Prevention of adverse effects of cevimeline hydrochloride hydrate for the treatment of xerostomia in patients with Sjoegren's syndrome: a clinical study

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  • TOIDA Makoto
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • KATO Keizo
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • YONEMOTO Kazuhiro
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • MAKITA Hiroki
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • HATAKEYAMA Daijiro
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • KUSUNOKI Yukihiro
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • MIYAMOTO Ken
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • FUJITSUKA Hideki
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • YAMASHITA Tomomi
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • ISHIMARU Jun-Ichi
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine
  • SHIBATA Toshiyuki
    Department of Oral and Maxillofacial Sciences, Gifu University Graduate School of Medicine

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Other Title
  • シェーグレン症候群患者の口腔乾燥症治療における塩酸セビメリン水和物の副作用発現とその予防に関する臨床的検討
  • シェーグレン ショウコウグン カンジャ ノ コウクウ カンソウショウ チリョウ ニ オケル エンサン セビメリン スイワブツ ノ フクサヨウ ハツゲン ト ソノ ヨボウ ニ カンスル リンショウテキ ケントウ

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Abstract

Cevimeline hydrochloride hydrate (CHH) shows excellent efficacy for the treatment of xerostomia in Sjögren's syndrome (SS) patients, with considerably frequent adverse effects consisting mainly of digestive symptoms.<BR>In the present study, the efficacy of CHH and the status of adverse effects were compared among the following three groups of SS patients with xerostomia, each of which had similar clinical backgrounds: Group A, which received 30mg of CHH three times daily for seven weeks (n=19); Group B, which received 30mg of CHH once daily for the first week and twice daily for the following six weeks (n=22); and Group C, which received the same dosage of CHH as Group B, except for the addition of 100mg of trimebutine maleate, twice daily for seven weeks (n=21).<BR>The three groups showed similar significant improvements in both salivary flow rate (p<0.01) and subjective symptoms of dryness of the mouth (p<0.01). Adverse effects were significantly less frequent in Groups B(27%) and C (24%) than in Group A (63%)(p<0.05). Moreover, the period from the start of dosage to the occurrence of adverse effects was significantly longer in Groups B (19.5±15.3 days) and C (20.3±12.6 days) than in Group A (6.5±6.2 days)(p<0.05). Thus, it is suggested that the methods in Groups B and C are useful to minimize adverse effects of CHH without any significant reduction of efficacy of this drug.

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