Bimatoprost/timolol fixed combination versus latanoprost in treatment-naïve glaucoma patients at high risk of progression: a pilot study

Esperanza Gutierrez-Diaz, Jose Silva Cotta, Francisco J Muñoz-Negrete, Consuelo Gutierrez-Ortiz, Robert J Morgan-Warren, John Maltman, Esperanza Gutierrez-Diaz, Jose Silva Cotta, Francisco J Muñoz-Negrete, Consuelo Gutierrez-Ortiz, Robert J Morgan-Warren, John Maltman

Abstract

Objective: To compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomatous progression.

Methods: Patients were enrolled at 15 sites in Spain and Portugal, and were randomized 1:1 to BTFC or LM. Patients instilled one drop of medication once per day at 8 pm for 12 weeks. The primary outcome was change in intraocular pressure (IOP) at 12 weeks.

Results: Of 81 patients enrolled, 43 were randomized to BTFC and 38 to LM. Mean (SD) change in IOP from baseline to 12 weeks was significantly greater for BTFC than for LM: -13.5 mmHg (4.48) versus -11.4 mmHg (3.19), respectively (P=0.003). Similarly, at 12 weeks, significantly more BTFC patients than LM patients had IOP reductions of ≥40% (74.4% versus 47.4%, P=0.015) or ≥50% (46.5% versus 15.8%, P=0.003). Adverse events were more frequent with BTFC than with LM (33 versus 13 events), but most were mild in severity. The only serious adverse event (colon cancer) was adjudged unrelated to the study medication.

Conclusion: BTFC was effective and well tolerated in treatment-naïve patients with OAG at high risk of progression.

Keywords: fixed combinations; open-angle.

Figures

Figure 1
Figure 1
Individual IOPs at baseline and at 12 weeks for the BTFC (n=43) and LM (n=38) groups. Abbreviations: BTFC, fixed combination of 0.03% bimatoprost and 0.5% timolol; IOP, intraocular pressure; LM, latanoprost monotherapy.
Figure 2
Figure 2
Proportions of patients achieving predefined IOP reductions at 12 weeks: (A) by percentage; (B) by absolute level. Note: Asterisks indicate significant difference between groups (Cochran–Mantel–Haenszel test). Abbreviations: BTFC, fixed combination of 0.03% bimatoprost and 0.5% timolol; IOP, intraocular pressure; LM, latanoprost monotherapy.

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Source: PubMed

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