Stratification-Based Investigation of Adjunctive Brimonidine or Timolol to a Prostaglandin Analogue in Japanese Patients with Normal-Tension Glaucoma

Figures & data

Figure 1 Distribution of IOP change after 12 weeks from baseline. The distributions of IOP changes with each eye drop added to PGA monotherapy after administration for 12 weeks were investigated and analyzed using the two-sided F-test.

Abbreviations: IOP, intraocular pressure; PGA, prostaglandin analogue.

Table 1 Effects of Patient Background Factors on IOP Decrease

Explanatory Variables	Estimate	SE	T value	P value
Eye drop (Brim)	0.110	0.110	1.00	0.3189
Sex (female)	0.003	0.109	0.03	0.9776
Age	−0.003	0.011	−0.33	0.7408
Baseline IOP	−0.271	0.080	−3.38	0.0010*

Note: *P < 0.01.

Abbreviations: IOP, intraocular pressure; SE, standard error.

Figure 2 IOP-lowering effects of Brim and Tim stratified by baseline IOP on PGA. For IOP < 12 mmHg, n = 9 for Brim and 6 for Tim; for IOP ≤ 12 and <14 mmHg, n = 28 for Brim and 26 for Tim; and for IOP ≤14 and ≤ 16 mmHg, n = 24 for Brim and 35 for Tim. *P < 0.05, **P < 0.01, vs baseline IOP. Error bars represent standard deviation.

Abbreviations: IOP, intraocular pressure; PGA, prostaglandin analogue.

Figure 3 Pulse rates stratified by age. **P < 0.001. The values inside the bars and the values in the parentheses indicate the mean value and the number of cases, respectively. Error bars represent standard error.

Figure 4 Blood pressures stratified by age. *P < 0.05, **P < 0.01. The values inside the bars indicate the mean value. Error bars represent standard error.

Table 2 Effects of Patient Background Factors on PR

Explanatory Variables	Estimate	SE	T value	P value
Eye drop (Brim)	2.626	0.486	5.40	< 0.0001*
Sex (female)	−0.217	0.484	−0.45	0.6546
Age	−0.089	0.047	−1.91	0.0587
Baseline PR	−0.255	0.051	−5.00	< 0.0001*

Note: *P < 0.0001.

Abbreviations: SE, standard error; PR, pulse rate.

Table 3 Effects of Patient Background Factors on BP (A and B)

Explanatory Variables	Estimate	SE	T value	P value
A: SBP
Eye drop (Brim)	0.017	0.926	0.02	0.9850
Sex (female)	1.183	0.921	1.28	0.2014
Age	−0.012	0.089	−0.14	0.8925
Baseline SBP	−0.013	0.097	−0.14	0.8910
B: DBP
Eye drop (Brim)	0.832	0.682	1.22	0.2252
Sex (female)	0.764	0.679	1.12	0.2631
Age	−0.053	0.065	−0.80	0.4235
Baseline DBP	−0.083	0.072	−1.15	0.2515

Abbreviations: SE, standard error; BP, blood pressure; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Table 4 Non-Inferiority Analysis of Brim to Tim After Stratification by Baseline IOP on PGA Monotherapy

		Brim				Tim				Difference Between Two Groups (Mean [95% CI])	Non-Inferiority
		n	IOP (mmHg)	Change in IOP (mmHg)	P value	n	IOP (mmHg)	Change in IOP (mmHg)	P value
Post-hoc analysis
Baseline IOP < 12 mmHg	Baseline	9	11.0 ± 0.8	−0.08 ± 0.88	0.7967	6	11.2 ± 0.2	−0.90 ± 1.43	0.1839	0.82 [−0.46–2.10]	No
	Overall		10.9 ± 1.0				10.3 ± 1.5
12 ≤ baseline IOP ≤ 16 mmHg	Baseline	52	13.9 ± 1.0	−1.24 ± 1.47	< 0.0001*	61	14.0 ± 1.1	−1.42 ± 1.06	< 0.0001*	0.18 [−0.29–0.65]	Yes
	Overall		12.6 ± 1.6				12.6 ± 1.4
Previous study^Citation7
	Baseline	61	13.4 ± 1.4			67	13.8 ± 1.3
	12 weeks		12.4 ± 2.0	−1.05 ± 1.81	< 0.0001*		12.3 ± 1.7	−1.41 ± 1.40	< 0.0001*	0.36 [−0.21–0.92]	No

Notes: IOP and change in IOP represent mean ± standard deviation, *P < 0.0001

Abbreviations: CI, confidence interval; IOP, intraocular pressure; PGA, prostaglandin analogue.

Mizoue S, Nitta K, Shirakashi M, et al. Multicenter, randomized, investigator-masked study comparing brimonidine tartrate 0.1% and timolol maleate 0.5% as adjunctive therapies to prostaglandin analogues in normal-tension glaucoma. Adv Ther. 2017;34(6):1438–1448. doi:10.1007/s12325-017-0552-5

 Web of Science ®Google Scholar