Latanoprost and Timolol Combination Therapy vs Monotherapy

Abstract

To compare the efficacy and safety of a fixed combination of 0.005% latanoprost and 0.5% timolol maleate administered once daily vs monotherapy with either 0.005% latanoprost once daily or 0.5% timolol twice daily. Methods: Patients with either primary or secondary open-angle glaucoma or ocular hypertension participated in a 6-month, randomized, double-masked, multicenter study with 3 parallel treatment groups. The double-masked period was preceded by a 2-to 4-week "run-in" treatment with timolol. Subjects could receive fixed combination therapy during a 6-month openlabel extension. Main Outcome Measure: The difference between groups in mean diurnal intraocular pressure reduction in study eye(s) from baseline through 6 months of treatment. Results: Overall, 418 patients were enrolled in the study; 332 completed the open-label phase. Diurnal intraocular pressure levels were similar at baseline, but at week 26, they were 19.9 ± 3.4 mm Hg in the fixed combination therapy group, 20.8 ± 4.6 mm Hg in latanoprosttreated patients, and 23.4 ± 5.4 mm Hg in timololtreated patients (data are given as mean±SD). The mean change from baseline was greater among patients receiving fixed combination therapy compared with each monotherapy group (PϽ.01). Fixed combination therapy effectively lowered intraocular pressure levels for up to 1 year. All treatments were well tolerated. Conclusion: The combination of 0.005% latanoprost and 0.5% timolol administered once daily is effective and well tolerated for up to 12 months.

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…This study showed that the latanoprost/timolol fixed combination caused a further reduction of intraocular pressure when switching from timolol, latanoprost, and the dorzolamide/timolol fixed combination. The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…This study showed that the latanoprost/timolol fixed combination caused a further reduction of intraocular pressure when switching from timolol, latanoprost, and the dorzolamide/timolol fixed combination. The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Changes in intraocular pressure following a switch from latanoprost monotherapy to latanoprost/timolol fixed combination therapy in patients with primary open-angle glaucoma or ocular hypertension: results from a clinical practice database

“…We found a statistically significant mean IOP reduction of 2.6 mmHg after an average of 4.1 months of followup; it is possible that some of the observed reduction may be caused by the regression towards the mean effect, however the observed magnitude is similar to reductions reported in other studies 7,8,[11][12][13] . For example, Hamacher et al 11 found that IOP levels decreased by a mean of 3.7 AE 4.5 mmHg (p50.001) in 53 patients followed for at least 2 months after changing from LM to LTFC.…”

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…This study showed that the latanoprost/timolol fixed combination caused a further reduction of intraocular pressure when switching from timolol, latanoprost, and the dorzolamide/timolol fixed combination. The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Changes in intraocular pressure following a switch from latanoprost monotherapy to latanoprost/timolol fixed combination therapy in patients with primary open-angle glaucoma or ocular hypertension: results from a clinical practice database

“…We found a statistically significant mean IOP reduction of 2.6 mmHg after an average of 4.1 months of followup; it is possible that some of the observed reduction may be caused by the regression towards the mean effect, however the observed magnitude is similar to reductions reported in other studies 7,8,[11][12][13] . For example, Hamacher et al 11 found that IOP levels decreased by a mean of 3.7 AE 4.5 mmHg (p50.001) in 53 patients followed for at least 2 months after changing from LM to LTFC.…”

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…This study showed that the latanoprost/timolol fixed combination caused a further reduction of intraocular pressure when switching from timolol, latanoprost, and the dorzolamide/timolol fixed combination. The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Intraocular Pressure and Safety in Glaucoma Patients Switching to Latanoprost/Timolol Maleate Fixed Combination from Mono- and Adjunctive Therapies

“…The previous regulatory trials are consistent with the findings of this study, in which a further decrease in pressure was noted with timolol and latanoprost monotherapy (1,2). The reason for the greater reduction in pressure with the latanoprost/timolol fixed combination in this study, however, compared to the previous regulatory trials, is not completely explained by our results.…”

Changes in intraocular pressure following a switch from latanoprost monotherapy to latanoprost/timolol fixed combination therapy in patients with primary open-angle glaucoma or ocular hypertension: results from a clinical practice database

“…We found a statistically significant mean IOP reduction of 2.6 mmHg after an average of 4.1 months of followup; it is possible that some of the observed reduction may be caused by the regression towards the mean effect, however the observed magnitude is similar to reductions reported in other studies 7,8,[11][12][13] . For example, Hamacher et al 11 found that IOP levels decreased by a mean of 3.7 AE 4.5 mmHg (p50.001) in 53 patients followed for at least 2 months after changing from LM to LTFC.…”