Abstract | PURPOSE: METHODS: An open-label, 12-week, multicenter, Canadian study was conducted. Patients with untreated OAG or ocular hypertension received DT for 12 weeks to reduce intraocular pressure (IOP). If target IOP was not reached after the first 6-week treatment period, a prostaglandin (PG) ( latanoprost) was added for the remaining 6 weeks. Primary outcome measures were changes in IOP from baseline to 6 and 12 weeks of treatment, and secondary outcome measures included the proportion of patients achieving target IOP and the proportion of patients achieving therapeutic response defined as a reduction of 5.0 mmHg or 20% in IOP from baseline. IOP values were the mean of 2 measures taken before and at least 2 h after patients administered the study medication. RESULTS: A total of 164 patients were enrolled. Mean [standard deviation (SD)] population age was 63.0 (12.3) years and 53.0% of the patients were men. At week 6, the mean (SD) absolute and percent change in IOP for the total population was (-11.1) (4.9) and (-36.4)% (13.9%), respectively, and 92.1% of the patients achieved a reduction in IOP of at least 5 mmHg. Therapeutic target was achieved by 136 (82.9%) patients (DT subgroup) at 6 weeks, whereas 28 (17.1%) patients were changed to a combination therapy of DT and latanoprost [DT plus PG (DT & PG) subgroup]. Between weeks 6 and 12, DT was effective in sustaining the IOP within therapeutic target, whereas addition of latanoprost reduced the IOP of the DT & PG subgroup by an additional 6.3 mmHg or 22.1% (20.1%). At week 12, patients in the DT subgroup experienced a clinically and statistically significant mean (SD) decrease in IOP from a baseline of 12.2 mmHg or 40.4% (11.9%) (P < 0.001), whereas these values corresponded to 13.4 mmHg and 39.7% (15.7%) (P < 0.001), respectively, in the DT & PG subgroup. The proportion of patients who achieved therapeutic response during the entire 12-week study period was over 82%. Treatment-related adverse events (AEs) were reported by 19 (14.0%) patients in the DT subgroup and by 6 (21.4%) patients in the combination subgroup. Eye disorders and nervous system disorders were among the most common treatment-related AEs in both subgroups. No serious AEs were reported during the study period. CONCLUSION: DT alone and DT in combination with a PG are effective in significantly reducing IOP in patients with untreated OAG or ocular hypertension. The treatment was safe and well tolerated with a low incidence of AEs.
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Authors | Andrew C S Crichton, Paul Harasymowycz, Cindy M L Hutnik, Rama Behki, Serge Boucher, Fahim Ibrahim, Aaron W Rifkind, Leon Solomon, Chuanhong Liao, Natacha R Bastien, John S Sampalis |
Journal | Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
(J Ocul Pharmacol Ther)
Vol. 26
Issue 5
Pg. 503-11
(Oct 2010)
ISSN: 1557-7732 [Electronic] United States |
PMID | 20874498
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drug Combinations
- Ophthalmic Solutions
- Prostaglandins F, Synthetic
- Sulfonamides
- Thiophenes
- dorzolamide-timolol combination
- Latanoprost
- Timolol
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Topics |
- Aged
- Drug Combinations
- Eye
(physiopathology)
- Female
- Glaucoma
(drug therapy)
- Glaucoma, Open-Angle
(drug therapy)
- Humans
- Intraocular Pressure
(drug effects)
- Latanoprost
- Male
- Middle Aged
- Multicenter Studies as Topic
- Ocular Hypertension
(drug therapy)
- Ophthalmic Solutions
(administration & dosage, pharmacology)
- Prostaglandins F, Synthetic
(administration & dosage, adverse effects, pharmacology)
- Sulfonamides
(adverse effects, pharmacology)
- Thiophenes
(adverse effects, pharmacology)
- Timolol
(adverse effects, pharmacology)
- Tonometry, Ocular
- Treatment Outcome
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