Thursday September 13, 2007 (Foodconsumer.org) -- Avandia or rosiglitazone may dramatically increase risk of heart attack and heart failure in diabetes patients while its rival Actos seems able to reduce the risk, according to two studies published in the September 12th issue of Journal of American Medical Association.

The first study led by Sonal Singh, M.D. at the Wake Forest University School of Medicine, Winston-Salem, N.C. and colleagues analyzed data from four randomized trials involving 14,291 type 2 diabetes patients who were followed one to four years.

The researchers found Avandia increased risk of heart attack by 42 percent and doubled the risk of heart failure in diabetes patients compared to the risk for those who received a control therapy.  But they found no association between use of the drug and risk of cardiovascular death.

“Regulatory agencies ought to reevaluate whether Avandia should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using Avandia in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,” the authors conclude.

In the second study, A. Michael Lincoff, M.D., at the Cleveland Clinic and colleagues analyzed data from 19 randomized trials involving 16,390 diabetes patients who were followed for four months to 2.5 years.

The researchers found 4.4 percent of those who were on Actos had a cardiovascular event such as heart attack, stroke or death in diabetes patients compared to 5.7 percent for the controls, meaning use of Actos led to an 18 percent reduction in the cardiovascular risk.

“These findings suggest that the net clinical cardiovascular benefit with Actos therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,” the authors write.

Sonal Singh later today published his comment on www.news.google.com on the reports of his study cited in verbatim as follows:

Our paper entitled Long-term Risk of Cardiovascular Events with Rosiglitazone - A Systematic review and Meta-analysis in the September 12th issue of JAMA is a rigorous analysis of the composite cardiovascular risk (heart attack, heart failure and cardiovascular death) of rosiglitazone(Avandia(r)) in long-term (> 1 year) trials in patients with type 2 diabetes in which these effects were monitored.

Four studies involving more than 14,000 patients found that long-term use of the diabetes drug rosiglitazone (Avandia(r)) increased the risk of heart attack by 42 percent and more than doubled the risk of heart failure compared to other oral hypoglycemic agents. We estimate that for every 220 diabetic patients treated with Avandia(r) for one year, one will have an additional heart attack linked to the drug. There would be one additional case of heart failure for every 30 people taking the drug for one year. The public health impact of these harms among millions of Avandia(r) users in the United States is substantial (conservative estimate of at least 4000 excess MIs and 9,000 excess heart failure events linked to Avandia(r) each year).

In addition, Avandia(r)has also shown been shown to double the risk of fractures in women with type 2 diabetes (who are already at a heightened risk of fractures) in several clinical trials. Avandia (r) has also been linked to numerous cases macular edema, a serious condition which can lead to blindness in spontaneous reports submitted to agencies in the US and Canada. Avandia(r) also causes serious weight gain and fluid retention.

There is no clinical trial evidence that Avandia(r) induced blood sugar control reduces any of the complications of diabetes mellitus. The composite evidence of harm from heart failure, heart attack, fractures in women, and blindness caused by Avandia and the availability of cheaper, more efficacious alternatives, which reduce the complications of diabetes ( eg metformin or sulfonylureas), without these serious long-term harmful effects, means that rosiglitazone should be avoided in diabetic patients at risk of heart disease.

The Avandia study finds patients with type 2 diabetes or impaired glucose tolerance who take the medication Avandia (rosiglitazone) appear to be at increased risk for a heart attack or heart failure.

Early in August, Dr. David Graham, a Food and Drug Administration drug safety reviewer and Dr. Sidney Wolfe of Public Citizen gave testimonies in front of the FDA advisory panel and urged the panelists to recommend withdrawal of the dangerous diabetes drug from the market.

Dr.    Graham said withdrawal of Avandia could save thousands of lives a year.    And another drug (Actos?) that is much safer than Avandia is available for dietetics.    Dr.   Wolfe listed a variety of dangers associated with use of Avandia.

The risk of heart failure associated with Avandia was 15.2 times higher compared to an old diabetes drug Glucotrol, reported Consumer Affairs citing Wolfe's testimony.    The risk of liver toxicity associated with Avandia was 9.5 times higher and liver failure risk was 14.8 times higher in dietetics who used Avandia.

According to news reports, the FDA advisory committee rejected the recommendations of Dr. Graham and Dr. Wolfe, believing that the diabetes drug Avandia should remain on the market.

We compiled the following nutrition basics for diabetes patients as well as those who want to prevent or treat diabetes just in case some of them might be interested.

Nutrition basics for diabetics

Biotin: Biotin is involved in glucose metabolism and deficiency of it results in ill-utilization of glucose.    Lower levels of biotin were found in insulin dependent diabetics than non-diabetic people. Supplementation of biotin reduced blood glucose levels in insulin-dependent diabetics.    Active yeast, wheat bran, cooked liver, cooked egg, avocado and raw cauliflower are rich in biotin.

