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      Eficacia de brimonidina 0,2% y dorzolamida 2% como tratamiento adyuvante a un beta-bloqueante Translated title: Efficiency of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers

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          Objetivo: Comparar la eficacia y tolerabilidad de brimonidina y dorzolamida dos veces al día cuando se utilizan como terapia coadyuvante con un betabloqueante en pacientes con glaucoma inadecuadamente controlados. Material y métodos: Realizamos un estudio prospectivo, multicéntrico, incluyendo 92 pacientes (180 ojos) diagnosticados de glaucoma o hipertensión ocular, tratados con un beta-bloqueante tópico y cuya presión intraocular (PIO) fuera igual o mayor de 18 mmHg. Se trataron de forma aleatoria con brimonidina 0,2% o dorzolamida 2% durante tres meses. Evaluamos la eficacia considerando el descenso medio de la PIO basal de un 15% al mes y a los 3 meses. Resultados: La PIO basal fue de 22,37 DE 2,82 mmHg en los que trataríamos con brimonidina y de 22,38 DE 2,27 en los del grupo de la dorzolamida; el descenso medio de la PIO basal al mes en el grupo de la brimonidina fue 4,39 mmHg y de 3,29 mmHg en el de la dorzolamida. A los tres meses no encontramos diferencias significativas. La respuesta clínica al mes se alcanzó en el 78,3% de los ojos a los que se había añadido brimonidina y en el 71% de los que se añadió dorzolamida (p=0,05). Los efectos adversos fueron poco frecuentes en ambos grupos, sin encontrar diferencias significativas. Cuatro pacientes del grupo de la brimonidina abandonaron el tratamiento por queratoconjuntivitis alérgica. En el grupo de la dorzolamida dos pacientes se retiraron del estudio por intolerancia local y tres pacientes por alergia ocular. Conclusiones: La brimonidina y la dorzolamida reducen eficazmente la PIO como tratamiento coadyuvante al beta-bloqueante cuando éste es insuficiente para conseguir una PIO adecuada en pacientes con hipertensión ocular o glaucoma primario de ángulo abierto.

          Translated abstract

          Purpose: To evaluate the clinical efficiency and tolerability of brimonidine and dorzolamide twice daily as an adjunctive therapy for glaucoma patients with an inadequate response to beta-blockers therapy. Methods: This multicenter prospective analysis included 92 patients (180 eyes) with primary open-angle glaucoma or ocular hypertension on therapy beta-blockers and with intraocular pressure (IOP) greater than or equal to 18mmHg. The patients were randomly treated either with brimonidine 0.2% or dorzolamide 2% added for three months. Efficiency was determined by the reduction in 15% IOP from baseline at the first and the third month. Results: Mean pre-treatment IOP was 22.37 DE 2.8 mmHg in the brimonidine group and 22.38 DE 2.6 mmHg in the dorzolamide group; mean post-treatment IOP decrease was 4.39 mmHg in the brimonidine group and 3.29 mmHg in the dorzolamide group. Clinical control at the first month was achieved in 78.3% and 71% of cases respectively (p=0.05). No statistical differences existed between groups for systemic adverse events. Four patients on brimonidine discontinued treatment due to local side effects. In the dorzolamide group, two patients left the treatment referring itching and three others left due to ocular allergy. Conclusions: This study found similar efficiency and safety when treating with brimonidine or dorzolamide as an adjunctive therapy for patients with hypertension or primary open-angle glaucoma.

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          Most cited references 17

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          Effects of brimonidine on aqueous humor dynamics in human eyes.

          To evaluate the mechanism by which brimonidine, a selective alpha 2-adrenergic agonist, lowers intraocular pressure (IOP) in humans. Twenty-one volunteers with ocular hypertension. Brimonidine tartrate (0.2%) was given topically twice daily for 1 week to one eye in a randomized, double-masked study. The fellow eye was similarly treated with brimonidine vehicle. Before (baseline) and after 1 week (day 8) of dosing, IOP, aqueous flow, episcleral venous pressure, and tonographic outflow facility were directly measured. Fluorophotometric outflow facility and uveoscleral outflow were calculated. Brimonidine-treated eyes were compared with vehicle-treated contralateral control eyes and with baseline measurements after 1 week of dosing. Brimonidine significantly (P < .001, Student's two-tailed t test) reduced IOP mean +/- SE of 4.7 +/- 0.7 and 4.2 +/- 0.4 mm Hg compared with the baseline day and with the vehicle-treated contralateral control eyes, respectively. Compared with the baseline day, aqueous flow was reduced by 20% (P = .002) and uveoscleral outflow was increased (P = .04). A slight contralateral decrease in IOP of 1.2 +/- 0.6 mm Hg (P = .05) and in aqueous flow of 12% (P = .05) was noted. No significant difference was seen in the outflow facility values or episcleral venous pressure compared with the baseline day or with the contralateral control eye. The brimonidine-induced reduction in IOP in humans is associated with a decrease in aqueous flow and an increase in uveoscleral outflow. The decrease in IOP and aqueous flow in the contralateral control eye on day 8 compared with the baseline day suggests a mild contralateral effect.
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            Twelve-month results of an ongoing randomized trial comparing brimonidine tartrate 0.2% and timolol 0.5% given twice daily in patients with glaucoma or ocular hypertension. Brimonidine Study Group 2.

