BERLIN, Germany, June 2 /PRNewswire/ --
- First Crossover Study to Compare Fixed Combination Therapies Presented at EGS
Greater intra-ocular pressure (IOP) lowering benefit can be achieved for glaucoma patients treated with a fixed combination of bimatoprost and timolol (Ganfort(R), Allergan), new data presented today has revealed. The results, presented today at the European Glaucoma Society (EGS), show that patients can achieve significantly greater IOP-lowering effect after 12 weeks' treatment with Ganfort compared to Xalacom (Xalacom(R), Pfizer)(1). IOP is the major risk factor for glaucoma, and lowering IOP is currently the only proven means of preserving the patient's visual field. Glaucoma is the second most common cause of blindness globally(2).
Dr Antonio Martinez, Principal Investigator, commented, "Although both medications are highly effective in lowering the IOP in patients previously treated with timolol alone, Ganfort provided greater IOP reductions than Xalacom at every time point at every study visit. This is relevant for clinical practice because even small decreases in IOP can significantly slow the rate of progression of glaucoma and help to preserve vision."
Significantly greater IOP-lowering effect with Ganfort(R)
The results of this 12-week crossover study demonstrate a significantly greater IOP-lowering effect of Ganfort instilled once per day in the evening compared with that of Xalacom administered once daily in the evening.
The mean IOP reduction from baseline for each time point and for the mean diurnal was significantly greater with Ganfort than with Xalacom after treatment for 12 weeks. The 12-hour IOP values were 22.0 (1.0) mmHg at baseline, 17.7 (0.8) mmHg on Ganfort and 18.5 mmHg (0.8) mmHg on Xalacom.
The study also evaluated the range of IOP at various time points over a 12-hour period (8am, 10am, 12pm, 6pm and 8pm) and shows that the mean fluctuation is lower with Ganfort compared to Xalacom. Studies show that lack of fluctuation in IOP is important in preventing visual field progression in glaucoma patients.(3),(4) Analysis of the relevance of the IOP reductions suggests for each mmHg of higher IOP, the risk of progression in early glaucoma may increase by 10% over that period.(5)
The study also evaluated the mean range of IOP. This was calculated as the difference between the highest and the lowest IOP reading within the 12-hour pressure curve. Xalacom provided a mean fluctuation of 5.9mmHg and Ganfort showed a significantly lower mean range of 4.8mmHg (p<0.001).
Current guidelines confirm benefits of fixed dose combination therapy
The primary goal of glaucoma treatment is to maintain the patient's quality of life at a sustainable cost by reducing IOP to a target pressure using a minimal number of medications.(6) However, current management guidelines recommend adding in a second therapy if IOP targets have not been achieved. In this case, fixed-dose combinations offer advantages over separate agents in terms of improved compliance, tolerability, efficacy and cost-effectiveness; recent European data suggests that 27-40% of patients in routine clinical practice are receiving combination therapy.(7)
About the study methodology
54 patients with open-angle glaucoma (OAG) were included in this prospective, randomised, evaluator masked, single centre crossover study. Patients with an IOP of 19mmHg or more who were already receiving treatment with a prostaglandin analogue were randomised to receive Ganfort(R) or Xalacom(R) for a 12-week period after a 6-week run-in period on timolol maleate 0.5% (one drop in each eye twice each day). Patients were then switched to the opposite treatment for the second period. Six 12-hour IOP curves were recorded for each patient at baseline, week-6 and week-12, for each treatment period.
Notes to Editors:
This study was conducted by Instituto Gallego de Oftalmologia, Spain and supported in part by a research grant provided by the Galician government. The authors do not have any financial interest in any of the products mentioned in this study.
(1). Martinez A, Sanchez M. Bimatoprost/timolol fixed combination versus latanoprost/timolol fixed combination in open-angle glaucoma patients
(2). World Health Organisation http://www.who.int/mediacentre/factsheets/fs282/en/print.html. Accessed 18/03/08
(3). Asrani S, Zeimer R, Wilensky J, et al. Large diurnal fluctuations in intraocular pressure are an independent risk factor in patients with glaucoma. J Glaucoma 2000;9:134-142
(4). Nouri-Mahdavi K, Hoffman D, Coleman AL et al. Predictive factors for glaucomatous visual field progression in the Advanced Glaucoma Intervention Study. Ophthalmology; 2004; 111: 1627-1635
(5). Leske MC, Heijl A et al. Factors for glaucoma progression and the effect of treatment. The Early Manifect Glaucoma Trial. Arch. Ophthalmol 2003; 121: 48-56
(6). European Glaucoma Society. Terminology and Guidelines for Glaucoma. 2003. 11th edition
(7). A + A Glaucoma Monitor Research, 2006
BERLIN, Germany, June 2 /PRNewswire/ --
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