abdominal pain, and incomplete evacuation. These symptoms occur frequently and can be severe in sufferers.3

Adult IBS-C sufferers reported frequent symptoms, including abdominal pain and constipation3,16*

In addition to these symptoms, IBS-C patients may also experience:

  • Bloating
  • Straining
  • Gas pain

Note: The symptoms listed here are not exhaustive. Patients may be suffering from other symptoms not listed here.

Many adult IBS-C sufferers reported self-treating with OTC medications and actively seeking physician care 3*

* This web-based survey was commissioned by Ironwood Pharmaceuticals, Inc. and Actavis. Based on their responses to a symptom checklist, 571 individuals qualified for the detailed survey after meeting Rome II, Rome III, or modified Manning criteria for IBS-C.3

Pathophysiology of IBS-C

The exact cause of IBS-C has not been identified. Instead, IBS-C is considered to be a disorder resulting from the interaction of a number of factors.22 Potential factors include:

Visceral hypersensitivity22

Visceral hypersensitivity is an enhanced responsiveness or perception within the intestine that can occur even in response to normal events. Sufferers may feel more pain than healthy individuals when their intestines are stimulated or stretched. Visceral hypersensitivity may also lead to changes in intestinal motility and secretion.

Disturbance in water balance and GI tract motility17,23

Colonic motility may be delayed in IBS-C sufferers, which may be due to decreased contractions that move contents through the colon leading to infrequent defecation. Water imbalance may also occur due to the colon absorbing too much water, resulting in stools that are hard, dry, and difficult to pass.

Brain-gut dysfunction17,22

IBS-C patients may have altered brain-gut communication leading to changes in motility, sensation, and secretion in the bowel.

Additional possible causes of IBS-C include local inflammation of the GI tract, intestinal bacterial overgrowth, and psychological factors.

CIC disease state overview

Constipation is one of the most frequent gastrointestinal (GI) complaints in the United States and one of the most common reasons for a physician visit. Constipation is defined as unsatisfactory defecation characterized by infrequent stools (less than 3/week), difficult stool passage, or both. Difficult stool passage includes straining, incomplete bowel movements (incomplete evacuation), hard/lumpy stools, prolonged time between bowel movements, or the need for manual removal of stool.5,6,24

CIC is defined as the chronic presence of these symptoms. “Idiopathic” means the cause of the constipation is unknown.1,5

In an Internet-based survey, adult CIC sufferers indicated that they often experience multiple symptoms, including constipation, having hard/lumpy stools, and incomplete evacuation. These symptoms occur frequently and can be severe in sufferers.3

Adult CIC sufferers reported frequent symptoms, including constipation and hard stools3†

In addition to these symptoms, CIC patients may also experience:

  • Stomach cramping
  • Gas pain
  • Bloating

Note: The symptoms listed here are not exhaustive. Patients may be suffering from other symptoms not listed here.

Many adult CIC sufferers reported self-treating with OTC medications and actively seeking physician care3†

This Web-based survey was commissioned by Ironwood Pharmaceuticals, Inc. and Actavis. Based on their responses to a symptom checklist, 1123 individuals qualified for the detailed survey after meeting Rome II, Rome III, or American College of Gastroenterology guidelines for CIC.3

Pathophysiology of CIC

Although CIC is by definition a disorder without an identifiable cause (idiopathic = unknown cause), several factors may contribute to its development, including water balance and motility in the colon.

Motility includes contractility (the rate at which the muscles in the colon contract to help pass the stool through) and transit (the time it takes stool to move through the GI system). Disturbances in both water balance and motility can affect stool consistency and frequency.5,16,17,25,26

If the colon absorbs too much water, the consistency of stools can be hard, dry, and difficult to pass. In addition, these hard, dry stools may be small and lack the bulk to stimulate the urge to defecate, resulting in infrequent bowel movements.5,20

When motility is slowed, movement of stool through the colon may be delayed, resulting in infrequent defecation. This slowed movement may also result in too much water absorption, causing the stool to become hard and dry.20

Next: Prescription Savings

Important Safety Information

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.

Contraindications
  • LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
  • LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
  • Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
  • Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC clinical trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC).

If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. For additional information about LINZESS, call Allergan Medical Information at 1.800.678.1605.

Please see below and full Prescribing Information for LINZESS.

Show
Important Safety Information

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.

Contraindications
  • LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
  • LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
  • Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
  • Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC clinical trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS‑C) and chronic idiopathic constipation (CIC).

If you are a patient, and have any questions, please discuss them with your doctor or healthcare professional. For additional information about LINZESS, call Allergan Medical Information at 1.800.678.1605.

Please see below and full Prescribing Information for LINZESS.