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

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Source: PubMed

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