Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension

Nevbahar Tamçelik, Belgin Izgi, Ahmet Temel, Nilgun Yildirim, Mehmet Okka, Altan Özcan, Nurşen Yüksel, Ufuk Elgin, Çiğdem Altan, Baris Ozer, Nevbahar Tamçelik, Belgin Izgi, Ahmet Temel, Nilgun Yildirim, Mehmet Okka, Altan Özcan, Nurşen Yüksel, Ufuk Elgin, Çiğdem Altan, Baris Ozer

Abstract

Objective: The objective of this study was to assess the intraocular pressure (IOP)-lowering efficacy, tolerability, safety, and usage patterns of prostaglandin analog/prostamide (PGA/P)-containing topical ocular hypotensives in ocular hypertension (OHT) and primary open-angle glaucoma in the Turkish clinical setting.

Methods: This non-interventional, multicenter study enrolled previously treated patients who failed to achieve target IOP (or experienced unacceptable adverse events [AEs]) and were prescribed a PGA/P-containing IOP-lowering agent. Treatment was initiated at baseline (V1), and patients returned at weeks 4-6 (V2) and 8-12 (V3). The primary efficacy measure was the change in IOP from baseline at V3 in each eye. The secondary measures were physician's assessment of IOP-lowering efficacy, patients (%) reaching target IOP determined at V1, hyperemia score, physician and patient assessment of study treatment tolerability at V3, and AE frequency/severity. A subgroup analysis of patients receiving the most common study treatment was conducted. All analyses were performed using the safety population (patients who received one or more doses and had any data available).

Results: Of 358 enrolled patients, 60.6% had primary open-angle glaucoma, 29.9% had secondary open-angle glaucoma (protocol amendment), and 13.1% had OHT; 13 patients had multiple diagnoses. At V3, the mean IOP change from baseline was ≥-4.2 mmHg (≥21.1%). IOP met or was lower than the target in 81.7% of patients, 95% exhibited none to mild conjunctival hyperemia (most common AE), and tolerability was rated good/very good by >91.1% of patients and physicians. The results were similar in patients who received the most common study treatment, bimatoprost 0.03%/timolol 0.5% (bim/tim; n=310).

Conclusion: PGA/P-containing medications, including bim/tim, significantly reduced IOP in previously treated patients with open-angle glaucoma or OHT; most reached their target IOP or an IOP even lower than their target and reported good/very good tolerability. PGA/P-containing medications such as bim/tim should be considered as a safe, effective therapeutic option for Turkish patients who exhibit poor response, tolerance, or adherence to their previous therapy.

Keywords: bimatoprost; glaucoma; ocular hypertension; prostaglandin analog; prostamide; timolol.

Conflict of interest statement

Disclosure Baris Ozer is an employee of Allergan plc. The other authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Mean IOP in the right eye (A) and left eye (B) of the total population and subgroup of patients who received bim/tim during the study. Notes: Results are expressed as mean ± SD at baseline and 8–12 weeks after switching to a PGA/P-containing therapy (final visit). *P<0.001, compared with baseline (Wilcoxon signed-rank test). Abbreviations: Bim/tim, bimatoprost 0.03%/timolol 0.5%; IOP, intraocular pressure; PGA/P, prostaglandin analog/prostamide; SD, standard deviation.

