Tiotropium More Effective Than Salmeterol in COPD

Laurie Barclay, MD

May 14, 2003

May 14, 2003 — Tiotropium is more effective than salmeterol for treating chronic obstructive pulmonary disease (COPD), according to the results of a study published in the May issue of Thorax. This long-acting, inhaled anticholinergic has not yet been approved.

"Exacerbations of COPD and health resource usage were positively affected by daily treatment with tiotropium," write V. Brusasco, from Universita di Genova in Italy, and colleagues. "With the exception of the number of hospital days associated with all causes, salmeterol twice daily resulted in no significant changes compared with placebo."

The investigators enrolled 1,207 COPD patients in two six-month randomized, placebo-controlled, double-blind, double-dummy studies of 18 µg tiotropium once daily via HandiHaler or salmeterol 50 µg twice daily via a metered dose inhaler.

Combined analysis of both trials revealed that compared with placebo, tiotropium but not salmeterol was associated with a significant delay in time to onset of the first exacerbation. Compared with placebo, there were significantly fewer COPD exacerbations per patient-year in the tiotropium group (1.07 vs. 1.49; P < .05), but not in the salmeterol group (1.23; P value was not significant).

Hospital admissions for COPD exacerbations were 0.10 per patient-year in the tiotropium group, 0.17 for salmeterol, and 0.15 for placebo. Hospital admissions for all causes were also reduced in the tiotropium group. Both the tiotropium group and the salmeterol groups had fewer days in hospital than did the placebo group.

The number of days during which patients could not perform their usual daily activities was lowest in the tiotropium group (8.3 ± 0.8 vs. 11.1 ± 0.8 for salmeterol and 10.9 ± 0.8 for placebo; P < .05). Health-related quality of life, as assessed by St. George's Respiratory Questionnaire total score, improved by 4.2 ± 0.7 with tiotropium, 2.8 ± 0.7 with salmeterol, and 1.5 ± 0.7 units with placebo ( P <.01 for tiotropium vs. placebo).

Compared with placebo, focal score on the transitional dyspnea index improved in both the tiotropium group (1.1 ± 0.3 units; P < .001) and in the salmeterol group (0.7 ± 0.3 units; P <.05). Spirometry showed that morning pre-dose FEV 1, peak FEV 1 and mean FEV 1 (0-3 hours) were superior for tiotropium compared with salmeterol, and that both active drugs were more effective than placebo.

"Tiotropium also improved health related quality of life, dyspnea, and lung function in patients with COPD," the authors write.

Boehringer Ingelheim Pharmaceuticals Inc., the maker of tiotropium, supported the study, and three study authors are employees of the company.

Thorax. 2003;58:399-404

Reviewed by Gary D. Vogin, MD

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