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

Ying Ying Chen, Tsing-Hong Wang, Catherine Liu, Kwou-Yeung Wu, Shin-Lin Chiu, Susan Simonyi, Da-Wen Lu, Ying Ying Chen, Tsing-Hong Wang, Catherine Liu, Kwou-Yeung Wu, Shin-Lin Chiu, Susan Simonyi, Da-Wen Lu

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.

Trial registration: Clinicaltrials.gov NCT01814761 . Registered 18 March 2013.

Keywords: Bimatoprost; Glaucoma; Hyperemia; Intraocular pressure; Normal-tension glaucoma; Ocular hypertension; Prostaglandin analog; Prostamide.

Figures

Fig. 1
Fig. 1
Patient disposition. AEs adverse events, ITT intent-to-treat
Fig. 2
Fig. 2
Shift in hyperemia severity grading from baseline at week 12 in (a) treatment-naïve and previously treated patients (P ≥ 0.2717 in both groups, compared with baseline), (b) patient subgroups previously treated with prostaglandin analog (PGA) or non-PGA monotherapy (P ≥ 0.2295 in both groups, compared with baseline), and (c) patient subgroups previously treated with latanoprost or travoprost monotherapy (P ≥ 0.1185 in both groups, compared with baseline)
Fig. 3
Fig. 3
Mean intraocular pressure (IOP) reduction at weeks 6 and 12 in treatment-naïve and previously treated patients. *P < 0.0001, compared with baseline
Fig. 4
Fig. 4
Mean intraocular pressure (IOP) reduction at week 12 in (a) patient subgroups previously treated with prostaglandin analog (PGA) or non-PGA monotherapy, and (b) patient subgroups previously treated with latanoprost or travoprost monotherapy. *P < 0.0001, compared with baseline; †P < 0.0002, compared with baseline

