Category Archives: Blood Pressure

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.”

Advertisements

Treating High Blood Pressure With Radio Waves

Researchers at Baker IDI Heart and Diabetes Institute in Melbourne will this week publish the results of a world-first trial of a new minimally invasive procedure for the treatment of difficult-to-treat high blood pressure by using radio waves.

In the first international randomized controlled trial of the technology, sympathetic nerves leading into and out of the kidneys were silenced using radio frequency energy emitted by a catheter device inserted into the renal arteries through the groin.

The Symplicity Catheter System – the device used to perform renal denervation – has now received TGA approval in Australia and it is anticipated that it will be available for routine clinical application within the next 12 months.

Known as ‘renal denervation’, this minimally invasive day procedure has been proven to be extremely effective in reducing blood pressure in patients with uncontrolled blood pressure – that is, blood pressure that is not responsive to medication.

Research has shown that each incremental 20/10 mmHg increase of blood pressure above normal levels is associated with a doubling of cardiovascular mortality over a 10 year period and that reducing systolic blood pressure by as little as 5 mmHg can reduce the risk of stroke by almost 30 per cent.

Professor Murray Esler, Associate Director, Cardiovascular Neurosciences at Baker IDI was the Chief Investigator for the international trial which involved 106 randomized patients in Europe and Australia across 24 separate sites.

In a presentation to the American Heart Association this week, Professor Esler will discuss the results of the trial. The key finding, which will be published simultaneously in The Lancet, was that the procedure resulted in an average blood pressure reduction of 33/11mmHg when compared to the control group that did not undergo the procedure.

The procedure is highly effective with 84 per cent of patients who underwent renal denervation experiencing a reduction in systolic blood pressure by more than 10 mmHg. The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.

Hypertension is the biggest killer worldwide with around 7.1 million deaths per year directly attributed to uncontrolled blood pressure. In Australia, between 25 to 30 per cent of the adult population is affected by high blood pressure and about half of those patients’ blood pressure is not controlled to target through medication.

Commenting on the trial, Professor Esler said; “Combined with findings from the earlier Symplicity HTN-1 study, which demonstrated the safety and durability of the therapy out to two years, these results, show that this procedure has the potential to become a truly revolutionary treatment with the scope to significantly impact the standard of care for the large number of patients suffering from uncontrolled blood pressure.”

Principle investigator Professor Markus Schlaich of Baker IDI said; “Hypertension often has no symptoms yet significantly increases a patient’s risk of heart attack, stroke or death.

“We know the renal sympathetic nerves play a crucial role in blood pressure elevation and this study proves they can be specifically targeted with our novel approach. Renal denervation is a safe, quick and minimally invasive procedure that leads to a substantial and sustained blood pressure reduction without major side effects. ”

In addition to hypertension, the therapy may hold promise for treating heart failure, diabetes and chronic kidney disease, conditions also characterised by elevated sympathetic nerve activity.

About the Symplicity Catheter System
The Symplicity Catheter System is used to perform a procedure termed renal denervation (RDN). In a straightforward endovascular procedure, similar to an angioplasty, the physician inserts the small, flexible Symplicity Catheter into the femoral artery in the upper thigh and threads it into the renal artery. Once in place within the renal artery, the device delivers low-power RF energy to deactivate the surrounding renal sympathetic nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is often the cause of chronic hypertension. The one-time procedure aims to permanently reduce blood pressure. RDN may also allow patients to reduce or eliminate the need for lifelong antihypertensive medications.

For more information, visit http://www.ardian.com/patients/symplicity.shtml

SOURCE: Baker IDI Heart and Diabetes Institute

Diabetes: Understanding Proteinuria

Proteinuria—also called albuminuria or urine albumin—is a condition in which urine contains an abnormal amount of protein. Albumin is the main protein in the blood. Proteins are the building blocks for all body parts, including muscles, bones, hair, and nails.

Proteins in the blood also perform a number of important functions. They protect the body from infection, help blood clot, and keep the right amount of fluid circulating throughout the body.

As blood passes through healthy kidneys, they filter out the waste products and leave in the things the body needs, like albumin and other proteins. Most proteins are too big to pass through the kidneys’ filters into the urine. However, proteins from the blood can leak into the urine when the filters of the kidney, called glomeruli, are damaged.

