Cost-effectiveness of Anti-VEGF treatments for age-related macular degeneration: a Brazilian perspective / Estudo de custo-efetividade de tratamentos para a degeneração macular relacionada à idade: uma perspectiva brasileira

ABSTRACT Purpose: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. Methods: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. Results: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. Conclusions: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.

RESUMO Objetivo: Estudar o custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade neovascular. Métodos: Utilizamos um modelo de árvore de decisão para analisar a relação custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade, sob a perspectiva do Sistema Único de Saúde. O ranibizumabe e bevacizumabe foram administrados a pacientes com o mesmo procedimento de tratamento, e a diferença nos custos do tratamernto foi calculada com base no custo dos medicamentos. Os custos diretos foram estimados utilizando as informações fornecidas pelo SUS. A efetividade foi determinada em anos de vida ajustados pela qualidade (QALY) baseados em valores de utilidade em deficiênciavisual. A razãoincremental custo-efetividadefoicalculada comparando os dois tratamentos. O horizonte analítico foi de um ano. Resultados: A análise da árvore de decisão mostrou que a diferença na efetividade do tratamento foi de 0,01 QALY. A razão incremental de custo-efetividade mostrou que o tratamento com ranibizumabe exigiu um custo anual incremental de R$ 2 milhões para gerar um QALY adicional, em comparação ao bevacizumabe. Conclusões: Do ponto de vista do SUS, o bevacizumabe é mais custo-efetivo que o ranibizumabe no tratamento da degeneração macular relacionada à idade neovascular. O seu uso poderia gerar uma grande economia anual para o orçamento em saúde.

Factors affecting visual loss and visual recovery in patients with pseudotumor cerebri syndrome / Fatores que influenciam na perda e na recuperação visual de pacientes com a síndrome do pseudotumor cerebral

ABSTRACT Purpose: To investigate the frequency of visual loss (VL), possible predictive factors of VL, and improvement in patients with pseudotumor cerebri (PTC) syndrome. Methods: We reviewed 50 PTC patients (43 females, seven males) who underwent neuro-ophthalmic examination at the time of diagnosis and after treatment. Demographic data, body mass index (BMI), time from symptom onset to diagnosis (TD), maximum intracranial pressure (MIP), occurrence of cerebral venous thrombosis (CVT), and treatment modalities were reviewed. VL was graded as mild, moderate, or severe on the basis of visual acuity and fields. Predictive factors for VL and improvement were assessed by regression analysis. Results: The mean ± SD age, BMI, and MIP were 35.2 ± 12.7 years, 32.0 ± 7.5 kg/cm2, and 41.9 ± 14.5 cmH2O, respectively. Visual symptoms and CVT were present in 46 and eight patients, respectively. TD (in months) was <1 in 21, 1-6 in 15, and >6 in 14 patients. Patients received medical treatment with (n=20) or without (n=30) surgery. At presentation, VL was mild in 16, moderate in 12, and severe in 22 patients. Twenty-eight patients improved and five worsened. MIP, TD, and hypertension showed a significant correlation with severe VL. The best predictive factor for severe VL was TD >6 months (p=0.04; odds ratio, 5.18). TD between 1 and 6 months was the only factor significantly associated with visual improvement (p=0.042). Conclusions: VL is common in PTC, and when severe, it is associated with a delay in diagnosis. It is frequently permanent; however, improvement may occur, particularly when diagnosed within 6 months of symptom onset. .

RESUMO Objetivo: Investigar a frequência de perda visual (PV) e os possíveis fatores preditivos para perda e para melhora visual em pacientes com a síndrome do pseudotumor cerebral (SPC). Métodos: Foram revisados 50 pacientes com SPC submetidos a exame neuroftalmológico no momento do diagnóstico e após o tratamento. Dados demográficos, índice de massa corpórea (IMC), tempo decorrido entre o início dos sintomas e o diagnóstico (TD), pressão intracraniana máxima (PIM), ocorrência de trombose venosa cerebral (TVC), e as modalidades de tratamento foram revisadas. PV foi graduada em discreta, moderada e grave, baseada na acuidade e no campo visual. Fatores preditivos para perda e melhora visual foram avaliados por análise de regressão linear. Resultados: Quarenta e três pacientes eram do sexo feminino. A média de idade, o IMC e a PIM (± desvio padrão) foram: 35,2 ± 12,7 anos, 32,0 ± 7,5 kg/cm2 e 41,9 ± 14,5 cmH2O, respectivamente. Sintomas visuais estavam presentes em 46 e TVC em 8 pacientes. TD (em meses) foi <1 em 21, 1-6 em 15 e >6 em 14 pacientes. Pacientes receberam tratamento clinico apenas (n=30) ou associado a tratamento cirúrgico (n=20). Na apresentação a PV era discreta em 16, moderada em 12 e grave em 22 pacientes. Vinte e oito pacientes melhoraram e 5 pioraram. PIM, TD e hipertensão arterial correlacionaram significativamente com PV grave. O melhor fator preditivo para PV grave foi o TD>6 meses (p=0,04; razão de chances 5,18). TD entre 1 e 6 meses foi o único fator significativamente associado com melhora visual após tratamento (p=0,042). Conclusões: Perda visual é comum na SPC e quando grave se mostra relacionado a atraso no diagnóstico. É usualmente permanente mas pode haver melhora visual especialmente quando a doença é diagnosticada nos primeiros 6 após o início dos sintomas. .

Resultados visuales en pacientes con macroprolactinoma tratados con agonistas de dopamina / Visual outcome in patients with macroprolactinoma treated with dopamine agonists

Background: Dopamine agonists (DA) effectively reduce tumor size of macroprolactinomas, with the consequent improvement of eventual visual impairment. Aim: To study the visual outcomes in patients with macroprolactinoma treated with DA. Material and Methods: Retrospective cohort study which included patients with macroprolactinoma controlled at a Neuro-endocrinology and Neuro-ophthalmology Department between 1997'and2011, and treated exclusively with DA (bromocriptine or cabergoline). Patients who were operated or had previous radiotherapy and those with an incomplete follow up, were excluded. We analyzed and compared the visual status before and after the beginning of DA treatment. Results: Thirty one patients aged 8 to 59years, were included. Eighteen patients (58%) had visual impairment at the moment of diagnosis (group 1) and 13 had no alterations (group 2). Mean follow up was 36.5 months. Fifteen patients from group 1 (83%) had visual improvement, two remained stable (11 %) and one had a visual deterioration (6%). In group 2, only one non-compliant patient had a visual deterioration. Conclusions: DAs are effective in the management of neuro-ophthalmic complications associated to macroprolactinomas and should be considered asfirst choice therapy in these tumors.

Keratouveitis caused by Euphorbia plant sap.

The milky sap or latex of Euphorbia plant is highly toxic and an irritant to the skin and eye. This report illustrates the spectrum of ocular inflammation caused by accidental inoculation of latex of Euphorbia plant. Three patients presented with accidental ocular exposure to the milky sap of Euphorbia species of recent onset. The initial symptoms in all cases were severe burning sensation with blurring of vision. Visual acuity reduced from 20/60 to counting fingers. Clinical findings varied from kerato-conjunctivitis, mild to severe corneal edema, epithelial defects, anterior uveitis and secondary elevated intraocular pressure. All symptoms and signs had resolved by 10-14 days with active supportive medication. People who handle Euphorbia plants should wear eye protection. It is always advisable to ask the patient to bring a sample of the plant for identification.

Atualização no diagnóstico e tratamento da degeneração macular relacionada à idade / Highlights on age-related macular degeneration diagnosis and treatment

A degeneração macular relacionada à idade (DMRI) representa a principal causa de cegueira legal em pacientes idosos no mundo ocidental. O presente artigo revisa os principais avanços no diagnóstico e tratamento da DMRI, servindo de auxílio para a atualização da comunidade médica quanto a esta doença (AU)

Age-related macular degeneration (AMD) is the leading cause of legal blindness in the elderly in the Western world. In this regard, to promote the medical education about this disease, we present a review of AMD diagnostic and therapeutic approaches (AU)

Síndrome de Charles Bonnet: Manejo con haloperidol en paciente nonagenaria. Caso clínico / Charle Bonnet syndrome: Report of one case managed with haloperidol

Charles Bonnet syndrome is an underrecognized condition characterized by complex visual hallucinations, ocular problems causing visual deterioration and preserved cognitive status. Its prevalence is 5/1000 in ambulatory ophthalmologic patients. Generally occurs in elderly people in whom it may be confused with delirium or dementia. The first management step is to improve vision, if possible. Hallucinations may be managed pharmacologically. We report a 94 year-old woman with the characteristic clinical picture of the syndrome that improved with haloperidol.

Unilateral dysphotopsia after bilateral intraocular lens implantation using the AR40e IOL model: case report

The authors report a recent complication during the postoperative period of cataract surgery. A patient was submitted to cataract surgery in both eyes with IOL implantation (Sensar®) inside the capsular bag. The postoperative period of right eye was uneventful, however, in the left eye the patient noted a dark shadow at the temporal visual field at the first postoperative week. This diagnosis was confirmed with the presence of a temporal scotoma revealed by the computerized visual field (first reported in this study) and also reducing the pupil area with miotic drops. The treatment of this complication was performed by using brimonidine tartrate and after 6 months this symptom completely disappeared as confirmed by the computerized visual field. The treatment should be based on reducing the pupil area with miotic drops and we also recommend to observe these cases until the 6th postoperative month before indicating an IOL exchange since the capsular edge that overlaps the IOL may opacify creating an optical barrier reducing or eliminating negative dysphotopsia.

Os autores relatam uma complicação no período pós-operatório relativamente recente na cirurgia de catarata. Trata-se de paciente que foi submetido à cirurgia de catarata bilateral não simultânea com implante sacular da lente intra-ocular (Sensar®). O pós-operatório do olho direito evoluiu sem nenhuma queixa, entretanto, no olho esquerdo o paciente referiu a presença de uma sombra em campo visual temporal na primeira semana de pós-operatório sendo diagnosticado disfotopsia negativa após exclusão de outras causas oculares, principalmente retinianas. Este diagnóstico foi confirmado com a presença de um escotoma temporal na campimetria visual computadorizada (relatado na literatura pela primeira vez neste estudo) e também com a redução medicamentosa do tamanho da pupila. Seu tratamento foi realizado com a administração de tartarato de brimonidina e após 6 meses o sintoma desapareceu sendo também documentado com o campo visual (ausência de escotoma). A disfotopsia negativa deve ser tratada visando reduzir a área pupilar e observar por pelo menos 6 meses antes de indicar a troca do lente intra-ocular, uma vez que a cápsula anterior que cobre a LIO pode opacificar criando uma barreira óptica reduzindo ou eliminando esta complicação.

Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (p<0.01) and almost identical results were observed with tears plus (difference was not statistically significant). Itone is considered to be a useful drug in computer vision syndrome.

Intravitreal gas for submacular haemorrhage.

Submacular haemorrhage is an important cause for sudden visual loss needing immediate intervention. We report a case of submacular haemorrhage causing profound visual loss, which resolved after intravitreal injection of perfluoropropane (C3F8) gas followed by strict prone positioning.

Comparative randomised controlled clinical trial of a herbal eye drop with artificial tear and placebo in computer vision syndrome.

A comparative randomised double masked multicentric clinical trial has been conducted to find out the efficacy and safety of a herbal eye drop preparation, itone eye drops with artificial tear and placebo in 120 patients with computer vision syndrome. Patients using computer for at least 2 hours continuosly per day having symptoms of irritation, foreign body sensation, watering, redness, headache, eyeache and signs of conjunctival congestion, mucous/debris, corneal filaments, corneal staining or lacrimal lake were included in this study. Every patient was instructed to put two drops of either herbal drugs or placebo or artificial tear in the eyes regularly four times for 6 weeks. Objective and subjective findings were recorded at bi-weekly intervals up to six weeks. Side-effects, if any, were also noted. In computer vision syndrome the herbal eye drop preparation was found significantly better than artificial tear (p < 0.01). No side-effects were noted by any of the drugs. Both subjective and objective improvements were observed in itone treated cases. So, itone can be considered as a useful drug in computer vision syndrome.