SESSION TITLE: COPD Treatment Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM
PURPOSE: To assess the effects of maintenance therapy with tiotropium, a long-acting anticholinergic, on health-related quality of life (HRQoL) in COPD patients using data from 16 clinical trials.
METHODS: Trials included patients with moderate-to-very severe COPD, ≥40 years, smoking history >10 pack-years. Tiotropium was delivered via HandiHaler® (Tio HH; 13 trials) or Respimat® inhaler (Tio R; 3 trials). In the HandiHaler trials, patients were randomized to daily tiotropium 18 μg (13 trials; n=5646), placebo (11 trials; n=4853) and (2 trials) /or (2 trials) active comparator (n=584). In the Respimat trials, patients were randomized to tiotropium 5 μg (Tio R5; 3 trials; n=2219), tiotropium 10 μg (Tio R10; 2 trials, n=619) or placebo (3 trials; n=2318). Treatment duration was 12 weeks to 4 years in the HandiHaler trials and 48 weeks in the Respimat trials. Assessments included: HRQoL, evaluated using the St George’s Respiratory Questionnaire (SGRQ) total score, and the proportion of patients with a minimal clinically important difference (MCID) of ≥4 decrease in SGRQ total score from baseline to trial end.
RESULTS: In the majority of the trials, the mean change in SGRQ total score was statistically significant (P<0.05; tiotropium vs placebo, 12/14 trials; tiotropium vs active comparator, 1/4 trials). Mean change in SGRQ for Tio HH compared with placebo ranged from -1.37 to -6.52 (P<0.05 to <0.0001, 9 trials; P>0.05, 2 trials) and from -1.24 to -4.86 compared with active control (P<0.01, 1 trial; P>0.05, 3 trials). The SGRQ MCID was met in 6 out of 13 HandiHaler trials (5 placebo-controlled, 1 active comparator). In the Respimat trials, the mean change in SGRQ compared with placebo ranged from -2.94 to -3.71(P<0.01, 3 trials) for Tio R5 and -3.45 to -4.24 (P<0.01, 2 trials) for Tio R10. In the HandiHaler trials, responder rate differences for Tio HH vs placebo ranged from 4.4-13.2% at 6 months (9 trials), 7.4-20.4% at 12 months (5 trials) and 8.3-9.0% at 24 months (2 trials). In the Respimat trials responder rate differences at 48 weeks ranged from 7.8-11.8% for Tio R5 (3 trials) and 8.4-13.0% for Tio R10 (2 trials).
CONCLUSIONS: Similar improvements in HRQoL were seen in COPD patients on maintenance therapy with tiotropium whether delivered via HandiHaler or Respimat. Treatment effects differed slightly between trials, possibly due to variations in study design.
CLINICAL IMPLICATIONS: Maintenance therapy with tiotropium delivered via HandiHaler or Respimat can significantly and consistently improve HRQoL in COPD patients.
DISCLOSURE: Donald Tashkin: Grant monies (from industry related sources): BI, Pearl, Sunovion, GSK , Consultant fee, speaker bureau, advisory committee, etc.: BI, AZ, Novartis, Pearl, Sunovion, Forest, Pfizer Paul Jones: Consultant fee, speaker bureau, advisory committee, etc.: BI Thomas Leonard: Employee: BI Dacheng Liu: Employee: BI Norbert Metzdorf: Employee: BI Valentina Zubek: Employee: BI Robert Wise: Grant monies (from industry related sources): GSK, BIPI, Merck, Pearl, Consultant fee, speaker bureau, advisory committee, etc.: GSK, BIPI, Mylan, Spiration, Sunovion, Pulmonx, Intermmune, Merck, Janssen, Medimmune, AZ, Novartis, Genentech
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