References

    1. Quigley HA. New paradigms in the mechanisms and management of glaucoma. Eye. 2005;19:1241–8. doi: 10.1038/sj.eye.6701746.
    1. Glaucoma facts and stats. Glaucoma research foundation website. 2015. . Accessed 18 Dec 2015.
    1. Fiscella RG, Lee J, Davis EJ, Walt J. Cost of illness of glaucoma: a critical and systematic review. Pharmacoeconomics. 2009;27:189–98. doi: 10.2165/00019053-200927030-00002.
    1. Lorenz K, Wolfram C, Breitscheidel L, Shlaen M, Verboven Y, Pfeiffer N. Direct cost and predictive factors for treatment in patients with ocular hypertension or early, moderate and advanced primary open-angle glaucoma: the CoGIS study in Germany. Graefes Arch Clin Exp Ophthalmol. 2013;251:2019–28. doi: 10.1007/s00417-013-2354-z.
    1. Varma R, Lee PP, Goldberg I, Kotak S. An assessment of the health and economic burdens of glaucoma. Am J Ophthalmol. 2011;152:515–22. doi: 10.1016/j.ajo.2011.06.004.
    1. Rudnicka AR, Mt-Isa S, Owen CG, Cook DG, Ashby D. Variations in primary open-angle glaucoma prevalence by age, gender, and race: a Bayesian meta-analysis. Invest Ophthalmol Vis Sci. 2006;47:4254–61. doi: 10.1167/iovs.06-0299.
    1. Kosoko-Lasaki O, Gong G, Haynatzki G, Wilson MR. Race, ethnicity and prevalence of primary open-angle glaucoma. J Natl Med Assoc. 2006;98:1626–9.
    1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90:262–7. doi: 10.1136/bjo.2005.081224.
    1. Chua J, Tham YC, Liao J, Zheng Y, Aung T, Wong TY, Cheng CY. Ethnic differences of intraocular pressure and central corneal thickness: the Singapore epidemiology of eye diseases study. Ophthalmology. 2014;121:2013–22. doi: 10.1016/j.ophtha.2014.04.041.
    1. Cedrone C, Mancino R, Cerulli A, Cesareo M, Nucci C. Epidemiology of primary glaucoma: prevalence, incidence, and blinding effects. Prog Brain Res. 2008;173:3–14. doi: 10.1016/S0079-6123(08)01101-1.
    1. Chan EW, Li X, Tham YC, Liao J, Wong TY, Aung T, Cheng CY. Glaucoma in Asia: regional prevalence variations and future projections. Br J Ophthalmol. 2015;100:78-85.
    1. Tsai CY, Woung LC, Chou P, Yang CS, Sheu MM, Wu JR, et al. The current status of visual disability in the elderly population of Taiwan. Jpn J Ophthalmol. 2005;49:166–72. doi: 10.1007/s10384-004-0164-x.
    1. Cho HK, Kee C. Population-based glaucoma prevalence studies in Asians. Surv Ophthalmol. 2014;59:434–47. doi: 10.1016/j.survophthal.2013.09.003.
    1. Kim JH, Kang SY, Kim NR, Lee ES, Hong S, Seong GJ, et al. Prevalence and characteristics of glaucoma among Korean adults. Korean J Ophthalmol. 2011;25:110–5. doi: 10.3341/kjo.2011.25.2.110.
    1. Park KH, Simonyi S, Kim CY, Sohn YH, Kook MS. Bimatoprost 0.01 % in treatment-naïve patients with open-angle glaucoma or ocular hypertension: an observational study in the Korean clinical setting. BMC Ophthalmol. 2014;14:160. doi: 10.1186/1471-2415-14-160.
    1. American Academy of Ophthalmology. Primary open-angle glaucoma. . Accessed 22 Dec 2015.
    1. European Glaucoma Society. Terminology and guidelines for glaucoma. 2014. . Accessed 22 Dec 2015.
    1. LUMIGAN® (bimatoprost ophthalmic solution) 0.03 % for topical use [prescribing information]. 2014. . Accessed 18 Dec 2015.
    1. Lee AJ, McCluskey P. Clinical utility and differential effects of prostaglandin analogs in the management of raised intraocular pressure and ocular hypertension. Clin Ophthalmol. 2010;4:741–64.
    1. Chiu SL, Chu CL, Muo CH, Chen CL, Lan SJ. Trends in glaucoma medication expenditures under universal health coverage: a national population-based longitudinal survey in Taiwan. J Ophthalmol. 2015;2015:243401. doi: 10.1155/2015/243401.
    1. Lin JC. The use of ocular hypotensive drugs for glaucoma treatment: changing trend in Taiwan from 1997 to 2007. J Glaucoma. 2015;24:364–71. doi: 10.1097/IJG.0b013e31829ea2e6.
    1. Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin analogs: a meta-analysis of randomized controlled clinical trials. J Glaucoma. 2008;17:667–73. doi: 10.1097/IJG.0b013e3181666557.
    1. Cohen JS, Gross RL, Cheetham JK, VanDenburgh AM, Bernstein P, Whitcup SM. Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(Suppl 1):S45–52. doi: 10.1016/j.survophthal.2003.12.019.
    1. Simmons ST, Dirks MS, Noecker RJ. Bimatoprost versus latanoprost in lowering intraocular pressure in glaucoma and ocular hypertension: results from parallel-group comparison trials. Adv Ther. 2004;21:247–62. doi: 10.1007/BF02850157.