References

    1. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121(11):2081–2090.
    1. Glaucoma Facts and Stats [webpage on the Internet] Glaucoma Research Foundation Website. [Accessed May 24, 2016]. p. 2015. Available from: .
    1. American Academy of Ophthalmology . Preferred Practice Pattern: Primary Open-Angle Glaucoma. San Francisco, CA: Elsevier; 2016. [Accessed May 24, 2016]. Available from: .
    1. European Glaucoma Society Terminology and Guidelines for Glaucoma. 4th ed. 2016. [Accessed May 24, 2016]. Available from: .
    1. Heijl A, Bengtsson B, Hyman L, Leske MC, Early Manifest Glaucoma Trial Group Natural history of open-angle glaucoma. Ophthalmology. 2009;116(12):2271–2276.
    1. Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014;311(18):1901–1911.
    1. Liu JH, Kripke DF, Weinreb RN. Comparison of the nocturnal effects of once-daily timolol and latanoprost on intraocular pressure. Am J Ophthalmol. 2004;138(3):389–395.
    1. Brubaker RF, Schoff EO, Nau CB, Carpenter SP, Chen K, Vandenburgh AM. Effects of AGN 192024, a new ocular hypotensive agent, on aqueous dynamics. Am J Ophthalmol. 2001;131(1):19–24.
    1. Gulati V, Fan S, Zhao M, Maslonka MA, Gangahar C, Toris CB. Diurnal and nocturnal variations in aqueous humor dynamics of patients with ocular hypertension undergoing medical therapy. Arch Ophthalmol. 2012;130(6):677–684.
    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(4):e001106.
    1. Orzalesi N, Rossetti L, Invernizzi T, Bottoli A, Autelitano A. Effect of timolol, latanoprost, and dorzolamide on circadian IOP in glaucoma or ocular hypertension. Invest Ophthalmol Vis Sci. 2000;41(9):2566–2573.
    1. Brandt JD, Cantor LB, Katz LJ, et al. Early Manifest Glaucoma Trial Group Bimatoprost/timolol fixed combination: a 3-month double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2008;17(3):211–216.
    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(4):1037–1043.
    1. Lewis RA, Gross RL, Sall KN, et al. Ganfort Investigators Group II The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2010;19(6):424–426.
    1. Hommer A; Ganfort Investigators Group I. A double-masked, randomized, parallel comparison of a fixed combination of bimatoprost 0.03%/timolol 0.5% with non-fixed combination use in patients with glaucoma or ocular hypertension. Eur J Ophthalmol. 2007;17(1):53–62.
    1. Centofanti M, Oddone F, Gandolfi S, et al. Comparison of Travoprost and Bimatoprost plus timolol fixed combinations in open-angle glaucoma patients previously treated with latanoprost plus timolol fixed combination. Am J Ophthalmol. 2010;150(4):575–580.
    1. Centofanti M, Oddone F, Vetrugno M, et al. Efficacy of the fixed combinations of bimatoprost or latanoprost plus timolol in patients uncontrolled with prostaglandin monotherapy: a multicenter, randomized, investigator-masked, clinical study. Eur J Ophthalmol. 2009;19(1):66–71.
    1. Macky TA. Bimatoprost/timolol versus travoprost/timolol fixed combinations in an Egyptian population: a hospital-based prospective randomized study. J Glaucoma. 2014;23(8):561–566.
    1. Martinez A, Sanchez M. A comparison of the safety and intraocular pressure lowering of bimatoprost/timolol fixed combination versus latanoprost/timolol fixed combination in patients with open-angle glaucoma. Curr Med Res Opin. 2007;23(5):1025–1032.
    1. Martinez A, Sanchez M. Bimatoprost/timolol fixed combination vs latanoprost/timolol fixed combination in open-angle glaucoma patients. Eye. 2009;23(4):810–818.
    1. Jothi R, Ismail AM, Senthamarai R, Pal S. A comparative study on the efficacy, safety, and cost-effectiveness of bimatoprost/timolol and dorzolamide/timolol combinations in glaucoma patients. Indian J Pharmacol. 2010;42(6):362–365.
    1. Cheng JW, Cheng SW, Gao LD, Lu GC, Wei RL. Intraocular pressure-lowering effects of commonly used fixed-combination drugs with timolol: a systematic review and meta-analysis. PLoS One. 2012;7(9):e45079.
    1. Yavaş GF, Küsbeci T, Polat O, Karadaş M, Ermiş SS, İnan UU. Comparison of latanoprost, brimonidine tartrate, and bimatoprost plus timolol maleate in fixed combinations. Turk J Med Sci. 2013;43(2):321–325.
    1. Paranhos A, Mendonça M, Silva MJ, et al. Hyperemia reduction after administration of a fixed combination of bimatoprost and timolol maleate to patients on prostaglandin or prostamide monotherapy. J Ocul Pharmacol Ther. 2010;26(6):611–615.
    1. European Medicined Agency [webpage on the Internet] Ganfort Authorisation Details. [Accessed March 1, 2017]. Available from: .
    1. Michelessi M, Lindsley K, Yu T, Li T. Combination medical treatment for primary open angle glaucoma and ocular hypertension: a network meta-analysis. Cochrane Database Syst Rev. 2014;2014(11):CD011366.
    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(4):661–671.e.
    1. Rossetti L, Gandolfi S, Traverso C, et al. An evaluation of the rate of non-responders to latanoprost therapy. J Glaucoma. 2006;15(3):238–243.
    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(11):1370–1373.
