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WGA Rescources

Abstract #3627 Published in IGR 4-2

Tolerability and efficacy of dorzolamide versus acetazolamide added to timolol

Stewart WC; Halper LK; Johnson Pratt L; Polis A; Hartenbaum D
Journal of Ocular Pharmacology and Therapeutics 2002; 18: 211-220


PURPOSE: To evaluate the safety and efficacy of dorzolamide versus acetazolamide when added to once daily 0.5% timolol maleate ophthalmic gel forming solution (timolol gel). METHODS: This was a randomized, double-masked, multicenter, active-controlled, parallel group study of 215 patients with open-angle glaucoma or ocular hypertension. Following a two-week treatment period with timolol gel, patients with intraocular pressure (IOP) ≤ 22 mmHg and who tolerated one week of acetazolamide 250-mg q.i.d. were randomized to either acetazolamide or dorzolamide 2% three times daily for 12 weeks. RESULTS: In 155 randomized patients (dorzolamide, n = 80, acetazolamide, n = 75), compared to the dorzolamide, acetazolamide had a statistically greater number of systemic adverse events (dorzolamide 50%, acetazolamide 75%, p = 0.001), adverse events associated with carbonic anhydrase inhibitor (CAI) therapy (dorzolamide 26%, acetazolamide 53%, p < 0.001) and discontinuations due to CAI adverse experiences (dorzolamide 8%, acetazolamide 24%, p = 0.007). Intent to treat analysis found that changes from baseline in IOP were similar at both troughs (dorzolamide 1.4 ± 0.46 mmHg, acetazolamide 0.8 ± 0.47 mmHg, p = 0.386). However, per-protocol analysis found statistically improved pressure control with acetazolamide (0.1 ± 0.42 mmHg) compared to dorzolamide (1.9 ± 0.43 mmHg) (p = 0.009). CONCLUSIONS: This study found a greater incidence of systemic and CAI adverse experiences and discontinuations due to acetazolamide compared to dorzolamide.

Dr. W.C. Stewart, Pharmaceutical Research Corporation, 1639 Tatum Street, Charleston, SC 29412-2464, USA. prnc@bellsouth.net


Classification:

11.5.2 Topical (Part of: 11 Medical treatment > 11.5 Carbonic anhydrase inhibitors)



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