Diabetes Management: Tight Cholesterol, BP Control Does Little Good for Diabetics

Lower isn't always better in diabetes management. In fact, pushing too hard may not help, and may actually hurt in some cases. This has been proved, once again, by the landmark Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, results released last week reveal. Indeed, the new lipid and blood pressure results round out the negative portrait of aggressive risk factor management in diabetes patients.

(ACCORD is one of the largest studies ever conducted in adults with type 2 diabetes who were at especially high risk of cardiovascular events, such as heart attacks, stroke, or death from cardiovascular disease. The multicenter clinical trial tested three potential strategies to lower the risk of major cardiovascular events: intensive control of blood sugar, intensive control of blood pressure, and treatment of multiple blood lipids. The lipids targeted for intensive treatment were high density lipoprotein (HDL) cholesterol and triglycerides, in addition to standard therapy of lowering low density lipoprotein (LDL) cholesterol. Read the Questions & Answers about the ACCORD Trial here.)

According to received wisdom, intensive blood pressure and blood fat management could drive down diabetics' higher risks of heart problems. But results from the ACCORD trial prove that when it comes to traditional measurements of heart disease risk, a blood pressure target of 120 mm Hg rather than the general population standard of 140 did not reduce nonfatal heart attacks, nonfatal strokes or death from cardiovascular causes.

Likewise, adding the cholesterol-busting drug fenofibrate to standard statin therapy did not reduce the chances of major adverse cardiovascular events. Indeed, tribal behavior by physicians that is no doubt driven by the big pharma marketing machinery, has raised concerns about the ramifications of recommending costly medications that don't confer real benefits to patients. (See my post ‘Increased Use of Fibrates in US Could Be A Triumph Of Marketing Over Medicine' here.)

Both studies ‒ part of the complex ACCORD trial ‒ were presented at the American College of Cardiology meeting in Atlanta, Ga. and released simultaneously online in the New England Journal of Medicine.

[A third part of this research ‒ one which examined intensive lowering of blood sugar to see if this had a positive effect ‒ was prematurely halted in 2008 because it turned out that patients receiving this approach actually had an increased, instead of decreased, risk of death. (See a related post ‘Aggressive Diabetes Therapy May Raise Death Risk’ here.)]

As for the newly released findings, the lipid arm of ACCORD included 5,518 patients with high risk of heart problems because of cardiovascular disease or at least two risk factors. LDL, or bad, cholesterol levels had to be between 60 and 180 mg/dL; HDL, or good cholesterol, levels had to be under 50 mg/dL or 55 mg/dL for women and blacks; and triglycerides had to be under 750 mg/dL if the patients were not on any therapy, or 400 mg/dL otherwise. Patients either received fenofibrate or a placebo in addition to statins.

What the researchers found was that lipid and triglyceride levels responded as expected. Despite this, however, the patients appeared to receive no benefit when it came to major heart problems such as heart failure, stroke and nonfatal heart attacks.

Meanwhile, the blood pressure portion of ACCORD compared a strategy of keeping systolic blood pressure under 120 mm Hg to one of under 140 mm Hg in 4,733 diabetes patients with high risk of cardiovascular events because of clinical or subclinical heart disease or at least two risk factors. In this trial, treatment effectively lowered blood pressure. But again, there was no impact on aspects of patient health including death risk, death related to heart problems and nonfatal heart attacks.

ABC News reported that the U.S. Food and Drug Administration will conduct a full review of findings from the ACCORD study. An FDA spokesperson said the agency planned to include a review of the labeling and indications for fenofibric acid (Trilipix) ‒ even though the trial used fenobrate (TriCor). Asked about the timing of the announcement, the spokesperson said the FDA was attempting to be more proactive.

Both Trilipix and TriCor are marketed by Abbott, and Trilipix is "the active metabolite of TriCor," according to Dr. Marshall Elam of the Memphis VA Medical Center. Elam, who was involved in the design of the lipid treatment arm of ACCORD said that "neither TriCor nor Trilipix has a label indication for cardiovascular disease."

