Long-term safety, efficacy, and patient acceptability of the tulobuterol patch

Abstract

Correspondence: Hisatoshi Sugiura Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan Tel +81 22 717 8539 Fax +81 22 717 8549 Email sugiura@rm.med.tohoku.ac.jp Abstract: The tulobuterol patch contains a β 2 -adrenergic agonist, is the first transdermal bronchodilator, and was developed in Japan. It relies on a matrix-type transdermal delivery system that contains both crystallized and molecular forms of tulobuterol. This delivery system enables the drug content to be released steadily over 24 hours. When the tulobuterol patch is applied to the skin at bedtime, the serum concentration of tulobuterol peaks in the early morning, suppressing the morning dip in pulmonary function. This pharmacological property also prevents steep increases in plasma drug levels, which reduces the risk of adverse events. Because the tulobuterol patch is easy to use and requires only once-daily application, treatment adherence in patients using the patch is superior to that of other therapies. The clinical efficacy of the patch in patients with asthma and chronic obstructive pulmonary disease at any age has been established in many clinical studies since launch in 1998, and the product has a good safety profile. Therefore, the tulobuterol patch is currently used for the long-term treatment of patients with asthma and chronic obstructive pulmonary disease. Here we review the characteristics of the tulobuterol patch and the results of clinical trials that have investigated the effects of the patch on pulmonary function, quality of life, and adherence. We also discuss the usefulness of the tulobuterol patch in clinical practice.