Proteinuria is a sign of chronic kidney disease (CKD), which can result from diabetes, high blood pressure, and diseases that cause inflammation in the kidneys. For this reason, testing for albumin in the urine is part of a routine medical assessment for everyone. Kidney disease is sometimes called renal disease.

If CKD progresses, it can lead to end-stage renal disease (ESRD), when the kidneys fail completely. A person with ESRD must receive a kidney transplant or regular blood-cleansing treatments called dialysis.

Who is at risk for proteinuria?
People with diabetes, hypertension, or certain family backgrounds are at risk for proteinuria. Indeed, diabetes is the leading cause of ESRD. In both type 1 and type 2 diabetes, albumin in the urine is one of the first signs of deteriorating kidney function. As kidney function declines, the amount of albumin in the urine increases.

Another risk factor for developing proteinuria is hypertension, or high blood pressure. Proteinuria in a person with high blood pressure is an indicator of declining kidney function. If the hypertension is not controlled, the person can progress to full kidney failure.

What are the signs and symptoms of proteinuria?
Proteinuria has no signs or symptoms in the early stages. Large amounts of protein in the urine may cause it to look foamy in the toilet. Also, because protein has left the body, the blood can no longer soak up enough fluid, so swelling in the hands, feet, abdomen, or face may occur. This swelling is called edema. These are signs of large protein loss and indicate that kidney disease has progressed. Laboratory testing is the only way to find out whether protein is in a person’s urine before extensive kidney damage occurs.

Several health organizations recommend regular urine checks for people at risk for CKD. A 1996 study sponsored by the US National Institutes of Health determined that proteinuria is the best predictor of progressive kidney failure in people with type 2 diabetes. The American Diabetes Association recommends regular urine testing for proteinuria for people with type 1 or type 2 diabetes. The National Kidney Foundation recommends that routine checkups include testing for excess protein in the urine, especially for people in high-risk groups.

What are the tests for proteinuria?
Until recently, an accurate protein measurement required a 24-hour urine collection. In a 24-hour collection, the patient urinates into a container, which is kept refrigerated between trips to the bathroom. The patient is instructed to begin collecting urine after the first trip to the bathroom in the morning. Every drop of urine for the rest of the day is to be collected in the container. The next morning, the patient adds the first urination after waking and the collection is complete.

In recent years, researchers have found that a single urine sample can provide the needed information. In the newer technique, the amount of albumin in the urine sample is compared with the amount of creatinine, a waste product of normal muscle breakdown. The measurement is called a urine albumin-to-creatinine ratio (UACR).

A urine sample containing more than 30 milligrams of albumin for each gram of creatinine (30 mg/g) is a warning that there may be a problem. If the laboratory test exceeds 30 mg/g, another UACR test should be done 1 to 2 weeks later. If the second test also shows high levels of protein, the person has persistent proteinuria, a sign of declining kidney function, and should have additional tests to evaluate kidney function.

What additional tests for kidney disease may be needed?
Tests that measure the amount of creatinine in the blood will show whether a person’s kidneys are removing wastes efficiently. Having too much creatinine in the blood is a sign that a person has kidney damage. The doctor can use the creatinine measurement to estimate how efficiently the kidneys are filtering the blood. This calculation is called the estimated glomerular filtration rate, or eGFR. CKD is present when the eGFR is less than 60 milliliters per minute (mL/min).

What should a person with proteinuria do?
If a person has diabetes, hypertension, or both, the first goal of treatment will be to control blood glucose, also called blood sugar, and blood pressure. People with diabetes should test their blood glucose often, follow a healthy eating plan, take prescribed medicines, and get the amount of exercise recommended by their doctor.

A person with diabetes and high blood pressure may need a medicine from a class of drugs called angiotensin-converting enzyme (ACE) inhibitors or a similar class called angiotensin receptor blockers (ARBs). These drugs have been found to protect kidney function even more than other drugs that provide the same level of blood pressure control. Many patients with proteinuria but without hypertension may also benefit from ACE inhibitors or ARBs. The American Diabetes Association and the American College of Cardiology recommend that people with diabetes keep their blood pressure below 130/80.

