Jorge Maspero1, Ivan Cherrez2, Dennis E Doherty3, Donald P Tashkin4, Piotr Kuna5, Wen-Ling Kuo6, Davis Gates6, Hendrik Nolte6, Leo T Chylack7. 1. Fundacion CIDEA Allergy and Respiratory Research Unit, Buenos Aires, Argentina. Electronic address: maspero@ciudad.com.ar. 2. Respiralab Allergy and Respiratory Center, Kennedy Hospital, Guayaquil, Ecuador. 3. University of Kentucky, Lexington, KY, USA. 4. David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. 5. Medical University of Lodz, Poland. 6. Merck & Co., Inc., Whitehouse Station, NJ, USA. 7. Harvard Medical School, Boston, MA, USA.
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. 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.).
RCT Entities:
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. CONCLUSION: No clinically relevant trends were observed in the LOCS III assessment of lenticular shifts during treatment of COPD and asthmapatients, 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.).