Table 1.
Efficacy of racecadotril in the treatment of acute diarrhea in adults.
| Outcome parameter | Number of patients | Racecadotril | Comparator | Reference |
|---|---|---|---|---|
| DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES IN ADULTS WITH ACUTE DIARRHEA | ||||
| Time to recovery, h | 54–55 per group vs. 49§ | 65.0–69.9 | 72.0 | data on file |
| % Probability for recovery on day 4 | 95 vs. 98 | 75* | 37 | Baumer et al. (1992) |
| Stool weight, g | 32 vs. 38 | 355 ± 35* | 499 ± 46 | Hamza et al. (1999) |
| DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES IN ADULTS WITH CHOLERA | ||||
| Total stool output, g | 54 vs. 56 | 315 ± 31 | 280 ± 21 | Alam et al. (2003) |
| STUDIES IN ADULTS WITH ACUTE DIARRHEA ASSOCIATED WITH CANCER CHEMOTHERAPY (5-FLUORO-URACIL) | ||||
| Number of stools per day | 15 (sequential racecadotril vs. no treatment) | 4.9* | 6.3 | Dorval et al. (1995) |
| STUDIES IN ADULTS WITH DELAYED DIARRHEA DUE CANCER CHEMOTHERAPY (IRINOTECAN) | ||||
| Treatment responder | 11 | 36% | – | Saliba et al. (1998) |
| Prophylaxis of diarrhea | 68 vs. 68 no treatment | 55% | 59% | Ychou et al. (2000) |
| OCTREOTIDE-CONTROLLED STUDIES IN ADULTS WITH TREATMENT-RESISTANT DIARRHEA IN AIDS PATIENTS | ||||
| Stools/day | 13 (cross-over) | −2.4* | −1.4 | Beaugerie et al. (1996) |
| DOUBLE-BLIND, LOPERAMIDE-CONTROLLED STUDIES IN ADULTS WITH ACUTE DIARRHEA | ||||
| Time to diarrhea resolution, days | 37 vs. 32 | 2.2 ± 0.2 | 2.3 ± 0.2 | Roge et al. (1993) |
| Number of stools | 82 vs. 75 | 3.5 ± 0.5 | 2.9 ± 0.4 | Vetel et al. (1999) |
| Duration of diarrhea, h | 473 vs. 472 | 55.0 | 55.0 | Prado (2002) |
| Duration of diarrhea, h | 31 vs. 31 | 19.5 | 13.0 | Wang et al. (2005) |
| Time recovery, h | 30 vs. 31 | 36 ± 4* | 63 ± 6 | Gallelli et al. (2010) |
*p < 0.05 vs. comparator; §dose-ranging study using 30, 100, and 300 mg racecadotril thrice daily. For details on individual studies see main text Section “Studies in the Gastro-Intestinal Tract.”