Bitter melon:    Bitter melon or otherwise known as bitter gourd is rich in a variety of nutrients including calcium, potassium, vitamin C, B1 to 3, phosphorus and dietary fiber.    In Asia, bitter melon is widely used to treat diabetes.    Studies found the fresh juice of the unripe bitter melon can lower blood sugars.

Chromium supplements:    Studies showed this supplement improved glucose utilization in people with impaired glucose tolerance, which is associated with elevated risk of heart disease, but not other complications that commonly occur with diabetes.    Broccoli, spices, green beans, ready to eat bran cereals, whole grams and processed meats are relatively rich in this element.

Coffee:    The majority of early studies suggested that higher intake of coffee may significantly reduce risk of type 2 diabetes mellitus. In one study, men who drank six cups or more of coffee daily had their risk reduced by 54 percent. The risk reduction for women who drank this much of coffee was 29 percent compared to women who did not drink.

Foods with low glycemic load:    Diabetes people should use low glycemic index foods.    Foods with a high glycemic index generate glucose rapidly, which would demand the system to produce high levels of insulin and cause loss of the insulin-secreting function of the pancreatic beta-cells.    One study showed women with the highest dietary glycemic loads were 37 percent more likely to develop type diabetes 2 during a six-year period.

Foods with trans fat and saturated fat:    Studies showed that both saturated fat and tarns fat are implicated in diabetes mellitus.    These fats can affect the pancreatic beta-cells.    Diabetics should try hard enough to avoid as much of these fats as possible.    Particularly trans fat, which is known to be implicated in heart disease and possibly kill tens of thousands each year in the United States.

Dietary fiber:    Using foods that lack fiber has been linked with increased prevalence of diabetes mellitus.    Prospective cohort studies showed diets with lots of fiber from whole grains were linked with reduced risk of developing type 2 diabetes mellitus.    Trials showed increased intake of fiber lowered the risk of developing type diabetes with impaired glucose tolerance.

Fruits and vegetables:    A diet rich in fruits and vegetables which provide tons of beneficial nutrients was linked with reduced risk of developing diabetes and improved blood glucose control.    One study showed those who consumed at least five servings of fruits and vegetables per day during a period of 20 years had their risk of diabetes reduced by 20 percent.

Beans:    Beans or also known as legumes including dry beans, peas and lentils are with low glycemic indices, which are friendlier to the pancreas than foods with high glycemic indices. Use of more beans means use of less foods with a high glycemic index, which would otherwise cause excessive blood glucose burden and excessive demand for insulin secretion.    Low glycemic load diets have been linked with reduced risk of developing type 2 diabetes.

Magnesium:    Many diabetics lose magnesium through urine because of poor control of diabetes and glucose levels.    Magnesium supplements at 400 mg per day were found effective in improving glucose tolerance in the elderly.    Magnesium was found to increase insulin resistance.

Alcohol:    Moderately drinking alcohol was found associated with lower risk of developing type 2 diabetes compared to those who did not drink while heavy drinking increased the risk.    Moderate drinking of alcohol was also linked with decreased blood insulin levels and improved insulin sensitivity.    But because alcohol is implicated in many adverse conditions or illnesses, those who do not drink should not start drinking.

Nuts:    Nuts are full of oil and proteins and have relatively lower levels of sugars and starch.    So nuts are generally friendly to diabetics.    One study known as the Nurses' health Study showed an inverse correlation between consumption of peanut butter and the risk of type 2 diabetes in women.    The study found those ate one ounce of nuts five times or more per week during the 16-year study were 27 percent less likely to develop type two diabetes mellitus.    But those who are allergic to nuts should not even try eating any.

Fish oil:    Fish oil is well known for its beneficial omega 3 fatty acids.    At least one study suggested that eating fatty fish or taking fish oil supplements may reduce risk of death from heart disease, which is the major cause of death for diabetics.    The study found that those who ate high amounts of fish were significantly less likely to suffer from coronary heart disease over the 16-year study period.    Omega fatty acids such as DHA and EPA which are present abundantly in fish oil provide many other health benefits.

Whole grains:    A few studies showed high intakes of whole grains were associated with reduced risk of type 2 diabetes mellitus.    One study found those who ate 3 daily servings of whole grain foods were 21 to 30 percent less likely to have type 2 diabetes.    The benefit may be due to the fact that the whole grain foods have low glycemic indices.

Diabetics need to know not only what they can eat, but also need to know what they should avoid.    Foods that have lots of sugars or that can release glucose rapidly should be avoided.   Diabetics should also reduce their dietary fat and meat to preferably around 10 percent.   In the U.S., the average intakes of fat and meat are 30 percent of total calories and 16 percent of total calories, respectively.

At least one study led by Frank B. Hu. M.D. at Harvard School of Public Health in Boston and colleagues found that high dietary fat and meat intake may increase risk of type 2 diabetes in men.   Their results were published in Diabetes Care 25:417-424, 2002.