Monthly Archives: March 2011

Mystery Mechanism Protects Some Diabetics From Developing Complications

WHY are some diabetics free of complications? Researchers are now asking the question the other way around. They want to know why some diabetic patients do not develop complications. What is protecting them? It seems some people with diabetes possess yet-unidentified factors that reduce the risk for and even prevent them from developing diabetes-related complications, despite living with the disease for decades.

If researchers can identify the mechanisms protecting these individuals ‒ who are clearly different because something protects them from devastating complications ‒ then it might be possible to develop drugs that can do the same thing.

I had reported end January that what 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. The small blood vessels are also damaged. Nearly 70 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.

Still, despite decades of intensive research on diabetes complications, the fundamental mechanisms are not yet fully known. Neither it is possible to prevent or treat the damage of the blood vessels that affects a majority of all diabetics.

“The blood vessels and other organs of the body are sugar coated and become stiff. It is reminiscent of a premature biological aging,” says Peter Nilsson of the Lund University Diabetes Centre in Sweden who isstudying diabetics with no complications in Sweden.

just-published study conducted by the Joslin Diabetes Center on people who have lived with type 1 diabetes for more than 50 years presents a strong case for the existence of a protective mechanism in some individuals that allows them to live relatively free of the problems typically associated with long-term duration of diabetes. These mechanisms, the study found, may be different for microvascular (such as kidney, nerve and eye disease) than macrovascular complications (such as heart disease).

press release issued by the American Diabetes Association yesterday quotes lead researcher George King, Chief Scientific Officer of the Joslin Diabetes Center and Professor of Medicine at Harvard Medical School saying: “If we can identify what constitutes this protective mechanism, we have the potential to induce such protections in others living with diabetes…That’s huge.”

The Joslin researchers looked at 351 U.S. residents known as the “Medalist” cohort and found that a subgroup of people who had lived with type 1 diabetes for more than 50 years remained free from such complications as proliferative diabetic retinopathy (PDR), a serious eye disease that can lead to blindness (42.6 percent of them); nephropathy, or kidney damage (86.9 percent of them); neuropathy, or nerve damage (39.4 percent); and cardiovascular disease (51.5 percent). Of those who did not develop PDR, 96 percent with no retinopathy progression in the first 17 years of their disease never experienced a worsening of symptoms, meaning that they likely possessed some type of protection specific to this complication.

Surprisingly, glycemic control was not a factor in providing this protective mechanism.

“That doesn’t mean of course that glycemic control doesn’t help to prevent complications. Numerous other studies have shown that it unquestionably does. In this case, it means only that there is a separate, protective mechanism in play that is not related to glycemic control that also helps to protect against diabetes-related problems. We are still working on identifying just what that is,” King said.

It’s important to note that most of the people in this study developed type 1 diabetes before strict glycemic control was even possible or used as the standard of medical care, the researchers write. The people in this study likely lived for several decades, therefore, without maintaining strict control.

The study also found that those with high plasma carboxyethyl-lysine and pentosidine, or advanced glycation end products (AGEs), were 7.2 times more likely to have some kind of complication than those who had low levels of this combination of AGEs. (AGEs are compounds that develop in the body after long exposure to high glucose levels and have generally been regarded as playing a role in diabetes-related complications.)

However, those with other types of AGE molecules exhibited protective features. Thus, this study suggests that not all AGEs are alike in their actions and raises the exciting possibility that some AGEs may be markers for protection against one or more diabetic complications.

In an accompanying editorial titled The Question Is, My Dear Watson, Why Did the Dog Not Bark?, Dr. Aaron Vinik, Director, Eastern Virginia Medical School Diabetes Research Center, writes that “the accumulation of AGEs may be one of the important factors in metabolic memory,” a phenomenon in which an initial period of good glycemic, lipid and blood pressure control results in a prolonged period of health benefits that last beyond the period of control.

However, while it is clear that for some there is a protective mechanism at play, it’s unclear whether metabolic memory is playing a role because glycemic control was not considered important until 1993, long after the study began.

What’s most interesting, Vinik points out, is that sRAGE (the circulating soluble receptor for AGEs) is deficient in those who have the most severe complications, and is present at high levels in those with the most longevity. “If this is the missing link, it is huge for the possible emergence of a new biomarker and the potential for therapy that might increase circulating sRAGE or sRAGE itself,” he said.

Diabetes: Implantable Gastric Stimulator May Make Bariatric Surgery Redundant

DIABESITY is the term used to describe the combination of the diabetes and obesity epidemics taking hold across the world and those whose goal it is to prevent even more people developing these conditions state the scale of the problem in no uncertain terms. The word aptly illustrates the close association between weight and diabetes (97 per cent of all cases of Type 2 diabetes are caused by excessive weight) and is a concrete example of the wider cluster of symptoms of a metabolic disorder known as Insulin Resistance Syndrome (also called Metabolic Syndrome X).

Currently undergoing extensive trials, a pacemaker-style device that delivers mild electric pulses to the stomach could be a new way to tackle type-2 diabetes, the most common form of the disease.

The matchbox-sized gadget called DIAMOND (Diabetes Improvement and Metabolic Normalization Device) ‒ a.k.a. TANTALUS™ ‒  is implanted under the skin on the abdomen, stimulates the stomach muscles when the patient is eating.

Studies show this boost in muscle movement causes more insulin ‒ the hormone is responsible for removing excess sugar in the blood ‒ to be released.

Gastric stimulation is based on the fact that electric signals applied to a cell in a certain specific time-period called the refractory period, can modify the cell’s biochemistry and in turn, lead to a change in its behavior.

This tricks brain into thinking more food has entered the stomach than the person has actually eaten. To deal with this supposedly large meal, the brain boosts insulin production as well as triggering the release of hormones that suppress appetite.

This means that the patient feels full much sooner than normal. A wireless charger system allows the patient to recharge the device at home by placing the charger over the abdomen for 45 minutes, once a week.

The result is an improvement in blood glucose levels, which is often accompanied by weight loss, and reduction of blood pressure, waist circumference and blood lipid level.

Recently performed studies have shown that stimulation of the stomach using the DIAMOND system implant can induce satiety and can trigger signaling to the brain, affecting glucose and fatty acid metabolism.

Developed by the Dusseldorf (Germany)-based medical device company MetaCure, DIAMOND is recommended for obese Type 2 Diabetes patients who do not succeed in reducing their HbA1c level below 7 per cent, despite treatment with several oral agents.

Currently, though doctors are prescribing multiple drugs for the majority of patients (called ‘polypharmacy’), it is ineffective in controlling blood sugar in only about two thirds of patients.

Basically, DIAMOND is an advanced minimally invasive implantable electrical stimulator used to apply gastric stimulation. Using innovative technology, the device works by enhancing the activity of the gastric muscles only when the patient eats.

The device automatically senses when a patient is eating, by detecting when the stomach starts to naturally contract, and fires small painless electrical signals into the muscles of the stomach.

DIAMOND is connected by small electrodes to the patient’s stomach. It uses them to automatically sense when the patient is eating, and to send gentle signals to the stomach muscles (and through them to the brain) which enhance the normal satiety feeling.

The DIAMOND system does all this on its own, and the patient does not even feel it working, the manufacturer claims. The rate of the stimulation is dictated by the patient’s natural gastric activity, this makes treatment using the DIAMOND system personalized to each patient’s specific eating habits and physiology, without causing anatomical changes, and without hassle to the patient.

Using a wireless home-based charger system the patient can recharge the Implantable Pulse Generator (IPG) unit simply by placing it over the abdomen for 45 minutes, once a week. Charging the device assures it has enough energy to provide treatment for years, and minimizes the need for battery replacement. The portable programmer allows medical personnel to adjust the DIAMOND signal parameters according to individual patient needs.

