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(1) Aims of the study: calculating the underreporting ratio for two different medications, a fixed combination of 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide (antiglaucoma) and a fixed combination of sodium hyaluronate 0.1% + chondroitin sulfate 0.18% (artificial tears) for characterizing the features influencing the reporting of adverse drug reactions (ADRs) in spontaneous reporting. (2) Methods: The underreporting ratio was calculated by comparing the adverse drug reactions reported in the spontaneous reporting database for every 10,000 defined daily doses marketed and the adverse drug reactions from an active surveillance study for every 10,000 defined daily doses used for different drugs (antiglaucoma and artificial tears). The factors related to the report in spontaneous reporting through statistical tests were also determined. (3) Results: The underreporting ratio of spontaneous reporting was 0.006029% for antiglaucoma and 0.003552% for artificial tears. Additionally, statistically significant differences were found for severity, unexpected adverse drug reactions, and incidence of adverse drug reactions in females when compared with spontaneous reporting and active surveillance. (4) Conclusions: The underreporting ratio of ADRs related to ophthalmic medications indicates worry since the cornerstone of pharmacovigilance focuses on spontaneous reporting. Additionally, since underreporting seems to b selective, the role of certain aspects, such as gender, seriousness, severity, and unexpected ADRs, must be considered in future research.
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BACKGROUND: Dry eye disease (DED) is a condition that compromises the ocular surface and affects millions of people around the world. In recent years, a scheme has been proposed for the treatment of DED, with the use of artificial tear being the mainstay of treatment. In this scheme, the use of secretagogues is suggested as part of the treatment for patients with moderate to severe affectation. With this systematic review, we aim to evaluate the effectiveness and safety of secretagogues for DED. METHODS: Electronic databases will be searched; we will include randomized controlled trials that compare secretagogues and artificial tears. Study inclusion will not be restricted on the basis of language or publication status. We will use Google Translate to assess studies written in languages other than English and Spanish. Identification, evaluation, data extraction, and assessment of risk of bias will be conducted by two authors of the review, a third review author will resolve any disagreement. The outcomes will be the ocular surface disease index score, tear film break-up time, Schirmer test score, VRQoL Score, and tear film osmolarity. We will use the Cochrane Collaboration Risk of Bias 2 (RoB 2) tool for assessing the risk of bias of the included studies. Based on the heterogeneity of the included studies, we will combine the findings in a meta-analysis using a fixed effect model if heterogeneity ≤ 50% or a random effect model if heterogeneity > 50%. If we deem meta-analysis as inappropriate, we will document the reasons and report findings from the individual studies narratively. DISCUSSION: Based on the evidence obtained, we will evaluate the effect of pilocarpine, cevimeline, and diquafosol and compare it to artificial tears on multiple outcome measures. This systematic review aims to determine the efficacy and safety of the secretagogues pilocarpine, cevimeline, and diquafosol to help clinicians in the decision-making process. TRIAL REGISTRATION: PROSPERO CRD42020218407 .
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Síndromes do Olho Seco , Lubrificantes Oftálmicos , Síndromes do Olho Seco/tratamento farmacológico , Humanos , Lubrificantes Oftálmicos/uso terapêutico , Metanálise como Assunto , Pilocarpina , Polifosfatos , Quinuclidinas , Secretagogos , Revisões Sistemáticas como Assunto , Tiofenos , Nucleotídeos de UracilaRESUMO
INTRODUCTION: Dry eye is one of the most common ocular surface disorders. Although artificial tear drops therapy is the most widely used treatment, it has recently been suggested that autologous serum could be a beneficial alternative treatment for this disorder, but its use is controversial. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE/PubMed, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified six systematic reviews, including seven primary studies overall, of which all were randomized trials. We concluded that autologous serum treatment might not lead to adverse effects compared to artificial teardrops, but the certainty of the evidence is low. On the other hand, we are uncertain whether autologous serum therapy improves the quality of life, severity of the pathology, pain or the corneal epitheliopathy grade compared to artificial tear drops as the certainty of the evidence has been assessed as very low.
