The additive intraocular pressure-lowering effect of latanoprost 0.005% daily once and pilocarpine 2% t.i.d. in patients with open-angle glaucoma or ocular hypertension. a 6-month, randomized, multicenter study. German Latanoprost Study Group.
OBJECTIVE
To compare the additional intraocular pressure-lowering effect of latanoprost 0.005% administered once daily with that of pilocarpine 2% administered three times daily in patients with primary open-angle glaucoma or ocular hypertension currently on monotherapy with timolol 0.5% twice daily.


METHODS
In a 6-month, multicenter, randomized, open-label study 242 patients with POAG or OH whose IOP was not controlled with timolol 0.5% b.i.d. were enrolled. Eyes had not been treated with pilocarpine and latanoprost for at least 2 years. An analysis of covariance with diurnal IOP change from baseline to month 6 for study eyes was performed.


RESULTS
Four patients on latanoprost 0.005% and 35 on pilocarpine 2% did not complete the study (P<0.001). Two hundred and forty patients were included in the intent-to-treat analysis. For both treatments the diurnal IOP reduction after 6 months was statistically significant (P<0.001). IOP (mean+/-SD) was reduced from 23.3+/-2.8 to 17.8+/-2.8 (-5.6) mmHg in the latanoprost 0.005% group and from 23.0+/-3.2 to 18.5+/-2.4 (-4.8) mmHg in pilocarpine 2% t.i.d.-treated eyes. The mean difference of -0.8 mmHg (per protocol, PP) and -1.6 mmHg (intend-to-treat, ITT) was statistically significant (P<0.04, PP; P<0.001, ITT) in favor of latanoprost 0.005%. Two eyes treated with latanoprost showed an iris color change. Thirty-six patients in the latanoprost group and 106 in the pilocarpine 2% group reported ocular adverse events (P<0.001).


CONCLUSIONS
From the data we conclude that the additivity of latanoprost 0.005% is at least as effective as pilocarpine 2% t.i.d. in reducing IOP when added to eyes currently on monotherapy with timolol 0.5% b.i.d. Latanoprost was better tolerated than pilocarpine 2% eye drops in this study. The increase in iris pigmentation requires further investigation.
Diestelhorst
M
M
Department of Ophthalmology, University of Cologne, Germany.
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D002940:Circadian Rhythm / Q000502:physiology; D004334:Drug Administration Schedule; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects* / Q000502:physiology; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D008916:Miotics / Q000008:administration & dosage*; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D009883:Ophthalmic Solutions; D010862:Pilocarpine / Q000008:administration & dosage*; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage*; D013999:Timolol / Q000008:administration & dosage; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D008916:Miotics; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D010862:Pilocarpine; D000077338:Latanoprost; D013999:Timolol