Iop Reduction In Clinical Trials

Numerous clinical trials have demonstrated the efficacy of PG analogs in lowering IOP. Clinical trials with latanoprost,1'2'29'31'47'81 bimatoprost'1'2'44'48 and travo-prost1-3'49 have all shown that these drugs given once daily are more effective than timolol 0.5% given twice a day in reducing mean diurnal IOP in patients with ocular hypertension or glaucoma (figure 2.5). PGs have also been shown to be as effective or more effective and often better tolerated than other topical glaucoma

Figure 2.5. Efficacy of PG analogs compared to timolol 0.5% twice daily in reducing IOP. (A) Latanoprost 0.005% once daily. Reprinted with permission from Camras CB. Comparison of latanoprost and timolol in patients with ocular hypertension and glaucoma: a six-month masked' multicenter trial in the United States. United States Latanoprost Study Group. Ophthalmology. 1996;103:138-147. (B) Bimatoprost 0.03% once daily. Reprinted with permission from Higginbotham EJ5 Schuman EK5 Goldberg I et al. One-year randomized study comparing bimatoprost and timolol in glaucoma and ocular hypertension. Arch Ophthalmol. 2002;120:1286-1293. (C) Travoprost 0.004% or 0.0015% once daily. Reprinted with permission from Netland PA5 Landry T Sullivan EK' et al. Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001;132:472-484.

Figure 2.5. Efficacy of PG analogs compared to timolol 0.5% twice daily in reducing IOP. (A) Latanoprost 0.005% once daily. Reprinted with permission from Camras CB. Comparison of latanoprost and timolol in patients with ocular hypertension and glaucoma: a six-month masked' multicenter trial in the United States. United States Latanoprost Study Group. Ophthalmology. 1996;103:138-147. (B) Bimatoprost 0.03% once daily. Reprinted with permission from Higginbotham EJ5 Schuman EK5 Goldberg I et al. One-year randomized study comparing bimatoprost and timolol in glaucoma and ocular hypertension. Arch Ophthalmol. 2002;120:1286-1293. (C) Travoprost 0.004% or 0.0015% once daily. Reprinted with permission from Netland PA5 Landry T Sullivan EK' et al. Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001;132:472-484.

Figure 2.6. Comparison of latanoprost 0.005%, bimatoprost 0.03%, and travoprost 0.004% in lowering IOP. Reprinted with permission from Parrish RK, Palmberg P, Sheu WP, et al. A comparison of latanoprost, bi-matoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, masked-evaluator multicenter study. XLT Study Group. Am J Ophthalmol. 2003;135:688-703.

medications,1 including pilocarpine, dorzolamide,82'83 timolol-dorzolamide combinations,84-87 and brimonidine.88

Based on pooled data from eight clinical trials (n = 1,389), latanoprost reduces mean diurnal IOP an average of 7.9mm Hg, or 32% (from a baseline of 24.6mm Hg).81 This is 1.6mm Hg more than the effect achieved by timolol. Unlike timolol, which shows a mild contralateral effect, PG analogs do not affect the IOP in untreated fellow eyes.30,47 Clinical trials with bimatoprost4,48 and travoprost49 show similar efficacy for these drugs (figure 2.5). The higher the baseline IOP, the greater the IOP reduction, as is the case for other ocular hypotensive drugs.

Several prospective, randomized clinical trials have demonstrated that the IOP reductions achieved by latanoprost, bimatoprost, and travoprost are similar (figure 2.6).1-3,38,45 In spite of isolated studies showing some modest differences,41,46 the bulk of the clinical evidence shows no substantial differences in IOP-lowering effect among these three drugs.1-3,38,45 Unoprostone, however, has significantly lower efficacy compared to the other PG analogs.8,9

PG analogs appear to be effective in a variety of ethnic groups. There is little difference in efficacy between African Americans and U.S. Caucasians.3,47,89,90 Prostaglandin analogs are more effective compared with timolol in African Amer-icans.3,90 Clinical studies in the United States (in either African Americans or Caucasians), United Kingdom, Scandinavia, Japan, Philippines, Mexico, Korea, and China consistently show latanoprost to be more effective than timolol in each of these patient populations,81 and the other PG analogs have shown similar efficacies when tested in various populations.

Prolonged treatment with PG analogs shows no loss of effect over a 1- to 2-year period,3,27,31,44 and 5

-year data for latanoprost show continued efficacy.28

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