INTRODUCCIÓN: El ojo seco es una de las patologías oculares más frecuentes. Si bien el tratamiento más utilizado es el uso de lágrimas artificiales, se ha planteado el uso de suero autólogo como una alternativa terapéutica beneficiosa para pacientes con esta condición. Sin embargo, su uso es controvertido. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE/PubMed, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método Grading of Recommendations Assessment, Development and Evaluation, GRADE. RESULTADOS Y CONCLUSIONES: Identificamos seis revisiones sistemáticas que en conjunto incluyeron siete estudios primarios, de los cuales, todos corresponden a ensayos aleatorizados. Concluimos que el uso de suero autólogo podría no presentar efectos adversos asociados a su uso, pero la certeza de la evidencia es baja. Por otro lado, no es posible establecer con claridad si el uso de suero autólogo tiene un efecto sobre la mejora de la calidad de vida, severidad del ojo seco, dolor o grado de epiteliopatía corneal debido a que la certeza de la evidencia existente ha sido evaluada como muy baja.
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Síndromes do Olho Seco/terapia , Lubrificantes Oftálmicos/administração & dosagem , Soluções Oftálmicas/uso terapêutico , Bases de Dados Factuais , Humanos , Dor , Qualidade de Vida , Soro , Cloreto de Sódio/uso terapêutico , Revisões Sistemáticas como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: Sodium hyaluronate/chondroitin sulfate fixed combination plays an essential role in the treatment of keratoconjunctivitis sicca, a multifactorial disease accompanied by ocular symptoms like alteration of the tear film. Despite low or no absorption of such drugs, these can cause secondary effects. An essential tool in the study of medication behavior is active pharmacovigilance. Unlike spontaneous reporting pharmacovigilance, this tool allows an appraisal of adverse drug reactions (ADRs)' real incidence, a higher capacity to identify safety signals, the relationship with concomitant drugs and pathologies prevalent in the study population. This study aimed to evaluate the safety profile and identify and/or assess adverse reactions in an uncontrolled population. METHODS: Active pharmacovigilance by Drug Event Monitoring was performed. A total of 3 follow-up calls were made for 30 days for the identification of the ADRs, tolerability (ADR severity, seriousness, long term sequelae, and duration) and the possible risks (safety signals, medical interactions) of sodium hyaluronate and chondroitin sulfate (HUM). RESULTS: Thirty-five ADRs were identified in the 212 patients included in the study (0.17 ADR/patient). The 35 ADRs were classified into 3 System Organ Class (SOC) groups: general disorders and administration site conditions (74.2%), eye disorders (22.9%), and nervous system disorders (2.9%); and 4 Preferred Term (PT) groups: burning sensation (74.2%), followed by blurred vision (20%), ocular pain (2.9%) and headache (2.9%). All the ADRs were categorized as mild and not serious. No statistically significant differences were found in concomitantly medications, posology and age groups. CONCLUSION: Good tolerability to the solution was identified, with a low incidence of ADRs. Just the same, all the associated ADRs were consistent with the information found in HUM's physicochemical profile and the physiopathology of DED. No unknown risks were identified, reinforcing HUM's safety profile.
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BACKGROUND: Dry eye disease (DED) is a chronic, multifactorial disease of the ocular surface leading to discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. AIM: The aim of this study was to assess the clinical benefit of a switch from preserved to preservative-free artificial tears (ATs) containing hyaluronate in patients with DED. MATERIALS AND METHODS: This is a nationwide, multicenter, noninterventional, and transversal observational survey. RESULTS: The mean age was 51.0±15.4 years, ranging from 6 to 96 years. The majority (61.4%) was female. The mean Ocular Surface Disease Index (OSDI) before the switch was surprisingly high at 56.0±23.5, and 73.0% of the patients had superficial punctate keratitis (SPK). The mean duration of use of preserved ATs before the switch was 15.8±12.1 months. OSDI scores and the presence of SPK correlated with the patients' ages but were independent of the duration of treatment with the preserved AT. The patients using ATs containing "soft" or "vanishing" preservatives presented exactly the same clinical pattern (level of OSDI and frequency of SPK) as those using ATs containing classical preservatives such as benzalkonium chloride (BAK). After switching to preservative-free AT containing hyaluronate (Hyabak®), the OSDI of 97.0% of the patients improved, decreasing from an average of 56.0 to an average of 28.2, with 23% of patients reporting a normal value of OSDI. The SPK frequency as well improved dramatically, with a frequency of positive fluorescein staining dropping from 73% to 46.1% of patients. A total of 94.0% of the patients considered that they preferred being treated with the preservative-free AT. CONCLUSION: In patients suffering from DED and treated with a preserved AT, switching to a preservative-free AT provides clinical benefit by decreasing the severity of DED and reducing the prevalence of SPK, even after only 3 weeks of daily use of the preservative-free AT.
