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Racecadotril (Hidrasec) for Acute Diarrhoea June 2012

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Racecadotril (Hidrasec) for acute diarrhoea June 2012 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes. The National Horizon Scanning Centre Research Programme is part of the National Institute for Health Research June 2012 Racecadotril (Hidrasec) for acute diarrhoea Target group • Acute diarrhoea: infants (older than 3 months), children and adults – add on to oral rehydration therapy. Technology description Racecadotril (Acetorphan; Hidrasec) is an antisecretory enkephalinase inhibitor. It is the racemic mixture of the enantiomers dexecadotril (retorphan) and ecadotril (sinorphan). Racecadotril inhibits the degradation of endogenous enkephalins, which reduces the hypersecretion of water and electrolytes into the intestinal lumen1. Racecadotril exerts its antidiarrhoeal action without modifying the duration of intestinal transit. Racecadotril is administered at 1.5mg/kg three times daily for infants and children, and 60mg three times daily for adults, for a maximum of 7 days. Innovation and/or advantages If licensed, racecadotril would represent the first in a new class of treatments for this patient group. Developer Abbott Healthcare Products Ltd (Licensee); Bioprojet Europe Ltd. NHS or Government priority area This topic is relevant to The National Service Framework for Child Health and Maternity (2004). Relevant guidance • NICE clinical guideline. Diarrhoea and vomiting in children: Diarrhoea and vomiting caused by gastroenteritis: diagnosis, assessment and management in children younger than 5 years. 20092. Clinical need and burden of disease Severe diarrhoea can quickly cause dehydration and become a life-threatening condition2. The majority of cases are attributed to either bacterial or viral infections, although many other chronic medical conditions can also cause diarrhoea, including Crohn’s disease, ulcerative colitis and irritable bowel syndrome2. In adults, the incidence of acute diarrhoea is estimated to be one episode per adult per year3. Severe acute diarrhoea is more prevalent in travellers, older people, adults in contact with children, homosexual men and immunocompromised patients4. Infectious diarrhoea occurs much more commonly in developing countries; in these settings, children typically experience 6 to 12 episodes per year, compared to 2 episodes per year in industrialised countries5. In a systematic analysis of population health data available for 2001, diarrhoeal diseases accounted for 1.78 million deaths (3.7% of total deaths) in low and middle income countries6. Most of these deaths occurred in children under 5 years of age. In a UK study, diarrhoeal illness accounted for 16% of medical presentations to a major paediatric emergency department7. In industrialised countries, deaths from infectious diarrhoea occur mainly in the elderly. Existing comparators and treatments The symptoms of acute diarrhoea usually resolve within a few days and are normally managed at home with an increase fluid intake. In patients who are more vulnerable to 2 June 2012 dehydration associated with diarrhoea, such as the very young or old, oral rehydration solution (ORS) can be used to help replace lost fluids and electrolytes. Anti-motility agents such as loperamide, codeine and co-phenotrope (diphenoxylate hydrochloride 2.5mg, atropine sulphate 25µg) may also be used to reduce the number of diarrhoeal episodes, however these are not recommended for acute diarrhoea in children8. Efficacy and safety Trial Use of racecadotril as outpatient treatment Racecadotril in the treatment of acute for acute gastroenteritis: a prospective, watery diarrhoea in children. randomised, parallel study. Sponsor Ferrer. Bioprojet Pharma. Status Published. Published. Source of Publication9. Publication10. information Location EU. Peru. Design Randomised, controlled. Randomised, placebo-controlled. Participants n=189; children aged 3 to 36 months; n=135; boys aged 3 to 35 months; and schedule acute gastroenteritis (3 loose stools within hospitalisation due to dehydration; watery the previous 24hrs). diarrhoea for 5 days or less with 3 or Randomised to racecadotril 10mg, 20mg more diarrhoeic stools in the past 24hrs. or 30mg three times daily in combination Randomised to racecadotril 1.5mg/kg with oral rehydration solution (ORS) or three times daily or placebo, both in ORS only. combination with ORS. Follow-up Active treatment until resolution of Active treatment until resolution of diarrhoea (occurrence of 2 stools of diarrhoea (occurrence of 2 stools of normal consistency or 12hrs without any normal consistency or 12hrs without any bowel movement) or until 7 days of bowel movement) or until 5 days of treatment; follow-up at 48hrs and 7 days treatment. after treatment initiation. Primary Number of diarrhoeic stools within 48hrs 48hr stool output. outcome of initiation of therapy. Secondary Duration of diarrhoea; number of visits to Total stool output; duration of diarrhoea; outcome the emergency room or primary care ORS intake. doctor; safety. Key results For racecadotril plus ORS vs ORS alone For racecadotril plus ORS vs placebo plus respectively (+SD): ORS respectively (+SE): Number of diarrhoeic stools after 24hrs, Mean 48hr stool output, 92g/kg (+12g/kg) 4.6 (+2.7) vs 4.6 (+2.5) (p>0.05); number vs 170g/kg (+15g/kg) (p<0.001); total of diarrhoeic stools after 48hrs, 3.8 (+2.4) stool output, 157g/kg (+27g/kg) vs vs 4.1 (+2.7) (p>0.05); average duration 331g/kg (+39g/kg) (p<0.001); median of diarrhoea, 4 days (+ 2.1) vs 4.7 days duration of diarrhoea, 28hrs (regardless of (+2.2) (p>0.05); number of emergency rotavirus status) vs 72 and 52hrs room visits within 48hrs, 5 vs 8 (p>0.05); (rotavirus positive and negative patients number of paediatrician visits within respectively) (p<0.001); mean ORS intake 48hrs, 6 vs 6 (p>0.05); number of on day 1, 439ml (+49ml) vs 658ml emergency room visits within 7 days, 5 vs (+59ml), mean ORS intake on day 2, 2 (p>0.05); number of paediatrician visits 414ml (+68ml) vs 640ml (+68ml) within 7 days, 1 vs 3 (p>0.05). (p<0.001). Adverse For racecadotril plus ORS vs ORS alone For racecadotril plus ORS vs placebo plus effects (AEs) respectively: ORS respectively: AEs occurred in 18 (19.1%) vs 19 AEs occurred in 7 (10%) vs 5 (7%). Most (20.2%) patients. Most frequent AEs frequent AEs included hypokalaemia, included respiratory illness (rhinitis, ileus, mild fever and vomiting. bronchitis, coughing, pneumonia and upper respiratory infection). 