Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China

Kaidi Wang, Li Xu, Zhilan Yuan, Ke Yao, Junmei Zhao, Liang Xu, Aiwu Fang, Mingzhi Zhang, Lingling Wu, Jian Ji, Jiamin Hou, Qing Liu, Xinghuai Sun, Kaidi Wang, Li Xu, Zhilan Yuan, Ke Yao, Junmei Zhao, Liang Xu, Aiwu Fang, Mingzhi Zhang, Lingling Wu, Jian Ji, Jiamin Hou, Qing Liu, Xinghuai Sun

Abstract

Background: To report the clinical outcomes in Chinese patients with primary open-angle glaucoma and ocular hypertension treated with bimatoprost 0.03% therapy.

Methods: Two hundred sixty-three Chinese patients with primary open-angle glaucoma and ocular hypertension who needed initial or additional intraocular pressure (IOP) lowering were recruited in this prospective, open-label, multicenter clinical study and were treated with bimatoprost 0.03%. Patients received bimatoprost 0.03% as initial, replacement or adjunctive IOP-lowering therapy, and follow-up visits were performed at week 1, and month 1 and 3 of the bimatoprost treatment. The efficacy outcome measure was the post-treatment IOP level. The safety outcome measures included the rate of medication-related symptoms, physical signs, reported adverse events, and the level of conjunctival hyperemia.

Results: Among 240 patients who could be categorized by pre-existing therapies and the bimatoprost therapy regimen in the study, IOP values observed in all medication conditions showed significant IOP reduction at all study visits compared with baseline. At 3 months, 8.0 ± 3.7 mmHg (32.0%) reduction in IOP was observed in treatment-naive patients after bimatoprost monotherapy; in the patients previously on various therapy regimens, 1.9 ± 2.8 mmHg (9.5%) to 6.4 ± 6.1 mmHg (24.8%) additional IOP lowering was achieved after switching to bimatoprost monotherapy or bimatoprost combination therapy. The most common adverse event was conjunctival hyperemia, mainly of trace and mild intensity.

Conclusions: Our results show that bimatoprost 0.03% was effective in lowering IOP with favorable safety in Chinese primary open-angle glaucoma and ocular hypertension patients.

Figures

Figure 1
Figure 1
Mean IOP of the patients in groups A through E, ITT population. Group A: treatment-naive patients received in-trial bimatoprost monotherapy; Group B: pretrial PG mono-treated patients received in-trial switch monotherapy with bimatoprost; Group C: pretrial non-PG mono- or combination-treated patients received in-trial switch monotherapy with bimatoprost; Group D: pretrial PG combination-treated patients received in-trial PM replacement with bimatoprost; Group E: pretrial non-PG mono- or combination-treated patients received bimatoprost as an adjunctive agent in addition to the previous treatment modality.
Figure 2
Figure 2
Conjunctival hyperemia scoring distribution at each visit. A, Percentage of patients with each grade; B, Percentage of patients with conjunctival hyperemia grade increase from baseline n = 250.

