Levobunolol. A four-year study of efficacy and safety in glaucoma treatment. The Levobunolol Study Group.
In a 4-year, double-masked, parallel, multicenter study comparing the efficacy and safety of levobunolol and timolol, 391 patients with open-angle glaucoma or ocular hypertension were randomly assigned to receive masked 0.5% or 1% levobunolol, or 0.5% timolol, twice daily. Mean decreases in intraocular pressure (IOP) over 4 years of therapy were 7.1, 7.2, and 7.0 mmHg for 0.5% levobunolol, 1% levobunolol, or 0.5% timolol, respectively. Little attenuation of ocular hypotensive efficacy occurred. The 4-year efficacy failure rate for the three groups, which did not differ from each other, was approximately 30%. Adverse experiences requiring cessation of therapy occurred in an additional 10% of patients. The vast majority of efficacy failures (79/95) and of adverse events (33/37) requiring removal from the study occurred during the first 2 years. Overall mean decreases in heart rate for the 4 years ranged from 3 to 6 beats per minute for all treatment groups; overall mean decreases in systolic and diastolic blood pressure ranged between 1 and 2 mmHg. The authors concluded that levobunolol is relatively effective and relatively safe for the long-term (4-year) treatment of elevated IOP.
D000293:Adolescent; D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D002040:Levobunolol / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009798:Ocular Hypertension / Q000188:drug therapy*; D011897:Random Allocation; D013997:Time Factors; D013999:Timolol / Q000627:therapeutic use; D014794:Visual Fields
D013999:Timolol; D002040:Levobunolol