Prospective randomized double-blind trial of racecadotril compared with loperamide in elderly people with gastroenteritis living in nursing homes.
OBJECTIVE
Our aim was to compare the efficacy and tolerability of loperamide and racecadotril in elderly patients with acute diarrhea.


METHODS
We performed a randomized, prospective, double-blind, and parallel group design implemented in geriatric nursing homes in Catanzaro, Italy, from February 2008 to March 2009. Patients of both sexes were randomly allocated to receive either one tablet of racecadotril 100 mg every 8 h or two tablets of loperamide 2.0 mg followed by one tablet after each unformed stool, up to four tablets in any 24-h period. Patients were treated until recovery, defined as the production of two consecutive normal stools or no stool production for a period of 12 h.


RESULTS
Normal stools were collected 36 +/- 4 h after the beginning of racecadotril and in 63 +/- 6 h from the beginning of loperamide administration (P < 0.01). The median time of abdominal pain in the intent-to-treat (ITT) population was 14 h for racecadotril and 28 h for loperamide. In the per-protocol (PP) population, the median time of abdominal pain was 14 h for racecadotril and 32 h for loperamide (P < 0.01). About the 50% of patients experienced at least one adverse event during the study: 12% in the racecadotril group and 60% in the loperamide group. The most frequently occurring adverse events were nausea and constipation. Genetic analysis did not report the presence of rapid or poor metabolizers. Pharmacoeconomic analysis performed at the end of our study documented an increase in costs in the loperamide group with respect to the racecadotril group (P < 0.01).


CONCLUSIONS
Racecadotril is more effective than loperamide-probably due to drug interaction with loperamide-and it is not related to pharmacogenetic susceptibility. Racecadotril is also more cost effective than loperamide.
Gallelli
Luca
L
School of Medicine and Surgery, Department of Experimental and Clinical Medicine, University Magna Graecia of Catanzaro, Mater Domini University Hospital, Catanzaro, Italy. gallelli@unicz.it
Colosimo
Manuela
M
Tolotta
Grazia A
GA
Falcone
Daniella
D
Luberto
Laura
L
Curto
Lucia S
LS
Rende
Pierandrea
P
Mazzei
Francesca
F
Marigliano
Norma M
NM
De Sarro
Giovambattista
G
Cucchiara
Salvatore
S
D015746:Abdominal Pain / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000930:Antidiarrheals / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D003577:Cytochrome P-450 Enzyme System / Q000235:genetics; D003681:Dehydration / Q000517:prevention & control; D003967:Diarrhea / Q000209:etiology / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000150:complications / Q000188:drug therapy*; D006707:Homes for the Aged; D006801:Humans; D008139:Loperamide / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D009735:Nursing Homes; D011110:Polymorphism, Genetic; D013223:Statistics as Topic; D015244:Thiorphan / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
D000930:Antidiarrheals; D008139:Loperamide; C049331:racecadotril; D003577:Cytochrome P-450 Enzyme System; D015244:Thiorphan