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Efficacy and safety of prostaglandin analogues in patients with predominantly primary open-angle glaucoma or ocular hypertension: a meta-analysis.

Eyawo O, Nachega J, Lefebvre P, Meyer D, Rachlis B, Lee CW, Kelly S, Mills E - Clin Ophthalmol (2009)

Bottom Line: First-line therapy for primary open-angle glaucoma and ocular hypertension generally involves prostaglandin analogue therapy.The relative efficacy of differing prostaglandin therapy is disputed.Travoprost was associated with greater incidence of conjunctival hyperemia than latanoprost (RR 5.71, 95% CI, 1.81 to 18.02, P </= 0.001, I2 = 97%, 95% CI, 95 to 98, P </= 0.001).

View Article: PubMed Central - PubMed

Affiliation: Faculty of Health Sciences, Simon Fraser University, Vancouver, Canada.

ABSTRACT

Background: First-line therapy for primary open-angle glaucoma and ocular hypertension generally involves prostaglandin analogue therapy. The relative efficacy of differing prostaglandin therapy is disputed.

Methods: A meta-analysis was conducted of head-to-head randomized trials of prostaglandin therapies. We included randomized trials assessing head-to-head evaluations of prostaglandin analogues travoprost, latanoprost and bimatoprost in patients with predominantly primary open-angle glaucoma or ocular hypertension. Findings were interpreted in light of equivalence margins.

Results: Our search identified 16 eligible trials, of which 15 were included in the meta-analysis. Trials were, in general, poorly reported. We pooled 9 trials assessing IOP-lowering effects of travoprost vs latanoprost (total n = 1098, weighted mean difference [WMD], -0.24 mmHg, 95% CI, -0.87 to 0.38, P = 0.45, I2 = 56%, 95% CI, 0 to 0.77, heterogeneity P = 0.01). Eight trials assessed travoprost vs bimatoprost (total n = 714, WMD, 0.88 mmHg, 95% CI, 0.13 to 1.63, P = 0.02, I2 = 56%, 95% CI, 0% to 78%, heterogeneity P = 0.02). And 8 trials assessed latanoprost vs bimatoprost (total n = 943, WMD, 0.73 mmHg, 95% CI, 0.10 to 1.37, P = 0.02, I2 = 47%, 95% CI, 0% to 74%, heterogeneity P = 0.06). Travoprost was associated with greater incidence of conjunctival hyperemia than latanoprost (RR 5.71, 95% CI, 1.81 to 18.02, P

Conclusion: Randomized head-to-head evaluations of prostaglandin therapy demonstrate similar efficacy effects, but differing hyperemia effects.

No MeSH data available.


Related in: MedlinePlus

Interpreting non-inferiority and equivalence trials.20 Error bars indicate 2-sided 95% confidence intervals (CI). Tinted area indicates zone of inferiority. A, If the CI lies wholly to the left of zero, the new treatment is superior. B and C, If the CI lies to the left of and includes zero, the new treatment is noninferior but not shown to be superior. D, If the CI lies wholly to the left of and wholly to the right of zero, the new treatment is noninferior in the sense already defined, but it is also inferior in the sense that a  treatment difference is excluded. This puzzling case is rare, since it requires a very large sample size. It can also result from having too wide a noninferiority margin. E and F. If the CI includes and zero, the difference is nonsignificant but the result for noninferiority is inconclusive. G, If the CI includes and is wholly to the right of zero, the difference is statistically significant but the result is inconclusive for possible inferiority of magnitude or worse. H, If the CI is wholly above, the new treatment is inferior. Reproduced with permission from Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006; 295:1152–1160.20 Copyright © 2006 American Medical Association, All rights reserved.
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Related In: Results  -  Collection


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f5-opth-3-447: Interpreting non-inferiority and equivalence trials.20 Error bars indicate 2-sided 95% confidence intervals (CI). Tinted area indicates zone of inferiority. A, If the CI lies wholly to the left of zero, the new treatment is superior. B and C, If the CI lies to the left of and includes zero, the new treatment is noninferior but not shown to be superior. D, If the CI lies wholly to the left of and wholly to the right of zero, the new treatment is noninferior in the sense already defined, but it is also inferior in the sense that a treatment difference is excluded. This puzzling case is rare, since it requires a very large sample size. It can also result from having too wide a noninferiority margin. E and F. If the CI includes and zero, the difference is nonsignificant but the result for noninferiority is inconclusive. G, If the CI includes and is wholly to the right of zero, the difference is statistically significant but the result is inconclusive for possible inferiority of magnitude or worse. H, If the CI is wholly above, the new treatment is inferior. Reproduced with permission from Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006; 295:1152–1160.20 Copyright © 2006 American Medical Association, All rights reserved.

Mentions: Interpreting noninferiority and equivalence studies may be challenging for readers. Figure 5 displays the recommended interpretation of confidence intervals for equivalence. Only 7 trials reported their analysis as intent-to-treat. As these trials were continuous outcomes and reported their changes by group, we were unable to calculate the intent-to-treat outcomes for each trial. This issue is now receiving debate within the trial community and some argue that only studies reporting intent-to-treat be included.43 Without access to individual data, it is impossible to calculate intent-to-treat outcomes.


