Tolerability of nepafenac evaluated in patients

March 15, 2008

Analysis of the effect of nepafenac 0.1% (Nevanac, Alcon Laboratories) indicated that compared with diclofenac 0.1% (Voltaren, Novartis Pharmaceuticals) nepafenac might be more tolerable by patients after cataract surgery.

Key Points

Des Plaines, IL-Analysis of the effect of nepafenac 0.1% (Nevanac, Alcon Laboratories) indicated that compared with diclofenac 0.1% (Voltaren, Novartis Pharmaceuticals) nepafenac might be more tolerable by patients after cataract surgery, said James Katz, MD, who is in private practice in Des Plaines, IL. Nepafenac scored better than diclofenac in the areas of pain, burning, stinging, and discomfort.

Both drugs are anti-inflammatory agents. Nepafenac 0.1% is approved to treat pain and inflammation associated with cataract surgery, and diclofenac 0.1% is indicated to treat inflammation resulting from cataract surgery and pain following corneal refractive surgery.

Dr. Katz and colleague Don Digby, MD, compared the tolerability of the drugs administered according to their approved labels in cataract patients undergoing phacoemulsification. Dr. Digby is in private practice in High Point, NC.

The two patient groups were similar. Twenty-three patients (11 men, 12 women; mean age, 68.86 ± 0.65 years) received nepafenac, and 27 patients (14 men, 13 women; mean age, 72.51 ± 7.93) received diclofenac.

Dr. Katz reported that the pain score was significantly lower for the patients who received nepafenac compared with those who received diclofenac on days 1, 3, 8, and 14 (p = 0.0369, p = 0.0214, p = 0.0031, and p = 0.0397, respectively). On the six-point pain scale, the mean scores for nepafenac were 1.06, 1.19, 1.06, and 1.06 at the respective examination, compared with 2.53, 2.43, 2.79, and 2.41 for diclofenac at the same time points.

The subjective evaluation of burning also yielded significantly lower scores for nepafenac compared with diclofenac. On a six-point scale ranging from 0 to 5 with higher scores indicating more burning, the mean scores for nepafenac at the four evaluations were 1.20, 1.24, 1.18, and 1.23 compared with 3.94, 3.67, 3.65, and 3.00 for diclofenac at the same time points (p = 0.0070, p = 0.0010, p = 0.0008, p = 0.0079, respectively).

The results of the stinging assessment were similar, with nepafenac receiving the following scores: 1.19, 1.25, 1.24, and 1.44 at the respective evaluations compared with 3.41, 3.43, 3.67, and 2.58 for diclofenac (p = 0.0198, p = 0.0038, p = 0.0013, and p = NS, respectively).

Nepafenac also scored better in its ability to soothe the eye. The scores at the four evaluations were 1.77, 1.50, 1.43, and 1.45 for nepafenac compared with 2.92, 2.92, 2.85, and 2.22 for diclofenac (p = NS, p = 0.0363, p = 0.0279, and p = NS, respectively).

The evaluation of discomfort yielded the following scores for nepafenac: 1.31, 1.56, 1.47, and 1.56, compared with 3.00, 2.50, 3.15, and 2.39 for diclofenac (p = 0.0434, p = NS, p = 0.0353 and p = NS, respectively).

Nepafenac also was determined to be superior to diclofenac at one time point in irritation, itchiness, comfort, and tearing. No difference was seen between the two drugs at four time points in their ability to moisturize the ocular surface, their smoothness, and in a pulsing sensation.

Based on these results, Dr. Katz found that nepafenac 0.1% showed a statistically significant advantage over diclofenac 0.1% in several tolerability categories, despite the small sample size of 50 patients.

"These data suggest that nepafenac 0.1% may be more tolerable than diclofenac 0.1% to patients after cataract surgery and warrants further investigation in a larger randomized trial," he concluded.