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Abstract
Objective: Orally disintegrating tablets (ODTs) offer a valuable treatment option, particularly when swallowing solid tablets with water is difficult or inconvenient. Montelukast is an effective treatment for asthma and allergic rhinitis (AR), and an ODT formulation became available in Japan in 2015. This study investigated levels of satisfaction with this new formulation among adults with asthma and/or AR in Japan.
Methods: Patients aged 20 years or older who were refilling a prescription for montelukast ODT in pharmacies across Japan completed questions on satisfaction with key features of montelukast ODT and the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Study variables were analyzed descriptively. Factors associated with TSQM-9 global satisfaction and convenience domain scores were examined using analysis of covariance.
Results: Of the 201 patients who participated, 89.6% reported overall satisfaction with montelukast ODT. Overall satisfaction was highest in patients with AR only (94.7% satisfied) or with asthma and AR (90.2% satisfied), and in patients with treatment duration <4 weeks (98.5% satisfied). Mean TSQM-9 global satisfaction and convenience domain scores were 58.9 and 66.7, respectively; scores were higher for patients with both asthma and AR and for those with longer disease duration. Overall ease of taking and dissolving speed were most closely associated with TSQM-9 global satisfaction scores, and ability to take without water and taste were most closely associated with TSQM-9 convenience scores.
Limitations: The generalizability of the findings was limited by the convenience sample and the descriptive, single-arm study design. The study was limited to adults with asthma and/or AR.
Conclusion: Montelukast ODT may be an acceptable dosage formulation for adults with mild-to-moderate asthma and/or AR in Japan. Satisfaction was high, particularly with respect to tablet size, dissolving speed, taste, and ease of taking.
Transparency
Declaration of funding
This study was funded by Merck & Co. Inc., Kenilworth, NJ, United States of America.
Author contributions
All authors were involved in the conception and design of the study, the drafting and reviewing of the manuscript, and approving the final version of the manuscript. Diane Whalley and Lawrence Rasouliyan were involved in the analysis and interpretation of the data. All authors agree to be accountable for all aspects of the work.
Declaration of financial/other relationships
D.W. and L.R. have disclosed that they are employees of RTI Health Solutions, which received research funding from Merck & Co. Inc. T.P. has disclosed that she is employed by Merck & Co. Inc. K.To. has disclosed that he is employed by MSD K.K. and has stock options in Merck & Co. Inc. K.Tu. has disclosed that he is employed by Merck & Co. Inc. and owns stock in Merck & Co. Inc.
The CMRO peer reviewer on this manuscript has received an honorarium from CMRO for the review work, but has no relevant financial or other relationships to disclose.
Acknowledgments
We thank the patients in Japan who completed the survey, as well as the pharmacy staff for their support. We also thank Japan Medical Research Institute Inc. for their contribution to the data collection, Rebecca Crawford for her project management support, and Stuart Yarr for his contribution to the statistical programming.