A DOUBLE-BLIND CONTROLLED STUDY OF AT-2266 AND PIPEMIDIC ACID IN COMPLICATED URINARY TRACT INFECTION

Abstract

AT-2266 (AT) is a new synthetic pyridonecarboxylic acid antimicrobial agent. It is a drug having high activities against both gram-positive and gram-negative organisms. We compared AT with pipemidic acid (PPA) in a double-blind design to evaluate the usefulness of the drug in the treatment of complicated urinary tract infection.
AT was administered in doses of 200mg after each meal, i. e. three times daily, while PPA was administered in doses of 500 mg after each meal and at bedtime, i. e. four times daily. Both drugs were administered for 5 days.The clinical efficacy of the drugs was evaluated on the fifth day according to the Criteria proposed by the UTI Committee, Japan.
Two-hundred and fifty patients (AT group, 129 patients; PPA group, 121 patients) who met the criteria for patient selection were included in the evaluation of clinical efficacy. The rate of “excellent response” was 38.8% in the AT group and 21.5% in the PPA group. The success rate covering “moderate” to “excellent” response was 80.6% and 47.9%, respectively. Both rates were significantly higher in the AT group. AT was significantly superior in the effects on pyuria and bacteriuria and in the rate of elimination of causative organisms. Moreover, in the utility evaluated by the attending physician, the AT group was significantly superior to the PPA group.
Side effects occurred in 3 (1.8%) each of the 171 AT group patients and 171 PPA group patients. Thus, no significant difference was found in the incidence of side effects between the two groups.
From these results, it is considered that AT-2266 is a highly useful drug as an oral medicine in the treatment of complicated urinary tract infection.