References

    1. Varma R, Lee PP, Goldberg I, Kotak S. An assessment of the health and economic burdens of glaucoma. Am J Ophthalmol. 2011;152:515–522. doi: 10.1016/j.ajo.2011.06.004.
    1. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90:262–267. doi: 10.1136/bjo.2005.081224.
    1. AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol. 2000;130:429–440.
    1. Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120:701–713. doi: 10.1001/archopht.120.6.701.
    1. Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E. Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003;121:48–56. doi: 10.1001/archopht.121.1.48.
    1. Ederer F, Gaasterland DA, Dally LG, Kim J, VanVeldhuisen PC, Blackwell B, Prum B, Shafranov G, Allen RC, Beck A. AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results. Ophthalmology. 2004;111:651–664.
    1. Musch DC, Gillespie BW, Niziol LM, Lichter PR, Varma R. CIGTS Study Group. Intraocular pressure control and long-term visual field loss in the collaborative initial glaucoma treatment study. Ophthalmology. 2011;118:1766–1773. doi: 10.1016/j.ophtha.2011.01.047.
    1. Ishida N, Odani-Kawabata N, Shimazaki A, Hara H. Prostanoids in the therapy of glaucoma. Cardiovasc Drug Rev. 2006;24:1–10. doi: 10.1111/j.1527-3466.2006.00001.x.
    1. Patil AJ, Vajaranant TS, Edward DP. Bimatoprost—a review. Expert Opin Pharmacother. 2009;10:2759–2768. doi: 10.1517/14656560903292649.
    1. Konstas AG, Katsimbris JM, Lallos N, Boukaras GP, Jenkins JN, Stewart WC. Latanoprost 0.005% versus bimatoprost 0.03% in primary open-angle glaucoma patients. Ophthalmology. 2005;112:262–266. doi: 10.1016/j.ophtha.2004.08.022.
    1. Orzalesi N, Rossetti L, Bottoli A, Fogagnolo P. Comparison of the effects of latanoprost, travoprost, and bimatoprost on circadian intraocular pressure in patients with glaucoma or ocular hypertension. Ophthalmology. 2006;113:239–246. doi: 10.1016/j.ophtha.2005.10.045.
    1. Stewart WC, Konstas AG, Nelson LA, Kruft B. Meta-analysis of 24-hour intraocular pressure studies evaluating the efficacy of glaucoma medicines. Ophthalmology. 2008;115:1117–1122. doi: 10.1016/j.ophtha.2007.10.004.
    1. Noecker RS, Dirks MS, Choplin NT, Bernstein P, Batoosingh AL, Whitcup SM. Bimatoprost/Latanoprost Study Group. A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma. Am J Ophthalmol. 2003;135:55–63. doi: 10.1016/S0002-9394(02)01827-5.
    1. Parrish RK, Palmberg P, Sheu WP. XLT Study Group. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. Am J Ophthalmol. 2003;135:688–703. doi: 10.1016/S0002-9394(03)00098-9.
    1. Cantor LB, Hoop J, Morgan L, Wudunn D, Catoira Y. Bimatoprost-Travoprost Study Group. Intraocular pressure-lowering efficacy of bimatoprost 0.03% and travoprost 0.004% in patients with glaucoma or ocular hypertension. Br J Ophthalmol. 2006;90:1370–1373. doi: 10.1136/bjo.2006.094326.
    1. Aptel F, Cucherat M, Denis P. Efficacy and tolerability of prostaglandin analogs: a meta-analysis of randomized controlled clinical trials. J Glaucoma. 2008;17:667–673. doi: 10.1097/IJG.0b013e3181666557.
    1. Kammer JA, Katzman B, Ackerman SL, Hollander DA. Efficacy and tolerability of bimatoprost versus travoprost in patients previously on latanoprost: a 3-month, randomised, masked-evaluator, multicentre study. Br J Ophthalmol. 2010;94:74–79. doi: 10.1136/bjo.2009.158071.
    1. Faridi UA, Saleh TA, Ewings P, Venkateswaran M, Cadman DH, Samarasinghe RA, Vodden J, Claridge KG. Comparative study of three prostaglandin analogues in the treatment of newly diagnosed cases of ocular hypertension, open-angle and normal tension glaucoma. Clin Exp Ophthalmol. 2010;38:678–682. doi: 10.1111/j.1442-9071.2010.02305.x.
    1. Huang HL, Sun XH, Xiao M. Comparison of intraocular pressure reducing effects of three prostaglandin eyedrops in open-angle glaucoma. Zhonghua Yan Ke Za Zhi. 2011;47:109–113.
    1. Curran MP. Bimatoprost: a review of its use in OAG and ocular hypertension. Drugs Aging. 2009;26:1049–1071. doi: 10.2165/11203210-000000000-00000.
    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;149:661–671. doi: 10.1016/j.ajo.2009.12.003.