3 June 2012 Trial Efficacy and tolerability of racecadotril in Benefit of racecadotril for acute diarrhoea acute diarrhoea in children. treatment and emergency department visit. Sponsor Bioprojet Pharma. Investigator led. Status Published. Published. Source of Publication11. Publication12. information Location EU. EU. Design Randomised, placebo-controlled. Randomised, controlled. Participants n=172; children aged 3 months to 4 years; n=164; children aged 3 to 36 months; acute and schedule acute diarrhoea (3 or more watery stools diarrhoea (3 watery stools within the last within the last 24hrs). 12hrs). Randomised to racecadotril 1.5mg/kg Randomised to racecadotril 10mg or 20mg three times daily or placebo. ORS three times daily in combination with ORS administered as required during the first or ORS only. 24hrs of the study. Follow-up Active treatment until resolution of Active treatment until resolution of diarrhoea (occurrence of 2 stools of diarrhoea (occurrence of 2 stools of normal normal consistency or 12hrs without any consistency or 12hrs without any bowel bowel movement) or until 5 days of movement) or until 7 days of treatment. treatment. Primary 48hr stool output. Number of medical examinations during outcome week after treatment initiation. Secondary 24hr stool output; recovery rate; food and Duration of diarrhoea; weight at day 7; outcome ORS intake. number of stools after 48hrs. Key results For racecadotril vs placebo respectively For racecadotril plus rehydration vs (121 patients fully evaluable): rehydration alone (+SD): Mean 48 hr stool, 9g/hr vs 15g/hr Number of medical examinations during (p=0.009) [per-protocol analysis, 7g/hr vs week after treatment initiation, 14 (18%) vs 16g/hr (p=0.001)]; mean 24 hr stool 27 (35%) (p<0.05); duration of diarrhoea, output, 10.5g/hr vs 16g/hr (p=0.025) [per- 97.2hrs (+35.6hrs) vs 137.7hrs (+42.4hrs) protocol analysis, 11g/hr vs 18g/hr (p<0.001); weight change at day 7, +4.4% (p=0.015)]; patients recovery within 5 vs +3.5% (p>0.05); number of stools in the days, males, 88% vs 79%, females, 90% first 48hrs, 6.8 (+3.8) vs 9.5 (+4.5) vs 82%. (p<0.001). Both groups had similar intake of food and ORS. However ORS intake decreased more rapidly in racecadotril group; patients requiring ORS on the second day, 19% and 35% in racecadotril and placebo group respectively. Adverse 9 patients reported a total of 21 AEs (10 Only AEs reported involved difficulties in effects (AEs) racecadotril and 11 placebo). Most AEs taking racecadotril due to taste. were classified as mild to moderate, and only 2 were thought to be due to related treatment – 1 case of moderate vomiting (racecadotril group) and 1 case of moderate facial eczema (placebo). The most common AE was vomiting seen in 7 patients receiving racecadotril and 3 receiving placebo. Trial Racecadotril – a novel drug for treatment The effectiveness of racecadotril in the of acute watery diarrhoea in Indian treatment of acute gastroenteritis. children. Sponsor Investigator led. Ferrer. 4 June 2012 Status Published. Published. Source of Abstract13. Publication14. information Location India. EU. Design Randomised, placebo-controlled. Non-randomised, controlled. Participants n=60; children aged 3 months to 5 years; n=148; children aged 3 to 36 months; and schedule acute diarrhoea (3 watery stools within acute diarrhoea (3 watery stools within the last 12hrs) of 5 days duration or less.
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  • The Private Sector Market for Diarrhea Treatment in India

    The Private Sector Market for Diarrhea Treatment in India

    The Private Sector Market for Diarrhea Treatment in India April 2012 Clinton Health Access Initiative New Delhi, India Table of Contents Abbreviations ..........................................................................................................................................................................3 Acknowledgments..................................................................................................................................................................4 Executive Summary ..............................................................................................................................................................5 Context .......................................................................................................................................................................................8 Methodology ............................................................................................................................................................................9 Diarrhea Treatment Private Sector Supply Chain.................................................................................................... 11 Regulatory Environment .................................................................................................................................................. 16 Manufacturing .....................................................................................................................................................................