title: Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma.
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.
  
  
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.).
authors.affiliation: Fundacion CIDEA Allergy and Respiratory Research Unit, Buenos Aires, Argentina. Electronic address: maspero@ciudad.com.ar.
authors.forename: Jorge
authors.initials: J
authors.lastname: Maspero
authors.affiliation: Respiralab Allergy and Respiratory Center, Kennedy Hospital, Guayaquil, Ecuador.
authors.forename: Ivan
authors.initials: I
authors.lastname: Cherrez
authors.affiliation: University of Kentucky, Lexington, KY, USA.
authors.forename: Dennis E
authors.initials: DE
authors.lastname: Doherty
authors.affiliation: David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
authors.forename: Donald P
authors.initials: DP
authors.lastname: Tashkin
authors.affiliation: Medical University of Lodz, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Kuna
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Wen-Ling
authors.initials: WL
authors.lastname: Kuo
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Davis
authors.initials: D
authors.lastname: Gates
authors.affiliation: Merck & Co., Inc., Whitehouse Station, NJ, USA.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Nolte
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Leo T
authors.initials: LT
authors.lastname: Chylack
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D002386:Cataract / Q000139:chemically induced* / Q000175:diagnosis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D036501:Metered Dose Inhalers; D008875:Middle Aged; D000068656:Mometasone Furoate; D015337:Multicenter Studies as Topic; D011244:Pregnadienediols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D004338:Drug Combinations; D004983:Ethanolamines; D005938:Glucocorticoids; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D000068759:Formoterol Fumarate
keywords: Asthma; COPD; Cataract; Inhaled corticosteroid; Lenticular opacity