The clinical effectiveness of tafluprost on Japanese normal-tension glaucoma patients

Figures & data

Figure 1 Patient flow diagram.

Abbreviations: IOP, intraocular pressure; MD, mean deviation.

Table 1 Patient demographics

Demographic	Safety analysis set	Visual field analysis set
Total number of patients analyzed	1,353	416
Sex
Male	594 (43.9%)	186 (44.7%)
Female	759 (56.1%)	230 (55.3%)
Age, years
Mean ± SD	65.2±12.6	63.1±12.1
Min–Max	24–91	28–88
MD at baseline
Mean ± SD	−5.2±3.8 dB	−5.3±4.0 dB
>−6 dB	864 (63.9%)	269 (64.7%)
−6 to −12 dB	404 (29.9%)	117 (28.2%)
<−12 dB	85 (6.3%)	30 (7.2%)
IOP at baseline, mmHg
Mean ± SD	15.0±3.1 mmHg	14.6±2.8 mmHg
≤15	777 (57.5%)	261 (62.9%)
>15	575 (42.5%)	154 (37.1%)
Unknown	0	1
Spherical equivalent, D
Mean ± SD	−2.1±3.4 D	−2.5±3.5 D
≤−6.0	174 (14.5%)	63 (17.5%)
>−6.0	1,023 (85.5%)	296 (82.5%)
Unknown	156	57
Concomitant ophthalmic disease (multiple entries)
None	491 (36.3%)	171 (41.1%)
Vitreoretinal disease	62 (4.6%)	9 (2.2%)
Cataract and lens disease	737 (54.5%)	197 (47.4%)
Keratoconjunctival disease	301 (22.2%)	94 (22.6%)
Eyelid and lacrimal disease	16 (1.2%)	4 (1.0%)
Others	38 (2.8%)	11 (2.6%)
Concomitant systemic disease (multiple entries)
None	818 (60.5%)	286 (68.8%)
Hypertension	299 (22.1%)	74 (17.8%)
Diabetes mellitus	131 (9.7%)	26 (6.3%)
Migraine	3 (0.2%)	1 (0.2%)
Others	251 (18.6%)	52 (12.5%)
Family history of glaucoma within second-degree relatives
Yes	74 (10.3%)	26 (10.0%)
No	647 (89.7%)	235 (90.0%)
Unknown	632	155
Optic disc hemorrhage, including past history
Yes	54 (4.0%)	16 (3.8%)
No	1,296 (96.0%)	400 (96.2%)
Unknown	3	0

Abbreviations: IOP, intraocular pressure; MD, mean deviation.

Table 2 MD slopes in differential analysis with treatment patterns in visual field analysis set

	MD at baseline (dB)	n	MD slope (dB/year)		ANOVA (P-value)
			Mean ± SD	95% CI
Total	−5.3±4.0	416	−0.09±0.85	−0.17 to −0.01	–
Monotherapy	−4.9±3.8	323	−0.03±0.78	−0.11 to 0.06	0.004a
Naïve	−4.8±3.8	263	−0.02±0.80	−0.12 to 0.08	0.015b
Switching	−5.3±3.5	60	−0.07±0.68	−0.24 to 0.11
Concomitant therapy	−6.8±4.2	93	−0.32±1.04	−0.53 to −0.10

Notes:

a Monotherapy vs concomitant therapy;

b naïve monotherapy vs switching monotherapy vs concomitant therapy.

Abbreviations: ANOVA, analysis of variance; MD, mean deviation.

Figure 2 Patients continuing tafluprost treatment in 1,353 patients over the observational period of 2–3 years by Kaplan–Meier curve.

Notes: A discontinuation of tafluprost treatment due to insufficient efficacy and safety reason is defined as an event.

Figure 3 IOP in each analysis group.

Notes: IOP changes in all patients and each treatment pattern. IOPs were aggregated every 3 months from 0 to 36 months. Error bars indicate SD. *P<0.05 compared to IOP month 0 (paired t-test) in all treatment patterns.
Abbreviations: IOP, intraocular pressure; VF, visual field.

