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Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America.

Abstract

BACKGROUND

The newer ocular hypotensive agents available to treat glaucoma and ocular hypertension (OHT) include latanoprost, a prostaglandin F(2alpha) analogue, and the fixed combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker.

OBJECTIVE

The aim of this study was to compare the efficacy and tolerability of latanoprost with that of the fixed combination of dorzolamide and timolol over 8 weeks.

METHODS

This interventional, 8-week, randomized, open-label, parallel-group study was conducted at 18 centers in 6 Latin American countries. Patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT were randomized to receive latanoprost, 1 drop in the affected eye QD (evening), or fixed-combination dorzolamide/timolol, 1 drop in the affected eye BID (morning and evening). Medications were self-administered, 1 drop per affected eye. At baseline and week 8, intraocular pressure (IOP) was measured 3 times each at 8:30 am, 10:00 am, 2:00 pm, and 5:00 pm and after the water-drinking test, which estimates the IOP peak of diurnal tension curve, performed following the 5:00 pm IOP assessment. The primary efficacy outcome was change in diurnal IOP (the mean of IOP measurements) from baseline to week 8. Adverse effect (AE) data were recorded at each visit.

RESULTS

A total of 229 patients were randomized (latanoprost, n = 112; dorzolamide/timolol, n = 117). Mean baseline diurnal IOP values were similar between the 2 groups. Mean (SD) diurnal IOP reductions at week 8 before the water-drinking test were 6.9 (3.0) mm Hg for the latanoprost group and 6.4 (3.2) mm Hg for the dorzolamide/timolol group. Mean IOP values were similar at all time points except at 5:00 pm, when levels were significantly lower in latanoprost-treated patients (P = 0.025). After the water-drinking test, the increase in IOP values was similar between groups at baseline but lower in latanoprost-treated patients at week 8 (adjusted difference, 1.08 mm Hg; P = 0.012). Fewer patients treated with latanoprost reported ocular or systemic AEs (P = 0.025 and P < 0.001, respectively).

CONCLUSIONS

In this study of patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT IOP reductions generally were similar between treatment groups, except at 5:00 pm, when the mean IOP level was significantly lower in latanoprost-treated patients. Latanoprost was better tolerated than fixed-combination dorzolamide and timolol.

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  • Authors+Show Affiliations

    ,

    Glaucoma Service, University of São Paulo, Av. São Gualter 99, 05455-000 São Paulo, Brazil. rsusanna@terra.com.br

    , ,

    Source

    Clinical therapeutics 26:5 2004 May pg 755-68

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Antihypertensive Agents
    Drug Combinations
    Female
    Glaucoma, Open-Angle
    Humans
    Intraocular Pressure
    Latanoprost
    Male
    Middle Aged
    Ocular Hypertension
    Prostaglandins F, Synthetic
    Sulfonamides
    Thiophenes
    Timolol

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    15220019

    Citation

    Susanna, Remo, et al. "Comparison of Latanoprost With Fixed-combination Dorzolamide and Timolol in Adult Patients With Elevated Intraocular Pressure: an Eight-week, Randomized, Open-label, Parallel-group, Multicenter Study in Latin America." Clinical Therapeutics, vol. 26, no. 5, 2004, pp. 755-68.
    Susanna R, Sussana R, Sheu WP, et al. Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America. Clin Ther. 2004;26(5):755-68.
    Susanna, R., Sussana, R., & Sheu, W. P. (2004). Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America. Clinical Therapeutics, 26(5), pp. 755-68.
    Susanna R, et al. Comparison of Latanoprost With Fixed-combination Dorzolamide and Timolol in Adult Patients With Elevated Intraocular Pressure: an Eight-week, Randomized, Open-label, Parallel-group, Multicenter Study in Latin America. Clin Ther. 2004;26(5):755-68. PubMed PMID: 15220019.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America. AU - Susanna,Remo,Jr AU - Sussana,Remo,Jr AU - Sheu,Wang-Pui, AU - ,, PY - 2004/03/08/accepted PY - 2004/6/29/pubmed PY - 2004/9/4/medline PY - 2004/6/29/entrez SP - 755 EP - 68 JF - Clinical therapeutics JO - Clin Ther VL - 26 IS - 5 N2 - BACKGROUND: The newer ocular hypotensive agents available to treat glaucoma and ocular hypertension (OHT) include latanoprost, a prostaglandin F(2alpha) analogue, and the fixed combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of latanoprost with that of the fixed combination of dorzolamide and timolol over 8 weeks. METHODS: This interventional, 8-week, randomized, open-label, parallel-group study was conducted at 18 centers in 6 Latin American countries. Patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT were randomized to receive latanoprost, 1 drop in the affected eye QD (evening), or fixed-combination dorzolamide/timolol, 1 drop in the affected eye BID (morning and evening). Medications were self-administered, 1 drop per affected eye. At baseline and week 8, intraocular pressure (IOP) was measured 3 times each at 8:30 am, 10:00 am, 2:00 pm, and 5:00 pm and after the water-drinking test, which estimates the IOP peak of diurnal tension curve, performed following the 5:00 pm IOP assessment. The primary efficacy outcome was change in diurnal IOP (the mean of IOP measurements) from baseline to week 8. Adverse effect (AE) data were recorded at each visit. RESULTS: A total of 229 patients were randomized (latanoprost, n = 112; dorzolamide/timolol, n = 117). Mean baseline diurnal IOP values were similar between the 2 groups. Mean (SD) diurnal IOP reductions at week 8 before the water-drinking test were 6.9 (3.0) mm Hg for the latanoprost group and 6.4 (3.2) mm Hg for the dorzolamide/timolol group. Mean IOP values were similar at all time points except at 5:00 pm, when levels were significantly lower in latanoprost-treated patients (P = 0.025). After the water-drinking test, the increase in IOP values was similar between groups at baseline but lower in latanoprost-treated patients at week 8 (adjusted difference, 1.08 mm Hg; P = 0.012). Fewer patients treated with latanoprost reported ocular or systemic AEs (P = 0.025 and P < 0.001, respectively). CONCLUSIONS: In this study of patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT IOP reductions generally were similar between treatment groups, except at 5:00 pm, when the mean IOP level was significantly lower in latanoprost-treated patients. Latanoprost was better tolerated than fixed-combination dorzolamide and timolol. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/15220019/Comparison_of_latanoprost_with_fixed_combination_dorzolamide_and_timolol_in_adult_patients_with_elevated_intraocular_pressure:_an_eight_week_randomized_open_label_parallel_group_multicenter_study_in_Latin_America_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149291804900756 DB - PRIME DP - Unbound Medicine ER -