In a statement released after the ACCORD results were reported, but before the FDA said it would conduct a review of the ACCORD findings, Abbott said the data from the ACCORD Lipid trial "supports the appropriate patient type and current treatment guidelines for fibrates. The top-line results of the study were widely expected, given that two-thirds of patients in the trial would not be recommended for fibrate therapy under current guidelines."

Wake-up Call: 50% Adult Americans Face Serious Health Risk

Nearly 50 percent of all adult Americans have high cholesterol, high blood pressure or diabetes. All conditions increase the risk of cardiovascular disease. Diabetics, of course, are at greater risk of having the other two conditions as well, and heart disease is one of the most common complications resulting from poor diabetes management.

A report released online Monday by the national Centers for Disease Control and Prevention said nearly 13 percent Americans have at least two of the conditions and three percent have all three, sharply increasing their risk. Of those with at least one condition, 15 per cent have not been diagnosed.

(Diabetes affects 8.3 percent of Americans of all ages, and 11.3 percent of adults aged 20 and older, according to the National Diabetes Fact Sheet for 2011. About 27 percent of those with diabetes—7 million Americans—do not know they have the disease. Prediabetes affects a whopping 35 percent of adults aged 20 and older.)

"The number that really surprises me is the penetration of these conditions into the U.S. population," said Dr. Clyde Yancy of Baylor University Medical Center, president of the American Heart Association. "When that number is nearly 50%, that's a huge wake-up call." It means there are a large number of people "who think they are healthy…but are working under a terrible misconception."

The data come from the ongoing National Health and Nutrition Examination Survey, which releases new figures every two years. The survey consists of interviews conducted in participants' homes, standardized physical examinations given to some participants and laboratory tests using blood and urine specimens.

"This report is so timely and important because it crystallizes exactly what the burden is," Yancy said. "It tells us the challenge we now face that could stress and potentially defeat any healthcare system we could come up with."

Personal responsibility plays a big role in creating these three health problems, he said. "This trio begins with a quartet of smoking, a junk diet, physical inactivity and obesity. Those are all things we can do something about."

Though researchers should be able to use the new data to plan interventions, "the main thing here is for people to be aware that they have these conditions and know that lifestyle modifications and medications can control them and reduce their risk for cardiovascular disease," said epidemiologist Cheryl D. Fryar of the CDC's National Center for Health Statistics, one of the study's authors.

Untreated Diabetes: Millions Risk Early Death Because of Poor Diagnosis and Ineffective Treatment

• In the United States alone, nearly 90% of adult diabetics – more than 16 million adults aged 35 and older – have blood sugar, blood pressure, and cholesterol that are not treated effectively, meaning they do not meet widely accepted targets for healthy levels of blood sugar, blood pressure, and cholesterol.

• In Mexico, 99% of adult diabetics are not meeting those targets.

• Up to 62% of diabetic men in Thailand are undiagnosed or untreated for diabetes. This translates to more than 663,000 people in that country.

A new study, published in the Bulletin of the World Health Organization's March edition, has found that millions of people worldwide may be at risk of early death from diabetes and related cardiovascular illnesses because of poor diagnosis and ineffective treatment.

The objective of the study was to examine the effectiveness of the health system response to the challenge of diabetes across different settings and explore the inequalities in diabetes care that are attributable to socio-economic factors.

Researchers at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, who examined diabetes diagnosis, treatment, and management in the US, Thailand, Mexico, Colombia, England, Iran, and Scotland have come to the conclusion that "too many people are not being properly diagnosed with diabetes and related cardiovascular risk factors. Those who are diagnosed aren't being effectively treated. This is a huge missed opportunity to lower the burden of disease in both rich and poor countries."

The percentage of diabetics in the seven countries studied who are reaching International Diabetes Federation treatment goals for blood glucose, blood pressure, and serum cholesterol is very low, ranging from 1% to 12%. The researchers conclude there are many missed opportunities to reduce the burden of diabetes through improved control of blood glucose levels and improved diagnosis and treatment of arterial hypertension and hypercholesterolaemia.

