Six-month comparison of bimatoprost once-daily and twice-daily with timolol twice-daily in patients with elevated intraocular pressure

The efficacy and safety of bimatoprost, a member of a new class of pharmaco logical agents: called prostamides were compared with the efficacy and safe ty of timolol in patients with glaucoma or ocular hypertension. Pooled 6-mo nth results fi om two ongoing, multicenter,, randomized, double-masked, cli nical trials were analyzed. Patients were randomized in a 2:2:1 ratio to tr eatment with bimatoprost 0.03% once a day ([QD] n = 474), bimatoprost 0.03% twice a day ([BID] n = 483), or timolol 0.5% BID (n = 241). Scheduled visi ts were at prestudy, baseline, week 2, week 6, month 5, and month 6. The pr imary outcome measure was in diurnal intraocular pressure ([IOP] 8 AM, 10 A M, 4 PM, 8 PM). Bimatoprost QD provided significantly greater mean IOP redu ctions from baseline than timolol at every time of the dry and at each stud y visit (p less than or equal to .05). BID dosing of bimatoprost also provi ded significantly greater mean IOP reductions than timolol at most timepoin ts, but was not as effective as QD dosing. The IOP lowering provided by bim atoprost QD was sustained for 6 months. At month 6, the menu IOP reduction from baseline at 10 AM was 8.1 mm Hg (33%) with bimatoprost QD, 6.3 mm Hg ( 26%) with bimatoprost BID, and 5.6 mm Hg (23%) with timolol. Low target pre ssures were achieved 1,) a significantly higher percentage of patients in t he bimatoprost QD group than in tile timolol group. At 10 AM (peak timolol effect) at month 6, IOP less than or equal to 17 mm Hg was achieved by 63.9 % of bimatoprost QD patients, compared with 37.3% of timolol patients (p < .001). Bimatoprost was safe and well-tolerated, with few discontinuations d ue to adverse events. The most frequent side effect was: trace-to-mild conj unctival hyperemia. Changes in iris pigmentation were reported in 1.1% of b imatoprost patients. There were no other significant findings in slit lamp examinations, ophthalmoscopy, visual acuity, or visual fields, and systemic safely parameters were also unaffected. Together these results indicate tl lal bimatoprost QD is statistically and clinically superior to timolol in l owering IOP, and is safe and well-tolerated in patients with glaucoma or oc ular hypertension. (C) 2001 by Elsevier Science Inc. All rights reserved.