PURPOSE: Concerns exist that inhaled corticosteroids may increase risk for ocular disorders in COPD patients. Effects of BUD/FM pMDI on ophthalmologic assessments were examined.
METHODS: In this 12-month randomized, double-blind, parallel-group, multicenter trial (NCT00206167 [N=1964]; Drugs. 2009;69:549-65), ophthalmology assessments were performed in a subset (n=461 with baseline and postbaseline measurements) of patients ≥40 years with moderate to very severe COPD receiving twice-daily BUD/FM pMDI 320/9μg, BUD/FM pMDI 160/9μg, FM DPI 9μg, or placebo. Ophthalmic history, intraocular pressure (IOP), and lenticular opacities (LOs) were assessed at baseline and 6 and 12 months by ophthalmologists certified in the Lens Opacities Classification System III. Decimalized LO scales were used: cortical and posterior subcapsular (PS), 0.1 (clear) to 5.9 (complete opacification); nuclear opalescence or nuclear color, 0.1 (clear) to 6.9 (advanced opacification). Least squares (LS) mean changes from baseline to end of treatment (EOT) in IOP and LOs (PS=most accurate measure of changes associated with corticosteroid use) were evaluated using analysis of covariance; categorical shifts from baseline to EOT were assessed.
RESULTS: In all treatment groups, small increases in IOP and LOs were observed over 12 months. LS mean increases ranged from 0.48 mmHg (BUD/FM 320/9) to 0.69 mmHg (BUD/FM 160/9) for IOP (n=461) and from 0.05 (BUD/FM 160/9) to 0.18 (BUD/FM 320/9) for PS (n=445). In patients with baseline IOP 10-20 mmHg (437/461), shifts to >20 mmHg that were considered clinically important (change of ≥5 mmHg) were few and not associated with a particular treatment. PS shifts ≥0.7 occurred in 11/122 patients in the BUD/FM 320/9 group, 3/105 in the BUD/FM 160/9 group, 5/118 in the FM group, and 5/116 in the placebo group.
CONCLUSION: Findings suggest no evidence of a clinically meaningful effect of BUD/FM pMDI on IOP or LO over 12 months. Increases in IOP and LO were small in all treatment groups with no clinically meaningful imbalance across groups, likely representing aging changes in this population.
CLINICAL IMPLICATIONS: Results enhance understanding of the safety profile of BUD/FM pMDI in COPD patients.
DISCLOSURE: Alan Laties, Grant monies (from industry related sources) This study was funded by AstraZeneca LP. Stephen I Rennard has received grant monies from Almirall, AstraZeneca, Biomark, Centocor, GSK, IFSH, Lorillard, Novartis, Pfizer, Philip Morris, Roche.; Shareholder Ubaldo J. Martin is a shareholder of AstraZeneca stocks.; Employee Lisa J. Suchower and Ubaldo J. Martin are employees of AstraZeneca.; Consultant fee, speaker bureau, advisory committee, etc. Alan Laties is a consultant to AstraZeneca. Stephen I Rennard is a consultant to Abbott, Able Associates, Almirall, Almirall/Forest, Altana, Anthera, APT Pharma/Britnall, Aradigm, AstraZeneca, Boehringer Ingelheim, Britnall and Nicolini, Defined Health, Dunn Group, Eaton Associates, Gerson, GSK, Infomed, Johnson & Johnson, KOL Connection, Leerink Swan, MedaCorp, Mpex, Novartis, Otsuka, Pfizer, Propagate, Pulmatrix, Quintiles, Roche, Scimed, TargeGen, Theravance, United Biosource, Vantage Point, VantagePoint Mgmt; and on the Advisory Board of Abbott, Almirall, Boehringer Ingelheim, COPDForum, Dey, GSK, Novartis, Nycomed, Nycomed/Strategicare, Pfizer, Pharmaxis, Schering-Plough, TargeGen.; Other Stephen I Rennard is a speaker for ACCP, AstraZeneca, Novartis, Network for Continuing Ed, Pfizer, SOMA, Creative Educational Concept, France Foundation. Donald P Tashkin has received grant support (administered through his university), fees for consulting/advisory boards, and/or honoraria for speaking from Boehringer Ingelheim, Pfizer, AstraZeneca, GSK, Schering-Plough, Novartis, Teva, and Dey Labs.; No Product/Research Disclosure Information