Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: A meta-analysis of two phase 3 studies

Louis B. Cantor, Ching Chi Liu, Amy L. Batoosingh, David A. Hollander

Research output: Contribution to journalArticle

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Abstract

Objective: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite* (P) 0.1% and brimonidine P 0.15%, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT). Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multi-center, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15% (n = 381), brimonidine P 0.2% (n = 383), or brimonidine 0.2% (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1% (n = 215) and brimonidine 0.2% (n = 218). Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs. Results: Treatment-related AEs were significantly reduced with brimonidine P 0.15% compared with brimonidine 0.2% in study 1 (p<0.001). Treatment-related AEs and discontinuations due to AEs were significantly reduced with brimonidine P 0.1% compared with brimonidine 0.2% in study 2 (p ≤ 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatmentrelated AEs was lower with brimonidine P 0.1% than with brimonidine P 0.15% (41.4 vs. 49.7%; p = 0.050). Although the incidence of treatment-related ocular AEs was similar with brimonidine P 0.1% and 0.15% (p = 0.461), treatment-related systemic AEs were less frequent with brimonidine P 0.1% than with brimonidine P 0.15% (4.7 vs. 14.2%; p<0.001), and there were fewer discontinuations due to systemic AEs with brimonidine P 0.1% than with brimonidine P 0.15% (p = 0.025). Conclusions: Brimonidine P 0.1% has improved systemic safety and tolerability compared with brimonidine P 0.15%. The ocular safety and tolerability of the formulations are similar. The present meta-analysis is based on only two clinical studies, and additional studies further evaluating the safety and tolerability of these medications are warranted.

Original languageEnglish (US)
Pages (from-to)1615-1620
Number of pages6
JournalCurrent Medical Research and Opinion
Volume25
Issue number7
DOIs
StatePublished - Jul 1 2009

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Meta-Analysis
Safety
Brimonidine Tartrate
Ocular Hypertension
Glaucoma
Therapeutics
Clinical Trials
Ophthalmic Solutions
Incidence
Intraocular Pressure

Keywords

  • Alpha-adrenergic agonist
  • Brimonidine
  • Glaucoma
  • Intraocular pressure
  • Ocular hypertension

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15% : A meta-analysis of two phase 3 studies. / Cantor, Louis B.; Liu, Ching Chi; Batoosingh, Amy L.; Hollander, David A.

In: Current Medical Research and Opinion, Vol. 25, No. 7, 01.07.2009, p. 1615-1620.

Research output: Contribution to journalArticle

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title = "Safety and tolerability of brimonidine purite 0.1{\%} and brimonidine purite 0.15{\%}: A meta-analysis of two phase 3 studies",
abstract = "Objective: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite* (P) 0.1{\%} and brimonidine P 0.15{\%}, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT). Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multi-center, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15{\%} (n = 381), brimonidine P 0.2{\%} (n = 383), or brimonidine 0.2{\%} (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1{\%} (n = 215) and brimonidine 0.2{\%} (n = 218). Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs. Results: Treatment-related AEs were significantly reduced with brimonidine P 0.15{\%} compared with brimonidine 0.2{\%} in study 1 (p<0.001). Treatment-related AEs and discontinuations due to AEs were significantly reduced with brimonidine P 0.1{\%} compared with brimonidine 0.2{\%} in study 2 (p ≤ 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatmentrelated AEs was lower with brimonidine P 0.1{\%} than with brimonidine P 0.15{\%} (41.4 vs. 49.7{\%}; p = 0.050). Although the incidence of treatment-related ocular AEs was similar with brimonidine P 0.1{\%} and 0.15{\%} (p = 0.461), treatment-related systemic AEs were less frequent with brimonidine P 0.1{\%} than with brimonidine P 0.15{\%} (4.7 vs. 14.2{\%}; p<0.001), and there were fewer discontinuations due to systemic AEs with brimonidine P 0.1{\%} than with brimonidine P 0.15{\%} (p = 0.025). Conclusions: Brimonidine P 0.1{\%} has improved systemic safety and tolerability compared with brimonidine P 0.15{\%}. The ocular safety and tolerability of the formulations are similar. The present meta-analysis is based on only two clinical studies, and additional studies further evaluating the safety and tolerability of these medications are warranted.",
keywords = "Alpha-adrenergic agonist, Brimonidine, Glaucoma, Intraocular pressure, Ocular hypertension",
author = "Cantor, {Louis B.} and Liu, {Ching Chi} and Batoosingh, {Amy L.} and Hollander, {David A.}",
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T1 - Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%

T2 - A meta-analysis of two phase 3 studies

AU - Cantor, Louis B.

