title: Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study.
abstract: BACKGROUND
  In randomized, controlled trials of open-angle glaucoma (OAG) or ocular hypertension (OHT), bimatoprost 0.01 % improved tolerability while retaining the intraocular pressure (IOP)-lowering efficacy of bimatoprost 0.03 %. Given geographic/racial differences in glaucoma presentation, the APPEAL study assessed the occurrence and severity of hyperemia produced by bimatoprost 0.01 %, and its efficacy, in the Taiwanese clinical setting.
  
  
  METHODS
  In this multicenter, open-label, observational study, treatment-naïve and previously treated patients with OHT or OAG received once-daily bimatoprost 0.01 % for 12 weeks. Hyperemia (primary endpoint) was graded at baseline, week 6, and week 12 using a photonumeric scale (0, +0.5, +1, +2, +3), grouped (≤ +1, none to mild; ≥ +2, moderate to severe), and reported as unchanged from baseline, improved, or worsened. IOP assessments followed the same schedule. Supplemental efficacy analyses were conducted based on previous therapies.
  
  
  RESULTS
  The intent-to-treat population (N = 312) included treatment-naïve (13.5 %) and previously treated (86.5 %) patients; mean age was 53.3 years. At baseline, 46.3 % of previously treated patients were receiving prostaglandin analog (PGA) monotherapy. At week 12, 91.2 %, 5.9 %, and 2.9 % of treatment-naïve patients exhibited unchanged, worsened, and improved hyperemia from baseline, respectively; 77.9 %, 12.9 %, and 9.2 % of previously treated patients showed no change, worsening, and improvement, respectively. There were no statistically significant shifts in hyperemia severity in either group, or in subgroups based on previous use of any PGA, any non-PGA, latanoprost, or travoprost monotherapies. In treatment-naïve patients, mean IOP reduction from baseline (18.0 ± 3.8 mm Hg) was 3.6 mm Hg at week 12 (P < 0.0001); 83.3 % had baseline IOP ≤ 21 mm Hg. In previously treated patients, mean additional IOP reduction from baseline (17.8 ± 3.9 mm Hg) was 2.6 mm Hg (P < 0.0001); similar results were observed in patient subgroups based on previous therapies.
  
  
  CONCLUSIONS
  In the Taiwanese clinical setting, bimatoprost 0.01 % provided significant IOP lowering in treatment-naïve patients (regardless of baseline IOP) and previously treated patients (even those with relatively low IOP on other therapies), while causing no significant changes in hyperemia from baseline.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01814761 . Registered 18 March 2013.
authors.affiliation: Kaohsiung Veterans General Hospital, Kaohsiung City, Taiwan.
authors.forename: Ying Ying
authors.initials: YY
authors.lastname: Chen
authors.affiliation: National Taiwan University Hospital, Taipei City, Taiwan.
authors.forename: Tsing-Hong
authors.initials: TH
authors.lastname: Wang
authors.affiliation: Taipei Veterans General Hospital, Taipei City, Taiwan.
authors.forename: Catherine
authors.initials: C
authors.lastname: Liu
authors.affiliation: Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan.
authors.forename: Kwou-Yeung
authors.initials: KY
authors.lastname: Wu
authors.affiliation: Changhua Christian Hospital, Changhua City, Taiwan.
authors.forename: Shin-Lin
authors.initials: SL
authors.lastname: Chiu
authors.affiliation: Allergan Singapore Pte Ltd., Singapore, Singapore.
authors.forename: Susan
authors.initials: S
authors.lastname: Simonyi
authors.affiliation: Tri-Service General Hospital, Taipei City, Taiwan. ludawen@yahoo.com.
authors.forename: Da-Wen
authors.initials: DW
authors.lastname: Lu
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069580:Bimatoprost / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D006940:Hyperemia / Q000209:etiology; D057194:Intention to Treat Analysis; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000959:Antihypertensive Agents; D000069580:Bimatoprost
keywords: Bimatoprost; Glaucoma; Hyperemia; Intraocular pressure; Normal-tension glaucoma; Ocular hypertension; Prostaglandin analog; Prostamide