8. ANALIZA COMPARATIVĂ A EFICACITĂŢII ŞI SIGURANŢEI LATANOPROSTULUI, TRAVOPROSTULUI ŞI A COMBINAŢIEI FIXE TIMOLOL-DORZOLAMIDĂ
-STUDIU RANDOMIZAT DUBLU ORB-

CHISELIŢĂ, INGRID ANTOHI, R. MEDVICHI, C. DANIELESCU
IST EYE CLINIC, UNIVERSITY OF MEDICINE AND PHARMACY, IASI

PURPOSE

To analyse comparatively the efficacy and tolerance of latanoprost, travoprost and the fixed combination timolol-dorzolamide in the treatment of primary open angle glaucoma and ocular hypertension.

METHOD

Prospective, investigator masked, randomized study that included 38 patients (38 eyes) with primary open angle glaucoma uncontrolled under beta blockers. Each patient received latanoprost, travoprost and the fixed combination timolol-dorzolamide (for 3 months each). The first drug and the order of the next drugs administered were randomized. The follow up period was 9 months. At the baseline and at the end of each therapeutic period (3 months) we determined the IOP (at 8, 10 a.m. and 4 p.m.), visual acuity, C/D ratio, blood pressure, heart rate and local tolerance. We have also photographed the eyelids, lashes, conjunctiva and iris. After each month of treatment we determined the IOP (at 8 and 10 am), visual acuity, blood pressure, heart rate and local tolerance.

RESULTS

The mean initial IOP was 25.1 2.89 mmHg and after 9 months of treatment 21.67 4.59mmHg. Each drug induced a statistically significant IOP decrease (the fixed combination timolol-dorzolamide decreased IOP with 14.33%, travoprost with 18.39% and latanoprost with 22.1%). The IOP lowering was comparable for the prostaglandin derivatives and superior to the fixed combination timolol-dorzolamide. None of these drugs had a negative influence on the visual field, C/D ratio, visual acuity, blood pressure and heart rate.

There was good local tolerance. The side effects were more frequent after travoprost (37) and latanoprost (22) than after the fixed combination timolol-dorzolamide (4 cases). The most important adverse events for the prostaglandin derivatives were conjunctival hyperemia, eyelashes pigmentation and growth, iris pigmentation. There was no necessary to stop the medication because of these effects.

CONCLUSIONS

Travoprost, latanoprost and the fixed combination timolol-dorzolamide are efficient in the treatment of primary open angle glaucoma. The prostaglandin derivatives determined similar IOP decrease, which was superior to the fixed combination timolol-dorzolamide; the local tolerance was good, the fixed combination causing the fewest side effects.

KEYWORDS: glaucoma, ocular hypertension, intraocular pressure, travoprost,latanoprost, fixed combination timolol-dorzolamide, efficacy, safety.