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EFFICACY
Acta Ophthalmologica 2010
Table 2. Baseline demographic and clinical patient characteristics. Data are expressed by did not differ between the treatment
patient as mean (standard deviation). groups.
Dorzolamide–timolol Brinzolamide–timolol
Number group (n = 70) group (n = 76) p-value Intraocular pressure
Sex* Baseline IOPs in the DT and BT
Male 37 (52.8%) 41 (53.9%) 0.974 groups are shown in Table 3. Mean
Female 33 (47.2%) 35 (46.1%) 0.974
Age, years baseline IOPs, at 22.7 mmHg (SD
Mean (SD) 64.0 (8.2) 63.7 (7.4) 0.821 1.2 mmHg) in the DT group and
95% CI 62.1–66.0 62.1–65.4 22.8 mmHg (SD 1.2 mmHg) in the
Min 50 51 BT group, did not differ significantly
Max 70 76 (p = 0.529).
SBP, mmHg The mean percentage IOP reduction
Mean (SD) 131.7 (6.8) 130.0 (6.9) 0.134 from baseline in observed cases at
95% CI 130.1–133.3 128.4–131.6 5 years was 20.3% (p < 0.0001) in the
Min 120 120 DT group and 21.0% (p < 0.0001) in
Max 140 140
DBP, mmHg the BT group.
Mean (SD) 68.5 (7.8) 68.6 (6.6) 0.965 At the end of the study, the differ-
95% CI 66.6–70.4 67.0–70.1 ence between groups in mean IOP
Min 55 55 reduction was not statistically signifi-
Max 85 80 cant (p = 0.159). Mean IOP at the
MAP, mmHg end of the study was < 18 mmHg in
Mean (SD) 89.6 (6.8) 89.0 (6.2) 0.619 42% (42 ⁄ 99) of eyes in the DT group
95% CI 87.9–91.2 87.6–90.4
Min 78.3 77.6 and 47% (54⁄ 116) of eyes in the BT
Max 100.0 100.0 group (p = 0.583).
Systemic medications*
High blood pressure 12 (17.1%) 16 (21.1%) 0.675
Cardiovascular disease 3 (4.3%) 5 (6.6%) 0.721 Retrobulbar blood flow
Arthrosis 9 (12.9%) 5 (6.6%) 0.263 In the last observation carried for-
ward for analysis, DT was associated
SD = standard deviation; 95% CI = 95% confidence interval; SBP = systolic blood pressure;
DBP = diastolic blood pressure; MAP = mean arterial pressure. with a significant increase from base-
P-values were calculated comparing the parameters at baseline between the two study groups line in mean EDV values, from
(one-way anova test); p-values were considered statistically significant at < 0.05. 8.8 cm⁄ s (SD 1.0 cm⁄ s) to 10.3 cm⁄ s
* Fisher’s exact test; p-values were considered statistically significant at < 0.05. (SD 1.3 cm ⁄s) (p < 0.0001) in the
MAP = DBP + 1 ⁄ 3 (SBP–DBP). OA, from 4.2 cm ⁄ s (SD 0.7 cm ⁄ s) to
4.8 cm⁄ s (SD 0.8 cm⁄ s) (p < 0.0001)
in the CRA, and from 4.5 cm⁄ s (SD
groups, respectively); five as a result Baseline mean VA scores were simi- 0.7 cm⁄ s) to 5.3 cm⁄ s (SD 0.6 cm⁄ s)
of allergic reactions (three in the DT lar in the treatment groups, at 0.16 (p < 0.0001) in the SPCA.
and two in the BT groups); two as a (SD 0.18) in the DT group and 0.14 However, BT had no effect on EDV,
result of treatment with argon laser (SD 0.10) in the BT group for which baseline and last observation
trabeculoplasty (in another centre); (p = 0.302). No significant changes in mean values were, respectively,
one to death (DT group), and one to VA occurred during treatment in any 9.0 cm⁄ s (SD 0.9 cm⁄ s) and 8.9 cm⁄ s
poor compliance. A total of 146 of group. (SD 1.0 cm⁄ s) (p = 0.424) in the OA,
the 161 selected patients made at least Systemic blood pressure showed no 4.2 cm⁄ s (SD 0.7 cm⁄ s) and 4.3 cm⁄ s
one valid visit at month 12. (Principal significant changes during treatment (SD 0.8 cm⁄ s) (p = 0.312) in the
baseline characteristics are shown in in any group. Ocular perfusion pres- CRA, and 4.6 cm ⁄ s (SD 0.6 cm⁄ s) and
Tables 2 and 3, respectively.) sure significantly increased from 4.5 cm⁄ s (SD 0.6 cm⁄ s) (p = 0.206) in
The DT group included 99 eyes (70 36.3 mmHg (4.6 mmHg) to 40.6 the SPCA.
patients) and the BT group included mmHg (3.8 mmHg) (p < 0.0001) in At the end of the study, EDV val-
116 eyes (76 patients). The median the DT group, and from 35.9 mmHg ues in all retrobulbar vessels were sig-
(5th, 95th percentiles) and mean (4.2 mmHg) to 40.8 mmHg (4.1 nificantly lower in the BT group than
lengths of follow-up amounted to 5.0 mmHg) (p < 0.0001) in the BT in the DT group (two-way anova;
(1.5, 7.0) years and 4.6 years (SD group. p < 0.001, respectively).
1.6 years), with 176 of 215 eyes (82%) At baseline, 10 of 12 and 13 of 16 In addition, DT was associated with
completing ‡ 3 years and 137 eyes patients with systemic hypertension a significant reduction in mean RI in
(64%) completing ‡ 5 years of follow- were taking calcium channel blockers all retrobulbar vessels, from 0.74 (SD
up. in the DT and BT groups, respectively. 0.02) to 0.70 (SD 0.03) (p < 0.0001)
There were no significant differences Few changes were made in general in the OA, from 0.66 (SD 0.03) to
between the groups in age, sex or medication profiles involving calcium 0.62 (SD 0.03) (p < 0.0001) in the
blood pressure (systolic, diastolic or channel blockers, non-steroidal anti- CRA, and from 0.66 (SD 0.03) to
MAP). inflammatory drugs or diuretics; this 0.62 (SD 0.02) (p < 0.0001) in the
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