Abstract
Purpose: :
The primary risk factor in primary open angle glaucoma (POAG) is ocular hypertension (OH). The prevalence of OH can reach up to 10% in patients over 70. The aim of the study was to assess the efficacy of latanoprost (prostaglandin analogue) in reducing intra–ocular pressure (IOP) in patients with either moderately high or very high baseline IOP (respectively, MH–IOP and VH–IOP – threshold 24 mm Hg).
Methods: :
This open–label, multicenter study was carried out in patients with a simple OH or POAG, with an IOP > 20 mmHg, naïve of previous anti–glaucoma treatment, and initiating a first line latanoprost therapy (single daily instillation in the evening). Patients were stratified according to their baseline IOP levels: MH–IOP group (20 mmHg ≤ IOP < 24 mmHg) and VH–IOP group (IOP ≥ 24 mmHg). The IOP was measured at baseline, 1 month, and 3 months.
Results: :
431 centers have recruited 600 patients (mean age: 59±12 years). The ITT efficacy analysis was carried out on 320 VH–IOP patients and 252 MH–IOP patients (respectively, mean baseline IOP: 26.7±2.8 and 22.2±0.9 mmHg). The proportion of glaucoma patients was higher in the VH–IOP (50% of patients vs 40%), while a more frequent family history of glaucoma or OH was observed in the MH–IOP group (34% vs 23%). The other initial characteristics (age, body mass index, high blood pressure, diabetes, sleep disorders) were similar in both groups. At month 1, 88% of the MH–IOP patients and 61% of the VH–IOP patients reached an IOP value ≤ 18 mmHg, such reduction was confirmed at month–3 assessment (respectively, 92% and 71%). 40% of MH–IOP patients reached an IOP value ≤ 15 mmHg, stable over the 3 months. At the end of the study, the reduction of IOP was significant in both groups (p<0.0001), and was larger in VH–IOP patients (–9±4 vs –6±2 mmHg). An IOP reduction over 30% was observed in 66% of the VH–IOP patients, and in 48% of MH–IOP patients (p<0.0001).
Conclusions: :
In this large clinical trial, a single daily instillation of latanoprost allowed normalization of IOP in naïve patients when initial IOP is moderately high (between 20 and 24 mmHg).
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure • lipids