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Evidence Table 7Prostaglandin analogues vs. sympathomimetics

Study detailsPatientsInterventionsOutcome measuresEffect sizeComments
Camras et al., 200518

Study design:
RCT
Single masked

Evidence level: 1+

Duration of follow-up: 6 months
Patient group: POAG and OHT patients

Setting: Multi-centre 23 centres in the USA

Inclusion criteria: Exclusion criteria: All patients
N: 303
Mean IOP:
Drop outs: 57 (19%)

Group 1 (reported as ITT group)
N: 151
Age (mean ± SEM): 62 ± 1.0
M/F: 70/81
Race:
Caucasian 104
African American 36
Other 11
Mean IOP ± SEM: 24.6 ± 0.3
Drop outs: 21 (14% including 4 adverse events, 8 IOP not controlled, 2 lost to follow-up and 2 protocol violations)

Group 2 (reported as ITT group)
N: 150
Age (mean ± SEM): 64 ± 1.0
M/F: 77/73
Race:
Caucasian 103
African American 39
Other 8
Mean IOP ± SEM: 24.8 ± 0.2
Drop outs: 36 (24% including 23 adverse events, 10 IOP not controlled, 2 lost to follow up, 1 protocol violation).
Group 1
Latanoprost 0.005% once daily (8 am) for 6 months

Group 2
Brimonidine 0.2% twice daily 8 am and 8 pm) for 6 months

All
Washout period completed as appropriate
6 visits:
Screening
Baseline
Week 2
3 months
6 months
Follow up

Goldmann applanation tonometer to record IOP reading (8am, 10 am, 12 pm and 4 pm except week 2 visit only 8 am)
Mean diurnal (8 am, noon and 4 pm) IOP at 6 months (mm Hg)Group 1: 18.8 ± 0.3 (± SEM)
Group 2: 21.5 ± 0.3 (± SEM)
p value: p < 0.001 (significantly lower than corresponding baseline values)
Funding:
Supported in part by Pharmacia corporation, a Pfizer company (New York) which manufactures latanoprost and an unrestricted grant from (University of Nebraska Medical Centre) from Research to Prevent Blindness Inc. (New York).

Limitations:
  • Open label
  • Use of adjusted and unadjusted means very confusing.
  • High drop out rate >20% in Brimonidine group
Additional outcomes:
Percentage of patients achieving pre-specified IOP levels (e.g. ≥ 40%, ≥ 30%, ≥ 10% etc.) after 6 months of treatment

Notes:
Randomisation using computer generated allocation. Masked outcome assessment.

Originally 303 patients (152/151) but 2 excluded and not considered in the ITT analysis (terminated after baseline and before instillation of treatment.
Differences in mean diurnal change in IOP between groups: baseline to 6 monthsMean: 2.5 ± 0.3 (± SEM)
95% CI: 1.9–3.2
p value: p < 0.001 in favour of group 1 (latanoprost)
Adjusted mean diurnal change in IOP from baseline to 6 monthsGroup 1: 5.7 ± 0.3 (± SEM)
Group 2: 3.1 ± 0.3 (± SEM)
p value: p < 0.001
Differences in mean diurnal change in IOP between groups: baseline to 6 months (Post hoc analyses including 10 am reading).Group 1: 5.5 ± 0.3 (± SEM)
Group 2 : 3.6 ± 0.3 (± SEM)
Difference in mean: 2.0 ± 0.4
95% CI: 1.3–2.6
p value: p < 0.001 in favour of group 1 (latanoprost)
Mean % reduction on diurnal IOP at month 6Group 1: 22.6%
Group 2: 12.8%
95% CI: NR
p value: p < 0.001
Adverse events resulting in withdrawal from studyAny adverse event
Group 1: 4/151 (3%)
Group 2: 23/152 (15%)
p value: p < 0.001 (Fisher’s exact test)

External ocular
Group 1: 2/151 (1%)
Group 2: 15/152 (10%)
p value: p = 0.06 (Fisher’s exact test)

Central nervous system
Group 1: 0
Group 2: 5/152 (3%)
p value: p < 0.001 (Fisher’s exact test)

Dry mouth:
Group 1: 0
Group 2: 1/152 (1%)

Other (including palpitations, reduced visual acuity, blurred vision, increased lacrimation, diplopia)
Group 1: 2/151 (2%)
Group 2: 2/152 (1%)
Kampik et al., 200270