Efficacy and safety of prostaglandin analogues in patients with predominantly primary open-angle glaucoma or ocular hypertension: a meta-analysis.

Eyawo O, Nachega J, Lefebvre P, Meyer D, Rachlis B, Lee CW, Kelly S, Mills E - Clin Ophthalmol (2009)

Interpreting non-inferiority and equivalence trials.20 Error bars indicate 2-sided 95% confidence intervals (CI). Tinted area indicates zone of inferiority. A, If the CI lies wholly to the left of zero, the new treatment is superior. B and C, If the CI lies to the left of and includes zero, the new treatment is noninferior but not shown to be superior. D, If the CI lies wholly to the left of and wholly to the right of zero, the new treatment is noninferior in the sense already defined, but it is also inferior in the sense that a  treatment difference is excluded. This puzzling case is rare, since it requires a very large sample size. It can also result from having too wide a noninferiority margin. E and F. If the CI includes and zero, the difference is nonsignificant but the result for noninferiority is inconclusive. G, If the CI includes and is wholly to the right of zero, the difference is statistically significant but the result is inconclusive for possible inferiority of magnitude or worse. H, If the CI is wholly above, the new treatment is inferior. Reproduced with permission from Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006; 295:1152–1160.20 Copyright © 2006 American Medical Association, All rights reserved.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2724035&req=5

f5-opth-3-447: Interpreting non-inferiority and equivalence trials.20 Error bars indicate 2-sided 95% confidence intervals (CI). Tinted area indicates zone of inferiority. A, If the CI lies wholly to the left of zero, the new treatment is superior. B and C, If the CI lies to the left of and includes zero, the new treatment is noninferior but not shown to be superior. D, If the CI lies wholly to the left of and wholly to the right of zero, the new treatment is noninferior in the sense already defined, but it is also inferior in the sense that a treatment difference is excluded. This puzzling case is rare, since it requires a very large sample size. It can also result from having too wide a noninferiority margin. E and F. If the CI includes and zero, the difference is nonsignificant but the result for noninferiority is inconclusive. G, If the CI includes and is wholly to the right of zero, the difference is statistically significant but the result is inconclusive for possible inferiority of magnitude or worse. H, If the CI is wholly above, the new treatment is inferior. Reproduced with permission from Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006; 295:1152–1160.20 Copyright © 2006 American Medical Association, All rights reserved.
Mentions: Interpreting noninferiority and equivalence studies may be challenging for readers. Figure 5 displays the recommended interpretation of confidence intervals for equivalence. Only 7 trials reported their analysis as intent-to-treat. As these trials were continuous outcomes and reported their changes by group, we were unable to calculate the intent-to-treat outcomes for each trial. This issue is now receiving debate within the trial community and some argue that only studies reporting intent-to-treat be included.43 Without access to individual data, it is impossible to calculate intent-to-treat outcomes.

Bottom Line: First-line therapy for primary open-angle glaucoma and ocular hypertension generally involves prostaglandin analogue therapy.The relative efficacy of differing prostaglandin therapy is disputed.Travoprost was associated with greater incidence of conjunctival hyperemia than latanoprost (RR 5.71, 95% CI, 1.81 to 18.02, P </= 0.001, I2 = 97%, 95% CI, 95 to 98, P </= 0.001).

View Article: PubMed Central - PubMed

Affiliation: Faculty of Health Sciences, Simon Fraser University, Vancouver, Canada.

ABSTRACT

Background: First-line therapy for primary open-angle glaucoma and ocular hypertension generally involves prostaglandin analogue therapy. The relative efficacy of differing prostaglandin therapy is disputed.

Methods: A meta-analysis was conducted of head-to-head randomized trials of prostaglandin therapies. We included randomized trials assessing head-to-head evaluations of prostaglandin analogues travoprost, latanoprost and bimatoprost in patients with predominantly primary open-angle glaucoma or ocular hypertension. Findings were interpreted in light of equivalence margins.

Results: Our search identified 16 eligible trials, of which 15 were included in the meta-analysis. Trials were, in general, poorly reported. We pooled 9 trials assessing IOP-lowering effects of travoprost vs latanoprost (total n = 1098, weighted mean difference [WMD], -0.24 mmHg, 95% CI, -0.87 to 0.38, P = 0.45, I2 = 56%, 95% CI, 0 to 0.77, heterogeneity P = 0.01). Eight trials assessed travoprost vs bimatoprost (total n = 714, WMD, 0.88 mmHg, 95% CI, 0.13 to 1.63, P = 0.02, I2 = 56%, 95% CI, 0% to 78%, heterogeneity P = 0.02). And 8 trials assessed latanoprost vs bimatoprost (total n = 943, WMD, 0.73 mmHg, 95% CI, 0.10 to 1.37, P = 0.02, I2 = 47%, 95% CI, 0% to 74%, heterogeneity P = 0.06). Travoprost was associated with greater incidence of conjunctival hyperemia than latanoprost (RR 5.71, 95% CI, 1.81 to 18.02, P

Conclusion: Randomized head-to-head evaluations of prostaglandin therapy demonstrate similar efficacy effects, but differing hyperemia effects.

No MeSH data available.


Related in: MedlinePlus