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Bimatoprost offers better profile at 3-month mark than combo drug
At key measurement points, bimatoprost lowered IOP significantly more than did timolol/dorzolamide over the course of the trial.
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LOS ANGELES — Patients on bimatoprost had statistically significant lower IOPs than those on timolol/dorzolamide after being treated with either Cosopt or bimatoprost for 3 months, an international study found. Bimatoprost provided better IOP lowering than timolol/ dorzolamide at all follow-up visits and all times points, study authors added.
Anne L. Coleman, MD, PhD, and colleagues conducted a 3-month, randomized, investigator-masked trial in 177 ocular hypertension-chronic glaucoma patients who were uncontrolled on beta-blocker therapy alone. Patient inclusion criteria included best corrected visual acuity of 20/100 or better in each eye and an IOP of at least 22 mm Hg but no greater than 34 mm Hg in at least one eye at baseline at 8 a.m. after at least 2 weeks on beta-blocker monotherapy.
Six patient visits were scheduled: prestudy, baseline, week 1 and at months 1, 2 and 3. Before baseline measurements were taken, all patients were treated with beta-blocker monotherapy. At baseline, the beta-blocker monotherapy was discontinued and patients were randomly assigned to treatment with Lumigan (bimatoprost 0.03%, Allergan) once daily or Cosopt (timolol 0.5%/dorzolamide 2%, Merck) twice daily.
Ninety patients were treated with bimatoprost and 87 were treated with timolol/dorzolamide. Four patients were dropped from the bimatoprost treatment: three because of adverse ocular events and one for failure to adhere to the protocol. Five patients were dropped from the timolol/dorzolamide treatment: three because of adverse ocular events, one because of failure to adhere to the protocol and one because the treatment was not efficacious. The mean age of patients receiving bimatoprost was 60; the mean age of patients treated with timolol/dorzolamide was 64.
Data analysis
During each study visit, IOP was measured at 8 a.m. and 10 a.m. At baseline and at month 3, IOP was also measured at 2 p.m., 4 p.m. and 8 p.m. Significantly higher percentages of patients in the bimatoprost group than the timolol/dorzolamide group achieved low target IOPs of 13 mm Hg 14 mm Hg, 15 mm Hg or 16 mm Hg or less at 8 a.m. at the month 3 visit (P < 0.08 or less).
Further, a higher percentage of patients receiving bimatoprost achieved very low IOP target levels compared with those receiving timolol/dorzolamide. Patients on bimatoprost were more than twice as likely than those on timolol/dorzolamide to achieve IOP levels under 16 mm Hg.
Of the patients on bimatoprost, 31% achieved IOP levels of 16 mm Hg or lower, compared with 14% on timolol/dorzolamide. In the bimatoprost group, 24% of patients treated with bimatoprost achieved a target IOP of 15 mm Hg or lower, compared with 9% of patients treated with timolol/dorzolamide.
For patients reaching IOP levels of 14 mm Hg or lower, 17% were treated with bimatoprost versus 2% who were treated with timolol/dorzolamide. Eight percent of patients treated with bimatoprost achieved target IOPs of 13 mm Hg or lower, compared with none of the patients treated with timolol/dorzolamide.
The between-group differences in diurnal mean IOP ranged from 0.5 mm Hg at 10 a.m. (P = .356) to 1.5 mm Hg at 8 a.m. and 8 p.m. (P < .004). At every follow-up visit during the 3-month study, bimatoprost lowered IOP at 8 a.m. 27% to 30% from baseline, while timolol/dorzolamide lowered IOP 18% to 20%.
At the 10 a.m. measurement, bimatoprost lowered IOP 6.9 mm Hg from baseline at week 1; 6.5 mm Hg from baseline at month 1; 6.6 mm Hg from baseline at month 2; and 6.4 mm Hg from baseline at month 3. At 10 a.m. during week 1, the mean timolol/dorzolamide IOP reduction was 5.1 mm Hg from baseline; at month 1, the reduction was 5.1 mm Hg from baseline. At month 2, the IOP reduction from baseline was 5.4 mm Hg and at month 3, the reduction was 5.6 mm Hg.
Twice as many patients on bimatoprost compared with timolol/dorzolamide developed conjunctival hyperemia (31 patients on bimatoprost compared with 15 patients on timolol/ dorzolamide). Twelve patients on timolol/dorzolamide (13.8%) developed burning eye sensations, compared with two patients (2.2%) on bimatoprost; nine patients on timolol/dorzolamide (10.3%) developed stinging eye sensations, compared with two patients on bimatoprost (2.2%).
Additionally, five patients (5.7%) on timolol/dorzolamide developed taste perversion, compared with none on bimatoprost. No significant differences were observed between the groups in blood pressure or heart rate, visual acuity, fundus pathology or cup-to-disc ratios.
For Your Information:
- Anne L. Coleman, MD, PhD, can be reached at Jules Stein Eye Institute, UCLA, 100 Stein Plaza 2-118, Los Angeles, CA 90095-7004; (310) 825-5298; fax: (310) 206-7773; e-mail: colemana@ucla.edu. Dr. Coleman is a paid consultant for Allergan and Merck.
- Allergan can be reached at 2525 Dupont Drive, Irvine, CA 92612; (714) 246-4324; fax: (714) 246-5913; Web site: www.allergan.com. Merck & Co. Inc. can be reached at 351 North Sumneytown Pike, North Wales, PA 19454; (267) 305-7896; fax: (267) 305-4283.