    1. Chen MJ, Chen YC, Chou CK, Hsu WM. Comparison of the effects of latanoprost and bimatoprost on intraocular pressure in chronic angle-closure glaucoma. J Ocul Pharmacol Ther. 2007;23:559–566. doi: 10.1089/jop.2007.0037.
    1. European Glaucoma Society. Terminology and Guidelines for Glaucoma (3rd Edition) .
    1. Geringer C, Imami N. Medical management of glaucoma. Int Ophthamol Clin. 2008;48:115–141. doi: 10.1097/IIO.0b013e318187e8b5.
    1. Coleman AL, Miglior S. Risk factors for glaucoma onset and progression. Surv Ophthalmol. 2008;53(Suppl 1):S3–10.
    1. Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M. Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120:1268–1279. doi: 10.1001/archopht.120.10.1268.
    1. Chauhan BC, Mikelberg FS, Balaszi AG, LeBlanc RP, Lesk MR, Trope GE. Canadian Glaucoma Study Group. Canadian Glaucoma Study: 2. risk factors for the progression of open-angle glaucoma. Arch Ophthalmol. 2008;126:1030–1036. doi: 10.1001/archopht.126.8.1030.
    1. Quinones R, Earl ML. The efficacy of bimatoprost 0.03% monotherapy in patients previously using topical beta-blocker monotherapy for the treatment of glaucoma or ocular hypertension. Adv Ther. 2004;21:370–379. doi: 10.1007/BF02850101.
    1. Feuerhake C, Buchholz P, Kimmich F. Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. Curr Med Res Opin. 2009;25:1037–1043. doi: 10.1185/03007990902816947.
    1. Sonty S, Donthamsetti V, Vangipuram G, Ahmad A. Long-term IOP lowering with bimatoprost in open-angle glaucoma patients poorly responsive to latanoprost. J Ocul Pharmacol Ther. 2008;24:517–520. doi: 10.1089/jop.2008.0033.
    1. Ichhpujani P, Katz LJ, Hollo G, Shields CL, Shields JA, Marr B, Eagle R, Alvim H, Wizov SS, Acheampong A, Chen J, Wheeler LA. Comparison of human ocular distribution of bimatoprost and latanoprost. J Ocul Pharmacol Ther. 2012;28:134–145. doi: 10.1089/jop.2011.0097.
    1. Walt JG, Lee JT. A cost-effectiveness comparison of bimatoprost versus latanoprost in patients with glaucoma or ocular hypertension. Surv Ophthalmol. 2004;49(Suppl 1):S36–44.
    1. Gao Y, Wu L, Li A. Daily cost of glaucoma medications in China. J Glaucoma. 2007;16:594–597. doi: 10.1097/IJG.0b013e318064c818.
    1. Wanichwecha-Rungruang B, Iemsomboon W. Efficacy and safety of bimatoprost for the treatment of open-angle glaucoma and ocular hypertension: a three-month, open-label study in community-based practices in Thailand. J Med Assoc Thai. 2005;88:1228–1235.
    1. Quinones R, Severin T, Mundorf T. Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial. J Ocul Pharmacol Ther. 2004;20:115–122. doi: 10.1089/108076804773710786.
    1. Whitson JT, Trattler WB, Matossian C, Williams J, Hollander DA. Ocular surface tolerability of prostaglandin analogs in patients with glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2010;26:287–292. doi: 10.1089/jop.2009.0134.
    1. Alagöz G, Bayer A, Boran C, Serin D, Kükner A, Elçioğlu M. Comparison of ocular surface side effects of topical travoprost and bimatoprost. Ophthalmologica. 2008;222:161–167. doi: 10.1159/000126078.
    1. Ge J, Sun XH, Wang NL, Zhao JL, Wu LL, Chen XM, Wang ZX, Li B. Intraocular pressure lowering efficacy and safety of travoprost 0.004% as a replacement therapy in patients with open angle glaucoma or ocular hypertension. Chin Med J (Engl) 2010;123:1417–1421.
    1. Herndon LW, Brunner TM, Rollins JN. The glaucoma research foundation patient survey: patient understanding of glaucoma and its treatment. Am J Ophthalmol. 2006;141(1 Suppl):S22–27.
    1. Abelson MB, Mroz M, Rosner SA, Dirks MS, Hirabayashi D. Multicenter, open-label evaluation of hyperemia associated with use of bimatoprost in adults with open-angle glaucoma or ocular hypertension. Adv Ther. 2003;20:1–13. doi: 10.1007/BF02850114.
    1. Trattler W, Noecker RJ, Earl ML. A multicentre evaluation of the effect of patient education on acceptance of hyperemia associated with bimatoprost therapy for glaucoma or ocular hypertension. Adv Ther. 2008;25:179–189. doi: 10.1007/s12325-008-0029-7.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj