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.