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Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma.
- Source :
-
Respiratory medicine [Respir Med] 2014 Sep; Vol. 108 (9), pp. 1355-62. Date of Electronic Publication: 2014 May 02. - Publication Year :
- 2014
-
Abstract
- Background: Long-term corticosteroid use may increase cataract risk. The Lens Opacities Classification System (LOCS) III ranked lens opacities as Class 1: 0.5-0.9 unit; Class 2: 1.0-1.4 units; or Class 3: ≥1.5 units in clinical trials of combined mometasone furoate and formoterol (MF/F) administered by metered-dose inhaler (MDI). We examined retrospectively shifts in lenticular opacity in patients with chronic obstructive pulmonary disease (COPD) or asthma.<br />Methods: We analyzed pooled LOCS III data from two COPD studies and separately analyzed LOCS III data from an asthma study. COPD subjects were randomized to twice daily MF/F 200/10 μg, MF/F 400/10 μg, MF 400 μg, F 10 μg, and placebo; asthma subjects were randomized to MF/F 200/10 μg, MF/F 400/10 μg, fluticasone propionate/salmeterol (FP/S) 250/50 μg, and FP/S 500/50 μg. Lenticular opacity changes were analyzed post hoc for proportions of subjects with LOCS III grade increases ≥0.5, ≥1.0, or ≥1.5 units at weeks 26 and 52.<br />Results: Proportions of subjects in the COPD studies with Class 1 (≥0.5 unit), 2 (≥1.0 unit), or 3 (≥1.5 units) increases in LOCS III at week 26 (N = 1675) ranged from 15.5 to 18.6%, 3.3-6.0%, and 0.9-2.2%, respectively. At week 52 (N = 1085), proportions of active-treated subjects with Class 1, 2, or 3 increases in LOCS III ranged from 26.6 to 28.9%, 6.3-10.7%, and 2.6-5.9%, respectively. Treatment differences in lenticular shifts were generally small and nonsignificant in the asthma study.<br />Conclusion: No clinically relevant trends were observed in the LOCS III assessment of lenticular shifts during treatment of COPD and asthma patients, although further study may be needed to confirm the findings presented here. In these trials, MF/F effects on lens opacity were not observed. (Clinicaltrials.gov numbers: NCT00383435, NCT00383721, and NCT00379288.).<br /> (Copyright © 2014 Elsevier Ltd. All rights reserved.)
- Subjects :
- Adrenergic beta-2 Receptor Agonists administration & dosage
Adrenergic beta-2 Receptor Agonists adverse effects
Adrenergic beta-2 Receptor Agonists therapeutic use
Adult
Cataract diagnosis
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Ethanolamines administration & dosage
Ethanolamines therapeutic use
Formoterol Fumarate
Glucocorticoids administration & dosage
Glucocorticoids adverse effects
Glucocorticoids therapeutic use
Humans
Metered Dose Inhalers
Middle Aged
Mometasone Furoate
Multicenter Studies as Topic
Pregnadienediols administration & dosage
Pregnadienediols therapeutic use
Randomized Controlled Trials as Topic
Severity of Illness Index
Asthma drug therapy
Cataract chemically induced
Ethanolamines adverse effects
Pregnadienediols adverse effects
Pulmonary Disease, Chronic Obstructive drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1532-3064
- Volume :
- 108
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Respiratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 25044280
- Full Text :
- https://doi.org/10.1016/j.rmed.2014.04.015