2006 OPEN FORUM Abstracts
Incidence of Exacerbations in COPD Patients of African Descent Participating in a Randomized Clinical Trial of Tiotropium
S. Conoscenti, MD1; Gerard
J. Criner, MD2; Cara Cassino, MD1; Steven Kesten, MD.1 1Boehringer Ingelheim
Pharmaceuticals, Inc., Ridgefield, CT; 2Temple University Hospital,
Background: Tiotropium has been shown to decrease the incidence of COPD exacerbations in clinical studies. In a recent trial of tiotropium in COPD patients of African descent, a pronounced reduction in exacerbations in the tiotropium group was noted. We sought to explore whether differences in the baseline characteristics of the exacerbators vs. non-exacerbators may have contributed to the magnitude of the reduction in exacerbations.
Methods: An 8-week, randomized, double-blind, placebo-controlled study was performed in COPD patients of African descent. Patients were allowed to continue all previously prescribed respiratory medications except open-label anticholinergics. The primary endpoint was FEV1 AUC0-3. COPD exacerbations were identified through adverse event reporting.
Results: COPD exacerbations were reported in 12 patients in the placebo group and 0 patients in the tiotropium group. Eleven of the 12 patients with exacerbations required treatment with steroids and/or antibiotics and 3 of the 12 required hospitalization. Baseline characteristics and respiratory medication use are described below:
|Characteristic||³1 Exacerbation||No Exacerbation|
|Placebo (N = 12)||Placebo (N = 74)||Tiotropium (N = 80)|
|Males [N (%)]||10 (83.3)||42 (56.8)||60 (75.0)|
|Age (yrs)*||61.5 ± 8.9||63.5 ± 9.6||61.8 ± 9.0|
|Current smokers [N (%)]||3 (25.0)||33 (44.6)||42 (52.5)|
|Smoking history (pack-years)*||59.8 ± 46.5||45.0 ± 20.8||45.6 ± 26.7|
|FEV1 (L)*||1.10 ± 0.49||0.95 ± 0.27||1.07 ± 0.43|
|FEV1 % predicted (%)*||40.4 ± 16.2||41.2 ± 10.3||41.9 ± 14.0|
|FVC (L)*||2.22 ± 0.77||2.06 ± 0.62||2.25 ± 0.70|
|Use of respiratory medication [N(%)]|
|Total any respiratory medication||10 (83.3)||61 (82.4)||69 (86.3)|
|Anticholinergics||5 (41.7)||42 (56.8)||49 (61.3)|
|LABA||6 (50.0)||26 (35.1)||41 (51.3)|
|SABA||5 (41.7)||44 (59.5)||55 (68.8)|
|ICS||7 (58.3)||29 (39.2)||44 (55.0)|
|Fixed combination of ICS & LABA||6 (50.0)||21 (28.4)||37 (46.3)|
*Mean ± SD; No patients in the tiotropium group experienced an exacerbation
LABA = long-acting beta-agonist; SABA = short-acting beta agonist; ICS = inhaled corticosteroid
Conclusions: The patients with exacerbations (placebo) showed a lower percentage of active smokers but a higher total number of pack-years than those with no exacerbations (tiotropium or placebo). Lung function was similar between groups. Although differences in baseline medication use were noted, no consistent pattern was identified across the 3 groups. A lower percentage of placebo patients with an exacerbation were taking anticholinergics at enrollment compared with tiotropium and placebo patients with no exacerbation, suggesting that withdrawal of anticholinergics upon entry into the study did not account for the differences in exacerbations noted in the 2 treatment groups. Further evaluation is necessary to determine whether the pronounced reduction in exacerbations in the tiotropium group in this study is indicative of differential responsiveness in this subgroup.
Funded by Boehringer Ingelheim and Pfizer.