title: Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study.
abstract: OBJECTIVE
  To evaluate intraocular pressure (IOP)-lowering efficacy, tolerability, and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% (Ganfort) among German patients.
  
  
  METHODS
  Multicenter, observational, open-label study of patients with primary open angle glaucoma or ocular hypertension (n = 606). As determined by participating physicians, patients had insufficient IOP control and required a medication change. They were switched to once-daily fixed-combination bimatoprost/timolol with no wash-out period. IOP was recorded at treated baseline, 4-6 weeks and 12 weeks after switching. Tolerability was measured using a 4-step scale (excellent, good, moderate, poor) and all adverse events were recorded.
  
  
  RESULTS
  A total of 405 patients switched from monotherapy, 97 switched from other fixed combinations, and 104 switched from non-fixed combinations. Among all patients, 32.5% had used prostaglandin analog (PGA) monotherapy, 8.7% had been using a fixed combination that included a PGA, and 6.9% had been using an adjunctive combination of a PGA and a beta-blocker. Mean treated baseline IOP (+/-SD) for all patients was 20.7 +/- 3.5 mmHg. Overall, changing medication to fixed-combination bimatoprost/timolol lowered IOP to 16.6 +/- 2.7 mmHg (p < 0.001 vs. baseline) after 4-6 weeks and to 16.1 +/- 2.6 mmHg (p < 0.001) after 12 weeks; reductions of 19.8% and 22.2%, respectively. Combined bimatoprost/timolol provided an additional IOP reduction versus baseline in most subgroups based on prior treatment. At week 12, patients who had previously used a beta-blocker achieved an additional 25.8% decrease from baseline and IOP was reduced by 22.6% in former PGA monotherapy patients. At week 12, 84.6% of all eyes reached a target pressure less than or equal to 18 mmHg. Tolerability of bimatoprost/timolol was rated excellent or good by the physicians for 98.7% of patients and by 96.7% of the patients themselves. Few adverse events occurred during the treatment period.
  
  
  CONCLUSIONS
  Although this study was limited by its observational design, our results show that the fixed combination of bimatoprost 0.03%/timolol 0.5% was effective, well tolerated, and safe in a broad patient population.
authors.affiliation: Burgdorfer Strasse 19/21, Lehrte, Germany. dr.feuerhake@augenzentrum-lehrte.de
authors.forename: Cord
authors.initials: C
authors.lastname: Feuerhake
authors.forename: Patricia
authors.initials: P
authors.lastname: Buchholz
authors.forename: Friedemann
authors.initials: F
authors.lastname: Kimmich
mesh_terms: D000577:Amides / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use; D000069580:Bimatoprost; D003008:Cloprostenol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D009798:Ocular Hypertension / Q000188:drug therapy*; D009898:Optic Disk / Q000187:drug effects / Q000503:physiopathology; D013999:Timolol / Q000009:adverse effects / Q000627:therapeutic use*; D014794:Visual Fields / Q000187:drug effects
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D003008:Cloprostenol; D013999:Timolol; D000069580:Bimatoprost