In an attempt to determine the cause of the low rates of diagnosis and effective treatment, researchers examined a range of factors and were surprised to find that “no large socio-economic inequalities were noted in the management of individuals with diabetes, financial access to care was a strong predictor of diagnosis and management.”

"We were very surprised to see that wealth did not have a big impact on diagnosis and treatment," said Dr. Emmanuela Gakidou, the paper's lead author and an Associate Professor of Global Health at IHME. "And in the three countries where we had health insurance data, we thought it was noteworthy that health insurance actually played a much bigger role than wealth, especially in the US."

In the US, people who had insurance were twice as likely to be diagnosed and effectively treated for diabetes as those who did not have insurance.

The researchers said the findings underscore the need for countries to tackle the growing problem of non-communicable diseases (NCDs) like diabetes, hypertension and cardiovascular diseases in part by gathering better data.

"We don't have enough data from actual physical exams to accurately document the trend in most countries," said Dr. Rafael Lozano, a co-author on the paper and a Professor of Global Health at IHME. "We looked at surveys from nearly 200 countries and only could find data on blood glucose, cholesterol, or blood pressure in seven. We hope that in the build-up to the UN Summit on NCDs this September, countries will make a commitment to more surveys that take blood samples from a representative percentage of the population."

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IHME researchers gathered data and performed their analysis in collaboration with researchers at the University of California, San Francisco, School of Medicine; the Harvard Global Equity Initiative; the National Institute of Public Health in Mexico; and Ramathibodi Hospital in Thailand.

For more information, please visit the IHME website 

All Diabetics Should Take Statins, Say Experts

The European Association for the Study of Diabetes (EASD) has recommended that all people suffering from diabetes should be taking statins, as research showed that the evidence for their effectiveness in reducing cardiovascular risk in diabetics, and even people without diabetes, is incontrovertible.

Professor John Betteridge, of University College London Medical School, pointed out at the EASD annual meeting in September 2010 that all people with diabetes should be taking statins to reduce their chances of having a heart attack or stroke, although he also warned that they should avoid any drug interactions with other medications being taken.

Betteridge has analysed a number of studies into the use of statins, such as the CollaborativeAtoRvastatin Diabetes Study (CARDS), funded by Diabetes UK, the Department of Health and Pfizer, which examined their benefits in people with type 2 diabetes who did not already have evidence ofcardiovascular disease .

In the CARDS study, atorvastatin 10mg/day was shown to reduce major cardiovascular events by 37 per cent and strokes by 48 per cent, reinforcing guidelines issued by the Joint British Society (JBS) regarding targets for low-density lipoprotein cholesterol in this high-risk group.

Betteridge argues that statins are safe if taken appropriately and drug interactions avoided, as they can lead to serious side effects, especially when patients are on a variety of drug treatments. Statins should also not be used by pregnant women at least six weeks before conception.

He realises that statins don’t always get a good press, and that many diabetics will be wary of this advice, but he points out that the evidence shows them to be highly effective in preventing major vascular events in patients with diabetes.

However, the idea of taking statins to offset the effects of junk food has been criticised by diabetes experts. New research had recommended that fast food outlets should give out free statin pills as a way of combating the impact of unhealthy food, as they can reduce the levels of bad cholesterol in the blood, which is why they are normally prescribed to decrease the risk of cardiovascular disease.

There are now worries that using statins could encourage people to lead unhealthier lives, eat more fast food and therefore increase the risk of developing type 2 diabets. Although studies have found that a single, cheap statin pill could offset the increased risk to the heart caused by the fat in a cheeseburger and a small milkshake, there are concerns that it is both irresponsible and dangerous to promote their use as a quick fix to counteract the effects of an unhealthy diet.

Zoe Harrison, Care Advisor at the charity Diabetes UK, said Statins can reduce the risk of cardiovascular disease by lowering the bad cholesterol in our blood which can be raised due to a high-fat diet. However, they don't prevent all the side effects that result from an excessive intake of fatty food.

Statins also have some serious side effects - such as damage to the liver, pancreas and muscles – which is why they should always be prescribed by your doctor who can then closely monitor how you are responding to the medication.

