PMID- 19469697
OWN - NLM
STAT- MEDLINE
DCOM- 20091130
LR  - 20151119
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 25
IP  - 7
DP  - 2009 Jul
TI  - Safety and tolerability of brimonidine purite 0.1% and brimonidine purite 0.15%: 
      a meta-analysis of two phase 3 studies.
PG  - 1615-20
LID - 10.1185/03007990902997655 [doi]
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, multicenter, 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 < or 
      = 0.014). In the meta-analysis of study 1 and study 2, the overall incidence of 
      treatment-related 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.
FAU - Cantor, Louis B
AU  - Cantor LB
AD  - Glaucoma Service, Eugene and Marilyn Glick Eye Institute, Indiana University 
      School of Medicine, Department of Ophthalmology, Indianapolis, IN 46202, USA. 
      lcantor@iupui.edu
FAU - Liu, Ching-Chi
AU  - Liu CC
FAU - Batoosingh, Amy L
AU  - Batoosingh AL
FAU - Hollander, David A
AU  - Hollander DA
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Quinoxalines)
RN  - 4S9CL2DY2H (Brimonidine Tartrate)
SB  - IM
MH  - Antihypertensive Agents/administration & dosage/adverse effects
MH  - Brimonidine Tartrate
MH  - *Clinical Trials, Phase III as Topic
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ocular Hypertension/*drug therapy
MH  - Ophthalmic Solutions/adverse effects
MH  - Osmolar Concentration
MH  - Quinoxalines/*administration & dosage/*adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Withholding Treatment
EDAT- 2009/05/28 09:00
MHDA- 2009/12/16 06:00
CRDT- 2009/05/28 09:00
PHST- 2009/05/28 09:00 [entrez]
PHST- 2009/05/28 09:00 [pubmed]
PHST- 2009/12/16 06:00 [medline]
AID - 10.1185/03007990902997655 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2009 Jul;25(7):1615-20. doi: 10.1185/03007990902997655.