Abstract
The efficacy of racecadotril (RC), an intestinal antisecretory drug acting via an enkephalinase inhibition, was reviewed in paediatric acute diarrhoea but not yet in adults. Objective: To estimate the effectiveness of RC in the symptomatic treatment of acute diarrhoea in adults. Data Sources: A systematic review of MedLine, Cochrane Controlled Trials Register, DARE, and Embase (up to November 2013). Additional studies were identified by contacting clinical experts and the manufacturer. Study Selection and Appraisal: Randomized Controlled Trials performed in adults suffering from acute diarrhoea using RC in one treatment arm. Independent extraction of articles using predefined data fields, and methodological quality measurement assessment. All randomised trials performed in adults suffering from acute diarrhoea with RC as the studied group. Statistics: The main efficacy endpoint was diarrhoea duration defined as time to recovery compared between groups by survival techniques and converted into hazard ratio (HR). We exclusively used a random-effect meta-analytic model. Constipation proportion was the main safety endpoint, evaluated between treatments by the Relative Risks (RR). Results: Twelve randomised trials (2619 patients) met inclusion criteria. Duration of diarrhoea was much shorter in the RC group, the proportion of patients having recovered at any time of the treatment period was 65% higher in the RC group, compared with placebo (HR = 1.65 [1.38-1.97], p p = 0.24, n = 1618). The proportions of constipated patients were similar in the RC and placebo groups 0.95 [0.24-3.68], p = 0.97), however, about 3 times more constipated patients were found in the loperamide group compared with the RC group (RR = 0.34 [0.22-0.51], p to placebo, RC is characterized by a clinically relevant earlier remission of diarrhoea. When compared to loperamide, diarrhoea duration was similar, however, significantly fewer secondary constipation adverse effects were observed.
Highlights
To examine whether RC reduces diarrhoea duration, we reviewed randomized, controlled trials that assessed the efficacy of this drug for the symptomatic treatment of acute diarrhoea compared to any comparator in adults
28 studies were identified through database searching and 4 additional studies were found from authors and Pharma sources (Bioprojet Pharma and Smith and Beecham international)
The excluded studies were: duplicate or translation of previous published trials [15], and review or meta-analysis [16]-[18], studies performed in infants or in children, in patients suffering from cholera [19], from HIV-related chronic diarrhoea [20] [21] or from subacute or recurrent diarrhoea induced by anticancerous chemotherapy [22]-[26] studies comparing 100 mg capsules RC to domestic Chinese 100 mg RC [27], to the RC isomer, dexecadotril [28], and to 175 mg tablets RC [29]-[31], due to the lack of a third comparator
Summary
The mortality induced by acute diarrhoea does occur mainly in infants, especially in the developing world. In the developed countries, the mortality in adults, especially in elderly, is underestimated because it occurs after a delay due to visceral failure secondary to dehydration [1] Almost acute gastroenteritis resolve spontaneously within a miscellaneous period of time, depending of epidemiological conditions. In this active population, shortening the period of incapacity can be a major concern because it induces a huge cost [2]. There is a need for a drug, with a safe profile, that means, in particular, devoid of antimotility action, and with an established efficacy in order to reduce the diarrhoea duration
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