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Rodríguez Álvarez, Martha Fabiola - One of the best experts on this subject based on the ideXlab platform.
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Treatment with Epinastine Hydrochloride to 0.05 % in Patients with Moderate Tear Dysfunction Syndrome
Universidad de La Salle. Revistas. Ciencia y Tecnología para la Salud Visual y Ocular., 2017Co-Authors: Carrizosa Murcia Marcelo, Rodríguez Álvarez, Martha FabiolaAbstract:Antihistamínicos como el clorhidrato de epinastina tienen actividad antinflamatoria y podrían usarse como tratamiento del síndrome de ojo seco. Objetivo: evaluar los cambios en la sintomatología, película lagrimal y superficie ocular antes y después del tratamiento con clorhidrato de epinastina en pacientes con síndrome de ojo seco. Materiales y métodos: se realizó un estudio piloto doble ciego en 20 pacientes con diagnóstico clínico de ojo seco moderado. Un ojo de cada paciente recibió tratamiento con clorhidrato de epinastina al 0,05 % y el otro recibió hialuronato de sodio al 0,4 %. Los dos ojos recibieron suplemento lagrimal con hialuronato de sodio al 0,4 %. La dosis de tratamiento fue una gota tres veces al día por 45 días. Antes del tratamiento y 30 y 45 días después, se aplicó cuestionario validado para ojo seco (osdi), test de Schirmer 1, but y lisamina verde. Se aplicó la prueba t de Student y rangos de Wilcoxon. Resultados: se encontró un mejoría estadísticamente significativa en sintomatología a los 30 días de intervención con epinastina (p = 0,000) y 45 días (p = 0,0000). En la superficie ocular hubo mejoría clínica y significativa estadísticamente a los 45 días (p = 0,0001). No se encontraron cambios significativos en la calidad ni en la cantidad de la película lagrimal. La reducción en la sintomatología y el grado de tinción con la epinastina a los 45 días fue estadísticamente significativa (p < 0,05) con respecto al grupo control. Conclusión: la combinación clorhidrato de epinastina al 0,05% y hialuronato de sodio al 0,4% mejora la sintomatología y la superficie ocular en los pacientes con ojo seco moderado.Antihistamines such as Epinastine hydrochloride have anti-inflammatory activity and could be used as a treatment for dry eye syndrome. Objective: To assess changes in symptoms, tear film and ocular surface before and after treatment with Epinastine hydrochloride in patients with dry eye syndrome. Materials and methods: A double-blind pilot study was carried out in 20 patients with clinical diagnosis of moderate dry eye. One eye of each patient was treated with 0.05% ofEpinastine hydrochloride and the other received 0.4% of sodium hyaluronate. Both eyes received tear supplement with 0.4% of sodium hyaluronate. The treatment dose was one drop three times a day for 45 days. Before treatment and 30 and 45 days after, the validated questionnaire for dry eye (osdi), the Schirmer 1 Test, but and lissamine green were used. The Student’s t test and Wilcoxon ranges were used. Results: A statistically significant improvement in symptoms after 30 days of the intervention with Epinastine was found (p = 0.000) and after 45 days (p = 0.0000). In the ocular surface there was clinically and statistically significant improvement after 45 days (p = 0.0001). No significant changes were found in quality or quantity of the tear film. The reduction in symptoms and in the degree of staining with Epinastine after 45 days was statistically significant (p < 0.05) compared with the control group. Conclusion: The combination of Epinastinehydrochloride 0.05% and sodium hyaluronate 0.4% improves symptoms and the ocular surface in patients with moderate dry eye
