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Impressum
A safety and efficacy evaluation of latanoprost (Xalatan®) versus the fixed combination of dorzolamide and timolol (Cosopt®) in patients with open angle glaucoma
1Hamacher T., 2Spiegel D., The Latanoprost Study Group
1Augenarztpraxis Starnberg, Maximilianstr. 2b, 82319 Starnberg, 2Universitätsklinikum, Franz-Josef Strauss Allee 1, 93053 Regensburg
Objective: A comparison of the intraocular pressure (IOP) lowering
effect of latanoprost (Lat) monotherapy to the fixed combination of dorzolamide
+timolol (Dor+Tim) in patients with uncontrolled IOP.
Methods: This prospective, multinational, open label study enrolled
patients with unilateral or bilateral open angle glaucoma or pseudo-exfoliative
glaucoma currently on mono- or dual therapy with a beta-blocker. 226 patients
with IOP >/= 21mmHg after 3 to 6 weeks of run-in treatment with 0.5%
Tim twice daily were randomized 1:1 to receive Lat once daily in the evening
(10 p.m.) or Dor+Tim twice daily (8 a.m. and 10 p.m.). Diurnal IOP average
of 10 a.m. and 5 p.m. measurements was recorded at the baseline (randomization)
visit and after 3 months of treatment.
Results: 103 Lat patients and 102 Dor+Tim patients were included.
At baseline, mean diurnal IOP was similar in the Lat and Dor+Tim groups,
23.2 and 23.1mmHg, respectively. After 3 months, least square mean analysis
showed both treatments resulted in a statistically significant (p<0.001)
reduction in diurnal IOP (Lat, -4.3mmHg/-19%; Dor+Tim, -4.0 mmHg/-17%).
The IOP-lowering effects of Lat and Dor+Tim were not statistically different
based on the 95% confidence interval (-1.1, 0.4 mmHg) for the difference
in mean diurnal IOP reduction between groups. The percentage of patients
achieving diurnal IOP reduction >/= 20% was higher in the Lat group
(52%) compared to the Dor+Tim group (43%). Mean IOP reductions at 10 a.m.
and 5 p.m. were statistically significant (p<0.001) in both the Lat
(-4.1 mmHg, -4.6 mmHg) and Dor+Tim groups (-4.2 mmHg, -3.8 mmHg). At 10
a.m. the two treatments had a comparable IOP-lowering effect, while at
5 p.m. Lat had a slightly better effect in reducing IOP (p=0.0454). Both
medications were welltolerated.
Conclusion: Monotherapy with latanoprost once daily is at least
as effective as twice daily treatment with Dor+Tim in patients with IOP
uncontrolled by Tim alone.