2009, Number 2
<< Back Next >>
Rev Mex Oftalmol 2009; 83 (2)
Estudio de la eficacia y seguridad de dos diferentes formulaciones de latanoprost al 0.005% en glaucoma primario de ángulo abierto
Gil-Carrasco F, Estrada L, Cervantes-Amezcua H
Language: Spanish
References: 17
Page: 67-71
PDF size: 135.29 Kb.
ABSTRACT
Purpose:
To compare the efficacy and tolerance of two different latanoprost formulations in patients with primary openangle glaucoma or with ocular hypertension.
Material and methods: This was a prospective, randomized, double blind study. Patients with primary open-angle glaucoma or with ocular hypertension were included. Patients were divided in two treatment groups. One group was treated with GAAP Ofteno® (Laboratorios Sophia), while the other with Xalatan® (Pfizer Laboratories). For both groups, the dose regimen was one drop each 24 hours. The intraocular pressure (IOP) was assessed and used as a primary parameter of efficacy; conjunctive hyperaemia and tearing were evaluated as parameters of safety and tolerance.
Results: 30 patients were included: (22 females, 8 males) with an average age of 58.2 ±2.8 years old. Both medicaments showed an important decrease in the IOP for each group separately. The IOP values behaviour in the GAAP Ofteno® group was not different compared to that of the Xalatan® group. Regarding other parameters, there were no statistically significant differences between both groups.
Conclusions: GAAP Ofteno® is as safe and efficient as Xalatan® in lowering the IOP in patients with primary openangle glaucoma and/or ocular hypertension.
REFERENCES
Van Buskirk EM, Cioffi GA. Glaucomatous optic neuropathy. Am J Ophthalmol 1992; 113:447-452.
Alward WL. Medical management of glaucoma. N Engl J Med 1998; 339:1298-307.
Kass MA, Heuer DK, Higginbotham E Y COLS. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol 2002; 120: 701-713.
Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E , Early Manifest Glaucoma Trial Group. Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol 2003; 121:48-56.
Realini T, Fechtner RD. 56,000 ways to treat glaucoma. Ophthalmology 2002; 109:1955-1956.
Camras CB, Bito LZ. Reduction of intraocular pressure in normal and glaucomatous primate (Aotus trivirgatus) eyes by topically applied prostaglandin F2 alpha. Curr Eye Res 1981;1:205-209.
Woodward DF, Regan JW, Lake S, Ocklind A. The molecular biology and ocular distribution of prostanoid receptors. Surv Ophtalmol1997; 41(supl 2):S15-S21.
Lee PY, Shao H, Xu LA, Qu CK. The effect of prostaglandin F2 alpha on intraocular pressure in normotensive human subjects. Invest Ophtalmol Vis Sci 1988; 29:1474-1477.
Stjernschantz JW. From PGF(2alpha)-isopropyl ester to latanoprost: a review of the development of Xalatan: the Proctor Lecture. Invest Ophthalmol Vis Sci 2001; 42:1134-1145.
Ravinet E, Mermoud A, Brignoli R. Four years later: a clinical update on latanoprost. Eur J Ophthalmol 2003; 13:162-175.
Sjöquist B, Basu S, Byding P, Bergh K, Stjernschantz J. The pharmacokinetics of a new antiglaucoma drug, latanoprost, in the rabbit. Drug Metab Dispos 1998; 26:745-754.
Sjöquist B, Stjernschantz J. Ocular and systemic pharmacokinetics of latanoprost in humans. Surv Ophthalmol 2002; 47:S6-S12.
Toris CB, Camras CB, Yablonski ME. Effects of PhXA41, a new prostaglandin F2 alpha analog, on aqueous humor dynamics in human eyes. Ophthalmology 1993; 100:1297-1304.
Loftsson T, Brewster ME. Pharmaceutical applications of cyclodextrins, I: drug solubilization and stabilization. J Pharm Sci 1996; 85:1017-1025.
Loftsson T, Masson M. Cyclodextrins in topical drug formulations: theory and practice. Int J Pharm 2001; 225:15-30.
Loftsson T, Stefansson E. Cyclodextrins in eye drop formulations: enhanced topical delivery of corticosteroids to the eye. Acta Ophthalmol Scand 2002; 80:144-150.
Gonzalez JR, Baiza-Duran L, Quintana-Hau J, Tornero-Montaño R y cols. Comparison of the stability, efficacy, and adverse effect profile of the innovator 0.005% latanoprost ophthalmic solution and a novel cyclodextrin-containing formulation. J Clin Pharmacol 2007; 47:121-126.