A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma.

Publisher: Elsevier Science Country of Publication: United States NLM ID: 0370500 Publication Model: Print Cited Medium: Print ISSN: 0002-9394 (Print) Linking ISSN: 00029394 NLM ISO Abbreviation: Am J Ophthalmol Subsets: MEDLINE

Publication: 1999- : New York, NY : Elsevier Science
Original Publication: [Chicago, etc., Ophthalmic Pub. Co., etc.]

Antihypertensive Agents/*therapeutic use ; Glaucoma, Open-Angle/*drug therapy ; Intraocular Pressure/*drug effects ; Lipids/*therapeutic use ; Prostaglandins F, Synthetic/*therapeutic use; Adult ; Aged ; Aged, 80 and over ; Amides ; Antihypertensive Agents/administration & dosage ; Antihypertensive Agents/adverse effects ; Bimatoprost ; Cloprostenol/analogs & derivatives ; Double-Blind Method ; Female ; Humans ; Latanoprost ; Lipids/administration & dosage ; Lipids/adverse effects ; Male ; Middle Aged ; Ocular Hypertension/drug therapy ; Ophthalmic Solutions ; Prospective Studies ; Prostaglandins F, Synthetic/administration & dosage ; Prostaglandins F, Synthetic/adverse effects ; Safety

Purpose: To compare the intraocular pressure (IOP)-lowering efficacy and safety of topical bimatoprost 0.03% with latanoprost 0.005%.
Design: Multicenter, randomized, investigator-masked clinical trial.
Methods: After washout of glaucoma medications, ocular hypertension or glaucoma patients were randomly assigned to once-daily bimatoprost 0.03% (n = 133) or latanoprost 0.005% (n = 136) for 6 months. The primary outcome measure was mean change from baseline IOP (8 AM, 12 PM, 4 PM). Secondary measures included mean IOP, ophthalmologic examination, adverse events, and the percentage of patients reaching specific target IOPs.
Results: Mean change from baseline IOP was significantly greater for bimatoprost patients than for latanoprost patients at all measurements on each study visit; 1.5 mm Hg greater at 8 AM (P <.001), 2.2 mm Hg greater at 12 PM (P <.001), and 1.2 mm Hg greater at 4 PM (P =.004) at month 6. At the end of the study, the percentage of patients achieving a > or = 20% IOP decrease was 69% to 82% with bimatoprost and 50% to 62% with latanoprost (P < or = .003). In addition, the distribution of patients achieving target pressures in each range (< or = 13 to < or = 15 mm Hg, >15 to < or = 18 mm Hg, and > 18 mm Hg) showed that bimatoprost produced lower target pressures compared with latanoprost at all times measured (P < or = .026). Few patients were discontinued for adverse events (6 on bimatoprost; 5 on latanoprost). On ophthalmologic examination, conjunctival hyperemia (P <.001) and eyelash growth (P =.064) were more common in bimatoprost patients.
Conclusions: Bimatoprost is more effective than latanoprost in lowering IOP. Both drugs were well tolerated, with few discontinuations for adverse events.

Comment in: Am J Ophthalmol. 2003 Jun;135(6):921-2; author reply 922-3. (PMID: 12788149)
Comment in: Am J Ophthalmol. 2003 Jul;136(1):217; author reply 217-8. (PMID: 12834708)
Comment in: Am J Ophthalmol. 2003 Aug;136(2):392; author reply 392-3. (PMID: 12888081)
Comment in: Am J Ophthalmol. 2003 Oct;136(4):727-8. (PMID: 14516814)

0 (Amides)
0 (Antihypertensive Agents)
0 (Lipids)
0 (Ophthalmic Solutions)
0 (Prostaglandins F, Synthetic)
4208238832 (Cloprostenol)
6Z5B6HVF6O (Latanoprost)
QXS94885MZ (Bimatoprost)

Date Created: 20021231 Date Completed: 20030127 Latest Revision: 20220321

20231215

10.1016/s0002-9394(02)01827-5

12504698