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New constipation drug gets a lukewarm response from DTB


Little published data on lubiprostone made it difficult to assess its efficacy, says the DTB

A lack of evidence supporting the use of lubiprostone means that the first chloride-channel activator launched to the UK market does not fit readily into management strategies for people with chronic idiopathic constipation, the latest Drug and Therapeutics Bulletin has concluded.

The analysis scrutinised the three papers proving efficacy — all of which were double-blind randomised controlled trials – that formed the basis of the UK marketing authorisation application. The DTB authors stated that the absence of any published trials comparing lubiprostone to standard therapies, plus the fact that only the abstract of a study evidencing its use in patients who have failed other laxative treatments has been published, meant that the role of the drug was “difficult to assess”.

Other concerns raised by the DTB article include the expense of lubiprostone compared with standard treatments such as osmotic and stimulant laxatives, the incidence of side effects such as nausea, and the uncertainty about how long the drug can be taken for and how often.

Lubiprostone (Sucampo’s Amitiza) was not endorsed for use in NHS Wales by the All Wales Medicine Strategy Group in 2013, while the National Institute for Health and Care Excellence is expected to issue a technology appraisal on the drug for treating chronic idiopathic constipation in October 2014. According to the British National Formulary, 56 capsules of lupiprostone, which are taken twice a day, cost £59.36.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11137249

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