Clinical efficacy and safety of transdermal tulobuterol in the treatment of stable COPD: an open-label comparison with inhaled salmeterol.
BACKGROUND
Long-acting bronchodilators are recommended for the management of stable COPD to relieve symptoms and improve quality of life. The tulobuterol patch (Hokunalin) is a transdermal patch preparation of the beta2-adrenoceptor agonist (beta2-agonist) tulobuterol designed to yield sustained beta(2)-agonistic effects for 24 hours when applied once daily.


OBJECTIVE
To compare the effectiveness of tulobuterol patch and inhaled salmeterol (Serevent Diskus) in the treatment of stable COPD.


METHODS
Clinically stable COPD patients (age > or = 40 years, postbronchodilator FEV1/FVC <70%, and postbronchodilator FEV1 <80% predicted) were enrolled in a multicenter, open-label randomized study. After a 2-week run-in period, patients were administered either tulobuterol (2mg once-daily applied as a patch) or salmeterol (50 microg per inhalation, twice a day) for 12 weeks.


RESULTS
Data for 92 patients (46 each for each treatment group) were analyzed. There were no significant differences in baseline characteristics in the tulobuterol versus salmeterol groups: age, 69.2 +/- 7.4 vs 71.6 +/- 7.3 years; male, 91% versus 96%; and patients with stage II (III) COPD, 32.6% (67.4%) versus 50% (50%). FEV1, FVC, and PEF improved during treatment in both groups compared with baseline, with no significant between group differences. The total St George's Respiratory Questionnaire (SGRQ) score was significantly improved relative to baseline in the tulobuterol group at 8 weeks (-4.7 units [U]), but not in the salmeterol group at all timepoints. Domain analysis of the SGRQ scores revealed significant improvement in the symptom score relative to baseline in the tulobuterol group at weeks 4 (-6.9U), 8 (-12.0U), and 12 (-11.7U), but not in the salmeterol group in any of the domains tested. Medical Research Council dyspnea scale score improved during treatment in both groups, with no significant differences between groups. Compliance with the treatment regimen was significantly better in the tulobuterol than in the salmeterol group (98.5% vs 94.1%; p < 0.05).


CONCLUSIONS
These findings indicate that once-daily transdermal sustained-release tulobuterol is as effective or better than the inhaled long-acting beta2-agonist salmeterol in the management of stable COPD, with significant effects on quality of life.
Fukuchi
Yoshinosuke
Y
Department of Respiratory Medicine, Juntendo University School of Medicine, Hongo, Tokyo, Japan. yfukuchi@tea.ocn.ne.jp
Nagai
Atsushi
A
Seyama
Kuniaki
K
Nishimura
Masaharu
M
Hirata
Kazuto
K
Kubo
Keishi
K
Ichinose
Masakazu
M
Aizawa
Hisamichi
H
D000279:Administration, Cutaneous; D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011788:Quality of Life; D000068299:Salmeterol Xinafoate; D011795:Surveys and Questionnaires; D013726:Terbutaline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors
D001993:Bronchodilator Agents; C010809:tulobuterol; D000068299:Salmeterol Xinafoate; D013726:Terbutaline; D000420:Albuterol