Abstract
Purpose: :
To compare time on therapy, efficacy, safety, and costs of latanoprost or usual care over 36 months in patients needing a change in intraocular pressure (IOP)-lowering therapy.
Methods: :
This open-label, multicenter study (19 sites in Sweden; 7 in Finland) included adults with ocular hypertension or primary open-angle, exfoliative, or pigmentary glaucoma whose intraocular pressure (IOP) was uncontrolled with monotherapy. Patients with mean diurnal IOPs ≥21 mmHg were randomized (1:1) to latanoprost or usual care (commercially available therapy except a prostaglandin analog) and followed (8 visits) over 36 months. Endpoints included time to treatment failure (change in/addition to study treatment), efficacy (diurnal IOP measured at months 6, 12, 24, and 36), safety, and direct costs to treat glaucoma/other ocular conditions. Unit costs (2006) from Sweden and Finland were applied to pooled resource utilization data; total direct costs and costs of hospitalizations, ocular surgical procedures, medications, and out-patient health care resource use were calculated.
Results: :
In all, 326 patients received ≥1 dose of latanoprost (n=162) or usual care (n=164). Median time to treatment failure was 3 times longer for latanoprost than usual care (36 vs 12 months, P<0.001 [log rank test]); 36-month success rates were 51.2% and 23.8%, respectively (P<0.001). Decreases from baseline in mean diurnal IOP levels were greater for latanoprost at months 6, 12, 24, and 36 (P<0.01 for all [ANCOVA]). Least squares mean reductions±SEM from baseline to month 36: latanoprost, -4.9±0.3 mmHg; usual care, -4.4±0.4 mmHg (95% CI for between-group difference: -1.8,-0.4; P=0.003; n=127). No serious adverse events were judged to be treatment related. Average total direct costs were similar in patients treated with latanoprost and usual care, but out-patient resource utilization and costs were higher for usual care-treated patients in Sweden.
Conclusions: :
In patients who had failed previous treatment, time on therapy was significantly longer in those switched to latanoprost versus usual care. Latanoprost’s IOP-reducing effect and safety were sustained over 36 months, and costs generally were similar in those receiving latanoprost or usual care.
Keywords: clinical (human) or epidemiologic studies: health care delivery/economics/manpower • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure