Effects of Fenofibric Acid on Diabetic Macular Edema: The MacuFen study

Abstract

Subjects treated with fenofibric acid had a modest improvement in TMV, although the study was probably underpowered to detect a benefit over placebo after 1 year.

Dyslipidemia and Diabetic Macular Edema

“…Although 1 study showed that individuals with DME receiving fenofibric acid achieved modest improvement in total macular volume on optical coherence tomography compared with placebo, no difference was seen between the 2 groups in relation to worsening of DME or progression of hard exudates on fundus photography. 35 Likewise, there was no significant difference in the severity of DME in either group (relative risk, 1.18; 95% CI, 0.75e1.86; P ¼ 0.48) (Fig 7).…”

“…11 Furthermore, 80% of those in the ophthalmology substudy had no or questionable diabetes-related retinopathy at baseline and thus represented a low-risk group for progression, making it likely that the study had limited power to explore the outcomes. The MacuFen study 35 reported that individuals with DME who received fenofibric acid showed modest improvement in total macular volume on optical coherence tomography compared with placebo; however, no difference was seen between the 2 groups in relation to worsening of DME or progression of hard exudates on fundus photography. The authors postulated that the study was underpowered to detect any benefit over placebo and suggested further studies to confirm any long-term benefit of fenofibric acid.…”

“…4 Therefore, we performed a qualitative analysis to examine the relationship among elevated serum TC, LDL cholesterol, HDL cholesterol, and TGs. 30 Cross-sectional 1414 TC, LDL-C, HDL-C, TG DM with non-CSME CSME NA 8* Zander et al, 2000 32 Cross-sectional 3359 TC, LDL-C, HDL-C, TG DM without DME DME NA 8* Idiculla et al, 2012 33 Cross-sectional 330 TC, LDL-C, HDL-C, TG DM without DR CSME NA 7* Rema et al, 2006 29 Cross-sectional 1736 TC, LDL-C, HDL-C, TG, TC-to-HDL-C ratio DM without DR DME NA 10* Miljanovic et al, 2004 25 Prospective cohort 1441 TC, LDL-C, HDL-C, TG, TC-to-HDL-C ratio DM without DR DME, hard exudates 6.5 9* Klein et al, 1999 28 Prospective cohort 765 TC, LDL-C, HDL-C, TG NA DME, hard exudates 5 8* Chew et al, 1996 9 Prospective cohort 2709 TC, LDL-C, HDL-C, TG DR without DME DME, hard exudates 7 8* Romero-Aroca et al, 2011 26 Prospective cohort 334 TC, LDL-C, HDL-C, TG, TC-to-HDL-C ratio DM without DR DME 10 8* Aroca et al, 2004 27 Prospective cohort 93 TC, LDL-C, HDL-C, TG DR without DME DME 4 8* Benarous et al, 2011 23 Case-control 500 TC, LDL-C, HDL-C, TG DR without DME CSME NA 7* Mohan et al, 1984 19 Case-control 50 TC, LDL-C, HDL-C, TG DM without DR DME NA 6* Ucgun et al, 2007 20 Case-control 54 TC, LDL-C, HDL-C, TG DR without DME DME NA 6* Jew et al, 2012 24 Case-control 300 TC, LDL-C, HDL-C, TG DR without DME DME NA 6* Cetin et al, 2013 12 Case-control 116 TC, LDL-C, HDL-C, TG DM without DR DME NA 6* Dodson and Gibson, 1991 22 Case-control 52 TC, LDL-C, HDL-C, TG DR without DME DME NA 6* Kameda et al, 2010 21 Case-control 53 TC, LDL-C, HDL-C, TG DR without DME DME NA 6* Massin et al, 2014 35 RCT …”

“…One was a single-center hospital-based study 34 , and 3 were multicenter studies. 11,35e36 The oral lipid-lowering drugs fenofibrate, 11,36 fenofibric acid, 35 and atorvastatin 34 were compared with placebo. The ETDRS grading system had been used to assess the change in areas of hard exudates and DME in all the studies.…”

Effect of micronized fenofibrate on microvascular complications of type 2 diabetes: a systematic review

“…The ACCORD Eye study included all ACCORD participants who did not have a history of laser photocoagulation or vitrectomy for DR in either eye at baseline [9]. Patients (n = 2856) were monitored for 4 years using fundus photographs, which were graded on the 10-step ETDRS severity scale as follows: no retinopathy (step 1), micro-aneurysms only (steps 2-3), mild nonproliferative DR (NPDR) (steps 4-5), moderate NPDR (steps 6-7), moderately severe NPDR (steps 8-9), and severe NPDR or PDR (steps [10][11][12][13][14][15][16][17]. The primary outcome was the composite end point of the occurrence of three or more steps of progression on the ETDRS severity scale or development of proliferative DR necessitating photocoagulation or vitrectomy.…”