Table 3 MD slopes in differential analyses in visual field analysis set

	N	MD slope (dB/year)		ANOVA (P-value)
		Mean ± SD	95% CI
Total	416	−0.09±0.85	−0.17 to −0.01	–
Sex
Male	186	−0.06±0.84	−0.19 to 0.06	0.548
Female	230	−0.12±0.87	−0.23 to −0.00
Age, years
<65	218	−0.05±0.76	−0.16 to 0.05	0.348
≥65	198	−0.13±0.94	−0.27 to −0.00
MD at baseline
>−6 dB	269	−0.13±0.70	−0.21 to −0.04	0.014
−6 to −12 dB	117	0.07±1.08	−0.13 to 0.27
<−12 dB	30	−0.40±1.00	−0.77 to −0.02
IOP at baseline (unknown: 1 patient), mmHg
≤15	261	−0.11±0.83	−0.21 to −0.01	0.446
>15	154	−0.04±0.88	−0.18 to 0.09
IOP reduction (not applicable: 15 patients), %
≥20	88	−0.04±0.88	−0.22 to 0.15	0.085
≥10, <20	112	−0.00±0.78	−0.15 to 0.14
≥0, <10	108	−0.06±0.87	−0.22 to 0.11
<0	93	−0.29±0.87	−0.47 to −0.11
Spherical equivalent (unknown: 57 patients), D
≤−6.0	63	−0.12±0.80	−0.33 to 0.08	0.685
>−6.0	296	−0.08±0.84	−0.17 to 0.02
Concomitant ophthalmic disease
No	171	−0.11±0.69	−0.21 to −0.00	0.753
Yes	245	−0.08±0.95	−0.20 to 0.04
Vitreoretinal disease
No	407	−0.10±0.84	−0.19 to −0.02	0.054
Yes	9	0.45±1.24	−0.50 to 1.40
Cataract and lens disease
No	219	−0.08±0.71	−0.18 to 0.01	0.829
Yes	197	−0.10±0.99	−0.24 to 0.04
Keratoconjunctival disease
No	322	−0.11±0.86	−0.21 to −0.02	0.405
Yes	94	−0.03±0.84	−0.20 to 0.14
Eyelid and lacrimal disease
No	412	−0.09±0.86	−0.18 to −0.01	0.573
Yes	4	0.15±0.41	−0.51 to 0.80
Concomitant systemic disease
No	286	−0.11±0.84	−0.20 to −0.01	0.599
Yes	130	−0.06±0.89	−0.21 to 0.10
Hypertension
No	342	−0.09±0.82	−0.18 to −0.00	0.989
Yes	74	−0.09±1.00	−0.33 to 0.14
Diabetes mellitus
No	390	−0.10±0.85	−0.18 to −0.01	0.505
Yes	26	0.02±0.84	−0.33 to 0.36
Migraine
No	415	−0.09±0.85	−0.17 to −0.01	0.677
Yes	1	−0.45	–
Family history of glaucoma within second degree relatives (unknown: 155 patients)
No	235	−0.15±0.79	−0.25 to −0.04	0.206
Yes	26	0.14±0.79	−0.18 to 0.46
Optic disc hemorrhage, including past history
No	400	−0.09±0.85	−0.18 to −0.01	0.818
Yes	16	−0.04±0.85	−0.50 to 0.41
Optic disc hemorrhage (newly observed)
No	387	−0.10±0.86	−0.18 to −0.01	0.697
Yes	29	−0.03±0.84	−0.35 to 0.29

Abbreviations: ANOVA, analysis of variance; IOP, intraocular pressure; MD, mean deviation.

