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Latanoprost Administered Once Daily Caused a Maintained Reduction Ofintraocularpressure in Glaucoma Patients Treated Concomitantly with Timolol 13

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Latanoprost Administered Once Daily Caused a Maintained Reduction Ofintraocularpressure in Glaucoma Patients Treated Concomitantly with Timolol 13 12 Britishj7ournalofOphthalmology 1995; 79: 12-16 Latanoprost administered once daily caused a maintained reduction ofintraocular pressure in Br J Ophthalmol: first published as 10.1136/bjo.79.1.12 on 1 January 1995. Downloaded from glaucoma patients treated concomitantly with timolol Albert Alm, Ingmar Widengard, Daniel Kjellgren, Mats Soderstrom, Bjorn Fristrom, Anders Heijl, Johan Stjerschantz Abstract In a first dose finding study with twice daily The long term effects of two dose regimens of administrations of latanoprost, ocular hyperten- latanoprost (PhXA41) administered to eyes sive eyes were treated for 4 weeks.5 There was no concomitantly treated with timolol which had significant difference between the three concen- not adequately been controlied by timolol trations of latanoprost eye drops used; 0 0035%, alone were compared. A total of50 patients, 17 0 006%, and 0-0115%, and all were significantly with primary open angle glaucoma and 33 with better than placebo. The initial response, on the capsular glaucoma, were recruited from five second day of treatment, was good with a 31- clinics. All had glaucomatous visual field 38% reduction of the IOP, but after 1 week of defects and an intraocular pressure (IOP) of at treatment there was some diminution of effect least 22 mm Hg despite treatment with 0*5% and after 4 weeks the IOP reduction was between timolol twice daily. Patients were randomised 19 and 22% for the three concentrations of to two treatment groups. In one group 0.006% latanoprost used. A partial diminution in the latanoprost was given twice daily, in the other IOP effect was also observed by Camras et al after group placebo was given at 8 am and latano- 5 days of treatment twice daily with 0-01% prost at 8 pm for 3 months, with concomitant latanoprost, but not with 0003%. Fristrom and timolol treatment in both groups. Average Nilsson also noted some reduction of the IOP daytime IOP (mean (SD)) at baseline (on effect with 0-006% latanoprost given twice daily timolol alone) and after 4 and 12 weeks' treat- for 1 week, similar to that observed for 2% ment was 24*8 (3.6), 16-8 (4.3), and 15*7 (2.4) pilocarpine administered three times daily.9 mm Hg respectively with once daily applica- They also found that the effect on IOP of tion of latanoprost and 24-9 (2.9), 18*1 (3.0), latanoprost and pilocarpine was at least partially and 18-0 (3.6) mm Hg respectively with latano- additive.9 Both drugs act on outflow; latanoprost prost twice daily. No clinically significant side has no effect on aqueous flow.'68 Thus one effects were observed during treatment. would expect latanoprost and an aqueous flow causes a marked and sustained suppressor to be a better combination. The effect http://bjo.bmj.com/ Department of Latanoprost Ophthalmology, IOP reduction in eyes which are also being on IOP of prostaglandin F20-isopropylester University Hospital, treated with timolol. Latanoprost given once (PGF20-IE) has previously been found to be Uppsala, Sweden daily is at least as effective and probably additive to that of timolol'"" and a direct com- A Alm I Widengard superior to a twice daily dose regimen parison ofthe additivity of latanoprost to timolol (BrJ Ophthalmol 1995; 79: 12-16) 0 5% twice daily and pilocarpine 2% three times Department of daily suggested that pretreatment with pilocar- Ophthalmology, 12 on September 30, 2021 by guest. Protected copyright. University Hospital, pine reduced the effect oflatanoprost on IOP. Umea, Sweden Several previous studies have demonstrated that The present study was designed to evaluate D Kjellgren the phenyl substituted prostaglandin F2a the effect oflatanoprost administered either once Department of analogue, 13,14-dihydro-17-phenyl-18, 19, or twice daily in addition to timolol. Treatment Ophthalmology, 20-trinor-prostaglandin F2a-isopropylester was given for 3 months to be able to detect any University Hospital, (latanoprost, PhXA41) and its epimeric mixture long term diminution in the effect of the drug on Huddinge, Sweden PhXA34 reduce significantly the intraocular IOP. M Soderstrom pressure (IOP) in normal, ocular hypertensive, Department of or glaucomatous eyes."18 The present study was Ophthalmology, to more on and methods University Hospital, undertaken obtain information dose Patients Linkoping, Sweden regimen, long term effect, and additivity to a 13 B Fristrom adrenergic antagonist, timolol. SUBJECT SELECTION Latanoprost has a long duration of effect on The study was performed as a five centre, Department of Ophthalmology, IOP, but whether it should be administered once randomised, parallel, double masked study of University Hospital, of twice daily is unclear. In two dose finding latanoprost, 0-006%, given either once, in the Malmo, Sweden studies with the epimeric mixture PhXA34 a evening, or twice daily for 12 weeks. Patients of A Heijl duration ofat least 24 hours was observed but the either sex over the age of 60, with primary open Pharmacia Ophthalmics, effect 24 hours after the dose was less pro- angle glaucoma (POAG) or capsular glaucoma, Uppsala, Sweden nounced than that seen at 12 hours after the in whom the IOP was not adequately controlled J Stjerschantz dose.' 2 Such an attenuation of the effect was not despite 0-5% timolol twice daily were included. Correspondence to: Albert Alm, MD, Department observed in a study on hospitalised patients Inadequate IOP control was defined as an IOP of of Ophthalmology, University treated with latanoprost,7 and in one dose at least 22 mm Hg on two occasions taken at an Hospital, S-751 85 Uppsala, Sweden. regimen study administration of 0-006% latano- interval of at least 1 hour at the pre-inclusion Accepted for publication prost once daily was at least as effective as twice examination. Ten patients were recruited from 10 August 1994 daily.4 each centre, five per treatment group. Patients Latanoprost administered once daily caused a maintained reduction ofintraocularpressure in glaucoma patients treated concomitantly with timolol 13 Table I Examination schedule Day O Day 14 Day 28 Week 12 Br J Ophthalmol: first published as 10.1136/bjo.79.1.12 on 1 January 1995. Downloaded from Pre-inclusion Week 6 Week 8 Week 10 Investigational event within I month 8 12 4 4 8 12 4 4 pm 4 pm 4 pm 8 12 4 Ocular examination * * Symptomatology * * * * * * * ** * * * * * Visual acuity * * * * Biomicroscopy * * ** * * * * * * * * * * Photography * * * * * * * Hyperaemia grading * * * * * ** ** * * * lop * * ** * **** * with a history of severe ocular trauma, severe STATISTICAL ANALYSIS AND EVALUATION OF ocular inflammation within the past 3 months, or EFFECT intraocular surgery within the last 6 months were Diurnal IOP was defined as the mean IOP over excluded. Exclusion criteria also included the day based on the values obtained at 8 am, 12 known contraindications to adrenergic noon, and 4 pm. Owing to differences in baseline blockers, a history of acute angle closure IOP between patients, baseline IOP was used as glaucoma, a history of significant dry eyes, and a covariate in statistical analysis of the IOP wearing contact lenses. The study protocols were reduction. The difference in IOP reduction reviewed and approved by the National Board of between treatment groups at week 12 at 4 pm was Health and Welfare and by the appropriate local analysed by two way analysis of covariance with review boards. Written informed consent was treatment group and centre as factors and base- obtained from all subjects. line IOP as covariate. Maximal hyperaemia was defined as the highest score from the three measurements during the day. Change in maxi- EXAMINATION SCHEDULE AND PROCEDURES mal hyperaemia at week 12 within treatment A pre-inclusion examination was performed groups was tested with the sign test. Comparison within 1 month before the study. We obtained a of change in maximal hyperaemia at week 12 medical and ophthalmic history including between treatment groups was performed with information on ocular symptoms. In addition to Wilcoxon rank sum test. The X2 test was used to IOP determinations the initial examination compare the number of patients who responded included measurement of refractive error and positively to latanoprost in the two groups. Snellen visual acuity, a slit-lamp evaluation of the anterior segment, ophthalmoscopic examina- tion of the optic nerve, and a visual field if one Results had not been performed within the last 6 Of the 50 patients who entered 48 were able to months. complete the study. The two patients who with- The examination schedule is presented in drew were in the group which administered Table 1. The patients visited the clinic three times latanoprost once daily. One patient developed a http://bjo.bmj.com/ on the baseline day and 4 and 12 weeks after keratitis after 4 weeks' treatment and one with- initiation of treatment but only once daily for drew after 6 weeks and 4 days' treatment owing examinations after 2, 6, 8, and 10 weeks' treat- to difficulties in distinguishing between the ment. The degree of conjunctival hyperaemia dropper bottles. was graded in the treated eye by comparison with Oral 1 blocking agents were used by one four standard photographs corresponding to no patient in the twice daily group compared with on September 30, 2021 by guest. Protected copyright. hyperaemia, mild, moderate, and severe hyper- seven patients in the once daily group. Otherwise aemia respectively. A photograph was taken of there were no major differences between treat- the anterior segment of the eye which was later ment groups with respect to demographic or evaluated in a masked manner. clinical data (Table 2). The patients were randomised to two treat- The mean diurnal IOPs at baseline and weeks ment groups. Each patient was provided with 4 and 12 for the two groups are presented in one bottle of 0-5% timolol (Blocadren, MSD) Table 3, and the IOPs measured at 4 pm at and two identical bottles, one labelled morning baseline and at 2 week intervals for 12 weeks are and one evening.
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