Ardelyx Presents Additional Data Detailing Educational Needs Related to IBS-C Management Across Healthcare Disciplines
Poster IND #37, entitled “Educational Needs Related to Irritable Bowel Syndrome with Constipation (IBS-C) Management Across Disciplines: a Comparison of Nurse Practitioners, Physician Assistants, and Physicians” includes findings from a case-based survey involving 410 cross-disciplinary healthcare professionals (HCPs) and sheds light on practice differences and educational requirements related to the diagnosis and management of IBS-C. The data reveals notable differences between nurse practitioners (NPs)/physician assistants (PAs) and physicians, particularly in their choice of IBS-C diagnostic criteria and testing methodologies, tendency to refer patients to specialists and approach to assessing pain levels. It also shows that gastroenterology HCPs are more likely to prescribe linaclotide, plecanatide or tenapanor for IBS-C patients who avoid social events due to discomfort, whereas primary care physicians are more likely to prescribe neuromodulators. These findings show the importance of tailoring educational initiatives to meet the specific needs of different clinical specialties and roles within the healthcare landscape.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the
IMPORTANT SAFETY INFORMATION
| WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. |
CONTRAINDICATIONS
IBSRELA is contraindicated in:
- patients less than 6 years of age due to the risk of serious dehydration
- patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Please see full Prescribing Information, including Boxed Warning, for additional risk information.
About
Investor and Media Contacts:
clowie@ardelyx.com
Source: Ardelyx, Inc.