People who have high blood pressure and proteinuria, but not diabetes, also benefit from taking an ACE inhibitor or ARB. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommends that people with kidney disease keep their blood pressure below 130/80. To maintain this target, a person may need to take a combination of two or more blood pressure medicines. A doctor may also prescribe a diuretic in addition to an ACE inhibitor or ARB. Diuretics are also called “water pills” because they help a person urinate and get rid of excess fluid in the body.

In addition to blood glucose and blood pressure control, the National Kidney Foundation recommends restricting dietary salt and protein. A doctor may refer a patient to a dietitian to help develop and follow a healthy eating plan.

Points to Remember
Proteinuria is a condition in which urine contains a detectable amount of protein.

Proteinuria is a sign of chronic kidney disease (CKD).

Groups at risk for proteinuria include people with diabetes or hypertension, and people who have a family history of kidney disease.

Proteinuria may have no signs or symptoms. Laboratory testing is the only way to find out whether protein is in a person’s urine.

Several health organizations recommend regular checks for proteinuria so kidney disease can be detected and treated before it progresses.
A person with diabetes, hypertension, or both should work to control blood glucose and blood pressure.

Source: National Kidney & Urologic Diseases Information Clearinghouse (NKUDIC)

News Updates: Getting To The Bottom Of Diabetes Management

Even as us diabetics suffer from a cramped lifestyle more than anything else, there comes news of esoteric research that brings good cheer to our sullen lot.

One such item caught my eye in the Times of India today. It seems that big bottom is good for you because it raises the levels of good cholesterol that protects against hardening of arteries and also cuts the risk of diabetes.

The IANS report said scientists also claim that people with lots of moles are years younger biologically than those with mark-free skin. They may retain their youthful looks for longer and could also be at lower risk of a host of age-related diseases, such as heart disease or osteoporosis.

One of the studies shows having a generous rear end rather than a pot belly, cuts levels of bad cholesterol and raises levels of good cholesterol that protects against hardening of arteries and also cuts the risk of diabetes.

Studies have also linked short legs to higher levels of liver and heart disease and diabetes.

Good news is also for those who store fat on the lower half of their body as chunky thighs prolong life.

So there you are. While thin people like me have much to gain in our diabetes management, our well endowed friends can raise a toast to breakthough research that may make our lives less miserable.

# I have been reporting tainted killer diabetes drug Avandi which was been put on watch after a series of damning studies that made two US Senators publish a highly critical report on Avandia. A Food and Drug Administration advisory panel will consider possible further restrictions on the drug next month.

Meanwhile, Reuters reported that pharma giant GlaxoSmithKline Plc has settled thousands more lawsuits brought by patients alleging its Avandia diabetes drug caused heart attacks, in a move that may defuse potentially massive claims over the medicine.

A company spokeswoman said on Tuesday that consolidated cases which had been due to come to court in Philadelphia this month had been settled. She declined to give further details and said the terms remained confidential.

The first product liability case involving Avandia will now go to court in the United States in October, she added.

The move follows the separate settlement of some 700 cases last month for about $60 million.

Analysts estimate Glaxo had faced a total of 13,000 claims for damages involving Avandia, of which around 5,000 were consolidated in Philadelphia, and there had been fears it could face damages of up to $6 billion.

However, last month’s relative modest settlement deal and the latest settlement in Philadelphia suggests the amount paid out by the British-based drugmaker is likely to be a lot lower.

“This implies that close to half of the cases have now been settled and should ease some fears about Vioxx-type liabilities,” said Deutsche Bank analyst Mark Clark.
He believes the cost is likely to be comfortably covered by the company’s 2 billion pounds ($2.9 billion) of litigation provisions.

And the total could be a lot less than that. Assuming the average pay-out rate of around $86,000 per claimant for the first 700 cases was applied to all 13,000, the amount would be just over $1.1 billion.

Merck & Co Inc agreed a $4.85 billion settlement with plaintiffs in 2007 after its arthritis pain drug Vioxx was pulled from the market in 2004.

Commercially, Avandia is no longer a major product for Glaxo, with sales declining sharply following controversy over the drug’s heart risks in 2007, and the medicine is set to lose exclusivity in the United States in 2012. But worries about liability claims have spiked up since February.

