RESUMO
Resumo Objetivo: avaliar a eficácia do colírio TRAVAMED® (travoprosta 0,004%) (Ofta, Brasil) na redução da pressão intraocular (PIO), em pacientes com glaucoma primário de ângulo aberto (GPAA) ou hipertensão ocular (HO), bem como avaliar os efeitos colaterais decorrentes do uso da droga. Métodos: estudo randomizado, controlado, com 70 olhos de 38 pacientes acima de 18 anos de idade, com diagnóstico de GPAA ou HO. Todos os pacientes receberam o colírio TRAVAMED® como primeira droga a ser introduzida no tratamento, tendo sido utilizada uma gota uma vez ao dia (à noite), e 30 dias após foram submetidos à tonometria de aplanação (Goldmann) para mensuração da PIO, com o mesmo examinador, no mesmo tonômetro e nos mesmos horários. Resultados: A média de redução da PIO após 30 dias de uso do TRAVAMED® foi de 7,46 mmHg. Em relação aos efeitos colaterais, 15,71% (11) dos olhos apresentaram hiperemia conjuntival, 8,57% (6) apresentaram dor, 8,57% (6) apresentaram ardência, 2,86% (2) apresentaram embaçamento visual e em 1,56% (1) dos olhos não houve queda significativa da PIO. Conclusão: A medicação TRAVAMED® foi eficiente na redução da PIO após 30 dias de uso contínuo, na dose de 1x/dia. Acerca dos efeitos colaterais, os mais observados foram hiperemia ocular (15,71%), dor (8,57%) e ardência (8,57%), porém estudos com maior tempo de seguimento se fazem necessários.
Abstract Objective: to evaluate how much decreases intraocular pressure (IOP) with TRAVAMED® (travoprost 0,004%) (Germed, Brazil) in patients with primary open angle glaucoma (POAG) and ocular hypertension (OH) and possible side effects. Methods: controlled and randomized study, it was evaluated 70 eyes of 38 patients with age of 18 years old or more diagnosed with POAG and OH. All the patients had TRAVAMED® as first drop for treatment used once daily (at night) and 30 days later they had IOP measured by Goldmann tonometry, with the same examiner in the same tonometer at the same times. Results: the mean decrease in IOP was 7,46 mmHg after 30 days using the drops. 15.71% (11) of eyes had conjunctival redness, 8.57% (6) had pain, 8.57% (6) had burning, 2.86% (2) had blurring vision and 1.56% (1) of the eyes there wasn't a significant reduction in IOP. Conclusion: TRAVAMED® was efficient when evaluating IOP decrease. The most correlated side effects were conjunctival redness (15.71%), pain (8.57%) and burning (8.57%), but studies with longer follow-up are needed.
Assuntos
Humanos , Glaucoma de Ângulo Aberto/tratamento farmacológico , Hipertensão Ocular/tratamento farmacológico , Travoprost/efeitos adversos , Travoprost/uso terapêutico , Ensaio Clínico Controlado AleatórioAssuntos
Humanos , Protocolos Clínicos/normas , Glaucoma/diagnóstico , Glaucoma/tratamento farmacológico , Guias de Prática Clínica como Assunto/normas , Acetazolamida/uso terapêutico , Bimatoprost/uso terapêutico , Brasil , Tartarato de Brimonidina/uso terapêutico , Anidrases Carbônicas/uso terapêutico , Continuidade da Assistência ao Paciente , Manitol/uso terapêutico , Prostaglandinas/uso terapêutico , Timolol/uso terapêutico , Travoprost/uso terapêuticoRESUMO
BACKGROUND: Prostaglandin analogs reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; however, these medications may affect the ocular surface and elicit ocular discomfort when preserved with benzalkonium chloride (BAK). METHODS: This was an open-label, single-arm study conducted in Latin America from February 2012 to May 2013. Patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost 0.005 % were transitioned to receive once-daily BAK-free travoprost 0.004 % containing polyquaternium-1 (Travatan® preserved with POLYQUAD® [PQ], Alcon Laboratories, Inc; Fort Worth, TX) for 12 weeks. Mean change in IOP from baseline (primary efficacy endpoint) and the percentage of patients who achieved a target IOP of ≤18 mmHg were evaluated at all on-therapy visits. Ocular hyperemia, patient preference, and self-projected adherence were assessed at week 12. Adverse events (AEs) were monitored throughout the study. RESULTS: All enrolled patients were included in the analysis (n = 191); the majority of patients (90.6 %, n = 173/191) completed the study. Mean (SD) patient age was 67.5 (11.3) years, and mean baseline IOP was 14.8 mmHg. Mean IOP was reduced by 0.94 mmHg at week 6 and by 1.09 mmHg at week 12 (P < 0.001 for both). A greater percentage of patients achieved a target IOP of ≤18 mmHg at week 6 (93.1 %; n = 163/175) and week 12 (93.3 %; n = 166/178) compared with baseline (89.5 %; n = 171/191). There was a 10.5 % increase in the percentage of patients with "none/trace" amounts of hyperemia. Most patients preferred the study medication (81.5 %; n = 141/173) and were confident that they would adhere to their preferred medication (90.8 %; n = 157/173). No serious AEs were reported, and eye irritation (3.7 %; n = 7/191) was the most common treatment-related AE. CONCLUSIONS: Transitioning from BAK-containing latanoprost 0.005 % to BAK-free travoprost 0.004 % preserved with PQ reduced IOP in patients with open-angle glaucoma or ocular hypertension who were intolerant of latanoprost. BAK-free travoprost 0.004 % is a viable alternative for patients who require switching their IOP-lowering medications because of tolerability issues. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01510145.