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.