Diabetic Neuropathy: No Clear Answers

Do high glucose levels cause neuropathy? That’s an issue that worries most diabetics. And unfortunately there are no clear answers.

Experts think of blood glucose values as a spectrum of numbers with no clear cutoff between nondiabetic and diabetic. In similar manner, there is a gray area of blood glucose that defines pre-diabetes. Many people use blood sugar and blood glucose interchangeably.

The definition of diabetes has changed over time. The numbers you quote might very well be considered diagnostic of diabetes today whereas they were not 20 years ago. In 1997, the American Diabetes Association definition of normal blood glucose decreased from 120 to 110 mg/dL (6.1 mmol/L). In 2002, the American Diabetes Association defined a normal fasting blood glucose as less than 100 mg/dL (5.6 mmol/L).

Today we consider fasting blood sugars of 100 mg/dl to 125mg/dl to be in the realm of glucose intolerance which is sometimes called pre-diabetes. These patients are at increased risk for developing frank diabetes. Several fasting glucose levels over 125 or a single random glucose over 200 mg are considered diagnostic of diabetes.

There are other tests used to make the diagnosis of pre-diabetes or diabetes. Pre-diabetes is defined as a blood sugar of 140 to 199 mg/dL (7.8 to 11.0 mmol/L) two-hour after drinking 75 grams of an oral glucose solution. The diagnosis of diabetes is confirmed with a blood sugar of 200 mg/dL or greater, two hours after ingestion of the glucose solution.

Hemoglobin A1C is a blood test that gives an estimate of blood sugar levels over the previous three months. Persons with a value of 5.7 to 6.4 percent are thought to have pre-diabetes. Those with a value of 6.5 percent or higher are considered diabetic.

About 30 percent of patients with frank diabetes for more than a decade have some neuropathy. It usually presents as numbness, itching or tingling in the legs but can also be pains. It can even present as digestive problems such as difficulty digesting food or diarrhea due to problems with nerves in the bowels.

Most diabetic neuropathy is caused by peripheral artery disease, in which the small blood vessels are obstructed or partially obstructed and cannot carry oxygenated blood to areas of the body. These areas have pain or other difficulties due to the lack of oxygen.

It is very possible for someone with numbers that are considered pre-diabetes to have some of the complications of diabetes This is especially true of big vessel disease such as myocardial infarction (heart attack), stroke and peripheral vascular disease. Retinopathy, neuropathy and kidney disease are rarer in pre-diabetics but can occur, especially in someone who has pre-diabetes and hypertension (high blood pressure).

The condition of pre-diabetes combined with hypertension is often referred to as the “metabolic syndrome.” Elevated cholesterol and triglyceride combined with diabetes and hypertension increases risk of neuropathy even further. Of note, there are some nondiabetics with neuropathy and peripheral vascular disease caused by elevated cholesterol and triglycerides only.

It is prudent that you have a relationship with a physician who will measure not just blood sugar, but cholesterols, triglycerides and blood pressure. He or she may decide that lowering your blood sugars through diet or medication or both might be beneficial for your long-term health. Lowering blood sugar can sometimes even better the pain of diabetic neuropathy.

Many pre-diabetics and diabetic patients are also treated for cholesterol and triglyceride problems and get a baby aspirin daily to decrease risk of heart disease. There are also a number of treatments for pain caused by neuropathy.

In addition to having the above tests, people with pre-diabetes and diabetes should get an annual eye examination to rule out early diabetic retinopathy. Diabetic retinopathy is treatable and is the most common cause of blindness.

It is also prudent to examine the feet for wounds that the patient might not appreciate due to loss of sensation as a part of diabetic neuropathy. Assessment of kidney function and some studies of the heart and vascular system may also be called for.

By the way, there are other causes of peripheral neuropathy. Not uncommon are amyloidosis, which is a disease in which excess protein is deposited in nerve tissue, and vasculitic neuropathy, a rheumatologic disease in which the patient has inflammation near the nerve.

Also we must consider alcoholic neuropathy in someone with an extreme drinking history and even lead poisoning as a possible cause. Patients who have been treated with chemotherapy for cancer and some rheumatologic diseases can also get some painful neuropathies.

Thank you Dr Otis Brawley

%d bloggers like this: