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Another Study Shows Fenofibrate Benefit on Diabetic Retinopathy

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STOCKHOLM, Sweden – New study data show that adding fenofibrate to a statin in patients with type 2 diabetes was associated with an 11% reduced risk of diabetic retinopathy progression. The drug combination was also found to reduce the risk of intravitreal injection therapy by 22%, a novel observation.

“This finding is not consistent with previous clinical studies where intravitreal injections were not widely used,” said lead author Nam Hoon Kim, MD.

“These results suggest that fenofibrate may delay or prevent the progression of diabetic retinopathy in patients with type 2 diabetes,” he claimed when presenting the results at this year’s European Association for the Study of Diabetes (EASD) annual meeting. introduced.

Kim explained the critical importance of early detection and intensive treatment of diabetic retinopathy, but added that therapeutic strategies, particularly for the early stages of the disease, are limited.

“Optimal glycemic and blood pressure control are still the mainstay of medical management for patients with diabetes to prevent or delay diabetic retinopathy,” said Kim, associate professor of endocrinology and metabolism at Korea University College of Medicine, Korea University Anam Hospital, South Korea .

His observational, propensity-matched study took a real-world perspective and aimed to determine whether fenofibrate therapy was beneficial in preventing the progression of diabetic retinopathy in patients with type 2 diabetes who are also being treated with statins .

Presenter Dr. Thomas Nyström, Professor of Medicine at the Karolinska Institute, Stockholm, Sweden, commented on the work.

“This was an excellent epidemiological study showing that fenofibrate saved the eyes [the effects of] diabetic retinopathy.”

“But I rarely use the combination of fenofibrate and statins,” he continued. “The FIELD study showed some positive results, but I think clinicians are not fully convinced of fenofibrate, especially when compared to statins. We also have PCSK9 inhibitors, but they are very expensive and the patient eligibility criteria are limiting.”

“This study is an observational study, so the level of evidence is not very high and we cannot write guidelines on that basis. We need a randomized controlled clinical trial,” emphasized Nyström. “As a clinician, I know that adding fenofibrate to statins can have side effects, and for that reason I would be cautious.”

Propensity-Matched Cohorts from Large Korean National Database

Patients with type 2 diabetes were selected for the study from a cohort composed of all South Korean citizens (approximately 50 million) who were at least 30 years old and had taken statins for more than 90 consecutive days after diagnosis. They were randomized 1:2 (statin plus fenofibrate or statin alone), leaving data for 23,692 and 46,223 participants, respectively, for analysis.

A particular strength of the study was the breadth of propensity matching used to limit bias and confounding. Among the many variables used for matching were age, gender, duration of diabetes, socioeconomic status, body mass index (BMI), fasting glucose, systolic blood pressure, pre-existing cardiovascular disease, and low-density lipoprotein (LDL )-cholesterol at baseline.

Baseline characteristics included a mean age of approximately 55 years, diabetes duration of 5.2 years, BMI of 26.7 kg/m2 and mean LDL-cholesterol of 2.6 mmol/L. Overall, 66% to 67% of the participants were men, 37% to 38% had pre-existing cardiovascular disease, and approximately 28% had diabetic retinopathy.

A composite primary endpoint of progression of diabetic retinopathy consisting of events related to vitreous hemorrhage, vitrectomy, laser photocoagulation, intravitreal injection therapy, and retinal detachment was used.

Rate of progression of diabetic retinopathy lower with combination

The incidence rate for progression of diabetic retinopathy was 14.3 per 1000 person-years in the statin monogroup and 12.7 per 1000 person-years in the statin plus fenofibrate group, with a hazard ratio (HR) in favor of the combination group (HR, 0.89; P=0.001).

At 10 years of follow-up, Kim reported a hazard ratio for the cumulative incidence of diabetic retinopathy progression of 0.89 (p=0.001), favoring patients on statin plus fenofibrate over statin alone.

The risk of vitreous hemorrhage was also lower in the statin plus fenofibrate group than in the statin group (HR 0.87; P=0.008), as was the incidence of laser photocoagulation (HR 0.89; P=0.022 ) and intravitreal injection therapy (HR, 0.78; p=0.003).

Kim and colleagues also analyzed the data based on whether or not the patients had retinopathy at baseline.

“We found evidence of a benefit of fenofibrate in patients with retinopathy at baseline [OR, 0.86; P = .001]but not in those who did not have retinopathy to begin with [OR, 0.9; P = .145]’ he reported.

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Regarding adverse events, Kim noted that “there was no significant increase or decrease between the two groups.”

Cardiovascular deaths were also significantly lower in the fenofibrate group [HR, 0.55; P = .003] about the 10-year follow-up.

Existing guidelines and study results are mixed

Existing guidelines for diabetic retinopathy recommend timely intervention with laser photocoagulation or intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) drugs.

Fenofibrate is approved by the US Food and Drug Administration for the treatment of patients with hypertriglyceridemia, primary hypercholesterolemia, or mixed dyslipidemia; The drug showed a benefit in diabetic retinopathy in several studies a few years ago.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study and the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study demonstrated the benefit of fenofibrate in reducing the impact of diabetic retinopathy.

In the FIELD study, fenofibrate reduced the risk of laser treatment by about 30% compared to placebo, Kim said.

And in the ACCORD Eye study, fenofibrate reduced the risk of diabetic retinopathy progression by 40% (odds ratio, 0.6; P=0.006), Kim noted.

Earlier this year, a large database study published in JAMA Ophthalmology, as reported by Medscape Medical News, showed that fenofibrate was associated with a reduced risk of progression to vision-threatening forms of diabetic retinopathy.

Fenofibrate was approved in Australia in 2013 to prevent diabetic retinopathy from getting worse.

Professional society guidelines have been inconsistent regarding fenofibrate in diabetic retinopathy, but the American Diabetes Association Guidelines for Medical Care in Diabetes – 2022 states that “in patients with dyslipidemia, the progression of retinopathy can be slowed by the addition of fenofibrate, especially with very mild non-proliferative diabetic retinopathy at baseline.”

Kim and Nystrom have not reported any relevant financial relationships.

EASD 2022. Presented September 21, 2022. Summary 125.

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