The efficacy of beta-agonists in elderly patients has received little attention to date. We performed an analysis based on pooled data from 2 large randomized, double-blind, multicenter clinical trials comparing Foradil® dry powder inhalation capsules 12μg b.i.d. (FOR12) and 24μg bid (FOR24) with placebo.
Of a total of 1634 COPD patients randomized, 598 were ≥65 years of age, comprising the elderly subgroup. Serial measurements of FEV1 were performed pre-dose, and 5, 15, 30 and 60 minutes and hourly through 12 hours post AM dose on the first day and after 3 months of treatment.
Elderly patients tended to have slightly lower FEV1 at baseline. Clinically and statistically significant bronchodilation (> 15% increase in FEV1) with both FOR doses compared to placebo was achieved throughout the 12 hour interval as shown by the area under the FEV1 curve (AUC; primary endpoint). These results were similar to the total study population (shown below). The incidence of adverse events (AEs) were also similar in the elderly subgroup compared to the full study population.
FOR provided clinically significant and sustained increases in airflow in elderly patients with COPD that was similar in magnitude to the total study population with a similar tolerability profile.
The elderly is a growing patient population that will have to studied carefully in the future, especially in the area of COPD. This study will give insight as to the efficacy and safety of formoterol in this subgroup.
AUC of FEV1(L x hours)Elderly Patients Trial 1Elderly Patients Trial 2Elderly Patients PooledAll Age Groups PooledContrastN=394N=397N=598N=1158**FOR24 vs Placebo1.701*2.753*2.251*2.430*FOR12 vs Placebo2.127*2.459*2.358*2.475*FOR24 vs FOR12-0.4260.294-0.108-0.045*
Indicates statistical significance at the 0.05 level
Umit Yegen, Employee