AU - Liu, Ching Chi

AU - Batoosingh, Amy L.

AU - Hollander, David A.

PY - 2009/7/1

Y1 - 2009/7/1

N2 - Objective: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite* (P) 0.1% and brimonidine P 0.15%, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT). Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multi-center, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15% (n = 381), brimonidine P 0.2% (n = 383), or brimonidine 0.2% (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1% (n = 215) and brimonidine 0.2% (n = 218). Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs. Results: Treatment-related AEs were significantly reduced with brimonidine P 0.15% compared with brimonidine 0.2% in study 1 (p<0.001). Treatment-related AEs and discontinuations due to AEs were significantly reduced with brimonidine P 0.1% compared with brimonidine 0.2% in study 2 (p ≤ 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatmentrelated AEs was lower with brimonidine P 0.1% than with brimonidine P 0.15% (41.4 vs. 49.7%; p = 0.050). Although the incidence of treatment-related ocular AEs was similar with brimonidine P 0.1% and 0.15% (p = 0.461), treatment-related systemic AEs were less frequent with brimonidine P 0.1% than with brimonidine P 0.15% (4.7 vs. 14.2%; p<0.001), and there were fewer discontinuations due to systemic AEs with brimonidine P 0.1% than with brimonidine P 0.15% (p = 0.025). Conclusions: Brimonidine P 0.1% has improved systemic safety and tolerability compared with brimonidine P 0.15%. The ocular safety and tolerability of the formulations are similar. The present meta-analysis is based on only two clinical studies, and additional studies further evaluating the safety and tolerability of these medications are warranted.

AB - Objective: To compare the safety and tolerability of two formulations of brimonidine ophthalmic solution, brimonidine Purite* (P) 0.1% and brimonidine P 0.15%, for reducing intraocular pressure in patients with glaucoma or ocular hypertension (OHT). Study design and methods: Meta-analysis of safety and tolerability results from two previously reported prospective, randomized, 12-month, double-masked, multi-center, parallel-group clinical studies with similar entry criteria and protocols. In study 1 (two clinical trials), after washout of previous medications, patients with glaucoma or OHT were randomized to thrice-daily treatment with brimonidine P 0.15% (n = 381), brimonidine P 0.2% (n = 383), or brimonidine 0.2% (n = 383). In study 2 (one clinical trial), the treatment arms were thrice-daily brimonidine P 0.1% (n = 215) and brimonidine 0.2% (n = 218). Main outcome measure: Treatment-related adverse events (AEs) and discontinuations due to AEs. Results: Treatment-related AEs were significantly reduced with brimonidine P 0.15% compared with brimonidine 0.2% in study 1 (p<0.001). Treatment-related AEs and discontinuations due to AEs were significantly reduced with brimonidine P 0.1% compared with brimonidine 0.2% in study 2 (p ≤ 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of treatmentrelated AEs was lower with brimonidine P 0.1% than with brimonidine P 0.15% (41.4 vs. 49.7%; p = 0.050). Although the incidence of treatment-related ocular AEs was similar with brimonidine P 0.1% and 0.15% (p = 0.461), treatment-related systemic AEs were less frequent with brimonidine P 0.1% than with brimonidine P 0.15% (4.7 vs. 14.2%; p<0.001), and there were fewer discontinuations due to systemic AEs with brimonidine P 0.1% than with brimonidine P 0.15% (p = 0.025). Conclusions: Brimonidine P 0.1% has improved systemic safety and tolerability compared with brimonidine P 0.15%. The ocular safety and tolerability of the formulations are similar. The present meta-analysis is based on only two clinical studies, and additional studies further evaluating the safety and tolerability of these medications are warranted.

KW - Alpha-adrenergic agonist

KW - Brimonidine

KW - Glaucoma

KW - Intraocular pressure

KW - Ocular hypertension

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