Therapeutic Research

Abstract

Objective：This use –results survey was conducted under the actual status of theusage to evaluate the safety and efficacy of pilocarpine hydrochloride（Salagen® tablets） in patients with xerostomia induced by radiotherapy for head and neck cancer. Methods：Of the specialized medical institutions equipped with radiotherapy equipment, eligible ones participated in this specific –institution all –case surveillance. The patients were observed for 12 weeks, and for those with continuous treatment, data were collected until week 52. Results：Of the 2155 patients evaluated for safety, 31.79％（685 patients, 849 episodes）experienced adverse drug reactions（ADRs）. The main ADRs included 466 episodes of hyperhidrosis, 39 of nausea, 28 of diarrhea, 24 of pollakiuria, and 22 of abdominal discomfort. Serious ADRs were encountered by 11 patients（14 episodes）. The incidence of cardiovascular system ADRs, one of the priority survey items, was 1.76％（38 patients, 42 episodes）. No marked increase in the incidence of ADRs occurred with the increase in the duration of administration. The efficacy rates at 12 weeks and final evaluation in the 1983 patients evaluated for efficacy were 56.2 and 53.4％, respectively, showing that improvement was noted in more than half of the patients surveyed. Conclusions：Long–term treatment with pilocarpine hydrochloride was confirmed to be safe and effective in this use –results survey in patients with xerostomia induced by radiotherapy for head and neck cancer.