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• W1569117748 abstract "Sirs, We read with interest the randomised controlled trial (RCT) by Goldberg et al. reporting the efficacy and tolerability of the selective 5-hydroxytryptamine-4 receptor agonist, velusetrag, in the treatment of chronic idiopathic constipation (CIC).1 The disorder is chronic with a relapsing and remitting natural history, and is difficult to treat. Tegaserod, a drug with proven efficacy in the condition,2 was withdrawn in 2007 amid concerns regarding serious adverse cardiac and cerebrovascular events.3 Novel efficacious and safe therapies are therefore required. Goldberg’s study was rigorous and well-designed, and demonstrated a significant increase in average number of weekly spontaneous bowel movements from baseline with velusetrag compared with placebo, after 4 weeks of therapy. The authors reported a number needed to treat (NNT) of between 3 and 4 when an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week from baseline was used to define response to therapy. However, there are some aspects of the analysis that warrant further discussion. Newer treatment trials in CIC are using more stringent definitions of response; for example, pivotal trials of both prucalopride and linaclotide used achievement of ≥3 CSBMs per week for all treatment weeks,4, 5 or ≥3 CSBMs per week and an increase of ≥1 CSBM relative to baseline for 75% of treatment weeks.6, 7 If these endpoints, which were also reported by the authors, are considered, the effect of velusetrag, while remaining statistically significant, is more modest, with NNTs of between 5 and 9. In addition, 75–85% of patients randomised to active treatment would not have achieved response. This does not take into account the fact that the authors used a last observation carried forward method to impute missing data. A true intention-to-treat analysis may further reduce the efficacy observed. It would therefore be interesting to see what effect a ‘worst case scenario’ analysis, with all dropouts assumed to be treatment failures, would have on the results of their study. In summary, while these data are interesting, the study was relatively short in duration and utilised less stringent primary endpoints than other recent treatment trials in CIC, although the authors justify adequately why these were not used in their article. Further data from RCTs with longer follow-up, using similar primary outcome measures to those for prucalopride and linaclotide, are required to assess fully the efficacy of velusetrag in CIC. Declaration of personal and funding interests: None." @default.
• W1569117748 created "2016-06-24" @default.
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• W1569117748 date "2010-12-14" @default.
• W1569117748 modified "2023-09-24" @default.
• W1569117748 title "Defining a responder in treatment trials for chronic idiopathic constipation" @default.
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• W1569117748 doi "https://doi.org/10.1111/j.1365-2036.2010.04504.x" @default.
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