Rapid health technology assessment of linaclotide in the treatment of constipated irritable bowel syndrome / 中国药房

ABSTRACT

OBJECTIVE To comprehensively evaluate the effectiveness， safety and economics of linaclotide in the treatment of constipated irritable bowel syndrome （IBS-C）， and to provide the evidence-based basis for clinical application. METHODS Rapid health technology assessment method was adopted； PubMed， Embase， the Cochrane Library， Web of Science， CNKI， Wanfang data， VIP database， SinoMed， and related HTA websites were searched. Systematic review/meta-analysis， HTA reports and pharmacoeconomic research about linaclotide were collected. After literature screening， data extraction and quality evaluation， descriptive analysis was used to classify and summarize the research results. RESULTS A total of 11 literature were included， involving 7 systematic reviews/meta-analyses and 4 pharmacoeconomic research. In terms of effectiveness， compared with placebo， linaclotide could achieve FDA specified endpoint and European Medicines Agency-recommended endpoint faster， significantly improved patients’ complete spontaneous bowel movements （CSBM）， abdominal pain， constipation and quality of life， and relieved patients’ global symptoms； compared with the indirect evidence of lubiprostone， plecanatide and tenapanor， the efficacy of linaclotide at the FDA specified endpoint， CSBM， abdominal pain relief， and global relief response were the best. In terms of safety， the incidence of overall adverse drug reactions， diarrhea and flatulence caused by linaclotide were significantly higher than placebo，but patients can tolerate them. In terms of economics， compared with traditional therapeutic drugs， linaclotide showed an economic advantage. CONCLUSIONS Linaclotide has advantages in efficacy， safety and economics in the treatment of IBS-C. It is an effective strategy for the treatment of IBS-C.