Therapeutic Research

Abstract

Objective：To evaluate the safety and effectiveness of tiotropium in patients with chronic obstructive pulmonary disease（COPD）in general clinical practice using post‒marketing surveillance（PMS）. Method：Three PMSs were conducted for Spiriva(R)（ tiotropium）. Safety was assessed by the incidence of adverse drug reactions（ADR）and effectiveness was assessed as the proportion of“ improved” patients judged by physicians. The first survey（PMS‒1）, conducted over a 4‒week observation period in 3000 patients（ClinicalTrial. gov NCT02177318）, and the second survey（PMS‒2）, conducted over a 52‒week observation period in 300 patients（NCT00638183）, evaluated the safety and effectiveness of tiotropium dry powder inhaler. The third survey（PMS‒3）was conducted over a 52‒week observation period in 300 patients（NCT01145053）and evaluated the safety and effectiveness of tiotropium soft mist inhaler. Results：The incidence of ADR in PMS‒1 was 4.19％（140/3340 patients）, with the most frequent ADR being dry mouth（1.14％）followed by dysuria（0.39％）. The improvement rate was 75.0％（2391/3188 patients）. The incidence of ADR in PMS‒2 was 7.24％ （27/373 patients）, with the most frequent ADR being dry mouth, stomatitis, and dysuria （1.07％, respectively）. The improvement rate was 68.8％（236/343 patients）. The incidence of ADR in PMS‒3 was 4.69％（16/341 patients）, with the most frequent ADR being cough（1.17％）. The improvement rate was 60.4％（191/316 patients）. Due to the inclusion of patients in PMS‒3 who had switched from tiotropium dry powder inhaler, the effect of prior treatment was also investigated by subgroup analysis. The incidence of ADR was 5.63％（8/142 patients）in the switched group and 4.02％（8/199 patients）in the non‒switched group. The improvement rate was 47.4％（63/133 patients）in the switched group, and 69.9％（128/183 patients）in the non‒switched group. Given that patients in the switched group were receiving the same active ingredient, 50.4％（67/133 patients）were“no change”and 47.4％（63/133 patients）were“improvement”in effectiveness, and this was considered to be clinically reasonable. Conclusion：The three surveys supported the clinical effectiveness of tiotropium dry powder inhaler and tiotropium soft mist inhaler in general clinical practice and did not find clinically relevant safety issues.