PMID- 28508306
OWN - NLM
STAT- MEDLINE
DCOM- 20171204
LR  - 20181102
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 34
IP  - 6
DP  - 2017 Jun
TI  - Multicenter, Randomized, Investigator-Masked Study Comparing Brimonidine Tartrate 
      0.1% and Timolol Maleate 0.5% as Adjunctive Therapies to Prostaglandin Analogues 
      in Normal-Tension Glaucoma.
PG  - 1438-1448
LID - 10.1007/s12325-017-0552-5 [doi]
AB  - INTRODUCTION: This study compared the efficacy and safety of adjunctive 
      brimonidine tartrate 0.1% ophthalmic solution (brimonidine) and timolol maleate 
      0.5% ophthalmic solution (timolol) in prostaglandin analogue (PGA)-treated 
      normal-tension glaucoma (NTG), assessing the non-inferiority of brimonidine in 
      terms of intraocular pressure (IOP) reduction. METHODS: In this multicenter, 
      randomized, investigator-masked, parallel-group, clinical study, adjunctive 
      brimonidine or timolol was administered twice daily for 12 weeks in eyes with NTG 
      that had been treated with PGA for at least 90 days and required additional 
      treatment despite an IOP of 16 mmHg or less. IOP was measured on at least three 
      visits before add-on therapy (mean baseline IOP), and at weeks 4, 8, and 12 after 
      adjunctive administration. Systolic/diastolic blood pressure, pulse rate, and 
      adverse events (AEs) were recorded at each visit. RESULTS: A total of 152 
      individuals were enrolled and 128 (84.2%) were eligible for efficacy analyses. 
      IOP in both groups at each visit decreased significantly from baseline 
      (P < 0.001). However, the difference in the change from baseline IOP at week 12 
      between the brimonidine (-1.05 +/- 1.81 mmHg) and timolol (-1.41 +/- 1.40 mmHg) 
      groups was 0.36 mmHg (95% confidence interval [CI] [-0.21, 0.92]), which exceeded 
      the value of the non-inferiority margin (0.75 mmHg). Baseline systolic/diastolic 
      blood pressure decreased significantly in both groups at certain visits 
      (P < 0.05), while baseline pulse rates decreased significantly in the timolol 
      group (P < 0.001), with no significant differences in the brimonidine group. 
      AE-related treatment discontinuation occurred in 2/71 (2.8%) and 2/75 (2.7%) 
      patients in the brimonidine and timolol groups, respectively. CONCLUSION: This 
      study demonstrated an add-on effect of brimonidine to PGAs, although 
      non-inferiority of brimonidine to timolol as adjunctive therapy in PGA-treated 
      NTG in terms of IOP reduction was not observed. Brimonidine was associated with 
      no adverse effects on pulse rate. FUNDING: Senju Pharmaceutical Co., Ltd. TRIAL 
      REGISTRATION: UMIN Clinical Trials Registry identifier, UMIN000014810.
FAU - Mizoue, Shiro
AU  - Mizoue S
AD  - Department of Ophthalmology, Ehime University Graduate School of Medicine, Ehime, 
      Japan. mizoue@m.ehime-u.ac.jp.
FAU - Nitta, Koji
AU  - Nitta K
AD  - Department of Ophthalmology, Fukui-ken Saiseikai Hospital, Fukui, Japan.
FAU - Shirakashi, Motohiro
AU  - Shirakashi M
AD  - Kido Eye Clinic, Niigata, Japan.
FAU - Nitta, Akiyoshi
AU  - Nitta A
AD  - Nitta Ophthalmological Clinic, Gunma, Japan.
FAU - Yamabayashi, Shigeki
AU  - Yamabayashi S
AD  - Yamabayashi Eye Clinic, Aichi, Japan.
FAU - Kimura, Tairo
AU  - Kimura T
AD  - Ueno Eye Clinic, Tokyo, Japan.
FAU - Ueda, Toshihiko
AU  - Ueda T
AD  - Nihonmatsu Eye Hospital, Tokyo, Japan.
FAU - Takeda, Ryuji
AU  - Takeda R
AD  - Faculty of Agriculture, Kindai University, Nara, Japan.
AD  - Faculty of Health Science for Welfare, Kansai University of Welfare Sciences, 
      Osaka, Japan.
FAU - Matsumoto, Shun
AU  - Matsumoto S
AD  - Department of Ophthalmology, Tokyo Teishin Hospital, Tokyo, Japan.
FAU - Yoshikawa, Keiji
AU  - Yoshikawa K
AD  - Yoshikawa Eye Clinic, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170515
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Prostaglandins, Synthetic)
RN  - 4S9CL2DY2H (Brimonidine Tartrate)
RN  - 817W3C6175 (Timolol)
EIN - Adv Ther. 2017 Aug 30;:. PMID: 28856599
MH  - Aged
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Brimonidine Tartrate/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Intraocular Pressure
MH  - Low Tension Glaucoma/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions/administration & dosage
MH  - Prostaglandins, Synthetic/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Single-Blind Method
MH  - Timolol/administration & dosage/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Brimonidine
OT  - Glaucoma
OT  - Intraocular pressure
OT  - Ophthalmology
OT  - Prostaglandin analogues
OT  - Timolol
EDAT- 2017/05/17 06:00
MHDA- 2017/12/05 06:00
CRDT- 2017/05/17 06:00
PHST- 2017/03/30 00:00 [received]
PHST- 2017/05/17 06:00 [pubmed]
PHST- 2017/12/05 06:00 [medline]
PHST- 2017/05/17 06:00 [entrez]
AID - 10.1007/s12325-017-0552-5 [pii]
AID - 10.1007/s12325-017-0552-5 [doi]
PST - ppublish
SO  - Adv Ther. 2017 Jun;34(6):1438-1448. doi: 10.1007/s12325-017-0552-5. Epub 2017 May 
      15.