Sigurnost i učinkovit ostfiksne kombinacije (travoprost 0,004%/timolol 0,5%) umjesto monoterapije u šestomjesečnom periodu praćenja

Abstract

Purpose: To assess the safety and efficacy of changing antiglaucoma therapy to the travoprost 0,004%/timolol 0,5% (TTF C) fixed combination from previous monotherapies. Methods: Prospective, open-label, observational, multicenter cohort. A change was done from prior monotherapy at day 0 to TTF C dosed once a day, regardless in the evening or in the morning, without washout period. Active evaluation of systemic and local tolerability (adverse events), and efficacy ie. intraocular pressure (IOP) lowering was done at control 1 (day 30), control 2 (day 90) and control 3 (day 120). Results: 40/155/170 patients (79/309/339 eyes) completed the study (120 days/ 90 days/baseline, respectfully). At control 1 excluded were patients with low tolerability (severe hyperemia (6 patients), discomfort (4), chest pain (1)) and non responders (IOP lowering less than 15% from baseline IOP or target IOP >18 mmHg (4 patients)). Mean IOP at control 1 was 15,92±1,85 mm Hg (21,66% reduction) for 155 patients (non responders excluded), at control 2 was for 155 patients 15,67±2,17 mm Hg (21,14% reduction), and at control 3 for 40 patients 16,28±1,59 mm Hg (19,86% reduction). At control 2 analysis of IOP reduction by 4 groups of previous monotherapy (timolol 0,5% (N=33/66), latanoprost 0,005% (N=49/98), betaxolol 0,5% (N=30/60), and travoprost 0,004% (N=43/85) was performed. 40 patients/79 eyes endured to control 3 (after day 90 free samples were not available for all patients). Analysis of IOP reduction by 4 groups of previous monotherapy medications was performed (timolol 0,5%(N=7/14), latanoprost 0,005% (N=14/28), betaxolol 0,5% (N=7/14), travoprost 0,004% (N=12/23)). Conclusions: Changing patients from prior monotherapy to TTF C can provide on average a further reduction in IOP, while demonstrating a favorable safety profile.CILJ: Zabilježiti sigurnost i učinkovitost promjene antiglaukomske terapije u travoprost 0,004%/timolol 0,5% (TTF C) fiksnu kombinaciju s prethodnih monoterapija. METODE: Prospektivna, otvorena, opservacijska, multicentrična populacija. Promjena s prethodne monoterapije na dan 0 u TTF C, doziran jednom dnevno, ili ujutro ili navečer, bez perioda ispiranja. Aktivno je ocijenjena sistemska i lokalna podnošljivost (popratne pojave), i učinkovitost tj.sniženje intraokularnog tlaka (IOT) na prvoj kontroli (dan 30), drugoj kontroli (dan 90) i trećoj kontroli (dan 120). REZULTATI: 40/155/170 bolesnika (79/309/339 očiju) završilo je studiju (120 dana/ 90 dana/početak). Na prvoj kontroli isključeni su svi bolesnici koji su slabo podnosili lijek: ozbiljna hiperemija (6 bolesnika), neugoda (4), bol u prsištu (1) i ne- responderi tj. sniženje IOT-a manje od 15% od početnog IOT ili ciljnog IOT >18 mmHg (4 bolesnika). Prosječni IOT na prvoj kontroli je bio 15,92±1,85 mm Hg (21,66% sniženja) kod 155 bolesnika (isključeni ne-responderi), na drugoj kontroli je kod 155 bolesnika bio 15,67±2,17 mm Hg (21,14% sniženja), i na trećoj kontroli kod 40 bolesnika 16,28±1,59 mm Hg (19,86% sniženja). Na drugoj kontroli je učinjena analiza sniženja IOT-a u 4 grupe prethodno korištene monoterapije: timolol 0,5% (N=33/66), latanoprost 0,005% (N=49/98), betaxolol 0,5% (N=30/60), i travoprost 0,004% (N=43/85). 40 bolesnika/79 očiju praćeno je do treće kontrole. Učinjena je analiza sniženja IOT-a u 4 grupe prethodno korištene monoterapije: timolol 0,5% (N=7/14), latanoprost 0,005% (N=14/28), betaxolol 0,5% (N=7/14), travoprost 0,004% (N=12/23). Zaključak: Promjena terapije s prethodne monoterapije u TTF C može u prosjeku omogućiti dodatno sniženje IOT-a, uz zadovoljavajući profil sigurnosti