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ABSTRACT: Ocular lubricants are used to supplement one or more layers of the lacrimal film. They are often prescribed to treat keratoconjunctivitis sicca (KCS) and other diseases of ocular surface in humans. These lubricants may also protect the ocular surface and promote epithelial regeneration. The active component of ocular lubricants is the lubricating agent. The key properties of different lubricating agents are the electrolyte composition, osmolarity, and addition of preservatives. Although lacrimomimetics are not typically used to treat KCS in dogs, they can be used as an adjunctive therapy. Knowledge of the properties of lacrimomimetics will help in making the appropriate therapeutic choice.
RESUMO: Lubrificantes oculares são usados como suplementos de uma ou mais camadas do filme lacrimal. São frequentemente prescritos para o tratamento da ceratoconjuntivite seca (CCS) no homem e em outras afecções da superfície ocular. Seu uso também pode gerar proteção da superfície ocular e promover regeneração epitelial. Os principais componentes de sua formulação são os agentes lubrificantes e as principais propriedades são a composição eletrolítica, a osmolaridade e a presença de conservantes. Embora lacrimomiméticos não sejam o tratamento da CCS em cães, eles podem ser utilizados como terapia adjuvante. O conhecimento de suas propriedades auxiliará na melhor opção terapêutica.
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Ocular lubricants are used to supplement one or more layers of the lacrimal film. They are often prescribed to treat keratoconjunctivitis sicca (KCS) and other diseases of ocular surface in humans. These lubricants may also protect the ocular surface and promote epithelial regeneration. The active component of ocular lubricants is the lubricating agent. The key properties of different lubricating agents are the electrolyte composition, osmolarity, and addition of preservatives. Although lacrimomimetics are not typically used to treat KCS in dogs, they can be used as an adjunctive therapy. Knowledge of the properties of lacrimomimetics will help in making the appropriate therapeutic choice.(AU)
Lubrificantes oculares são usados como suplementos de uma ou mais camadas do filme lacrimal. São frequentemente prescritos para o tratamento da ceratoconjuntivite seca (CCS) no homem e em outras afecções da superfície ocular. Seu uso também pode gerar proteção da superfície ocular e promover regeneração epitelial. Os principais componentes de sua formulação são os agentes lubrificantes e as principais propriedades são a composição eletrolítica, a osmolaridade e a presença de conservantes. Embora lacrimomiméticos não sejam o tratamento da CCS em cães, eles podem ser utilizados como terapia adjuvante. O conhecimento de suas propriedades auxiliará na melhor opção terapêutica.(AU)
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Animais , Cães , Lubrificantes Oftálmicos/análise , Lubrificantes Oftálmicos/química , Lubrificantes Oftálmicos/uso terapêutico , Ceratoconjuntivite Seca/tratamento farmacológico , Ceratoconjuntivite Seca/veterináriaRESUMO
PURPOSE: To evaluate the ability of Systane(®) Balance (SYSB) administered four times per day for 4 weeks to increase noninvasive tear film break-up time (NITFBUT) over baseline compared with a saline (SAL) control in patients with lipid-deficient dry eye (DE). PATIENTS AND METHODS: Patients aged ≥18 years with DE and evidence of meibomian gland dysfunction (ie, abnormal gland expression and missing meibomian glands) were included in this randomized, parallel-group, controlled, investigator-masked comparison study. Patients were randomized to SYSB or SAL four times daily for 4 weeks. The primary efficacy variable was mean change in NITFBUT from baseline at week 4. Ocular surface staining, goblet cell density, and meibomian gland expression were also assessed. Safety assessments included adverse events (AEs), best-corrected visual acuity, and ocular signs. RESULTS: A total of 49 patients received study treatments (SYSB, n=25; SAL, n=24). Most patients were women (67.4%) and Caucasian (63.3%); mean ± standard deviation (SD) age was 44±19 years. DE characteristics at baseline were similar between groups. After 4 weeks of treatment, the mean ± SD NITFBUT increase from baseline was significantly greater with SYSB (2.83±0.74 seconds) compared with SAL (0.66±0.55 seconds; P<0.001, t-test). Improvements in conjunctival and corneal staining, percentage of patients with increased goblet cell density, and meibomian gland expression were also observed with 4 weeks of SYSB over SAL. No AEs were reported for either treatment group; best-corrected visual acuity and ocular signs remained stable or improved compared with baseline. CONCLUSION: SYSB restored tear film stability, improved ocular surface healing, and improved meibomian gland functionality after 4 weeks of use in patients with lipid-deficient DE. No AEs were reported with either SYSB or SAL.