Clinical study of RAK-591 (Etodolac, Hypen<SUP>®</SUP> tablet) in treatment of temporomandibular joint disorders

DOI 5 Citations 18 References
  • WAJIMA Kouichi
    Department of Dentistry and Oral Surgery, School of Medicine, Keio University
  • MURAKAMI Kenichiro
    Department of Oral Maxillofacial Surgery, Graduate School of Medicine, Kyoto University
  • KAKUDO Kenji
    Second Department of Oral and Maxillofacial Surgery, Osaka Dental University
  • KOGAI Hideki
    Department of Dentistry and Oral Surgery, School of Medicine, Keio University
  • TAGAMI Aki
    Department of Dentistry and Oral Surgery, School of Medicine, Keio University Tagami Dental Clinic
  • FUJIMURA Kazuma
    Department of Oral Maxillofacial Surgery, Graduate School of Medicine, Kyoto University Department of Oral and Maxillofacial Surgery, Kanazawa Medical University
  • YASUDA Shinya
    Department of Oral Maxillofacial Surgery, Graduate School of Medicine, Kyoto University
  • TAKAHASHI Katsu
    Department of Oral Maxillofacial Surgery, Graduate School of Medicine, Kyoto University
  • ARIKA Takumi
    Second Department of Oral and Maxillofacial Surgery, Osaka Dental University
  • NISHIMURA Kayako
    Second Department of Oral and Maxillofacial Surgery, Osaka Dental University
  • IMAMURA Yoshiki
    Department of Dental Anesthesiology, Kyushu Dental College
  • OHURA Kiyoshi
    Department of Pharmacology, Osaka Dental University

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Other Title
  • 顎関節症に対するＲＡＫ‐５９１（Ｅｔｏｄｏｌａｃ：ハイペン錠）の臨床的有効性および安全性に関する検討

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To evaluate the efficacy and safety of RAK-591 in the treatment of patients with temporomandibular joint disorders, RAK-591 was orally administered, at a dose of 200mg, twice daily, for 4 weeks. In a total of 101 subjects, the efficacy was evaluated in 86 cases, and safety in 90 cases. The improvement rate of pain on exercise (including “improved” or better) was 45.0% (36/80 cases) after 2 weeks, 50.0% (29/58 cases) after 4 weeks, and 57.0% (49/86 cases) at the end of medication (49 improved cases consisted of 16 completely improved cases at 2 weeks, and 33 improved-or-better-rated cases at 4 weeks). The pain on exercise on VAS was 51.8mm on average before administration, and 16.1mm on average at the end, showing a significant reduction (p<0.001). The maximal range of passive and pain-free opening expanded from 32.9mm, on average, before administration, to 41.4mm, on average, after 2 weeks, and 42.6mm, on average, at the end, indicating significant improvement (p<0.001). On the other hand, adverse reactions were observed in 17 of 90 cases (18.9%), but none were serious. The main adverse reactions were gastrointestinal symptoms, and these recovered after stopping the medication without any treatment.<BR>In conclusion, RAK-591 exhibited good clinical efficacy and high safety in the treatment of temporomandibular joint disorders, and it was considered to be a useful drug.

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