Vol.69 No.1 January 2021
Safety and effectiveness of paromomycin sulfate for the treatment of intestinal amebiasis: A drug use-results survey
1)Post Marketing Study Strategy and Management, Pfizer R&D Japan G.K., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, Japan
2)Biometrics and Data Management, Pfizer R&D Japan G.K.
Abstract
Paromomycin sulfate (AMEPAROMOⓇ capsules 250 mg) was approved for the treatment of intestinal amebiasis in December 2012. We conducted a drug use-results survey to evaluate the safety and effectiveness of this drug in daily medical practice in Japan. This safety analysis included 115 patients, with a male: female ratio of approximately 9:1 and a mean patient age of approximately 47 years. Among the patients, 15 (13.04%) developed 1 adverse drug reaction (ADR), namely, diarrhea, each; of the 15, 14 recovered and 1 was on the path to recovery. None of the patients had any serious ADRs. There were no unexpected ADRs. In the analysis set in which the cyst positivity rate in the stool after treatment was examined (n=53), 52 patients (98.1%) were found to be cyst-negative, and 1 patient was cyst-positive after the observation period. In the clinical response analysis set (n=106), the treatment was judged as effective in 99 patients, as ineffective in 1 patient, and as indeterminate in 6 patients. Among the patients who were switched to paromomycin sulfate from a prior drug that was effective, 100% of patients were cyst-negative (44 negative, 0 positive, and 0 patients indeterminate) in the cyst analysis set; the response was judged as effective in 85 patients, ineffective in 0 patients, and as indeterminate in 5 patients in the clinical response analysis set. In contrast, of the patients who were switched to paromomycin sulfate from a prior drug that proved ineffective (n=2), one was cyst-positive and the clinical response was judged as ineffective in one case. These results indicate that paromomycin sulfate is effective in patients who have responded effectively to prior drugs, supporting the present treatment course of intestinal amebiasis. We did not find any special concerns about the safety or effectiveness of this drug.
Key word
paromomycin, post-marketing surveillance, intestinal infection, amebiasis, Entamoeba histolytica
Received
May 28, 2020
Accepted
October 29, 2020
Jpn. J. Chemother. 69 (1): 13-23, 2021