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Tratamiento con clorhidrato de epinastina al 0,05 % en pacientes con síndrome de disfunción lagrimal moderado
2012Co-Authors: Carrizosa Murcia Marcelo, Rodríguez Álvarez, Martha FabiolaAbstract:Antihistamines such as Epinastine hydrochloride have anti-inflammatory activity and could be used as a treatment for dry eye syndrome. Objective: To assess changes in symptoms, tear film and ocular surface before and after treatment with Epinastine hydrochloride in patients with dry eye syndrome. Materials and methods: A double-blind pilot study was carried out in 20 patients with clinical diagnosis of moderate dry eye. One eye of each patient was treated with 0.05% ofEpinastine hydrochloride and the other received 0.4% of sodium hyaluronate. Both eyes received tear supplement with 0.4% of sodium hyaluronate. The treatment dose was one drop three times a day for 45 days. Before treatment and 30 and 45 days after, the validated questionnaire for dry eye (osdi), the Schirmer 1 Test, but and lissamine green were used. The Student’s t test and Wilcoxon ranges were used. Results: A statistically significant improvement in symptoms after 30 days of the intervention with Epinastine was found (p = 0.000) and after 45 days (p = 0.0000). In the ocular surface there was clinically and statistically significant improvement after 45 days (p = 0.0001). No significant changes were found in quality or quantity of the tear film. The reduction in symptoms and in the degree of staining with Epinastine after 45 days was statistically significant (p < 0.05) compared with the control group. Conclusion: The combination of Epinastinehydrochloride 0.05% and sodium hyaluronate 0.4% improves symptoms and the ocular surface in patients with moderate dry eye.Antihistamínicos como el clorhidrato de epinastina tienen actividad antinflamatoria y podrían usarse como tratamiento del síndrome de ojo seco. Objetivo: evaluar los cambios en la sintomatología, película lagrimal y superficie ocular antes y después del tratamiento con clorhidrato de epinastina en pacientes con síndrome de ojo seco. Materiales y métodos: se realizó un estudio piloto doble ciego en 20 pacientes con diagnóstico clínico de ojo seco moderado. Un ojo de cada paciente recibió tratamiento con clorhidrato de epinastina al 0,05 % y el otro recibió hialuronato de sodio al 0,4 %. Los dos ojos recibieron suplemento lagrimal con hialuronato de sodio al 0,4 %. La dosis de tratamiento fue una gota tres veces al día por 45 días. Antes del tratamiento y 30 y 45 días después, se aplicó cuestionario validado para ojo seco (osdi), test de Schirmer 1, but y lisamina verde. Se aplicó la prueba t de Student y rangos de Wilcoxon. Resultados: se encontró un mejoría estadísticamente significativa en sintomatología a los 30 días de intervención con epinastina (p = 0,000) y 45 días (p = 0,0000). En la superficie ocular hubo mejoría clínica y significativa estadísticamente a los 45 días (p = 0,0001). No se encontraron cambios significativos en la calidad ni en la cantidad de la película lagrimal. La reducción en la sintomatología y el grado de tinción con la epinastina a los 45 días fue estadísticamente significativa (p < 0,05) con respecto al grupo control. Conclusión: la combinación clorhidrato de epinastina al 0,05% y hialuronato de sodio al 0,4% mejora la sintomatología y la superficie ocular en los pacientes con ojo seco moderado
Mark B. Abelson - One of the best experts on this subject based on the ideXlab platform.
