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.
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).
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.