BACKGROUND: Although linaclotide has been approved to treat moderate to severe IBS-C, no data are available on its effectiveness and tolerability in patients in a real-life setting. METHODS: A prospective single-center study of the effectiveness and tolerability of linaclotide was carried out on patients (n = 40) with moderate to severe IBS-C, all fulfilling the Rome IV criteria. Clinical information was recorded using a dietary questionnaire at baseline, and 3 and 6 months after initiating treatment. The end-points to measure effectiveness included abdominal pain and bloating (11-NRS), the number of bowel movements and patient satisfaction. Tolerability was assessed through the frequency of adverse events. KEY RESULTS: In terms of efficacy, an improvement in abdominal pain and in the intensity of bloating was evident in the cohort after 6 months of linaclotide therapy. The proportion of patients with moderate or severe symptoms of bloating fell from 93.3% to 33.3% and those with pain from 93.4% to 20%. Weekly bowel movements also improved and accordingly, 97% of the patients were moderately or very satisfied with the treatment. At the end of the study, diarrhea was the most frequent adverse event (10%), although it was considered mild in 66.7% of these subjects and moderate in 33.3%. A lack of efficacy (n = 3) and excessive diarrhea (n = 7) were motives for discontinuing the treatment. CONCLUSIONS AND INFERENCES: Linaclotide proved to be a safe and effective drug to reduce the main symptoms of IBS-C in everyday clinical practice, with an improvement comparable to that seen in clinical trials.
BACKGROUND: Although linaclotide has been approved to treat moderate to severe IBS-C, no data are available on its effectiveness and tolerability in patients in a real-life setting. METHODS: A prospective single-center study of the effectiveness and tolerability of linaclotide was carried out on patients (n = 40) with moderate to severe IBS-C, all fulfilling the Rome IV criteria. Clinical information was recorded using a dietary questionnaire at baseline, and 3 and 6 months after initiating treatment. The end-points to measure effectiveness included abdominal pain and bloating (11-NRS), the number of bowel movements and patient satisfaction. Tolerability was assessed through the frequency of adverse events. KEY RESULTS: In terms of efficacy, an improvement in abdominal pain and in the intensity of bloating was evident in the cohort after 6 months of linaclotide therapy. The proportion of patients with moderate or severe symptoms of bloating fell from 93.3% to 33.3% and those with pain from 93.4% to 20%. Weekly bowel movements also improved and accordingly, 97% of the patients were moderately or very satisfied with the treatment. At the end of the study, diarrhea was the most frequent adverse event (10%), although it was considered mild in 66.7% of these subjects and moderate in 33.3%. A lack of efficacy (n = 3) and excessive diarrhea (n = 7) were motives for discontinuing the treatment. CONCLUSIONS AND INFERENCES: Linaclotide proved to be a safe and effective drug to reduce the main symptoms of IBS-C in everyday clinical practice, with an improvement comparable to that seen in clinical trials.