A Clinical Study on the Effect of K-708 (Acemetacin)-A Double Blind Comparative Study with Ibuprofen in Upper Respiratory Tract Inflammation with Fever

The efficacy and safety of a new anti-inflammatory agent, K-708 (acemetacin), was evaluated in patients with acute upper respiratory inflammation, placing special emphasis on its antipyretic effect. The studies were performed on an open basis at the beginning, followed by a double blind comparison using ibuporfen as a standard drug. As for the antipyretic effect, a single dose of K-708 (30 mg) was as effective as that of ibuprofen (300 mg) in relieving the feverish conditions caused by various infectious diseases. In case of ibuprofen, the patients' mean body temperature reached the lowest level two hours after the administration and then it began to rise again gradually, on the other hand, the antipyretic effect of K-708 atained its maximum level three hours after the administration and the body temperature was kept at the same level up to four hours after dosing. Thus, it is clear from the above that the antipyretic effect of K-708 is apparently long-lasting as compared with that of ibuprofen. In a double blind controlled study in 230 patients, the global improvement rate in the K-708 group (90 mg/day), was 71.6% and 71.7% in the ibuprofen group (900 mg/day), no significant differnce was noted between the two groups. As for the global improvement rating of each symptom, antipyretic effect and utlity, the both groups gave almost the same results, again no significant difference was seen between the groups. The incidence of side effects in the K-708 group was 6.0% and 3.5% in the ibuprofen group, and there was no significant difference between the groups. Most of the side effects observed ere mild in nature and disappeared spontaneously without any special treatment. From the foregoing it can be concluded that K-708 is a useful drug for the treatment of acute upper respiratory inflammation and that K-708 has the potential for exerting ten times greater maximum effect as compared with ibuprofen. In this double blind study, the objective evaluation by the committee members was also prformed tentatively in accordance with the standardized clinical criteria, and was compared with that by the attending pysicians.