Impact of symptom severity in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D): results from two separate surveys of HCPs and patients with IBS-D.

BACKGROUND: Management of diarrhoea-predominant irritable bowel syndrome (IBS-D) is generally based on patient-reported symptoms; however, limited information on symptom severity exists. The objective of the study was to assess the impact of IBS-D severity on patient burden and patient and healthcare professional attitudes towards IBS. METHODS: We conducted two web-based surveys of healthcare professionals and patients from Australia, Canada and Europe. We analysed patient characteristics and attitudes by IBS-D severity, which was assessed retrospectively using a composite of four variables: worst abdominal pain, IBS symptom frequency, Bristol Stool Form Scale and quality of life. RESULTS: Of 679 healthcare professional respondents, one-third routinely classified patients by severity. The patient survey was completed by 513 patients with mild (26%), moderate (33%) and severe (41%) IBS-D, classified using the composite scale. Age, sex and treatment satisfaction did not change with severity; however, 19% of patients classified with severe IBS-D agreed with the statement: 'When my IBS is bad, I wish I was dead' versus 4 and 7% of patients with mild and moderate IBS-D, respectively (p < 0.05). Significantly more patients classified with severe IBS-D reported medication use versus mild IBS-D. CONCLUSION: Compared with milder symptoms, severe IBS-D was associated with increased medication use and a negative perspective of IBS-D. This highlights the need for a validated severity scale to inform treatment decisions.

Economic burden of moderate to severe irritable bowel syndrome with constipation in six European countries.

BACKGROUND: Irritable bowel syndrome with predominant constipation (IBS-C) is a complex disorder with gastrointestinal and nervous system components. The study aim was to assess the economic burden of moderate to severe IBS-C in six European countries (France, Germany, Italy, Spain, Sweden and the UK). METHODS: An observational, one year retrospective-prospective (6 months each) study of patients diagnosed in the last five years with IBS-C (Rome III criteria) and moderate to severe disease at inclusion (IBS Symptom Severity Scale score ≥ 175). The primary objective was to assess the direct cost to European healthcare systems. RESULTS: Five hundred twenty-five patients were included, 60% (range: 43.1-78.8%) suffered from severe IBS-C. During follow-up 11.1-24.0% of patients had a hospitalisation/emergency room (ER) visit, median stay range: 1.5-12.0 days and 41.1-90.4% took prescription drugs for IBS-C. 21.4-50.8% of employed patients took sick leave (mean: 11.6-64.1 days). The mean annual direct cost to the healthcare systems was €937.1- €2108.0. The total direct cost (combined costs to healthcare systems and patient) for IBS-C was €1421.7-€2487.1. CONCLUSIONS: IBS-C is not a life-threatening condition; however, it has large impact on healthcare systems and society. Direct and indirect costs for moderate to severe IBS-C were high with the largest direct cost driver being hospitalisations/ER visits.

Understanding symptom burden and attitudes to irritable bowel syndrome with diarrhoea: Results from patient and healthcare professional surveys.

BACKGROUND: Irritable bowel syndrome with diarrhoea (IBS-D) comprises multiple troublesome symptoms and negatively impacts patients' quality of life. OBJECTIVE: The objective of this article is to assess IBS-D patient burden and patient and healthcare professional (HCP) attitudes towards IBS. METHODS: Patients and HCPs from Australia, Canada, France, Germany, Italy, Spain and the United Kingdom completed internet-based surveys via market research panels. Attitudes to IBS-D-related statements were scored using seven-point Likert scales. RESULTS: The patient survey included 513 patients (70% female, mean age 40.9 years). Faecal urgency was reported as the most troublesome symptom (27%) and fatigue occurred on the most days per month (mean: 18); 61% of patients used ≥3 types of treatment daily or intermittently; 19% used antidepressants daily. Thirty-three per cent thought HCPs should listen and provide more support and 46% reported willingness to 'try anything' to help manage their IBS-D. The HCP survey included 366 primary care physicians and 313 gastroenterologists: A total of 70% and 65%, respectively, agreed it was important that IBS-D patients feel listened to and supported; 73% agreed their main aim was to improve quality of life; ∼30% expressed frustration at managing IBS-D. CONCLUSION: IBS-D imposes a substantial burden on patients and HCPs. These findings point towards a need for improved patient-HCP communication.

Efficacy and tolerability of linaclotide in the treatment of irritable bowel syndrome with constipation in a real­world setting - results from a German noninterventional study.

BACKGROUND: Linaclotide is a minimally absorbed peptide guanylate cyclase-C agonist approved for the treatment of irritable bowel syndrome with constipation (IBS-C). This study assessed the efficacy and tolerability of linaclotide in IBS-C in routine clinical practice in Germany. METHODS: This was a 52-week, noninterventional study of linaclotide in patients aged ≥ 18 years with moderate to severe IBS-C. Severity of abdominal pain and bloating and frequency of bowel movements were assessed over 5 study visits. Treatment-related adverse events were recorded. RESULTS: The study enrolled 375 patients; the mean observation duration was 4.4 months. Linaclotide marketing was halted during the study period for economic reasons, accounting for low patient numbers and short observation duration. Linaclotide significantly reduced mean (standard deviation [SD]) scores between treatment start (visit 1) and study end (visit 5) for abdominal pain intensity (visit 1: 4.87 [2.63] vs. visit 5: 2.40 [2.20], p < 0.0001), mean [SD] bloating intensity (visit 1: 5.30 [2.70] vs. visit 5: 2.86 [2.34], p < 0.0001), and increased mean [SD] bowel movement frequency (visit 1: 2.71 [1.80] vs. 4.38 [1.86], p < 0.0001). Diarrhea, occurring in 5.1 % of patients, was the most common adverse event. CONCLUSION: Linaclotide is effective in improving the major symptoms of IBS-C and demonstrates a favorable safety profile in the real-world environment of routine clinical practice. DRKS (www.drks.de/): DRKS00005088.