Dual Effect (Diabetic Retinopathy & Cholesterol) for Lofibra or Tricor (Fenofibrate)
Diabetic retinopathy occurs when the normal blood vessels of the retina are damaged because of high blood glucose (sugar) levels. It is the leading cause of adult blindness in North America. In First Nation Canadian communities, diabetes is three to five times more prevalent and is now growing to epidemic levels.
Diabetes can cause serious health problems if not properly managed, but the risk of developing complications from this disease appears to be greater in certain families. More than 4 million diabetics in the United States have diabetic retinopathy and, according to the National Eye Institute, one in 12 of those experiences at least some vision loss.
Total blood cholesterol levels above 240 mg/dL are associated with a significantly increased risk of vision loss. As with high blood pressure, treatments to improve your blood cholesterol may include lifestyle changes and medications. In its earliest stages, retinopathy often has no overt symptoms but can progress over time to a phase in which the blood vessels of the eye leak and rupture easily, eventually causing blindness. Treatment for diabetic retinopathy may include:
- Laser surgery and photodynamic therapy - often used to treat macular edema and proliferative retinopathy; involves shrinking the abnormal blood vessels, or sealing the leaking ones. These treatments are designed to seal the leaking blood vessels, halting the damage they can inflict upon the retina. These treatments are effective in slowing the progression of wet macular degeneration and are sometimes used in combination with Lucentis or Avastin. Research is underway to find new and more effective treatments for this condition.
- Vitrectomy - a type of procedure that involves removing the cloudy vitreous (the clear, jelly-like substance that fills the center of the eye) and replacing it with a salt solution. Vitrectomies are particularly effective in persons with insulin-dependent diabetes, who may be at a greater risk of blindness due to a hemorrhage in the eye.
Diabetic macular edema affects up to 10 percent of all patients with diabetes. It is caused when high blood sugar, through a cascade of events, causes damage in normal retinal blood vessels and a decrease in the supply of oxygen and nutrients. Macular edema, a first stage of retinopathy, occurs when, over time, excess uncontrolled blood sugar damages the tiny blood vessels in the eye, causing fluid and fat to leak onto the retina at the back of the eye. The swelling interferes with focus and blurs vision. Making matters worse, a lack of oxygen often then triggers VEGF's production cycle.
Diabetic retinopathy occurs when the normal blood vessels of the retina are damaged because of high blood glucose (sugar) levels. It is the leading cause of adult blindness in North America. In First Nation Canadian communities, diabetes is three to five times more prevalent and is now growing to epidemic levels. It suggests that, to the extent that good glucose control can delay complications' onset, women may need to be more diligent in keeping blood glucose under control.
Diabetics treated for cholesterol with fenofibrate had fewer non-fatal heart attacks, and other cardiovascular events, yet no reduction in fatal heart attacks, researchers said today in a late-breaking clinical trial report at the American Heart Association’s Scientific Sessions 2005.
A study by Imperial College in United Kingdom shown that fenofibrate is unique among the fibrates because of its uricosuric properties and has been shown to lower serum urate levels by 19 percent in men with gout receiving established therapy with allopurinol and has recently been shown to prevent the progression of coronary artery disease. Later study concluded that fenofibrate might therefore have a particularly useful role in insulin-resistance syndromes, such as type 2 diabetes, because of its additional uricosuric effect.
In 2003, a systematic review summarized the benefits of statins in patients with diabetes.4 In the increasing worldwide challenge to reduce morbidity and mortality from diabetes, the FIELD study shows that fenofibrate may have beneficial effects on microvascular disease and reduce risk of macrovascular events while improving lipid profiles.
Another research study by department of Cardiology in Korea and National Institutes of Health, Bethesda, Maryland suggested that fenofibrate combined with candesartan improves endothelial function and reduces inflammatory markers to a greater extent than monotherapy in hypertriglyceridemic hypertensive patients. Fenofibrate, combined therapy, and candesartan significantly increased plasma adiponectin levels and insulin sensitivity relative to baseline measurements.
Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomized controlled trial, Lancet 2005 concluded their study and suggested that in patients with type 2 diabetes mellitus; long term fenofibrate therapy did not reduce major coronary events but may reduce total cardiovascular disease events.
Recently a new study suggested a dual beneficial effect of Lofibra and TriCor (Fenofibrate) and reported that among patients with type 2 diabetes, fenofibrate therapy is associated with a significant reduction in the need for laser surgery for retinopathy over a 5-year period, compared with placebo treatment.