European latanoprost study group

Study design:
RCT
Single masked

Evidence level: 1+

Duration of follow-up: 6 months
Patient group: POAG and OHT patients

Setting: Multi-centre- 30 eye clinics in Germany, UK, Spain and Finland

Inclusion criteria: Exclusion criteria: All patients
N: 379
Age (mean):
M/F: 154/225
Mean IOP: NR
Drop outs: 52 (13.3%)

Group 1
N: 187
Age (mean): 64 ± 11
M/F: 77/110
Mean IOP: 25.1 ± 3.7
This group had significantly (p=0.027) more OHT patients than group 2.
Drop outs: 5 (including IOP not controlled, ocular irritation, Argon laser trabeculoplasty and corneal oedema)

Group 2
N: 192
Age (mean ): 65 ± 12
M/F: 77/115
Mean IOP: 24.9 ± 3.0
Drop outs: 47 (including 4 before instillation of treatment. Other reasons for withdrawing included 14 ocular allergic reactions, 13 IOP not controlled, withdrawal of consent and Argon laser trabeculoplasty).
Group 1
Latanoprost 0.005% once daily (10 pm) for 6 months

Group 2
Brimonidine 0.2% twice daily (8 am and 10 pm) for 6 months.

All
At least 4 weeks washout period 4 visits during 6 month study:
Baseline
2 weeks
3 months
6 months

3 IOP measurements in each eye using Goldmann applanation tonometer taken at:
-

10 am and 5 pm at baseline, 3 months and 6 months

-

Only before 12 noon at 2 weeks The mean of the 3 measurements was taken and if both eyes were study eyes the mean of the 2 eyes was used.

Mean ± SD diurnal IOP at baseline (mm Hg)Group 1: 25.1 ± 3.7
Group 2: 24.9 ± 3.0
Funding:
Supported by a research grant from Pharmacia Corporation (Peapack, NJ) manufacturers of latanoprost

Limitations: Additional outcomes:
Percentage of patients achieving prespecified IOP levels (e.g. ≤21, ≤20, ≤15 etc.) after 6 months of treatment

Notes:
Masked outcome assessment. Statistical analysis does not include the 4 patients randomised to receive brimonidine who withdrew consent.

*includes respiratory, dry mouth, headaches, fatigue and infection

**includes ocular irritation, ocular allergic reaction, increased iris pigmentation, disturbed vision and conjunctival disorders
Mean ± SD diurnal IOP at 6 months (mm Hg)Group 1: 18.0 ± 2.9
Group 2: 19.8 ± 3.1
Mean ± SD diurnal change in IOP from baseline at 6 months (mm Hg)Group 1: 7.1 ± 3.3 p value: p < 0.001 (ANCOVA)
Group 2: 5.2 ± 3.5 p value: p < 0.001 (ANCOVA)
% reduction in mean IOP from baselineGroup 1: 28%
Group 2: 21%
p value: p < 0.001 (ANCOVA) favouring latanoprost
Mean ± SD IOP at 10 am and 5 pm at 6 months (mm Hg)IOP 10 am:
Group 1: 18.1 ± 2.9
Group 2: 19.5 ± 3.2
p < 0.001 (ANCOVA) in favour of latanoprost

IOP 5 pm:
Group 1 : 17.8 ± 3.0
Group 2: 19.8 ± 3.4
p value: p < 0.001 (ANCOVA) in favour of latanoprost
Number of patients with systemic adverse events*Group 1: 23 (including 4 respiratory)
Group 2: 56 (including 4 respiratory, 1 serious)
p value: p < 0.005 Fisher exact test (this is for all systemic side effects as defined in the paper).
95% CI: NR
Number of patients with ocular adverse events**Group 1: 62
Group 2: 95
p value: NS except for significantly more ocular allergic reactions (p < 0.001 Fisher exact test) in the brimonidine group.
95% CI: NR

Abbreviations: NR=not reported, M/F=male/female, NA=not applicable, N=total number of patients randomised, SD=Standard Deviation, CI95%= 95% Confidence Interval, ITT=Intention to Treat

From: Appendix D, Evidence tables

Cover of Glaucoma
Glaucoma: Diagnosis and Management of Chronic Open Angle Glaucoma and Ocular Hypertension.
NICE Clinical Guidelines, No. 85.
National Collaborating Centre for Acute Care (UK).
Copyright © 2009, National Collaborating Centre for Acute Care.

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