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      Demonstration of an online tool to assist managed care formulary evidence-based decision making: meta-analysis of topical prostaglandin analog efficacy

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          Abstract

          Background

          The purpose of this paper was to demonstrate the use of an online service for conducting a systematic review and meta-analysis of the efficacy of topical prostaglandin analogs in reducing intraocular pressure (IOP) in glaucoma and ocular hypertension.

          Methods

          An online service provider (Doctor Evidence) reviewed and extracted data from the peer-reviewed literature through September 2009. Randomized controlled studies of at least three months’ duration assessing at least two prostaglandin analogs in patients with primary open-angle glaucoma, ocular hypertension, or normal-tension glaucoma were included. The primary endpoint was mean IOP. Summary estimates were created using random-effects models. The Q Chi-square test was used to assess statistical heterogeneity.

          Results

          Sixteen studies satisfied the inclusion criteria and were analyzed. On average, greater IOP-lowering was seen with bimatoprost relative to latanoprost (1 mmHg, P = 0.025) and travoprost (0.8 mmHg, P = 0.033) based on mean IOP after 12–26 weeks of treatment. No statistical difference was observed in IOP-lowering between latanoprost and travoprost ( P = 0.841). Findings were similar to previously published meta-analyses of topical prostaglandin analogs.

          Conclusion

          Systematic reviews relying on meta-analytic techniques to create summary statistics are considered to be the “gold standard” for synthesizing evidence to support clinical decision-making. However, the process is time-consuming, labor-intensive, and outside the capability of most formulary managers. We have demonstrated the effectiveness of a commercial service that facilitates the process of conducting such reviews.

          Most cited references22

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          The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration.The AGIS Investigators.

          (2000)
          To investigate the association between control of intraocular pressure after surgical intervention for glaucoma and visual field deterioration. In the Advanced Glaucoma Intervention Study, eyes were randomly assigned to one of two sequences of glaucoma surgery, one beginning with argon laser trabeculoplasty and the other trabeculectomy. In the present article we examine the relationship between intraocular pressure and progression of visual field damage over 6 or more years of follow-up. In the first analysis, designated Predictive Analysis, we categorize 738 eyes into three groups based on intraocular pressure determinations over the first three 6-month follow-up visits. In the second analysis, designated Associative Analysis, we categorize 586 eyes into four groups based on the percent of 6-month visits over the first 6 follow-up years in which eyes presented with intraocular pressure less than 18 mm Hg. The outcome measure in both analyses is change from baseline in follow-up visual field defect score (range, 0 to 20 units). In the Predictive Analysis, eyes with early average intraocular pressure greater than 17.5 mm Hg had an estimated worsening during subsequent follow-up that was 1 unit of visual field defect score greater than eyes with average intraocular pressure less than 14 mm Hg (P =.002). This amount of worsening was greater at 7 years (1.89 units; P <.001) than at 2 years (0.64 units; P =.071). In the Associative Analysis, eyes with 100% of visits with intraocular pressure less than 18 mm Hg over 6 years had mean changes from baseline in visual field defect score close to zero during follow-up, whereas eyes with less than 50% of visits with intraocular pressure less than 18 mm Hg had an estimated worsening over follow-up of 0.63 units of visual field defect score (P =.083). This amount of worsening was greater at 7 years (1.93 units; P <.001) than at 2 years (0.25 units; P =.572). In both analyses low intraocular pressure is associated with reduced progression of visual field defect, supporting evidence from earlier studies of a protective role for low intraocular pressure in visual field deterioration.
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            Intraocular pressure-lowering effects of all commonly used glaucoma drugs: a meta-analysis of randomized clinical trials.

            To estimate the intraocular pressure (IOP) reduction achieved by the most frequently prescribed glaucoma drugs and a placebo in a meta-analysis of randomized clinical trials. Meta-analysis of randomized clinical trials. Twenty-seven articles reporting on 28 randomized clinical trials. These articles reported 6953 participants for the trough and 6841 for the peak. Articles published up to December 2003 were identified in the following data sources: Medline, Embase, and the Cochrane Controlled Trials Register, and references from relevant articles. Over 85% of the patients had to be diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OH), and articles had to be written in English, German, French, or Dutch. Quality of trials was assessed by a Delphi list with additions. The pooled 1-month IOP-lowering effect from baseline at peak and trough was calculated by performing meta-analysis using the random effects model. Absolute and relative change in IOP from baseline, for peak and trough moments. Relative IOP reductions from baseline [mean (95% confidence interval)] were -23% (-25% to -22%) for a peak and -20% (-23% to -17%) for a trough for 0.5% betaxolol; peak, -27% (-29% to -25%), and trough, -26% (-28% to -25%), for 0.5% timolol; peak, -22% (-24% to -20%), and trough, -17% (-19% to -15%), for 2.0% dorzolamide; peak, -17% (-19% to -15%), and trough, -17% (-19% to -15%) for 1.0% brinzolamide; peak, -25% (-28% to -22%), and trough, -18% (-21% to -14%) for 0.2% brimonidine; peak, -31% (-33% to -29%), and trough, -28% (-30% to -26%) for 0.005% latanoprost; peak, -31% (-32% to -29%), and trough, -29% (-32% to -25%) for 0.004% travoprost; peak, -33% (-35% to -31%), and trough, -28% (-29% to -27%) for 0.03% bimatoprost; and peak, -5% (-9% to -1%), and trough, -5% (-10% to -0%) for the placebo. The difference in absolute IOP reduction from baseline between timolol and prostaglandin analogs or prostamide varied from -0.4 to 0.1 mmHg at trough and from 1.0 to 1.5 mmHg at peak. Quality scores of included studies were generally high, a mean of 14.2 on a scale from 0 to 20 (interquartile range, 13-16). This meta-analysis suggests that bimatoprost, travoprost, latanoprost, and timolol are the most effective intraocular pressure-reducing agents in POAG and OH patients.
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              A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study.

              To Internet Advance publication at ajo.com Feb 13, 2003. compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost, bimatoprost, and travoprost in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). Interventional study. This 12-week, randomized, parallel-group study was conducted at 45 US sites. Previously treated patients with OAG or OH and an IOP > or =23 mm Hg in one or both eyes after washout received either latanoprost 0.005%, bimatoprost 0.03%, or travoprost 0.004% once daily in the evening. At baseline and after 6 and 12 weeks of therapy, masked evaluators measured IOP in triplicate at 8:00 AM, 12 noon, 4:00 PM, and 8:00 PM, and masked investigators graded conjunctival hyperemia before the 8:00 AM IOP measurement. The primary efficacy outcome measure was change between baseline and Week 12 in the 8:00 AM IOP (time of peak drug effect). In all, 410 of 411 randomized patients were included in intent-to-treat analyses (latanoprost, 136; bimatoprost, 136; travoprost, 138). Baseline mean 8:00 AM IOP levels were similar (P =.772); by week 12, reductions were observed in all 3 groups (P <.001 for each). Adjusted (ANCOVA) reductions in mean IOP at 8:00 AM were similar (P =.128) as were those at 12 noon, 4:00 PM, and 8:00 PM. Fewer latanoprost-treated patients reported ocular adverse events (P <.001, latanoprost vs bimatoprost), fewer reported hyperemia (P =.001, latanoprost vs bimatoprost), and average hyperemia scores were lower at week 12 (P =.001, latanoprost vs bimatoprost). Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in OAG and OH patients. Latanoprost exhibited greater ocular tolerability.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                1176-6336
                1178-203X
                2011
                2011
                12 July 2011
                : 7
                : 283-290
                Affiliations
                [1 ]Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA
                [2 ]Health Outcomes, Allergan Inc, Irvine, CA, USA
                [3 ]Doctor Evidence LLC, Santa Monica, CA, USA
                [4 ]Global Medical Affairs, Allergan Inc, Irvine, CA, USA
                Author notes
                Correspondence: Steven M Kymes, Department of Ophthalmology and Visual Sciences, 660 South Euclid, Campus Box 8096, Washington University School of Medicine, St Louis, MO 63110-1093, USA, Tel +1 314 747 4612, Fax +1 314 747 2851, Email kymes@ 123456vrcc.wustl.edu
                Article
                tcrm-7-283
                10.2147/TCRM.S20495
                3150474
                21845051
                483686b7-a486-4895-97eb-3d4c0f4fcab0
                © 2011 Kymes et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                History
                Categories
                Original Research

                Medicine
                evidence-based medicine,meta-analysis,review,systematic,prostaglandin analogs,glaucoma
                Medicine
                evidence-based medicine, meta-analysis, review, systematic, prostaglandin analogs, glaucoma

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