    1. Williams RD, Cohen JS, Gross RL, Liu CC, Safyan E, Batoosingh AL, For the Bimatoprost Study Group Long-term efficacy and safety of bimatoprost for intraocular pressure lowering in glaucoma and ocular hypertension: year 4. Br J Ophthalmol. 2008;92:1387–92. doi: 10.1136/bjo.2007.128454.
    1. Inoue K, Shiokawa M, Fujimoto T, Tomita G. Effects of treatment with bimatoprost 0.03 % for 3 years in patients with normal-tension glaucoma. Clin Ophthalmol. 2014;8:1179–83. doi: 10.2147/OPTH.S60538.
    1. Tsumura T, Yoshikawa K, Suzumura H, Kimura T, Sasaki S, Kimura I, Takeda R. Bimatoprost ophthalmic solution 0.03% lowered intraocular pressure of normal-tension glaucoma with minimal adverse events. Clin Ophthalmol. 2012;6:1547–52. doi: 10.2147/OPTH.S36628.
    1. Sato S, Hirooka K, Baba T, Mizote M, Fujimura T, Tenkumo K, et al. Efficacy and safety of switching from topical latanoprost to bimatoprost in patients with normal-tension glaucoma. J Ocul Pharmacol Ther. 2011;27:499–502. doi: 10.1089/jop.2011.0020.
    1. Chen MJ, Cheng CY, Chen YC, Chou CK, Hsu WM. Effects of bimatoprost 0.03 % on ocular hemodynamics in normal tension glaucoma. J Ocul Pharmacol Ther. 2006;22:188–93. doi: 10.1089/jop.2006.22.188.
    1. Dirks MS, Noecker RJ, Earl M, Roh S, Silverstein SM, Williams RD. A 3-month clinical trial comparing the IOP-lowering efficacy of bimatoprost and latanoprost in patients with normal-tension glaucoma. Adv Ther. 2006;23:385–94. doi: 10.1007/BF02850159.
    1. Kaštelan S, Tomić M, Metež Soldo K, Salopek-Rabatić J. How ocular surface disease impacts the glaucoma treatment outcome. Biomed Res Int. 2013;2013:696328.
    1. Servat JJ, Bernardino CR. Effects of common topical antiglaucoma medications on the ocular surface, eyelids and periorbital tissue. Drugs Aging. 2011;28:267–82. doi: 10.2165/11588830-000000000-00000.
    1. Cate H, Bhattacharya D, Clark A, Fordham R, Holland R, Broadway DC. Improving adherence to glaucoma medication: a randomised controlled trial of a patient-centred intervention (The Norwich Adherence Glaucoma Study) BMC Ophthalmol. 2014;14:32. doi: 10.1186/1471-2415-14-32.
    1. Hwang DK, Liu CJ, Pu CY, Chou YJ, Chou P. Persistence of topical glaucoma medication: a nationwide population-based cohort study in Taiwan. JAMA Ophthalmol. 2014;132:1446–52. doi: 10.1001/jamaophthalmol.2014.3333.
    1. LUMIGAN® (bimatoprost ophthalmic solution) 0.01 % [prescribing information]. 2014. . Accessed 18 Dec 2015.
    1. Figus M, Nardi M, Piaggi P, Sartini M, Guidi G, Martini L, Lazzeri S. Bimatoprost 0.01 % vs bimatoprost 0.03 %: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients. Eye. 2014;28:422–9. doi: 10.1038/eye.2013.304.
    1. Katz LJ, Cohen JS, Batoosingh AL, Felix C, Shu V, Schiffman RM. Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol. 2010;149:661–71. doi: 10.1016/j.ajo.2009.12.003.
    1. Nixon DR, Simonyi S, Bhogal M, Sigouin CS, Crichton AC, Discepola M, et al. An observational study of bimatoprost 0.01 % in treatment-naïve patients with primary open angle glaucoma or ocular hypertension: the CLEAR trial. Clin Ophthalmol. 2012;6:2097–103.
    1. Pfennigsdorf S, Ramez O, von Kistowski G, Mäder B, Eschstruth P, Froböse M, et al. Multicenter, prospective, open-label, observational study of bimatoprost 0.01 % in patients with primary open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2012;6:739–46. doi: 10.2147/OPTH.S31330.
    1. Chung SD, Ho J, Lin HC, Kao LT, Tsai MC. Incremental healthcare service utilization for open-angle glaucoma: a population-based study. J Glaucoma. 2015;24:116–20. doi: 10.1097/IJG.0000000000000222.
    1. Crichton AC, Nixon DR, Simonyi S, Bhogal M, Sigouin CS, Discepola MJ, et al. An observational study of bimatoprost 0.01 % in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan® RC Early Analysis Review (CLEAR) trial. Clin Ophthalmol. 2014;8:1031–8.
    1. Kook MS, Simonyi S, Sohn YH, Kim CY, Park KH. Bimatoprost 0.01 % for previously treated patients with open-angle glaucoma or ocular hypertension in the Korean clinical setting. Jpn J Ophthalmol. 2015;59:325. doi: 10.1007/s10384-015-0392-2.
    1. Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01 % monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012;2; doi:10.1136/bmjopen-2012-001106.
    1. Crichton AC, Vold S, Williams JM, Hollander DA. Ocular surface tolerability of prostaglandin analogs and prostamides in patients with glaucoma or ocular hypertension. Adv Ther. 2013;30:260–70. doi: 10.1007/s12325-013-0014-7.

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