Tolerability and effectiveness of preservative-free dorzolamide-timolol (preservative-free COSOPT) in patients with open-angle glaucoma or ocular hypertension.

PURPOSE: To assess the effect of preservative-free dorzolamide-timolol on nonvisual symptoms and intraocular pressure (IOP) in newly diagnosed and untreated patients with open-angle glaucoma or ocular hypertension. METHODS: This was a prospective, 8-week, open-label, Canadian multicenter study. All patients were treated with preservative-free dorzolamide-timolol formulation. The primary outcome was the change in the nonvisual symptom score of the Glaucoma Symptom Scale (GSS-SYMP-6) from baseline to 8 weeks. Secondary effectiveness outcome measures were absolute and percent changes in IOP from baseline to 4 and 8 weeks. RESULTS: One hundred and seventy-eight patients were enrolled. Mean (SD) age was 65.6 (12.1) years and 90 (50.6%) were females. There were 92 patients diagnosed with open-angle glaucoma, 62 with ocular hypertension, and 23 with both diseases (diagnosis was missing for one patient). The mean (SD) GSS-SYMP-6 score increased from 73.6 (21.8) at baseline to 76.1 (20.7) at 8 weeks (P = 0.097). Mean (SD) IOP significantly decreased by 11.7 (5.1) mmHg at 4 weeks (P < 0.001) and by 11.5 (5.3) mmHg at 8 weeks (P < 0.001), representing reductions of -38.5% (P < 0.001) and -38.0% (P < 0.001), respectively. CONCLUSION: Preservative-free dorzolamide-timolol does not increase eye discomfort while significantly reducing IOP in patients with open-angle glaucoma or ocular-hypertension.

Montelukast as add-on therapy to inhaled corticosteroids in the management of asthma (the SAS trial).

AIM: To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy. DESIGN: An eight-week, multicentre, open-label, observational study. RESULTS: Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean +/- SD ACQ score decreased from 1.13+/-0.28 to 0.57+/-0.50 (P<0.001) for controlled patients at baseline and from 2.38+/-0.73 to 1.03+/-0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement. CONCLUSION: Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.