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efficacy and tolerability of ophthalmic Epinastine a randomized double masked parallel group active and vehicle controlled environmental trial in patients with seasonal allergic conjunctivitis
Clinical Therapeutics, 2004Co-Authors: Scott M Whitcup, R Bradford, Rhett M Schiffman, Mark B. AbelsonAbstract:Abstract Background: Epinastine hydrochloride is an antihistamine with mast cell-stabilizing and anti-inflammatory activity. Objective: The aim of this study was to assess the efficacy and tolerability of ophthalmic Epinastine in patients with seasonal allergic conjunctivitis (SAC) exposed to environmental allergens. Methods: This randomized (age-stratified), double-masked, parallel-group, active- and vehicle-controlled, environmental, Phase III clinical trial was conducted at 6 ophthalmology clinics in the United States. Patients aged ≥9years diagnosed with SAC and who had a positive reaction in a conjunctival allergen challenge were enrolled. Patients were randomly assigned in a 2:2:1 ratio to receive 1 drop/eye BID of Epinastine hydrochloride 0.05% ophthalmic solution, levocabastine hydrochloride 0.05% ophthalmic suspension, or vehicle of Epinastine, respectively, for 8 weeks. The primary end point was ocular itching, and secondary end points included ocular hyperemia, chemosis, ocular mucous discharge (all assessed on a 5-point scale), eyelid swelling (assessed on a 4-point scale), and tearing (present or absent). Efficacy analyses used assessments from the two 1-week periods with the highest pollen counts. For tolerability assessment slit-lamp biomicroscopy and visual acuity examinations were conducted at each study visit (weeks 0, 2, 4, 6, and 8). Results: Two-hundred ninety-eight patients (159 females, 139 males; mean [SD] age, 32.7 [14.6] years [range, 9–71 years]) entered the study; 118 received Epinastine, 118 received levocabastine, and 62 received vehicle. Epinastine-treated patients reported significantly less ocular itching than those receiving vehicle ( P = 0.045); scores for hyperemia were similar between these 2 groups. Ocular itching and hyperemia scores were similar between the Epinastine and levocabastine groups. No clinically or statistically significant between-group differences were seen in slit-lamp biomicroscopy findings, changes in visual acuity from baseline, or the incidence of treatment-related adverse effects. Conclusions: In this study of patients with SAC, ophthalmic Epinastine instilled twice daily was more effective than vehicle for the control of ocular itching and was similar in efficacy to levocabastine for control of ocular itching and hyperemia. Epinastine was well tolerated.
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efficacy and tolerability of ophthalmic Epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis
Clinical Therapeutics, 2004Co-Authors: Mark B. Abelson, Paul J Gomes, R Bradford, Rhett M Schiffman, Jerome H Crampton, Scott M WhitcupAbstract:Abstract Background: Epinastine hydrochloride is a nonsedating antihistamine with a high affinity for histamine H 1 receptors, together with mast cell-stabilizing and anti-inflammatory activities. Objective: The aim of this study was to assess the efficacy and tolerability of topically administered ophthalmic Epinastine using the conjunctival antigen challenge (CAC) model in patients with a history of allergic conjunctivitis. Methods: This prospective, single-center, randomized, double-masked, vehicle-controlled, Phase III clinical trial was conducted at the Ophthalmic Research Associates study center (North Andover, Massachusetts) from November 2000 to January 2001. Eligible participants were asymptomatic but had a history of allergic conjunctivitis and had positive CAC reactions at the initial screening (week 0) and at a confirmation visit (week 1). Patients were randomly assigned by eye to receive Epinastine hydrochloride 0.05% ophthalmic solution in 1 eye and vehicle in the contralateral eye. Each eye received 1 drop of study medication 15 minutes before antigen application (onset challenge; week 3) or 8 hours before antigen application (duration challenge; week 5). Primary end points were ocular itching and conjunctival hyperemia. Itching was recorded 3, 5, and 10 minutes after antigen challenge. Hyperemia was recorded 5, 10, and 20 minutes after antigen challenge, as were secondary end points, which included eyelid swelling, episcleral and ciliary hyperemia, chemosis, tearing, and ocular mucous discharge. Tolerability was assessed by patient interview and slit-lamp biomicroscopy. Results: Sixty-seven patients (37 females, 30 males; mean [SD] age, 38.4 [14.2] years [range, 12–67 years]) were included in the study. Mean severity scores for the following signs and symptoms were significantly lower with Epinastine compared with vehicle at all time points after onset and duration challenges: ocular itching ( P P P P P P ⪯ 0.009). The percentage of eyes with tearing was significantly lower with Epinastine compared with vehicle at all time points ( P ≤ 0.021), except at 5 minutes after the duration challenge. Adverse events (AEs), reported for 7.5% (567) of patients, included only symptoms of upper respiratory tract infection. No ocular or treatment-related AEs were reported. Conclusions: In this CAC model, multiple signs and symptoms of allergic conjunctivitis were significantly reduced by instillation of Epinastine compared with vehicle. Epinastine showed prompt onset (3 minutes) and long duration of action (≥8 hours). The tolerability of Epinastine was similar to that of vehicle.