    1. DuBiner H, Cooke D, Dirks M, Stewart WC, VanDenburgh AM, Felix C. Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost. Surv Ophthalmol. 2001;45(suppl 4):S353–S360.
    1. Gandolfi S, Simmons ST, Sturm R, Chen K, VanDenburgh AM, Bimatoprost Study Group 3 Three-month comparison of bimatoprost and latanoprost in patients with glaucoma and ocular hypertension. Adv Ther. 2001;18(3):110–121.
    1. Noecker RS, Dirks MS, Choplin NT, et al. 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(1):55–63.
    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(5):688–703.
    1. Walters TR, DuBiner HB, Carpenter SP, Khan B, VanDenburgh AM, Bimatoprost Circadian IOP Study Group 24-Hour IOP control with once-daily bimatoprost, timolol gel-forming solution, or latanoprost: a 1-month, randomized, comparative clinical trial. Surv Ophthalmol. 2004;49(suppl 1):S26–S35.
    1. Kurtz S, Mann O. Incidence of hyperemia associated with bimatoprost treatment in naïve subjects and in subjects previously treated with latanoprost. Eur J Ophthalmol. 2009;19(3):400–403.
    1. Day DG, Schacknow PN, Wand M, et al. Timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily to patients with primary open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2003;135(2):138–143.
    1. Kim TW, Kim M, Lee EJ, Jeoung JW, Park KH. Intraocular pressure-lowering efficacy of dorzolamide/timolol fixed combination in normal-tension glaucoma. J Glaucoma. 2014;23(5):329–332.
    1. Parmaksiz S, Yüksel N, Karabas VL, Ozkan B, Demirci G, Caglar Y. A comparison of travoprost, latanoprost, and the fixed combination of dorzolamide and timolol in patients with pseudoexfoliation glaucoma. Eur J Ophthalmol. 2006;16(1):73–80.
    1. Ling Z, Zhang M, Hu Y, et al. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J. 2014;127(5):905–910.
    1. Brief G, Lammich T, Nagel E, Pfennigsdorf S, Spraul CW, Ho S. Fixed combination of bimatoprost and timolol in patients with primary open-angle glaucoma or ocular hypertension with inadequate IOP adjustment. Clin Ophthalmol. 2010;4:1125–1129.
    1. Leske MC, Heijl A, Hussein M, et al. Early Manifest Glaucoma Trial Group Factors for glaucoma progression and the effect of treatment: the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2003;121(1):48–56.
    1. Chauhan BC, Mikelberg FS, Balaszi AG, et al. Canadian Glaucoma Study Group Canadian Glaucoma Study: 2. risk factors for the progression of open-angle glaucoma. Arch Ophthalmol. 2008;126(8):1030–1036.
    1. Kim KE, Jeoung JW, Kim DM, Ahn SJ, Park KH, Kim SH. Long-term follow-up in preperimetric open-angle glaucoma: progression rates and associated factors. Am J Ophthalmol. 2015;159(1):160–168.
    1. Cumurcu T, Kilic R, Yologlu S. The frequency of pseudoexfoliation syndrome in the middle Black Sea region of Turkey. Eur J Ophthalmol. 2010;20(6):1007–1011.
    1. Kiliç R, Sezer H, Comcali SÜ, et al. The frequency of exfoliation syndrome in the Central Anatolia region of Turkey. J Ophthalmol. 2014;2014:139826.
    1. Yalaz M, Othman I, Nas K, et al. The frequency of pseudoexfoliation syndrome in the eastern Mediterranean area of Turkey. Acta Ophthalmol (Copenh) 1992;70(2):209–213.
    1. Tastan S, Iyigun E, Bayer A, Acikel C. Anxiety, depression, and quality of life in Turkish patients with glaucoma. Psychol Rep. 2010;106(2):343–357.
    1. Wang SY, Singh K, Lin SC. Prevalence and predictors of depression among participants with glaucoma in a nationally representative population sample. Am J Ophthalmol. 2012;154(3):436–444.
    1. Yochim BP, Mueller AE, Kane KD, Kahook MY. Prevalence of cognitive impairment, depression, and anxiety symptoms among older adults with glaucoma. J Glaucoma. 2012;21(4):250–254.
    1. Agorastos A, Skevas C, Matthaei M, et al. Depression, anxiety, and disturbed sleep in glaucoma. J Neuropsychiatry Clin Neurosci. 2013;25(3):205–213.
    1. Mabuchi F, Yoshimura K, Kashiwagi K, et al. High prevalence of anxiety and depression in patients with primary open-angle glaucoma. J Glaucoma. 2008;17(7):552–557.
    1. Zhou C, Qian S, Wu P, Qiu C. Anxiety and depression in Chinese patients with glaucoma: sociodemographic, clinical, and self-reported correlates. J Psychosom Res. 2013;75(1):75–82.
    1. McCambridge J, Witton J, Elbourne DR. Systematic review of the Hawthorne effect: new concepts are needed to study research participation effects. J Clin Epidemiol. 2014;67(3):267–277.
    1. Hommer A, Mohammed Ramez O, Burchert M, Kimmich F. IOP-lowering efficacy and tolerability of preservative-free tafluprost 0.0015% among patients with ocular hypertension or glaucoma. Curr Med Res Opin. 2010;26(8):1905–1913.
    1. Crichton AC, Nixon DR, Simonyi S, et al. An observational study of bimatoprost 0.01% in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan((R)) RC Early Analysis Review (CLEAR) trial. Clin Ophthalmol. 2014;8:1031–1038.
    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(5):325–334.
    1. Chen YY, Wang TH, Liu C, et al. 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. BMC Ophthalmol. 2016;16(1):162.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa