Desarrollo de hiperemia conjuntival tras el empleo de la combinación fija de latanoprost/timolol: revisión sistemática y metaanálisis de ensayos clínicos publicados

Vinuesa-Silva, J.M.; Vinuesa-Silva, I.; Pinazo-Durán,; Soto-Álvarez, J.; Delgado-Ortega, L.; Díaz‐Cerezo, Silvia

doi:10.4321/s0365-66912009000400006

Cited by 4 publications

(1 citation statement)

References 22 publications

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“…Seven of the 21 reviews described within-class comparisons of different prostaglandins (i.e., one prostaglandin analog versus another), 9,11,13,16,18,19,22 and the remaining 14 of 21 reviews described between-class comparisons or a combination of within-class and between-class comparisons. 3–8,10,12,14,15,17,20,21,23 Some systematic reviews in the sample of 21 were published in well-regarded journals, including leading ophthalmology journals published in the United States and the United Kingdom. One-third of the reviews (7/21) were funded by the pharmaceutical industry.…”

Section: Resultsmentioning

confidence: 99%

Citation of Previous Meta-analyses on the Same Topic

Li¹,

Dickersin²

2013

Ophthalmology

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Clinical relevance Systematic reviews and meta-analyses serve as a basis for decision-making and clinical practice guidelines and should be carried out using appropriate methodology to avoid incorrect inferences. Topic We describe the characteristics, statistical methods used for meta-analyses, and citation patterns of all 21 glaucoma systematic reviews we identified pertaining to the effectiveness of prostaglandin analog eye drops in treating primary open-angle glaucoma, published between December 2000 and February 2012. Methods We abstracted data, assessed whether appropriate statistical methods were applied in meta-analyses, and examined citation patterns of included reviews. Results We identified two forms of problematic statistical analyses in 9 of the 21 systematic reviews examined. Except in 1 case, none of the 9 reviews that used incorrect statistical methods cited a previously published review that used appropriate methods. Reviews that used incorrect methods were cited 2.6 times more often than reviews that used appropriate statistical methods. We speculate that by emulating the statistical methodology of previous systematic reviews, systematic review authors may have perpetuated incorrect approaches to meta-analysis. Conclusions The use of incorrect statistical methods, perhaps through emulating methods described in previous research, calls conclusions of systematic reviews into question and may lead to inappropriate patient care. We urge systematic review authors and journal editors to seek the advice of experienced statisticians before undertaking or accepting for publication a systematic review and meta-analysis.

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Section: Resultsmentioning

confidence: 99%

Citation of Previous Meta-analyses on the Same Topic

Li¹,

Dickersin²

2013

Ophthalmology

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Hyperemia Reduction After Administration of a Fixed Combination of Bimatoprost and Timolol Maleate to Patients on Prostaglandin or Prostamide Monotherapy

Paranhos

Mendonça²,

Silva³

et al. 2010

Journal of Ocular Pharmacology and Therapeutics

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Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension

Aptel

Pfeiffer

Schmickler³

et al. 2019

Journal of Glaucoma

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Précis: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension.Purpose: The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprosttimolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension.Methods: Phase III, randomized, parallel-group, investigatormasked study in 10 countries. A total of 242 patients aged 18 years or older with open-angle glaucoma or ocular hypertension in both eyes controlled with a preserved latanoprost-timolol fixed combination (15.7 ± 2.4 mm Hg overall before inclusion) were randomized at day 0 with no washout period to receive the preservativefree alternative T2347 (N = 127) or remain on the preserved comparator (N = 115) for 84 days. Intraocular pressure changes from day 0 were measured at 9:00 am ( ± 1 hour) on day 42 and day 84, and noninferiority of T2347 to the preserved comparator was analyzed statistically at day 84. Safety parameters were also reported. Results:The mean change in intraocular pressure from baseline to day 84 was −0.49 ± 1.80 mm Hg for preservative-free T2347 and −0.49 ± 2.25 mm Hg for the preserved comparator. These results met the noninferiority limits. Similar results were observed at day 42. There was no difference between groups in the incidence of adverse events or ocular signs. The total ocular symptoms score was better for T2347 than BPLT upon instillation at day 84 (45.9%/ 44.3%/9.8% of patients with improvement/no change/worsening vs. 33.6%/47.3%/19.1%; P = 0.021), reflecting improvements in individual symptoms such as irritation/burning/stinging (P < 0.001), and itching (P < 0.01) on day 84.Conclusions: Preservative-free latanoprost-timolol fixed combination T2347 showed noninferior efficacy compared with the preserved comparator and was well tolerated.

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Desarrollo de hiperemia conjuntival tras el empleo de la combinación fija de latanoprost/timolol: revisión sistemática y metaanálisis de ensayos clínicos publicados

Abstract: The use of a fixed combination of latanoprost/timolol is associated with a significant reduction (53%; CI 95%: 10%-76%) in the development of conjunctival hyperemia against the other compared options for the treatment of glaucoma.

Cited by 4 publications

References 22 publications

Citation of Previous Meta-analyses on the Same Topic

Citation of Previous Meta-analyses on the Same Topic

Hyperemia Reduction After Administration of a Fixed Combination of Bimatoprost and Timolol Maleate to Patients on Prostaglandin or Prostamide Monotherapy

Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension

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