Bromfenac trial suggests possibility of twice-daily corticosteroid dosing

June 1, 2009

A prospective, randomized, investigator-masked study was conducted to compare twice-daily and four-times-daily dosing of a corticosteroid after cataract surgery. All patients also received bromfenac 0.09% (Xibrom, Ista Pharmaceuticals). No significant differences in macular thickening or anterior chamber cell and flare were observed between groups.

Key Points

San Francisco-In patients being treated with bromfenac 0.09% (Xibrom, ISTA Pharmaceuticals) twice daily after uncomplicated cataract surgery, reducing the dosing frequency of concomitant topical corticosteroid treatment from the standard four-times-daily regimen to twice daily may be a reasonable option, according to results of a randomized, investigator-masked, multicenter study presented at the annual meeting of the American Society of Cataract and Refractive Surgery.

The study included 95 patients who began twice-daily bromfenac therapy 3 days before surgery and continued taking the topical non-steroidal anti-inflammatory drug (NSAID) for 4 weeks after surgery, said Carlos Buznego, MD, the principal investigator, who works with William B. Trattler, MD, at Center for Excellence in Eye Care in Miami.

Prednisolone acetate 1% (Pred Forte, Allergan) was started after surgery and continued for 4 weeks on a twice-daily (50 patients) or four-times-daily (45 patients) regimen, and all patients also used a fourth-generation fluoroquinolone pre- and postoperatively for endophthalmitis prevention. The two study groups were well-matched with respect to surgical time and type of cataract.

"A [four-times-daily] regimen of prednisolone acetate is standard in patients who undergo cataract surgery, although we are not aware of any studies that have investigated whether this dosing frequency is really optimal," he said. "Reducing the dosing frequency of a corticosteroid would be expected to minimize corticosteroid-related risks, but its efficacy has not been determined.

"Our study may not have been sufficiently powered to demonstrate statistical significance of small differences between groups. However, the differences observed were not clinically relevant," he said. "We believe the results suggest that when used with the potent topical NSAID bromfenac, the simpler, [twice-daily] corticosteroid regimen does not appear to increase the risk of inflammation-related sequelae after cataract surgery."

Bromfenac was chosen for the NSAID treatment because it has the simplest dosing regimen among all ophthalmic NSAIDs, Dr. Buznego said.

Macular thickness was measured with ocular coherence tomography as an objective assessment of edema. The mean value was 210.2 µm in both the four-times-daily and twice-daily groups preoperatively. At the last visit, mean macular thickness essentially was unchanged from baseline in the four-times-daily group (209.5 µm) and had increased slightly in the twice-daily group (215.4 µm), but the difference between groups was not statistically significant.

BCVA, IOP differences

Mean logMAR BCVA at the last visit was 0.04 in the four-times-daily group and 0.08 in the twice-daily group. The difference between groups of approximately one line was statistically significant (p = 0.02). The reason for the difference was unclear to the investigators, because it did not appear to be accounted for by any difference between groups in inflammation-related events, Dr. Buznego said.

"If the BCVA was worse because of greater inflammation in patients using the corticosteroid [twice daily], we would have expected to also see differences in macular thickening or anterior chamber cell and flare, but these were not observed," he said. "Perhaps in the case of the BCVA outcome, the statistical difference is due to chance."

Mean IOP at 4 weeks was 14.36 mm Hg in the twice-daily group and 15.95 mm Hg in the four-times-daily group (p = 0.015).

"Although the difference between groups is statistically significant, the mean values are still within the normal range in both groups," Dr. Buznego concluded.

Related Content:

News