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G. Chaine, S. Cohen, C. Corbé, M.-A. Espinasse-Berrod, J. Garcia-Sanchez, A. Gaudric, A. Hullo, A. Leys, J. Sahel, G. Soubrane; Drug Effects on Neovascularisation and on Atrophy Are Differents in AMD : Results of FRANCE DMLA 2 Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5579.
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To evaluate the effect of trimetazidine 35 mg (TMZ) on the emergence of choroidal neovascularisation (primary criteria) or geographic atrophy (GA) and on the evolution of angiographic semiology in AMD.
1086 patients (416 men, mean age 74) from France, Belgium and Spain were randomized in a double blind study to placebo (P) or trimetazidine 35 mg twice a day (TMZ), during a median follow up of 38 months. All patients presented soft drusen or retinal pigment epithelium (RPE) abnormalities on the evaluated eye and a neovascular form of AMD on the controlateral eye. A reviewing committee performed double-blind analysis of initial and follow up angiographies.
358 patients developed neovascularisation during the study (TMZ: 181 - P: 177).The incidence per 100 patient-years of neovascularisation was 10.86 (TMZ) vs 11.13 (P) (NS). A surface atrophy exceeding 1/3 of the papillary diameter of the evaluated eye was detected in 171 patients (TMZ: 78 - P: 93). The incidence per 100 patient-years of GA was 5.11 (TMZ) vs 6.45 (P) (p=0.069). Statistical significant results are found among men (p=0.016 -TMZ vs P), patients below 75 years old (p=0.01) and patients presenting any pigmentary abnormalities at inclusion (p=0.005), depigmentation (p=0.01), or hyperpigmentation (p=0.044). Tolerance was good.
The physiopathogeny of AMD might be due to blood flow decrease to the choriocapillaris, to rarefaction of this choriocapillaris and/or to tissue hypoxia. Besides, coronary artery diseases seem to be associated to the most advanced form of AMD. Therefore, it was particularly interesting to perform a study with an antiischemic drug such as TMZ, in order to assess the importance of ischemic phenomenon in the worsening of AMD and its different evolving forms. The antiischemic TMZ did not confirm its potential to prevent neovascularisation bilateralization in AMD. However, data strongly suggest that TMZ exerts a protective effect in preventing GA.
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