In the Fenofibrate Intervention and Event-Lowering in Diabetes (FIELD) trial, 9,795 patients between the ages of 50 and 75 years old with type 2 diabetes were randomly assigned to treatment with fenofibrate or placebo.
The results were presented here at the American Heart Association's Scientific Sessions 2007 by Dr. Anthony Keech of the University of Sydney in Australia. Fenofibrate, also known by the trade names Lofibra and TriCor, is a cholesterol-lowering drug designed to reduce the fat accumulation along the walls the arteries.
As the patients were followed, the researchers looked for signs of diabetic retinopathy, which often occurs as the disease progresses and the small blood vessels in the eye that supply the retina begin to deteriorate. Tiny hemorrhages occur, the vessels leak and swell, resulting in the progressive loss of vision.
After 5 years of follow-up, "there was a 31 percent reduction in risk of laser surgery with fenofibrate therapy," Keech told Reuters Health. Specifically, 3.4 percent of patients receiving fenofibrate and 4.9 percent receiving the placebo required laser surgery for retinopathy.
In a subset of 1,012 patients who had retinopathy at the beginning of the trial, 9.6 percent on fenofibrate required laser surgery compared with 12.3 percent of those on placebo, for a similar reduction in risk compared with the group as a whole, Keech added.
The results of the FIELD study are being released online by The Lancet to coincide with Keech's meeting presentation. "These results are very striking," Keech said. "Laser surgery isn't curative and it leaves a scar. In contrast, fenofibrate appears to slow disease progression," he noted.
"The benefit (with fenofibrate) is very rapid, occurring within eight months," he added. While the benefits were greatest in patients with good blood sugar control, there was still some gain in those with higher than normal blood sugar levels.
This suggests that fenofibrate's mechanism of action is completely different from the system that keeps blood sugar in balance, he commented. "It may have an anti-inflammatory or an antioxidant effect." Animal studies have shown that the drug reduces the death of the cells that line the inside of the retinal vessels.
"The finding on the reduction in need for laser surgery (with fenofibrate) is most likely going to change the way diabetics are managed," Keech predicted.
The FIELD study is endorsed by the National Heart Foundation of Australia, Diabetes Australia, and the New Zealand Society for the Study of Diabetes and the Finnish Diabetes Association. The FIELD study was conducted at 63 sites in Australia, Finland and New Zealand and was coordinated independently of the sponsors by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia, Laboratories Fournier SA, of Dijon, France, sponsored FIELD and supplied fenofibrate and matching placebo medication.
Atherosclerosis is the most common complication of diabetes. Correction of hyperglycemia helps to prevent microvascular complications but has little effect on macrovascular disease. According to Pubmd, "treatment with fenofibrate reduces the angiographic progression of coronary-artery disease in type 2 diabetes". Also suggested Fenofibrate significantly changed lipoprotein levels and improved the percent flow-mediated dilator response to hyperemia as well as lowered levels of tumor necrosis factor-alpha (TNF-alpha), fibrinogen, and plasminogen activator inhibitor type 1 antigen.
Britain’s Heart Protection Study (HPS), one of the first with a large number of diabetic subjects, reported that simvastatin reduced the risk of heart attacks, strokes and need for revascularization by one-third in diabetics. The HPS, which Keech also helped design and coordinate, was the first randomized statin study with a large number of diabetic patients. Its results indicated that even diabetics with normal cholesterol levels and no obvious heart disease could benefit from taking statins. That prompted doctors around the world to prescribe statins to their diabetic patients.
According to lead researcher, Melanie Green Cree at the University of Texas Medical Branch, Galveston concluded that improving fat metabolism with fenofibrate, which is traditionally used to lower plasma triglycerides, would improve the insulin sensitivity. There is conflicting data about the relationship between glucose and fat metabolism. However, acute burn trauma
seriously affects both glucose and fat metabolism, and our results show that by increasing cell mitochondrial fat metabolism with fenofibrate (marketed as Tricor by Abbott Laboratories), glucose metabolism can also be improved,
Several studies have shown that fenofibrate enhances the toxic effect of ultraviolet (UV) radiation from the sun, which might result in side effects such as skin rashes. Taking fenofibrate together with food dramatically increases the absorption of the drug.4 Therefore fenofibrate should be taken with a meal.Detailed information of the eye is helpful to ophthalmologists monitoring patients with diseases like age-related macular degeneration or diabetic retinopathy. In addition to getting an annual eye exam, be alert to any sudden changes in your vision.
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