Corrigendum

Brief G, Lammich T, Nagel E, Pfennigsdorf S, Spraul CW, Ho S. Fixed combination of bimatoprost and timolol in patients with primary open-angle glaucoma or ocular hypertension with inadequate IOP adjustment. Clin Ophthalmol. 2010:4 1125–1129.Dr Stefan Pfennigsdorf was incorrectly identified as Dr Sabine Pfennigsdorf in this work.Read the original articl

Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice

Lutz E Pillunat,1 Peter Eschstruth,2 Stefan Häsemeyer,3 Ulrich Thelen,4 Christian Foja,5 Richard Leaback,6 Stefan Pfennigsdorf7 1Department of Ophthalmology, University Hospital Carl Gustav Carus, Dresden, 2Ophthalmology Practice, Kiel, 3Eye Center Kraichgau, Wiesloch, 4Department of Ophthalmology, University of Münster, Münster, 5Ophthalmology Practice, Leipzig, Germany; 6Allergan Holdings Ltd., Marlow, UK; 7Ophthalmology Practice, Polch, Germany Background: Intraocular pressure (IOP)-lowering medications for primary open-angle glaucoma and ocular hypertension commonly contain preservatives that can cause ocular surface damage in many patients. The purpose of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF) bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension (IOP ≥18 mmHg) in a clinical practice setting. Methods: This open-label study observed patients who were switched to PF bimatoprost 0.03% for medical reasons. IOP was measured at baseline and ~12 weeks later at the final visit, and the change in IOP was calculated. Tolerability and continuation of therapy were assessed at two follow-up visits. Results: A total of 1,830 patients were included in the study, and complete IOP data were available for 1,543 patients. Mean IOP was reduced by 23% from 21.64 mmHg to 16.59 mmHg (P<0.0001). In subgroup analyses, the mean IOP was significantly reduced compared with baseline, regardless of prior therapy, including those previously treated with PF monotherapy. A total of 85.7% of physicians reported the IOP-lowering efficacy of PF bimatoprost 0.03% to be as expected or better than expected. Adverse events (AEs) were experienced by 5.7% of patients, and there were no serious AEs reported. The most common AEs were eye irritation (1.7%) and hyperemia (1.4%). Physician-reported treatment compliance was reported as better than (48.7%) or equal to (43.6%) prior treatment in most patients. Most patients (82%) were expected to continue PF bimatoprost 0.03% after the end of the study. Conclusion: This observational study showed that, in clinical practice, switching to PF bimatoprost 0.03% was associated with a significant IOP reduction from baseline. There was a low AE rate. PF bimatoprost 0.03% may, therefore, be an effective treatment option for patients who are intolerant of preservatives or have an inadequate response to prior IOP-lowering treatments. Keywords: bimatoprost 0.03%, intraocular pressure, prostaglandin, preservative free, benzalkonium chloride fre

Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice

Stefan Pfennigsdorf,1 Peter Eschstruth,2 Stefan Häsemeyer,3 Cord Feuerhake,4 Gerrett Brief,5 Ioana Grobeiu,6 Andrew Shirlaw6 1Polch Ophthalmology Practice, Polch, 2Ophthalmology Practice, Kiel, 3Ophthalmology Practice, Wiesloch, 4Ophthalmology Practice, Lehrte, 5Ophthalmology Practice, Dortmund, Germany; 6Allergan Holdings Ltd., Marlow, UK Purpose: The aim of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF), fixed-combination (FC) bimatoprost 0.03%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension in a clinical practice setting.Patients and methods: This open-label study observed patients switched to PF FC bimatoprost 0.03%/timolol 0.5% due to insufficient intraocular pressure (IOP) control on previous therapies. IOP was measured at baseline and at ~12 weeks. Tolerability and continuation of therapy were also assessed.Results: A total of 1,553 patients were included in the study, and the per-protocol population comprised 1,391 patients. There were some minor deviations from protocol: some patients with no prior therapy and some who switched for reasons other than insufficient IOP control were included in the analysis. The mean IOP was reduced by 27.4%, from 22.2 mmHg to 16.1 mmHg. In subgroup analyses, the mean IOP was significantly reduced from baseline, irrespective of whether previous treatment was monotherapy or combination therapy, and preserved or PF therapy. Physicians mostly (88.1%) reported the IOP-lowering efficacy of PF FC bimatoprost 0.03%/timolol 0.5% to be as expected or better than expected. Switching to PF FC bimatoprost 0.03%/timolol 0.5% resulted in reductions from baseline in the number of patients reporting ocular symptoms. Adverse events were reported by 6.2% of patients, the most common being eye irritation (1.6%) and eye pruritus (1.0%). Physicians reported treatment compliance as better or unchanged compared with prior treatment in almost all patients (93.9%). Most patients were expected to continue PF FC bimatoprost 0.03%/timolol 0.5% after the end of the study.Conclusion: Switching to PF FC bimatoprost 0.03%/timolol 0.5% was associated with significant IOP reductions from baseline over 12 weeks. Adverse events were uncommon, and compliance was high compared with previous therapy. PF FC bimatoprost 0.03%/timolol 0.5% may be a suitable treatment for patients with inadequately controlled IOP or who are sensitive to preservatives. Keywords: bimatoprost 0.03%/timolol 0.5%, intraocular pressure, prostaglandin, preservative free, glaucoma, fixed combinatio

A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension

Stefan Pfennigsdorf,1 Leo de Jong,2 Stefan Makk,3 Yvette Fournichot,4 Alain Bron,5 Robert J Morgan-Warren,6 John Maltman6 1Ophthalmology Practice, Polch, Germany; 2Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; 3Ophthalmology Practice, Graz, Austria; 4Ophthalmology Practice, Schlieren, Switzerland; 5Department of Ophthalmology, University Hospital, Dijon, France; 6Allergan Ltd, Marlow, UK Objective: The aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy. Methods: Patient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers. Results: BTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by -9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a &szlig;-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as "good" or "very good" by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment. Conclusion: In routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance. Keywords: bimatoprost 0.03%, intraocular pressure, ocular hypotensive medication, prostaglandin analog, &szlig;-blocke

Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

Stefan Pfennigsdorf,1 Osman Ramez,2 Gerrit von Kistowski,3 Birgit M&amp;auml;der,4 Peter Eschstruth,5 Michael Frob&amp;ouml;se,6 Ulrich Thelen,7 Christoph Spraul,8 Dietmar Schnober,9 Hazel Cooper,10 Thomas Laube111Polch Ophthalmology Practice, Polch, 2Buxtehude Ophthalmology Practice, Buxtehude, 3N&amp;uuml;rnberg Ophthalmology Practice, N&amp;uuml;rnberg, 4Wei&amp;szlig;wasser Ophthalmology Practice, Wei&amp;szlig;wasser, 5Ophthalmology Practice, Kiel, 6Ophthalmology Practice, Bielefeld, 7Group Practice, M&amp;uuml;nster, 8Group Practice, Ulm, 9Ophthalmology Practice, Werdohl, Germany; 10Allergan, Marlow, UK, 11Group Practice, D&amp;uuml;sseldorf, GermanyBackground: Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice.Methods: Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10&amp;ndash;14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians&amp;rsquo; discretion.Results: Bimatoprost 0.01% significantly lowered mean IOP from baseline by &amp;ndash;4.1 mmHg (P &amp;lt; 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by &amp;ndash;6.5 mmHg (P &amp;lt; 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of &amp;beta;-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment.Conclusion: Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.Keywords: bimatoprost 0.01%, glaucoma, observational, ocular hypertension, intraocular pressur