Xalatan Monotherapy Equivalent To Timolol/Dorzolamide Combination For IOP
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Xalatan Monotherapy Equivalent To Timolol/Dorzolamide Combination For IOP

NEW ORLEANS, LA -- Nov. 11, 1998 -- Patients with open-angle glaucoma switched to Xalatan (latanoprost ophthalmic solution) monotherapy experienced the same reduction in intraocular pressure (IOP) as do patients taking a combination of timolol (a commonly used beta blocker) and dorzolamide (a carbonic anhydrase inhibitor), according to German researchers. Open-angle glaucoma is a leading cause of blindness.

Xalatan, from Pharmacia & Upjohn, is indicated for patients who are intolerant of or insufficiently responsive to other IOP-lowering medication.

The results of this open-label study demonstrate that a switch to latanoprost monotherapy after two to four weeks on timolol is an effective alternative to combination therapy with two aqueous flow suppressors. IOP reduction was achieved following a switch from timolol to latanoprost in this group and the addition of dorzolamide to timolol in other patients not adequately controlled on timolol alone.

"These results represent useful information for the management of glaucoma patients," said Karl-Heinz Emmerich, M.D. of the Darmstadt Eye Clinic at the Academic Hospital of the University of Frankfurt, Germany, who presented this study at the American Academy of Ophthalmology annual meeting in New Orleans, LA. "Latanoprost should be considered as an alternative for patients in whom timolol no longer controls the IOP sufficiently.

“And, since this study shows that latanoprost as once-daily monotherapy has the same effect on IOP as a combination of other glaucoma medications, treatment compliance can be expected to benefit.”

One hundred and eighty-three patients with primary open-angle glaucoma, capsular glaucoma or ocular hypertension were enrolled in the three-month randomised, open-label, multicentre study. Ninety patients were randomised to latanoprost and 93 to the combination of timolol and dorzolamide. After a two to four week run-in period on timolol, 5mg ml/twice daily, the patients were randomised to treatment with either latanoprost, 50 mcg/ml once daily, or the combination of timolol, 5 mg/ml twice daily and dorzolamide 20 mg/ml twice daily.

At baseline, the mean diurnal IOP was 22.2 plus/minus 2.3 mmHg for patients randomised to treatment with latanoprost and 22.2 plus/minus 2.1 mmHg for patients randomised to timolol plus dorzolamide. Change in mean diurnal IOP was the primary endpoint after three months of treatment as compared to baseline.

Switching from timolol to latanoprost reduced mean diurnal IOP by 4.5 plus/minus 0.2 mmHg and adding dorzolamide to timolol reduced mean diurnal IOP by 4.4 plus/minus 0.2 mmHg. At the end of the study, the mean diurnal IOP was 17.6 plus/minus 2.0 for patients randomised to treatment with latanoprost, reducing IOP by 20 percent and 17.6 plus/minus 1.9 mmHg for patients randomised to timolol plus dorzolamide, also reducing IOP by 20 percent. No serious side effects were observed with either treatment.

Patients were examined at baseline, after two weeks and after three months of treatment with the study medications. Three measurements were taken for each eye, alternating between the eyes. Each of the three measurements were used in the analysis.

"The effects of latanoprost after two weeks of treatment were identical to the effect seen at the end of the study," Dr. Emmerich said. "Significant improvement with latanoprost was observed quite early."

Glaucoma is a complex group of eye disorders having a common feature of optic nerve damage. It is a leading cause of blindness and vision loss affecting more than three million people, up to half of whom are undiagnosed. Conditions commonly associated with glaucoma include elevated intraocular pressure, cupping of the optic disc and loss of visual field. The pressure comes from an inability of the eye to drain the fluid properly. There are usually no warning signs with glaucoma.

Xalatan is related to the class of compounds, prostaglandins, which are naturally present in various forms throughout the body. In the eye, prostaglandins appear to act locally to increase drainage of aqueous humor and reduce intraocular pressure. The most frequently reported side effects of glaucoma patients who were treated with Xalatan include blurred vision, burning and stinging, conjunctival hyperemia, foreign-body sensation, increased iris pigmentation, itching and punctate epithelial keratopathy.

Related Links: Xalatan and Pharmacia & Upjohn

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