Evidence map›Paper›PMID 41971206›Full record

Trial reportRomanian journal of ophthalmology

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

Ashish Markan, Aniruddha Agarwal, Deeksha Katoch, Sanjay Bhadadaxys, Vishali Gupta, Reema Bansal

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Romanian journal of ophthalmology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ashish MarkanEye7 Chaudhary Eye Centre, New Delhi, India.
Aniruddha AgarwalCleveland Clinic, Abu Dhabi, United Arab Emirates.
Deeksha KatochDepartment of Ophthalmology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Sanjay BhadadaxysDepartment of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Vishali GuptaDepartment of Ophthalmology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Reema BansalDepartment of Ophthalmology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

AtorvastatinDiabetes Mellitus, Type 2Diabetic RetinopathyHydroxymethylglutaryl-CoA Reductase InhibitorsMacular EdemaRanibizumabVascular Endothelial Growth Factor AVisual AcuityAgedAngiogenesis InhibitorsDose-Response Relationship, DrugDrug Therapy, CombinationFemaleFluorescein AngiographyFollow-Up StudiesHumansAngiogenesis InhibitorsAtorvastatinHydroxymethylglutaryl-CoA Reductase InhibitorsRanibizumabVascular Endothelial Growth Factor Aadjunct therapyanti-VEGFBCVA = Best Corrected Visual AcuityCAD = Coronary Artery DiseaseCKD = Chronic Kidney DiseaseCMT = Central Macular ThicknessCOVID = Coronavirus DiseaseCSMECSME = Clinically Significant Macular Edemadiabetic retinopathyDM = Diabetes MellitusDME = Diabetic Macular EdemaETDRS = Early Treatment Diabetic Retinopathy StudyFBS = Fating Blood SugarFFA = Fundus Fluorescein AngiographyHDL = High Density LipoproteinHTN = HypertensionIOP = Intraocular PressureKFT = Kidney Function TestsLDL = Low Density LipoproteinLFT = Liver Function TestsNPDR = Non-Proliferative Diabetic RetinopathyOCT = Optical Coherence TomographyPRN = Pro Re NataPTH = Para Thyroid HormoneSGOT = Serum Glutamic Oxaloacetic TransaminaseSGPT = Serum Glutamic Pyruvic TransaminaseSPSS = Statistical Package for Social Sciencesstatin therapyTG = Triglyceridestype 2 diabetesVEGF - Vascular Endothelial Growth Factor

Identifiers

PMID41971206
PMCPMC13065104

What Socratic holds

Texttitle and abstract
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.