Assessing the Role of Statins as an Adjunctive Anti-VEGF Therapy for Clinically Significant Macular Edema (CSME) in Type 2 Diabetes Mellitus.

Abstract

Aim: This study aimed to evaluate the effectiveness of statin therapy as an adjunctive treatment to anti-VEGF therapy in type 2 diabetic patients with non-proliferative diabetic retinopathy (NPDR) and clinically significant macular edema (CSME).

Materials and methods: In this prospective, randomized interventional study, patients were randomized into two groups: Group A received low-dose atorvastatin (10-20 mg), and Group B received high-dose atorvastatin (30-40 mg). All participants also received three loading doses of intravitreal ranibizumab (0.5 mg) at monthly intervals, followed by pro re nata treatment over six months. Primary outcomes included the number of anti-VEGF injections required, best-corrected visual acuity (BCVA), and central macular thickness (CMT). Serum VEGF levels were measured at baseline and six months.

Results: The mean number of injections over six months was 3.4, with no significant difference between Group A (3.55) and Group B (3.33) (p = 0.24). Group A demonstrated substantial improvement in BCVA at both 3 and 6 months, accompanied by a notable reduction in CMT. In contrast, Group B's BCVA improvement was only significant at 3 months, with less consistent CMT reduction at 6 months. Serum VEGF levels decreased in Group A but increased in Group B, though these changes were not statistically significant.

Discussion: The findings suggest that low-dose atorvastatin, when used in conjunction with anti-VEGF therapy, may provide superior functional and anatomical outcomes in patients with CSME compared to high-dose statin therapy. The observed reduction in central macular thickness and improvement in visual acuity indicate a potential adjunctive benefit of statins, likely due to their pleiotropic effects, including anti-inflammatory and anti-angiogenic properties. Although the number of injections required was similar between groups, the better response in the low-dose group highlights the need for further investigation into the dose-dependent effects of statins in the management of diabetic macular edema.

Conclusions: Low-dose atorvastatin (10-20 mg) as an adjunct to anti-VEGF therapy resulted in better functional and anatomical outcomes in diabetic patients with CSME compared to high-dose atorvastatin. These findings suggest potential additional benefits of low-dose statins in managing patients with chronic subdural hematoma (CSME).