Clinical evaluation of CS-670 in the treatment of postexodontic pain

We carried out a multicenter double-blind clinical study to evaluate the efficacy and usefulness of CS-670, a newly-developed nonsteroidal anti-inflammatory drug, in the treatment of pain in patients undergoing extraction of a mandibular impacted wisdom tooth. The following results were obtained:1) Three groups were compared. The CS20 group received 20 mg of CS-670, the CS40 group received 40 mg of CS-670, and LOX60 group received 60 mg of loxoprofen sodium as control.2) Eighty-six patients in the CS20 group, 85 in the CS40 group, and 80 in the LOX60 group were included in analyses.3) There were no significant differences in demographic factors or extraction conditions among the 3 groups.4) Based on the patient's impression, the improvement rates of cases assessed as “very effective” or “effective” were 71.6% in the CS20 group, 91.6% in the CS40 group, and 88.5% in the LOX60 group. The differences between the CS20 group and the latter 2 groups were significant.5) Based on the investigator's evaluation, the improvement rates of cases showing an “excellent” or “moderate” response were 67.9% in the CS20 group, 91.5% in the CS40 group, and 84.6% in the LOX60 group. The differences between the CS20 group and the latter 2 groups were significant.6) As adverse effects, drowsiness occurred in 3 patients (3.5%) in the CS20 group and 2 (2.4%) in the CS40 group. One patient (1.3%) in the LOX60 group complained of a feeling of sickness. However, all cases were evaluated to be unrelated to the study drugs.7) According to the criteria of the Evaluation Committee, excellent or good pain suppression was obtained in 48.1% of the CS20 group, 61.0% of the CS40 group, and 57.7% of the LOX60 group. The differences among the 3 groups were not significant. The onset of action was noted within one hour in 69.1% of the CS20 group, 82.9% of the CS40 group, and 83.3% of the LOX60 group. The difference between the CS20 group and the LOX60 group was significant. The duration of analgesic effect was more than 3 hours in 66.7% of the CS20 group, 92.6% of the CS40 group, and 82.1% of the LOX60 group. The differences between the CS20 group and the latter 2 groups were significant. The rates of excellent or good responses, evaluated based on the analgesic effect, the onset of action, and the duration of action, were 61.7% in the CS20 group, 76.5% in the CS40 group, and 80.8% in the LOX60 group. The difference between the former 2 groups was significant. Usefulness rates were 61.7% in the CS20 group, 72.3% in the CS40 group, and 80.8% in the LOX60 group. There were no significant differences among the 3 groups.These results demonstrate that the analgesic effect of 40 mg CS-670 is equal to or better than that of 60 mg loxoprofen sodium without inducing adverse effects. Thus, CS-670 is a very useful analgesic.