Scott M Whitcup - One of the best experts on this subject based on the ideXlab platform.
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efficacy and tolerability of ophthalmic Epinastine a randomized double masked parallel group active and vehicle controlled environmental trial in patients with seasonal allergic conjunctivitis
Clinical Therapeutics, 2004Co-Authors: Scott M Whitcup, R Bradford, Rhett M Schiffman, Mark B. AbelsonAbstract:Abstract Background: Epinastine hydrochloride is an antihistamine with mast cell-stabilizing and anti-inflammatory activity. Objective: The aim of this study was to assess the efficacy and tolerability of ophthalmic Epinastine in patients with seasonal allergic conjunctivitis (SAC) exposed to environmental allergens. Methods: This randomized (age-stratified), double-masked, parallel-group, active- and vehicle-controlled, environmental, Phase III clinical trial was conducted at 6 ophthalmology clinics in the United States. Patients aged ≥9years diagnosed with SAC and who had a positive reaction in a conjunctival allergen challenge were enrolled. Patients were randomly assigned in a 2:2:1 ratio to receive 1 drop/eye BID of Epinastine hydrochloride 0.05% ophthalmic solution, levocabastine hydrochloride 0.05% ophthalmic suspension, or vehicle of Epinastine, respectively, for 8 weeks. The primary end point was ocular itching, and secondary end points included ocular hyperemia, chemosis, ocular mucous discharge (all assessed on a 5-point scale), eyelid swelling (assessed on a 4-point scale), and tearing (present or absent). Efficacy analyses used assessments from the two 1-week periods with the highest pollen counts. For tolerability assessment slit-lamp biomicroscopy and visual acuity examinations were conducted at each study visit (weeks 0, 2, 4, 6, and 8). Results: Two-hundred ninety-eight patients (159 females, 139 males; mean [SD] age, 32.7 [14.6] years [range, 9–71 years]) entered the study; 118 received Epinastine, 118 received levocabastine, and 62 received vehicle. Epinastine-treated patients reported significantly less ocular itching than those receiving vehicle ( P = 0.045); scores for hyperemia were similar between these 2 groups. Ocular itching and hyperemia scores were similar between the Epinastine and levocabastine groups. No clinically or statistically significant between-group differences were seen in slit-lamp biomicroscopy findings, changes in visual acuity from baseline, or the incidence of treatment-related adverse effects. Conclusions: In this study of patients with SAC, ophthalmic Epinastine instilled twice daily was more effective than vehicle for the control of ocular itching and was similar in efficacy to levocabastine for control of ocular itching and hyperemia. Epinastine was well tolerated.
