Background:This study compared the efficacy of the EX-PRESS® glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery.Methods:Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS glaucoma filtration device or underwent a trabeculectomy were followed for up to an additional four years (five total) beyond the original study (39 eyes per treatment group). Risk-benefit data were obtained for up to five years after glaucoma surgery. Outcome variables were intraocular pressures and intraocular pressure medications. Complete success was denoted by intraocular pressure values ≤ 18 mmHg without medication.Results:The EX-PRESS glaucoma filtration device controlled intraocular pressure more effectively without medication for more patients from year 1 (86.8% versus 61.5%, P = 0.01) to year 3 (66.7% versus 41.0%, P = 0.02) than trabeculectomy. At year 1, only 12.8% of patients required intraocular pressure medication after EX-PRESS implantation, compared with 35.9% after trabeculectomy. The proportions became closer at year 5 (41% versus 53.9%). The responder rate was higher with EX-PRESS and time to failure was longer. In addition, surgical interventions for complications were fewer after EX-PRESS implantation.Conclusion:This five-year analysis confirmed and extended the results reported after one year. Compared with trabeculectomy, EX-PRESS provided better intraocular pressure control in the first three years, and patients required fewer intraocular pressure medications and fewer surgical interventions during the five-year study period. For patients with primary open-angle glaucoma, the EX-PRESS glaucoma filtration device, implanted under a superficial scleral flap, produced significantly higher success rates than trabeculectomy. EX-PRESS is an effective device for long-term treatment of primary open-angle glaucoma.
Brimonidine/timolol fixed-combination therapy is as safe and effective as concomitant treatment with the individual components. Its simplified dosing regimen has the potential to improve compliance.
ObjectiveThe 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.MethodsPatient 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.ResultsBTFC 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 β-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.ConclusionIn 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.
Objective Combine and evaluate data from four clinical practice studies investigating the intraocular pressure (IOP)-lowering ability, tolerability of and patient adherence to bimatoprost 0.01% therapy in patients with primary open-angle glaucoma or ocular hypertension. Methods Data were combined from four multicenter, prospective, observational studies. Patients (n=2,593) were recruited from 328 sites in Austria, Belgium, Switzerland, and the Netherlands. Assessments were at study entry (baseline) and after 10–14 weeks. Results Bimatoprost 0.01% lowered mean IOP by 5.0 mmHg from baseline to final visit ( P <0.0001). Individual IOP goals were achieved in 75.5% of patients. Results were similar in right and left eyes; right-eye data are presented here for brevity. The greatest mean IOP reduction was 6.7±4.7 mmHg (28.8% reduction from baseline to final visit, P <0.0001) in treatment-naïve patients. Switching to bimatoprost 0.01% monotherapy from previous monotherapy reduced mean IOP by a further 3.2±3.6 mmHg (17.2%, P <0.0001). Switching to bimatoprost 0.01% from previous prostaglandin monotherapy reduced mean IOP by 2.9±3.5 mmHg (15.5%), including by 3.1±3.4 mmHg (15.8%) and 3.3±4.1 mmHg (16.9%) for previous latanoprost and travoprost treatment, respectively (all P <0.0001). IOP reduction in patients previously treated with a fixed combination was 2.7±4.0 mmHg (14.2%, P <0.0001). The most commonly reported adverse events were conjunctival hyperemia (5.2%) and eye irritation (4.7%). Tolerability was rated as “very good” or “good” by 90.1% of patients. Adherence was rated by physicians as “better than” or “equal to” previous treatment in 97.2% of patients. Conclusion The combined studies demonstrated in a clinical practice setting, bimatoprost 0.01% lowered IOP effectively in treatment-naïve and previously treated ocular hypertension and primary open-angle glaucoma patients, and was associated with good tolerability and patient adherence over 12 weeks.
costs in intraoperative changes of the surgical plan and reductions in unnecessary surgery associated with the use of PV-MRI. Results from the previous study VALUE, which showed that no patient with PV required additional imaging tests as part of a Phase IV, confirm the results obtained in the present analysis (resulting in even slightly lower cost than the total cost of diagnosis using PV-MRI).OBJECTIVES: Cervical cancer incidence in Serbia has been identified as one of the highest in Europe, showing slow but steady increase during the last decade. Despite the National Programme for Prevention of Cervical Cancer that has recently been established, an organised Pap screening is far from full implementation. This study aims to assess the effectiveness and cost effectiveness of absolute adherence to the proposed policy compared to the current practice. METHODS: A Markov model simulating the natural history of cervical cancer was developed. Calibration was performed using country specific data, sourcing incidence and mortality from Serbian cancer registries. Accordingly, the screening algorithm incorporated in the model was based on the local guidelines. We followed a hypothetical cohort of 100,000 15-year old girls until the end of their lifetime. Subsequently, the actual cytological screening practice covering only 20% of the targeted population was compared to a scenario of absolute adherence to the national screening programme. A discount rate of 1.5% for health and 4% for cost outcomes was applied. RESULTS: The natural history model showed that limited benefit is currently being achieved from cytological screening. The hypothetical cohort analysis indicated that absolute guidelines adherence would result in 422 deaths averted and an incremental cost effectiveness ratio (ICER) of 3272 €/LYG. The ICER estimate did not exceed the national annual GDP (3857 €/capita) -a commonly used informal threshold. CONCLUSIONS: This research identified that full adherence to the screening policy is very likely to be cost effective. In general, the low screening coverage that has been observed appeared as the most serious obstacle to the prevention of cervical cancer. The new methods in cervical cancer prevention, however, such as HPV vaccination and HPV testing, require further pharmacoeconomic assessment.
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