Background:Linaclotide, a guanylate cyclase C agonist, has been shown in clinical trials to improve symptoms of irritable bowel syndrome with constipation (IBS-C). Here we report data from a real-world study of linaclotide in the UK.Methods:This 1-year, multicentre, prospective, observational study in the UK enrolled patients aged 18 years and over initiating linaclotide for IBS-C. The primary assessment was change from baseline in IBS Symptom Severity Scale (IBS-SSS) score at 12 weeks, assessed in patients with paired baseline and 12-week data. Change from baseline in IBS-SSS score at 52 weeks was a secondary assessment. Adverse events were recorded.Results:In total, 202 patients were enrolled: 185 (91.6%) were female, median age was 44.9 years (range 18.1–77.2) and 84 (41.6%) reported baseline laxative use. Mean (standard deviation) baseline IBS-SSS score was 339 (92), with most patients (n = 129; 66.8%) classified as having severe disease (score ⩾300). In patients with paired data, there was a significant mean (95% confidence interval) decrease in IBS-SSS score from baseline to 12 weeks [−77.0 (−96.3, −57.7); p < 0.001; n = 124] and baseline to 52 weeks [−70.7 (−95.0, −46.5); p < 0.001; n = 76]. Overall, 174 adverse events were reported in 77 (38.1%) patients, most commonly diarrhoea (n = 54; 26.7%), abdominal pain (n = 21; 10.4%) and abdominal distension (n = 13; 6.4%).Conclusion:Linaclotide significantly improved IBS-SSS score at 12 and 52 weeks. These results provide insights into outcomes with linaclotide treatment over 1 year in patients with IBS-C in real-world clinical practice.
IntroductionIron deficiency anaemia (IDA) is common with BSG guidance suggesting Gastrointestinal (GI) blood loss from colonic or gastric cancer, and malabsorption in coeliac disease are the most important causes.1 Serum ferritin, microcytosis and hypochromia are the most sensitive markers for iron deficiency.2 Our objective was to investigate the correlation between MCV/ferritin and GI pathology in patients with IDA by comparing GI pathology in patients with low ferritin versus normal ferritin; and in patients with microcytosis versus normocytosis.MethodsRetrospective cohort study for consecutive patients who had undergone bi-directional endoscopy and/or GI imaging to investigate unexplained anaemia were included. Data was retrieved including Hb, MCV, folate, B12, co-morbidities and findings at endoscopy, histology and imaging were recorded. Patients with normal haemoglobin as per our laboratory’s cut off were excluded. Included patients were stratified according to serum ferritin and MCV into 2 groups (low/normal) for each marker. We used the cut-off concentration as per our local laboratory (10 µg/l for ferritin and 78 FL for MCV). The outcome assessed was any GI pathology found that may explain the IDA. Data was analysed including and excluding the diagnosis of gastritis/oesophagitis as possible GI causes of anaemia.Results265 included patients (mean age: 68; range: 16–91 years old; 124 males and 141 females) had undergone GI investigations for IDA. Of these, 84 patients had low ferritin (31.6%) whereas 181 patients had normal ferritin. GI pathology excluding gastritis/oesophagitis occurred in 40 (47.6%) and 68 (37.5%) patients in low and normal ferritin group respectively. P = 0.12.Based on MCV, 96 patients had low MCV (36.2%) whereas 169 patients had normal MCV. GI pathology occurred in 38 patients in low MCV group (39.5%) and in 70 patients with normal MCV (41.4%), P = 0.76. No differences were noted upon including gastritis/oesophagitis.Abstract PTU-014 Table 1GI PathologyLow FerritinNormal FerritinLow MCVNormal MCVGastric/duodenal ulcer112211Coeliac disease6244Polyps/adenomas17221326Colitis/IBD3627Angiodysplasia1946Haemorrhoids3021Upper GI malignancy3746Colorectal malignancy61079Total number40/8468/18138/9670/169ConclusionThere was no clinical or statistical difference in GI pathology in patients presenting with anaemia with or without evidence of iron deficiency. Although a significant number of patients had a GI workup despite no evidence of iron deficiency, the lesion pickup was similar in both groups. Therefore, our study demonstrates the MCV/ferritin might be sensitive markers for IDA but they don’t correlate with GI pathology.References1 Gut 2011;60:1309e–1316. doi:10.1136/gut.2010.2288742 Prevalence of hypochromia vs microcytosis in iron deficiency. Clin Lab Haematol 2000;22:79e80.Disclosure of InterestNone Declared
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