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efficacy and tolerability of ophthalmic Epinastine assessed using the conjunctival antigen challenge model in patients with a history of allergic conjunctivitis
Clinical Therapeutics, 2004Co-Authors: Mark B. Abelson, Paul J Gomes, R Bradford, Rhett M Schiffman, Jerome H Crampton, Scott M WhitcupAbstract:Abstract Background: Epinastine hydrochloride is a nonsedating antihistamine with a high affinity for histamine H 1 receptors, together with mast cell-stabilizing and anti-inflammatory activities. Objective: The aim of this study was to assess the efficacy and tolerability of topically administered ophthalmic Epinastine using the conjunctival antigen challenge (CAC) model in patients with a history of allergic conjunctivitis. Methods: This prospective, single-center, randomized, double-masked, vehicle-controlled, Phase III clinical trial was conducted at the Ophthalmic Research Associates study center (North Andover, Massachusetts) from November 2000 to January 2001. Eligible participants were asymptomatic but had a history of allergic conjunctivitis and had positive CAC reactions at the initial screening (week 0) and at a confirmation visit (week 1). Patients were randomly assigned by eye to receive Epinastine hydrochloride 0.05% ophthalmic solution in 1 eye and vehicle in the contralateral eye. Each eye received 1 drop of study medication 15 minutes before antigen application (onset challenge; week 3) or 8 hours before antigen application (duration challenge; week 5). Primary end points were ocular itching and conjunctival hyperemia. Itching was recorded 3, 5, and 10 minutes after antigen challenge. Hyperemia was recorded 5, 10, and 20 minutes after antigen challenge, as were secondary end points, which included eyelid swelling, episcleral and ciliary hyperemia, chemosis, tearing, and ocular mucous discharge. Tolerability was assessed by patient interview and slit-lamp biomicroscopy. Results: Sixty-seven patients (37 females, 30 males; mean [SD] age, 38.4 [14.2] years [range, 12–67 years]) were included in the study. Mean severity scores for the following signs and symptoms were significantly lower with Epinastine compared with vehicle at all time points after onset and duration challenges: ocular itching ( P P P P P P ⪯ 0.009). The percentage of eyes with tearing was significantly lower with Epinastine compared with vehicle at all time points ( P ≤ 0.021), except at 5 minutes after the duration challenge. Adverse events (AEs), reported for 7.5% (567) of patients, included only symptoms of upper respiratory tract infection. No ocular or treatment-related AEs were reported. Conclusions: In this CAC model, multiple signs and symptoms of allergic conjunctivitis were significantly reduced by instillation of Epinastine compared with vehicle. Epinastine showed prompt onset (3 minutes) and long duration of action (≥8 hours). The tolerability of Epinastine was similar to that of vehicle.
Martin Nitschke - One of the best experts on this subject based on the ideXlab platform.
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In vitro investigations with the histamine H1 receptor antagonist, Epinastine (WAL 801 CL), on isolated human allergic effector cells
Inflammation Research, 2000Co-Authors: Ulrich Amon, Bernhard F. Gibbs, G. Buss, Martin NitschkeAbstract:Objective and Design: Skin mast cells, basophils and eosinophils are effector cells of acute and subacute allergic responses due to their capacity to produce a large number of (pro)inflammatory mediators. Histamine H1 receptor antagonists, such as Epinastine (WAL 801 CL), have been described to partially exert antiallergic and anti-inflammatory effects both in vivo and in vitro in addition to their antihistaminergic properties. The aim of the present study was to investigate whether Epinastine could influence the in vitro activation of isolated human skin mast cells, basophils and eosinophils induced by different secretagogues.¶Methods: Cells were isolated from healthy women following plastic surgery and healthy blood donors, respectively. Mast cells were isolated by enzymatic digestion of the skin. Blood cells were isolated by gradient centrifugation and negative selection with magnetic beads.¶Results: A wide range of concentrations of the drug (1 nmol/l to 100 mmol/l) did not significantly inhibit histamine release from basophils induced by immunologic (anti-IgE, concanavalin A, priming factors interleukin-3 and interleukin-5) and non immunologic (A23187, ionomycin, 12-o-tetradecanoyl-phorbol-13-acetate, C5a, formyl-methionyl-leucyl-phenylalanine) stimuli. Furthermore, the drug had no effect on A23187-induced release of eosinophil cationic protein from eosinophils. However, at a concentration >0.1nmol/l, IgE-mediated LTC4 production from basophils was significantly suppressed. Histamine release from skin mast cells due to anti-IgE or A23187 was inhibited by Epinastine in a dose-dependent fashion, whereas substance P-induced activation as well as stem cell factor priming were not. Epinastine did not inhibit isolated protein kinase C from rat brain.¶Conclusion: The results confirm previous in vivo and in vitro observations obtained from animal models that Epinastine exerts antiallergic and antiinflammatory effects. Whether the observed effects are due to non specific membrane interactions or by influencing intracellular signal transduction elements has to be further elucidated.
