PMID- 23640612
OWN - NLM
STAT- MEDLINE
DCOM- 20140130
LR  - 20211021
IS  - 1476-5454 (Electronic)
IS  - 0950-222X (Print)
IS  - 0950-222X (Linking)
VI  - 27
IP  - 7
DP  - 2013 Jul
TI  - Fixed-combination brinzolamide 1%/brimonidine 0.2% vs monotherapy with 
      brinzolamide or brimonidine in patients with open-angle glaucoma or ocular 
      hypertension: results of a pooled analysis of two phase 3 studies.
PG  - 841-7
LID - 10.1038/eye.2013.83 [doi]
AB  - PURPOSE: To describe pooled efficacy and safety data from two phase 3 studies 
      comparing brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) with its 
      component medications, brinzolamide and brimonidine, in patients with open-angle 
      glaucoma or ocular hypertension. METHODS: Data were pooled from two nearly 
      identical clinical trials comparing BBFC with its component medications, each 
      given three times daily. The 3-month efficacy outcome was mean intraocular 
      pressure (IOP) at 0800, 1000, 1500, and 1700 hours. Safety outcomes included 
      adverse events (AEs), best-corrected visual acuity, examination of ocular 
      structures, pachymetry, perimetry, and vital signs. RESULTS: A total of 1350 
      patients were enrolled and included in this analysis (BBFC, n=437; brinzolamide, 
      n=458; brimonidine, n=455). Baseline mean IOP levels were similar among the three 
      treatment groups. At 3 months, mean IOP of the BBFC group was significantly lower 
      than that of either monotherapy group (P<0.0001) at all the four time points. A 
      total of 272 patients (20.1%) experienced at least one treatment-related AE 
      (BBFC, 24.6%; brinzolamide, 18.7%; brimonidine, 17.4%), the majority of which 
      were ocular AEs. One serious AE, moderate intensity chest pain, was considered 
      related to brinzolamide treatment and resulted in study discontinuation. 
      CONCLUSIONS: This analysis strengthens the conclusions drawn from the two 
      individual phase 3 studies showing that, in patients with open-angle glaucoma or 
      ocular hypertension, BBFC had significantly superior IOP-lowering activity 
      compared with either brinzolamide or brimonidine alone and a safety profile 
      consistent with that of its individual components.
FAU - Realini, T
AU  - Realini T
AD  - Department of Opthalmology, West Virginia University Eye Institute, Morgantown, 
      WV 26506, USA. realinia@wvuhealthcare.com
FAU - Nguyen, Q H
AU  - Nguyen QH
FAU - Katz, G
AU  - Katz G
FAU - DuBiner, H
AU  - DuBiner H
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130503
PL  - England
TA  - Eye (Lond)
JT  - Eye (London, England)
JID - 8703986
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Quinoxalines)
RN  - 0 (Sulfonamides)
RN  - 0 (Thiazines)
RN  - 4S9CL2DY2H (Brimonidine Tartrate)
RN  - 9451Z89515 (brinzolamide)
SB  - IM
MH  - Aged
MH  - Antihypertensive Agents/adverse effects/*therapeutic use
MH  - Brimonidine Tartrate
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - Glaucoma, Open-Angle/*drug therapy
MH  - Humans
MH  - Intraocular Pressure/drug effects
MH  - Male
MH  - Middle Aged
MH  - Ocular Hypertension/*drug therapy
MH  - Quinoxalines/adverse effects/*therapeutic use
MH  - Sulfonamides/adverse effects/*therapeutic use
MH  - Thiazines/adverse effects/*therapeutic use
MH  - Visual Acuity/drug effects
PMC - PMC3709402
EDAT- 2013/05/04 06:00
MHDA- 2014/01/31 06:00
PMCR- 2013/07/01
CRDT- 2013/05/04 06:00
PHST- 2013/02/15 00:00 [received]
PHST- 2013/02/21 00:00 [accepted]
PHST- 2013/05/04 06:00 [entrez]
PHST- 2013/05/04 06:00 [pubmed]
PHST- 2014/01/31 06:00 [medline]
PHST- 2013/07/01 00:00 [pmc-release]
AID - eye201383 [pii]
AID - 10.1038/eye.2013.83 [doi]
PST - ppublish
SO  - Eye (Lond). 2013 Jul;27(7):841-7. doi: 10.1038/eye.2013.83. Epub 2013 May 3.