Healio
Healio
February 01, 2001
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Latanoprost lowers IOP better than unoprostone

An 8-week randomized study compared their efficacy in patients with glaucoma or ocular hypertension.

SAO PAULO, Brazil — Xalatan lowered IOP more effectively than Rescula, in a study conducted by Remo Susanna Jr., MD, director of the glaucoma service at the University of Sao Paulo.

The 8-week, randomized, double-masked study compared the efficacy and safety of Xalatan (latanoprost 0.005% ; Pharmacia Corp.) once daily to Rescula (unoprostone 0.12%; CIBA Vision) twice daily.

Patients randomized

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Dr. Susanna enrolled patients 18 years or older with unilateral or bilateral glaucoma or ocular hypertension.

Inclusion criteria included untreated primary open-angle glaucoma (POAG) greater than or equal to 21 mm Hg at baseline or untreated ocular hypertension greater than or equal to 25 mm Hg at baseline. Treated patients needed to have more than 21 mm Hg at baseline after a washout period.

Patients were excluded for previous treatment with latanoprost or unoprostone, a history of angle-closure glaucoma, or any ocular surgery, inflammation or infection within the previous 3 months.

Latanoprost patients received a placebo in the morning and a drug in the evening. Unoprostone patients received the drug twice daily.

Patients in the latanoprost group were a mean of 63 ±12 years old, with a range of 33 to 81 years. In this group of 54 patients, 33 were white, 14 were black, one was Asian, three were Hispanic and three were of other races. Also, 48 had POAG and five had ocular hypertension. One diagnosis was missing.

Two patients in the latanoprost group were lost to follow-up and one withdrew because of an adverse event.

In the unoprostone group, patients were a mean of 62 ±13 years old, with a range from 28 to 88 years. Of the 54 patients, 35 were white, 13 were black, and six were other races. Also, 48 had open-angle glaucoma and six had ocular hypertension.

In this group, two withdrew because of adverse events. One event, angina pectoris, was considered serious. Two more were lost to follow-up, one withdrew consent, one was noncompliant and one had uncontrolled IOP.

Magnitude of reduction

Latanoprost showed a mean IOP reduction of 6.7 mm Hg (28%) at 8 weeks. Unoprostone showed a mean reduction of 3.3 mm Hg (14%) at 8 weeks.

Also, 74% of latanoprost patients achieved more than a 20% reduction in IOP, 40% achieved more than a 30% reduction in IOP and 14% achieved more than a 40% reduction. In the unoprostone group, 27% of patients achieved more than a 20% reduction, 2% achieved more than a 30% reduction and none achieved a 40% reduction.

“This magnitude of IOP reduction has been shown to be important in halting or decreasing the rate of visual field progression in normotensive glaucomas,” Dr. Susanna said. “It may be more important in hypertensive glaucomas, in which IOP may be a more important causal factor.”

He added that only 10% of latanoprost patients were considered nonresponders with less than 10% IOP reduction, while 27% of unoprostone patients were nonresponders.

Adverse events

In the latanoprost group, seven patients experienced ocular irritation and three experienced conjunctivitis. One had a conjunctival hemorrhage, one had hypertrichosis, one experienced a change in iris pigmentation and one had a mild change of visual acuity. Systemically, one patient had back pain and one had a tongue fissure.

In the unoprostone group, three had ocular irritation, five had conjunctivitis, one had corneal deposits, one had conjunctival hyperemia, one had an ocular trauma, one had chalazion and one had a mild change in visual acuity. Systemically, one had angina pectoris, one had depression and one had headaches.

“The side effects are similar between both drugs, but latanoprost administered once per day was more effective than unoprostone administered twice daily,” Dr. Susanna said.

For Your Information:
  • Remo Susanna Jr., MD, can be reached at Glaucoma Service, University of Sao Paulo Department of Ophthalmology, Av Sao Gualter 99, Sao Paulo, 05455-000, Brazil; +(55) 11-3022-2738; fax: +(55) 11-3022-4300. Dr. Susanna has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any company mentioned.
  • Pharmacia Corp. can be reached at 100 Route 206 N, Peapack, NJ 07977 U.S.A.; +(1) 908-901-8517; fax: +(1) 908-901-1874.
  • CIBA Vision can be reached at 11460 Johns Creek Parkway, Duluth, GA 30097-1556 U.S.A.; +(1) 678-415-3646; fax: +(1) 678-415-3592.