Table 4 MD slopes in naïve monotherapy patients of the visual field analysis set

	n	MD slope (dB/year)		ANOVA (P-value)
		Mean ± SD	95% CI
Total	263	−0.02±0.80	−0.12 to 0.08	–
Sex
Male	117	−0.01±0.74	−0.14 to 0.13	0.825
Female	146	−0.03±0.85	−0.17 to 0.11
Age, years
<65	135	−0.02±0.65	−0.13 to 0.09	0.962
≥65	128	−0.02±0.94	−0.19 to 0.14
MD at baseline, dB
>−6	183	−0.07±0.65	−0.16 to 0.03	<0.001
−6 to −12	63	0.26±1.00	0.01 to 0.51
<−12	17	−0.52±1.14	−1.11 to 0.07
IOP at baseline, mmHg
≤15	148	−0.10±0.82	−0.24 to 0.03	0.049
>15	115	0.09±0.77	−0.05 to 0.23
Spherical equivalent (unknown: 19 patients), D
≤−6.0	42	0.07±0.76	−0.17 to 0.30	0.536
>−6.0	202	−0.02±0.79	−0.13 to 0.09
Concomitant ophthalmic disease
No	114	−0.04±0.63	−0.16 to 0.07	0.646
Yes	149	0.00±0.91	−0.15 to 0.15
Vitreoretinal disease
No	257	−0.03±0.78	−0.13 to 0.06	0.037
Yes	6	0.66±1.37	−0.78 to 2.10
Cataract and lens disease
No	150	−0.02±0.67	−0.13 to 0.09	0.964
Yes	113	−0.02±0.95	−0.20 to 0.16
Keratoconjunctival disease
No	210	−0.02±0.82	−0.13 to 0.10	0.891
Yes	53	−0.03±0.72	−0.23 to 0.17
Eyelid and lacrimal disease
No	260	−0.02±0.81	−0.12 to 0.08	0.629
Yes	3	0.20±0.48	−1.00 to 1.41
Concomitant systemic disease
No	185	−0.06±0.77	−0.17 to 0.05	0.242
Yes	78	0.07±0.88	−0.13 to 0.27
Hypertension
No	217	−0.05±0.77	−0.15 to 0.06	0.225
Yes	46	0.11±0.93	−0.16 to 0.39
Diabetes mellitus
No	250	−0.04±0.81	−0.14 to 0.06	0.125
Yes	13	0.31±0.51	0.01 to 0.62
Migraine
No	262	−0.02±0.80	−0.11 to 0.08	0.593
Yes	1	−0.45	–
Family history of glaucoma within second degree relatives (unknown: 90 patients)
No	155	−0.08±0.77	−0.20 to 0.04	0.229
Yes	18	0.21±0.92	−0.25 to 0.66
Optic disc hemorrhage, including past history
No	252	−0.03±0.80	−0.13 to 0.07	0.521
Yes	11	0.13±0.80	−0.41 to 0.67
Optic disc hemorrhage (newly observed)
No	250	−0.02±0.81	−0.12 to 0.08	0.661
Yes	13	0.08±0.73	−0.37 to 0.52

Abbreviations: ANOVA, analysis of variance; IOP, intraocular pressure; MD, mean deviation.

Table 5 MD slopes in differential analysis with % IOP reduction in naïve-monotherapy patients of the visual field analysis set

	n	MD slope (dB/year)		ANOVA (P-value)
		Mean ± SD	95% CI
Total	263	−0.02±0.80	−0.12 to 0.08	–
IOP reduction, %
Four categories in units of 10%
≥20	75	0.05±0.79	−0.13 to 0.23	0.001
≥10 to <20	74	0.18±0.67	0.03 to 0.34
≥0 to <10	67	−0.11±0.78	−0.30 to 0.08
<0	35	−0.45±1.00	−0.79 to 0.11
Two categories, %
≥10	149	0.11±0.73	−0.00 to 0.23	0.001
<10	102	−0.22±0.87	−0.39 to 0.05

Note: IOP reduction could not be calculated in 12 patients.

Abbreviations: ANOVA, analysis of variance; IOP, intraocular pressure; MD, mean deviation.