A 12-Week, Randomized, Double-Masked, Multicenter Study of the Fixed Combination of Latanoprost and Timolol in the Evening versus the Individual Components

Diestelhorst, Michael; Li, Larsson

doi:10.1016/j.ophtha.2005.06.027

Cited by 89 publications

(65 citation statements)

References 22 publications

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“…However, on comparison between the two groups there was no statistically significant difference (P > 0.05) thereby suggesting equal efficacy of both the groups in reducing IOP and thus failing to prove the superiority of the two groups over each other. This is in accordance to the previously published reports Diestelhorst et al [18] and Zhao et al [19] who revealed the similar efficacy of both the groups in reducing IOP. In addition, fixed combination was found to be non-inferior to the concomitant administration of both the drugs.…”

Section: Discussionsupporting

confidence: 93%

Evaluation of efficacy of the fixed vs unfixed combination of latanoprost and timolol in patients of open-angle glaucoma and ocular hypertension insufficiently controlled on timolol and latanoprost monotherapy

Gupta¹,

Gupta²,

Gupta³

et al. 2017

Natl J Physiol Pharm Pharmacol

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Background: Glaucoma is a term describing a group of ocular disorders with multifactorial etiology united by a clinically characteristic intraocular pressure (IOP) associated optic neuropathy. Elevated IOP is identified as the only known risk factor which can be modified by anti-glaucomatous treatments. Patients who do not achieve target IOP levels with a single ocular hypotensive agent often are prescribed concomitant therapy with a medication that has a different mechanism of action. Aims and Objectives: The aim was to evaluate the efficacy of the fixed and unfixed combinations of latanoprost and timolol in patients of open-angle glaucoma and ocular hypertension (OH). Materials and Methods: A comparative randomized open-label trial was conducted on newly diagnosed patients of open-angle glaucoma and OH who were receiving either latanoprost 0.005% once daily or either timolol SR 0.5% once or twice daily in the preceding 4 weeks and whose IOP was not controlled with the prior monotherapy of latanoprost or timolol and remained ≥21 mmHg were included in the study. Patients were randomized to two groups to receive the following medication -Group I: Fixed combination eye drops of latanoprost (0.005%) and timolol SR (0.5%), once a day, in the dose of 1 drop at 9 LTFC and Group II: Unfixed combination of latanoprost (0.005%), once a day in the dose of 1 drop at 9 pm and timolol SR (0.5%), once a day in the dose of 1 drop at 9 am (LTuFC). Patients were evaluated at 0, 2, 4, 6, and 12 weeks for the assessment of IOP and Visual acuity. Results: Both LTFC (Group I) and LTuFC (Group II) caused a reduction in IOP which was statistically highly significant (P < 0.01) at all the intervals but on comparison both the groups affected the IOP in a similar fashion and demonstrated no difference statistically (P > 0.05). Conclusion: Both the regimens on comparison revealed similar efficacy thereby failing to prove superiority over each other. Thus, the clinicians have a wider choice of fixed or unfixed combinations of latanoprost and timolol, when monotherapy of either drug fails.

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Section: Discussionsupporting

confidence: 93%

Evaluation of efficacy of the fixed vs unfixed combination of latanoprost and timolol in patients of open-angle glaucoma and ocular hypertension insufficiently controlled on timolol and latanoprost monotherapy

Gupta¹,

Gupta²,

Gupta³

et al. 2017

Natl J Physiol Pharm Pharmacol

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“…Diestelhorst and Larsson 23 showed that the latanoprost/timolol fixed combination (Xalacom TM , Pfizer Inc., New York, NY, USA), dosed in the morning, was 1.1 mmHg less effective than its unfixed combination (latanoprost dosed in the evening, timolol dosed twice daily). However, a repeat study by Diestelhorst and Larsson, 24 with evening dosing of latanoprost, found the fixed combination only 0.3 mmHg less effective than the unfixed combination. In addition, several articles have evaluated morning-dosed travoprost/timolol fixed combination with its unfixed components (travoprost dosed in the evening and timolol once daily).…”

Section: Discussionmentioning

confidence: 94%

“…3 In previous trials, with the exception of Goni and co-workers, there were differences in the frequency of dosing between the fixed and unfixed therapy combinations (eg, timolol once versus twice daily or dorzolamide twice versus three times daily) or with the dosing schedule (eg, the prostaglandin dosed in the evening versus morning). 23,24,27,28 These design differences in the dosing may have accounted for the small differences in pressures between the fixed and unfixed combinations in previous studies.…”

Section: Eyementioning

confidence: 98%

Twenty-four-hour efficacy of the brimonidine/timolol fixed combination versus therapy with the unfixed components

Konstas

Katsimpris

Kaltsos

et al. 2007

Eye

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Purpose To evaluate the 24-h intraocular pressure (IOP) control of brimonidine/timolol fixed combination (BTFC) versus the unfixed combination of its individual components, each dosed twice daily, in patients with primary open-angle glaucoma or ocular hypertension. Methods An observer-masked, randomized, crossover, active-controlled, two-centre comparison. Following a 6-week medicine-free period, patients were randomized to BTFC or to the unfixed combination of brimonidine and timolol for 3 months. Patients then were crossed over to the opposite treatment for another 3 months. At the end of the medicinefree period, and each treatment period, patients underwent 24-h IOP measurements at 0600, 1000, 1400, 1800, 2200, and 0200 hours. Results Twenty-eight patients completed this study. Both BTFC and the unfixed components showed a significant IOP reduction from untreated baseline (Po0.0001), and were statistically equal when compared directly, for each individual time point and for the 24-h IOP curve (P40.05). The mean 24-h IOP was 24.671.9 for baseline, 19.271.9 for BTFC, and 19.271.6 mmHg for the unfixed components (P ¼ 1.0). Four patients were discontinued due to side effects. The most common ocular adverse event was ocular hyperaemia (n ¼ 3 with BTFC and n ¼ 5 with the unfixed components, P ¼ 0.7) and systemic adverse events were rare. Conclusion This study suggests that both BTFC and the unfixed components of brimonidine and timolol provide a significant 24-h IOP reduction from untreated baseline, and statistically equal control when compared directly, at each time point and for the 24-h pressure curve.

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“…17,28 In the present research, both combination therapies showed a mean IOP-reducing effect from baseline of about 35%. As far as FC latanoprost/timolol is concerned, this level of reduction is toward the high end of the range of decreases found in previous studies 31,[33][34][35][36][37][38][39] with morning dosing and no timolol run-in (range, 31.5-36.0%). With regard to the FC 40 use of systemic b-blockers was not an exclusion criterion in this study if the subject and dosage were stable for 3 months before screening and if the dosage was not expected to change during the study.…”

Section: Fixed-combination Ocular Hypotensives S Miglior Et Almentioning

confidence: 55%

Efficacy and safety of fixed combinations of latanoprost/timolol and dorzolamide/timolol in open-angle glaucoma or ocular hypertension

Miglior

Grunden

Kwok

2009

Eye

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Aims To compare intraocular pressure (IOP) reductions with fixed-combination (FC) latanoprost/timolol once daily in the evening vs FC dorzolamide/timolol twice daily. Methods This evaluator-masked, multicentre, controlled clinical trial randomized subjects with primary open-angle glaucoma or ocular hypertension with IOP insufficiently responsive to b-blocker therapy (screening IOP421 and o37 mm Hg) to FC latanoprost-timolol (N ¼ 135) or FC dorzolamide/timolol (N ¼ 135). At screening, baseline, and after 4 and 12 weeks of therapy, IOP was measured three times at 0800, 1200, and 1600 hours. Adverse events were recorded at each visit. The primary efficacy end point was whether either FC could be shown to be inferior to the other with respect to change in mean daytime IOP from baseline to week 12. Results Mean daytime IOP levels were similar at baseline. Mean reductions in daytime IOP from baseline to week 12 were À9.7 mm Hg for FC latanoprost-timolol and À9.5 mm Hg for FC dorzolamide/timolol. The difference between FC latanoprost/ timolol-FC dorzolamide-timolol was À0.2 mm Hg (95% confidence interval (CI), À0.8 to -0.4 mm Hg). The upper bound of the 95% CI was o1.5 mm Hg, indicating that neither FC is inferior to the other. However, a significantly greater percentage of subjects treated with FC latanoprost/timolol achieved IOP levels p16 and p15 mm Hg (Pp0.01). Both treatments were well tolerated. Conclusions When b-blocker therapy is inadequate, either FC may achieve the desired IOP level, but FC latanoprost/timolol more oftenly achieves a pressure of p16 mm Hg. Both FCs were well tolerated.

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A 12-Week, Randomized, Double-Masked, Multicenter Study of the Fixed Combination of Latanoprost and Timolol in the Evening versus the Individual Components

Cited by 89 publications

References 22 publications

Evaluation of efficacy of the fixed vs unfixed combination of latanoprost and timolol in patients of open-angle glaucoma and ocular hypertension insufficiently controlled on timolol and latanoprost monotherapy

Evaluation of efficacy of the fixed vs unfixed combination of latanoprost and timolol in patients of open-angle glaucoma and ocular hypertension insufficiently controlled on timolol and latanoprost monotherapy

Twenty-four-hour efficacy of the brimonidine/timolol fixed combination versus therapy with the unfixed components

Efficacy and safety of fixed combinations of latanoprost/timolol and dorzolamide/timolol in open-angle glaucoma or ocular hypertension

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