Journal of drug assessment · 2021
Efficacy and safety of timolol-dorzolamide fixed-combination three times a day versus two times a day in newly diagnosed open-angle glaucoma.
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Pakravan Mohammad, Naderi Beni Afsaneh, Yazdani Shahin, Esfandiari Hamed, Mirshojaee Shahram
Аннотация
OBJECTIVE: This study aimed to compare the therapeutic efficacy and safety of dorzolamide/timolol fixed-combination(Cosopt) in newly diagnosed primary open-angle glaucoma (POAG) patients.
METHODS: In this prospective, interventional case series, newly POAG patients were included. Patients were started on Cosopt twice a day (BID) for one month and then switched to three times a day (TDS) for an additional month. Patients underwent comprehensive ophthalmic examination, diurnal intraocular pressure (IOP), blood pressure (BP), and 24-h heart rate (HR) measurements at baseline, month 1(BID), and month 2(TDS). Throughout the study, all adverse events were monitored by the investigators.
RESULTS: In 31 POAG patients that completed the study, the mean baseline IOP was 23.1 ± 3.15 mmHg. IOP was decreased significantly 16.5 ± 2.21 at one month (p < .0001) and 13.9 ± 2.23 mmHg at 1 and 2 months follow up (p < .0001). IOP was significantly lower in month 2 compared to month 1 (p = .0004). While Cosopt BID significantly reduced the mean 24-h systolic BP and mean 24-h HR from baseline (p < .0001), the mean 24-h systolic BP and HR remained unchanged with Cosopt TDS compared to BID (p = .62).
CONCLUSIONS: Cosopt TDS has a superior IOP-lowering effect than Cosopt BID in POAG patients with comparable safety profiles.
METHODS: In this prospective, interventional case series, newly POAG patients were included. Patients were started on Cosopt twice a day (BID) for one month and then switched to three times a day (TDS) for an additional month. Patients underwent comprehensive ophthalmic examination, diurnal intraocular pressure (IOP), blood pressure (BP), and 24-h heart rate (HR) measurements at baseline, month 1(BID), and month 2(TDS). Throughout the study, all adverse events were monitored by the investigators.
RESULTS: In 31 POAG patients that completed the study, the mean baseline IOP was 23.1 ± 3.15 mmHg. IOP was decreased significantly 16.5 ± 2.21 at one month (p < .0001) and 13.9 ± 2.23 mmHg at 1 and 2 months follow up (p < .0001). IOP was significantly lower in month 2 compared to month 1 (p = .0004). While Cosopt BID significantly reduced the mean 24-h systolic BP and mean 24-h HR from baseline (p < .0001), the mean 24-h systolic BP and HR remained unchanged with Cosopt TDS compared to BID (p = .62).
CONCLUSIONS: Cosopt TDS has a superior IOP-lowering effect than Cosopt BID in POAG patients with comparable safety profiles.