We performed clinical experience investigation on safety and efficacy of MIMIENA
®, a pimaricin otic suspension for canine otitis externa. The investigation on safety was to survey mainly a trend of adverse drug reactions (ADRs). The efficacy of MIMIENA
® evaluated in this study including the anti-fungal activity of that against
M. pachydermatis as a causative agent of otitis externa was compared with the result in clinical trial before approval. Among 644 dog cases collected for the safety evaluation, 555 cases and 82 cases were used for the efficacy evaluation and for comparison of efficacy between the result in this investigation and that in the clinical trial before approval, respectively. ADRs were observed 2 of 644 cases (0.31%) and were redness or pruritis at the local application sites. The frequency of ADRs in this investigation was not significantly different from that in the clinical trial before approval in which no ADRs were observed in 145 cases. The efficacy rate in 555 cases in this investigation was 74.1% and that in 82 cases was 73.2%, which was comparable with the efficacy rate in 65 cases in the clinical trial (73.9%). These results indicated that the efficacy of the medicine did not significantly change after marketing. We suspected the reason of the unchanged efficacy that the anti-fungal activity against causative agents of otitis externa might have been well maintained because MIC
90 against
M. pachydermatis was 6.25 μg/ml and 4.0 μg/ml in approval result and in this study, respectively.
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