             Aaron LeBlanc (1998)
            To compare the long-term safety and ocular-hypotensive efficacy of brimonidine tartrate 0.2% with timolol maleate 0.5% administered twice daily in patients with glaucoma or ocular hypertension. A double-masked, parallel-group, active-controlled, multicenter clinical trial of 12 months' duration. Four hundred eighty-three patients with glaucoma or ocular hypertension were enrolled. Of these, 463 were evaluated according to the protocol criteria (280 in the brimonidine tartrate group and 183 in the timolol group). Brimonidine tartrate 0.2% or timolol maleate 0.5% was administered twice daily. The primary efficacy variable was intraocular pressure (IOP). Brimonidine and timolol produced significant (P < 0.001) and sustained mean reductions in IOP throughout the 1-year follow-up when measured at hour 0 (trough) and at hour 2 (peak). At weeks 1 and 2 and month 12, significantly greater mean decreases in IOP measured at peak (P < or = 0.007) were observed in patients treated with brimonidine as compared to timolol, whereas the mean decreases in IOP measured at trough was significantly greater in patients treated with timolol as compared to brimonidine (P < 0.001) at all follow-up visits. Both drugs were well-tolerated. The incidence of adverse events was similar in both treatment groups, except for ocular allergy, oral dryness, and conjunctival follicles, which occurred more frequently in the brimonidine group, and burning-stinging, which occurred more frequently in the timolol group. Patients receiving timolol experienced significant decreases in heart rate at all follow-up visits. Topically applied twice daily for 12 months, brimonidine tartrate 0.2% was safe and effective in lowering IOP in patients with glaucoma or ocular hypertension.
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              Clinical experience with brimonidine 0.2% and timolol 0.5% in glaucoma and ocular hypertension.

               J Schuman (1996)
              The ocular hypotensive efficacy and safety of brimonidine tartrate 0.2%, a highly selective alpha 2-adrenergic agonist, was compared with that of timolol 0.5%, a nonselective beta-blocker in two multicenter, randomized, double-masked studies. Combined data from a 12-month completed study and 6-month interim data from an ongoing study are reported. Efficacy and safety were evaluated at baseline, weeks 1 and 2, and months 1, 2, 3, 6, 9, and 12. Intraocular pressure (IOP) was measured at peak (2 hours after the morning dose) and trough (12 hours after the evening dose). Patients (n = 926) instilled either brimonidine tartrate 0.2% or timolol maleate 0.5% twice daily. At peak, the mean decreases from baseline IOP ranged from 5.9 +/- 3.2 mm Hg to 7.6 +/- 3.6 mm Hg for brimonidine and 6.0 +/- 3.4 mm Hg to 6.6 +/- 3.6 mm Hg for timolol (p < 0.001 within groups compared with baseline). No significant between-group differences were seen at peak except for weeks 1 and 2 and month 3 (p < or = 0.04), when brimonidine had lower mean IOP. At trough the mean decreases from baseline ranged from 3.7 +/- 4.0 mm Hg to 5.0 +/- 3.0 mm Hg for brimonidine and 5.9 +/- 3.4 to 6.6 +/- 3.0 for timolol. A significant between-group difference was seen at trough at all visits (< 0.001), when timolol had a lower mean IOP. Brimonidine and timolol showed sustained efficacy. Both drugs were well-tolerated. The brimonidine group had more ocular allergy, oral dryness and conjunctival follicles. The timolol group had more burning and stinging. In the brimonidine group, 38/513 (7.4%) discontinued treatment due to ocular allergy. The timolol group had significantly lower mean heart rate compared to baseline. The effect on blood pressure was minimal for both drugs. Brimonidine showed efficacy similar to timolol and a relatively low rate of ocular allergy. Brimonidine 0.2% administered twice daily is an effective and safe ocular hypotensive agent that maintains IOP-lowering in chronic use.

                Author and article information

                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Archivos de la Sociedad Española de Oftalmología
                Arch Soc Esp Oftalmol
                Sociedad Española de Oftalmología (, , Spain )
                April 2004
                : 79
                : 4
                : 163-168
                Madrid orgnameHospital Fundación Alcorcón

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