Here's an overview of Diabetes and Statins
Diabetes and statins have a complex relationship and are the focus of intense patient and healthcare debate. Statins are cholesterol-lowering drugs.

Statins are used in diabetes care due to the knowledge that people with diabetes face a greater likelihood of heart attack and stroke.

When used alongside good blood glucose control and other medication, the case for statins argues that they cut cholesterol levels and lower the risk of a cardiovascular event.

Type 2 diabetes in particular is certainly a disease of the circulatory system, and this argument has some weight.

How can I lower my risk of cardiovascular problems without taking statins?
There are many ways to lower your risk of stroke and cholesterol levels. These include stopping smoking and controlling your blood pressure. Diet and exercise can help to lower raised blood pressure, and a healthy lifestyle can cut cholesterol levels. However, some doctors prescribe statins to help reduce cholesterol levels.

What do statins do for people with diabetes?
Statins slow the action of the liver in manufacturing cholesterol, causing blood cholesterol levels to fall.

Do statins work for people with diabetes?
Statins definitely lower cholesterol, and major studies have shown that the risk of heart attack and stroke plummets amongst people with diabetes taking statins. Results indicate that statins can prevent cardiovascular disease by reducing heart attack and stroke risks.

What are the side effects of statins?
Statins are usually well-tolerated by people with diabetes. Side effects can include:

• Headaches

• Affect on liver function

• Stomach problems such as abdominal pain, constipation, flatulence, diarrhoea and vomiting

• Rashes

• Disorder of the muscles (myopathy)

Shouldn’t all people with diabetes therefore take statins?

Statins are the subject of current and ongoing healthcare debate when it comes to diabetes patients. Further research is in progress to make the wider use of statins in diabetes care more clear.

Often, people under 40 may not benefit from taking a statin.

A statin is also just one part of diabetes care and shouldn’t be used instead of good diet, exercise, smoking and excess drinking avoidance.

Source: diabetes.co.uk

Diabetics Who Suffer No Complications To Be Studied

What the current research provides is an admission that the fundamental mechanisms that create the environment for the development of diabetes complications are still very much unknown.

When one is diagnosed with diabetes, the patient is prepared to prevent and avoid the complications from the disease. There have been so many studies and research on diabetes complications. Now, researchers are looking at the problem from a different perspective since they have found diabetics who do not develop complications.

Now the question is, why don’t these diabetics develop complications? A new research is now being conducted to find out. This is called the PROLONG study and is focused on the nearly fifteen percent of all diabetics that live life complications free. The study is headed by Valeriya Lyssenko and Peter Nilsson from Lund University Diabetes Center.

What the current research provides is an admission that the fundamental mechanisms that create the environment for the development of diabetes complications are still very much unknown.

One aspect of the disease though that is very well documented is the damage that the disease wreaks on an individual’s blood vessels. Diabetes does not kill the individual but the complications often do. Among the top of the list of complications is cardiovascular disease, as diabetics have three times of the risk compared to non-diabetics. Smaller blood vessels are damaged. Nearly seventy percent of patients would have suffered from kidney damage leading to end stage renal failure. Many others suffer from eye complications with nearly two percent of these diabetics going blind eventually.

“The blood vessels and other organs of the body become sugar coated and stiff. It is reminiscent of premature biological ageing”, says Peter Nilsson.

The pilot study is being conducted in Skåne, Sweden and is projected to study diabetes patients for the next thirty years. They would be comparing complication developments in patients in specific timelines and observe those that do not develop complications during the whole duration.

Participants would be answering inquiries about their lifestyle and how the disease affects them. Also part of the study would be genetic testing, blood sampling and history reviews. The researchers believe that thirty years would be the turning point for a diabetic since the absence of complications beforehand would not develop complications during the remainder of their lives.

“If we can identify factors protecting these individuals from devastating complications, then it might be possible to develop drugs that can do the same thing,” said Valeriya Lyssenko, who will lead the study. “Clearly they are different and we want to find out what it is that protects them.”