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Efficacy and safety of the fixed combinations latanoprost/timolol versus dorzolamide/timolol in patients with elevated intraocular pressure.

Abstract

PURPOSE

To compare the efficacy and safety of the fixed combination of latanoprost and timolol with those of the fixed combination of dorzolamide and timolol in patients with elevated intraocular pressure (IOP).

DESIGN

Three-month, randomized, parallel group, evaluator-masked, multicenter study.

PARTICIPANTS

Patients with primary open-angle glaucoma or ocular hypertension with elevated IOP insufficiently responsive to monotherapy; 253 randomized: 125 to receive a fixed combination of latanoprost 0.005% and timolol 0.5% once daily, and 128 to receive a fixed combination of dorzolamide 2% and timolol 0.5% twice daily.

METHODS

Visits were at screening (current ocular hypotensive therapy was discontinued), 2 weeks (if needed for an IOP-safety check), baseline (randomization), and after 1 and 3 months of therapy. Intraocular pressure was measured in triplicate at 8 am, 12 pm, and 4 pm at each study visit, and diurnal IOP was calculated as the mean value of these recordings. Adverse events were recorded at each visit.

MAIN OUTCOME MEASURE

The difference between treatment groups in the change in mean diurnal IOP from baseline to month 3.

RESULTS

Mean diurnal IOP levels were similar at baseline. Mean (+/- standard error of the mean) reductions in diurnal IOP from baseline to month 3 were 9.4+/-0.27 mmHg in the latanoprost/timolol fixed-combination group, versus 8.4+/-0.26 mmHg in patients receiving the dorzolamide/timolol fixed combination. The mean difference in diurnal IOP reduction between treatments was 1.00 mmHg (95% confidence interval, 0.31-1.69; P = 0.005) in favor of the latanoprost/timolol fixed combination. Both treatments generally were well tolerated.

CONCLUSIONS

The fixed combination of latanoprost and timolol was slightly more effective than that of dorzolamide and timolol in reducing mean diurnal IOP, and both treatments were generally well tolerated.

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  • Authors+Show Affiliations

    ,

    Kresge Eye Institute, Wayne State University, Detroit, Michigan, USA.

    , ,

    Source

    Ophthalmology 111:2 2004 Feb pg 276-82

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Antihypertensive Agents
    Double-Blind Method
    Drug Evaluation
    Drug Therapy, Combination
    Female
    Glaucoma, Open-Angle
    Humans
    Intraocular Pressure
    Latanoprost
    Male
    Middle Aged
    Ocular Hypertension
    Ophthalmic Solutions
    Prostaglandins F, Synthetic
    Safety
    Sulfonamides
    Thiophenes
    Timolol
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    15019375

    Citation

    Shin, Dong H., et al. "Efficacy and Safety of the Fixed Combinations Latanoprost/timolol Versus Dorzolamide/timolol in Patients With Elevated Intraocular Pressure." Ophthalmology, vol. 111, no. 2, 2004, pp. 276-82.
    Shin DH, Feldman RM, Sheu WP, et al. Efficacy and safety of the fixed combinations latanoprost/timolol versus dorzolamide/timolol in patients with elevated intraocular pressure. Ophthalmology. 2004;111(2):276-82.
    Shin, D. H., Feldman, R. M., & Sheu, W. P. (2004). Efficacy and safety of the fixed combinations latanoprost/timolol versus dorzolamide/timolol in patients with elevated intraocular pressure. Ophthalmology, 111(2), pp. 276-82.
    Shin DH, et al. Efficacy and Safety of the Fixed Combinations Latanoprost/timolol Versus Dorzolamide/timolol in Patients With Elevated Intraocular Pressure. Ophthalmology. 2004;111(2):276-82. PubMed PMID: 15019375.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and safety of the fixed combinations latanoprost/timolol versus dorzolamide/timolol in patients with elevated intraocular pressure. AU - Shin,Dong H, AU - Feldman,Robert M, AU - Sheu,Wang-Pui, AU - ,, PY - 2002/06/26/received PY - 2003/05/14/accepted PY - 2004/3/17/pubmed PY - 2004/3/24/medline PY - 2004/3/17/entrez SP - 276 EP - 82 JF - Ophthalmology JO - Ophthalmology VL - 111 IS - 2 N2 - PURPOSE: To compare the efficacy and safety of the fixed combination of latanoprost and timolol with those of the fixed combination of dorzolamide and timolol in patients with elevated intraocular pressure (IOP). DESIGN: Three-month, randomized, parallel group, evaluator-masked, multicenter study. PARTICIPANTS: Patients with primary open-angle glaucoma or ocular hypertension with elevated IOP insufficiently responsive to monotherapy; 253 randomized: 125 to receive a fixed combination of latanoprost 0.005% and timolol 0.5% once daily, and 128 to receive a fixed combination of dorzolamide 2% and timolol 0.5% twice daily. METHODS: Visits were at screening (current ocular hypotensive therapy was discontinued), 2 weeks (if needed for an IOP-safety check), baseline (randomization), and after 1 and 3 months of therapy. Intraocular pressure was measured in triplicate at 8 am, 12 pm, and 4 pm at each study visit, and diurnal IOP was calculated as the mean value of these recordings. Adverse events were recorded at each visit. MAIN OUTCOME MEASURE: The difference between treatment groups in the change in mean diurnal IOP from baseline to month 3. RESULTS: Mean diurnal IOP levels were similar at baseline. Mean (+/- standard error of the mean) reductions in diurnal IOP from baseline to month 3 were 9.4+/-0.27 mmHg in the latanoprost/timolol fixed-combination group, versus 8.4+/-0.26 mmHg in patients receiving the dorzolamide/timolol fixed combination. The mean difference in diurnal IOP reduction between treatments was 1.00 mmHg (95% confidence interval, 0.31-1.69; P = 0.005) in favor of the latanoprost/timolol fixed combination. Both treatments generally were well tolerated. CONCLUSIONS: The fixed combination of latanoprost and timolol was slightly more effective than that of dorzolamide and timolol in reducing mean diurnal IOP, and both treatments were generally well tolerated. SN - 0161-6420 UR - https://www.unboundmedicine.com/medline/citation/15019375/Efficacy_and_safety_of_the_fixed_combinations_latanoprost/timolol_versus_dorzolamide/timolol_in_patients_with_elevated_intraocular_pressure_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(03)01162-X DB - PRIME DP - Unbound Medicine ER -