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in vitro investigations with the histamine h 1 receptor antagonist Epinastine wal 801 cl on isolated human allergic effector cells
Inflammation Research, 2000Co-Authors: Ulrich Amon, Bernhard F. Gibbs, G. Buss, Martin NitschkeAbstract:Objective and Design: Skin mast cells, basophils and eosinophils are effector cells of acute and subacute allergic responses due to their capacity to produce a large number of (pro)inflammatory mediators. Histamine H1 receptor antagonists, such as Epinastine (WAL 801 CL), have been described to partially exert antiallergic and anti-inflammatory effects both in vivo and in vitro in addition to their antihistaminergic properties. The aim of the present study was to investigate whether Epinastine could influence the in vitro activation of isolated human skin mast cells, basophils and eosinophils induced by different secretagogues.¶Methods: Cells were isolated from healthy women following plastic surgery and healthy blood donors, respectively. Mast cells were isolated by enzymatic digestion of the skin. Blood cells were isolated by gradient centrifugation and negative selection with magnetic beads.¶Results: A wide range of concentrations of the drug (1 nmol/l to 100 mmol/l) did not significantly inhibit histamine release from basophils induced by immunologic (anti-IgE, concanavalin A, priming factors interleukin-3 and interleukin-5) and non immunologic (A23187, ionomycin, 12-o-tetradecanoyl-phorbol-13-acetate, C5a, formyl-methionyl-leucyl-phenylalanine) stimuli. Furthermore, the drug had no effect on A23187-induced release of eosinophil cationic protein from eosinophils. However, at a concentration >0.1nmol/l, IgE-mediated LTC4 production from basophils was significantly suppressed. Histamine release from skin mast cells due to anti-IgE or A23187 was inhibited by Epinastine in a dose-dependent fashion, whereas substance P-induced activation as well as stem cell factor priming were not. Epinastine did not inhibit isolated protein kinase C from rat brain.¶Conclusion: The results confirm previous in vivo and in vitro observations obtained from animal models that Epinastine exerts antiallergic and antiinflammatory effects. Whether the observed effects are due to non specific membrane interactions or by influencing intracellular signal transduction elements has to be further elucidated.
Seiji Kawana - One of the best experts on this subject based on the ideXlab platform.
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Effect of Epinastine hydrochloride on murine self-scratching behavior after skin-scratching stimulation
Archives of Dermatological Research, 2009Co-Authors: Halifu Yilinuer, Junichi Yamaoka, Seiji KawanaAbstract:The itch–scratch cycle aggravates chronic inflammatory skin diseases. We have previously reported that mice begin to scratch themselves within several minutes after skin-scratching stimulation. This is associated with an increase in release of substance P (SP) from sensory nerve fibers in the skin, and the self-scratching behavior is suppressed by neurokinin-1 receptor (NK-1R) antagonist. Thus, SP may play a pivotal role in self-scratching behavior. The purpose of this study was to investigate the effect of second-generation histamine H_1-receptor antagonists on self-scratching behavior in mice. After oral administration of Epinastine hydrochloride (Epinastine) (total dose 50 ± 5 mg/kg for 7 days) or the vehicle only to ICR mice for 7 days, skin-scratching stimulation was administered to the dorsal skin for 10 min. Self-scratching behavior was recorded by video camera for 10 min. Twenty-four hours later, skin tissue was harvested and stained with toluidine blue. Immunohistochemical staining for SP was performed, and SP and nerve growth factor (NGF) concentrations were measured by enzyme-linked immunosorbent assay. Self-scratching behavior, mast cell degranulation, and NGF concentration decreased, and the length of SP-positive nerve fibers and SP concentrations increased significantly in the Epinastine-treated group, when compared with the vehicle control group. We conclude that Epinastine inhibits mast cell degranulation by attenuating SP release from sensory nerve fibers, which results in inhibition of self-scratching behavior. These results suggest that second-generation histamine H_1-receptor antagonists might efficaciously control itch–scratch cycle-related skin diseases.