Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma.
Author(s): Maspero JF, Nolte H, Cherrez-Ojeda I
Affiliation(s): Fundacion CIDEA, Allergy/Respiratory Research, Buenos Aires, Argentina. email@example.com
Publication date & source: 2010-12, J Asthma., 47(10):1106-15. Epub 2010 Nov 1.
Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: The combination of inhaled corticosteroid (ICS) and long-acting beta-agonist is recommended for treatment of patients with persistent asthma inadequately controlled on ICS monotherapy. This study was conducted to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) administered through metered-dose inhaler (MDI) in patients with persistent asthma previously on medium- to high-dose ICS. METHODS: This was a 52-week, randomized, multicenter, parallel-group, open-label, evaluator-blinded study. At baseline, 404 patients (aged >/=12 years) were stratified according to their previous ICS dose (medium or high), then randomized 2:1 to receive twice-daily treatment of MF/F (200/10 or 400/10 mug) or fluticasone propionate/salmeterol (FP/S; 250/50 or 500/50 mug). The primary endpoint was the number and percentage of patients reporting any adverse event (AE). Additional safety evaluations included plasma cortisol 24-hour area under the curve (AUC(0-24 h)) and ocular changes. Pulmonary function, asthma symptoms, and use of rescue medication were monitored. RESULTS: The incidence of >/=1 treatment-emergent AE was similar across treatment groups (MF/F 200/10 mug, 77.3% [n= 109]; FP/S 250/50 mug, 82.4% [n= 56]; MF/F 400/10 mug, 79.2% [n= 103]; FP/S 500/50 mug, 76.9% [n= 50]). Rates of treatment-related AEs were also similar across treatment groups (MF/F 200/10 mug, 28.4%; FP/S 250/50 mug, 23.5%; MF/F 400/10 mug, 23.1%; FP/S 500/50 mug, 20.0%). Headache (3.7%) and dysphonia (2.7%) were the most common treatment-related AEs overall. The nature and frequency of AEs and the decreases in plasma cortisol AUC(0-24 h) observed with MF/F treatment were similar to those observed with FP/S treatment. Ocular events were rare (2-6% overall incidence among treatment groups); in particular, no posterior subcapsular cataracts were reported. Only three patients discontinued the study because of treatment-related ocular AEs (two for lens disorders in the MF/F 400/10 mug group; one for reduced visual acuity in the FP/S 250/50 mug group) and no asthma-related deaths occurred. Furthermore, MF/F showed numerical improvement in lung function and clinical benefits by reducing asthma symptoms and rescue medication use. CONCLUSIONS: One-year treatment with the new combination therapies - twice-daily MF/F-MDI 200/10 and 400/10 mug - is safe and well tolerated in patients with persistent asthma.