The Science Journal of the American Association for Respiratory Care

2004 OPEN FORUM Abstracts

The Influence of Concurrent Use of Inhaled Steroids or Long-Acting Beta-Agonists on the Reduction of COPD Exacerbations with Once-Daily Tiotropium in the VA Medical System

D Niewoehner, MD1; K Rice, MD1; L Korducki2; C Cassino, MD2; S Kesten, MD2. 1VA Medical Center, Minneapolis, MN; 2Boehringer Ingelheim, Ridgefield, CT USA.

Background: Exacerbations of COPD are periodic worsenings of COPD that can lead to significant morbidity. We previously reported that tiotropium (TIO) reduces the frequency of COPD exacerbations in a 6-month, prospective, randomized, double-blind, parallel-group, placebo (PBO)-controlled trial in the VA Medical System. We sought to retrospectively explore whether the impact of tiotropium was influenced by concurrent use of inhaled steroids (ICS), or long-acting beta-agonists (LABA).

Method: A COPD exacerbation was defined as >1 respiratory symptom (new onset or increase) for >3 days requiring treatment with antibiotics, steroids, or hospitalization. Patients kept a daily record about their COPD, and exacerbation data was collected by interviews at study visits and by telephone between visits. Data on concomitant medication use prior to study enrollment were collected at the screening visit. Patients were permitted to use all previously prescribed respiratory medications with the exception of open label anticholinergic agents during the treatment period.

Results: 1,829 (TIO=914, PBO=915) patients at 26 VA medical centers were randomized. Mean age 68 yrs; 99% male; mean baseline FEV1=1.04 L (36% predicted). At baseline, a lower FEV1 (% predicted) was observed in those treated with ICS or LABA (34.2% and 33.7%, respectively) compared with those not treated with ICS or LABA (37.5% and 36.8%, respectively). The frequencies of exacerbations, exacerbation days and the ratio (TIO/PBO) are displayed below:

    Exacerbations Exacerbation Days
  n (per patient year) (per patient year)
    TIO PBO Ratio TIO PBO Ratio
ICS 1041 1.020 1.229 0.830* 15.32 18.30 0.837*
No ICS 788 0.619 0.833 0.743* 8.823 13.11 0.673*
               
LABA 713 1.011 1.150 0.879 14.77 16.99 0.869*
No LABA 1216 0.751 0.988 0760* 11.22 15.31 0.733*

*p<0.05

Conclusions: Exacerbations and exacerbation days were reduced with TIO regardless of concomitant therapy with ICS or LABA. An accurate assessment of the absolute magnitude of the impact on exacerbation frequency according to these treatment subgroups can be best assessed in a prospective evaluation with consideration of differences in baseline severity of disease.

Funded by Boehringer Ingelheim and Pfizer.


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