The DIAMOND IPG and electrodes are implanted in a minimally-invasive (laparoscopic) procedure under general anesthesia. The laparoscopic approach ‒ widely used surgical technique used for various procedures such as cholecystectomy ‒ allows for a rapid recovery with minimal discomfort. Patients implanted with DIAMOND are typically able to start eating a few hours after surgery. Hospital stay is usually 1 to 2 days.

The device does not put the patient at risk for hypoglycemia and helps to control your blood sugar levels without the need of adding medications. And unlike bariatric surgery, the procedure does not alter the patient’s physiology, and is completely reversible, allowing the device to be turned off or removed at any point. Patients living with the DIAMOND system are not limited in their diet and can maintain an active lifestyle (not including contact sports or activities which could damage the implanted system). Maintaining a healthy and balanced diet contributes to the success of the treatment.

The DIAMOND system delivers a gentle stimulation to the stomach during meals. The stimulation corresponds with the body’s natural gastric physiology and rhythm, is safe, and has minimal effect on the patient’s anatomy.

Once implanted, DIAMOND operates automatically requires no activation. There is a need to charge the battery using a portable charger once a week for about 45 min. Charging is wireless, non-invasive and painless, and can easily be done while reading or watching TV.

Over 200 patients are using the DIAMOND system to date, many of them for over two years, and many for over four years. Trials at the Medical University of Vienna showed the device reduced blood glucose levels by a quarter over three months and the DIAMOND has been shown to significantly reduce blood glucose levels and blood pressure levels.

Researchers say small-scale studies also show improvements in blood pressure and cholesterol levels, as well as an average weight reduction of up to 5 kg over a year. Several large-scale trials are now underway in Europe and the U.S. (At the moment, DIAMOND is not available for sale in the USA.)

The DIAMOND system is the first CE-approved (European standard) implanted device for treating Type 2 Diabetes and obesity since 2007. It is currently the only active device that selectively exerts its treatment at the correct physiological context – after meals, and is approved to treat diabetes for periods longer than 12 months.

MetaCure Claims DIAMOND is better that surgical intervention, which is constantly gaining recognition as a treatment for diabetes, with 78 per cent of patients showing resolution of their diabetes post-surgery, and sustaining this status for at least two years. (See my blogpost ‘IDF Endorses Early Bariatric Surgery’ here.)

However, when looking deeper into types of surgery, it seems that reversible “lap-band” procedures are significantly less effective than the more serious gastric bypass surgeries which are irreversible and come with a significant risk to the patient. Till recently, these procedures were prescribed only to the seriously obese patients but now there’s a big push to include patients with a BMI as low as 26.

Besides, despite availability of several classes of pharmacological anti-diabetic agents there is still a clear unmet need for a safe treatment that would comprehensively address the entire metabolic syndrome and will bring about weight loss with minimal requirement for patient compliance.

In the event, DIAMOND presents a significant step forward ‒ on the one hand it is very effective in both weight reduction as well as controlling blood sugar levels (maintaining both the weight and blood sugar effects for long follow-up periods), while on the other hand it is implanted in a minimally invasive, fully reversible implantation procedure – exactly the solution required for the moderate BMI population!

IDF Endorses Early Bariatric Surgery

Return on Investment Make Gastric Bypass Cost-Effective, Claims Position Statement Issued at 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The International Diabetes Federation (IDF) has issued a “radical statement” at an international conference today saying gastric banding and similar surgeries should no longer be a last resort for severely obese people with type 2 diabetes, it is recommending that surgery be considered at a much earlier stage.

“The statement highlights that there is increasing evidence that the health of obese people with type 2 diabetes, including their glucose control and other obesity related comorbidities (conditions), can benefit substantially from bariatric surgery under certain circumstances,” says the IDF press release.

The IDF says gastric banding and other surgeries to alter stomach anatomy should now be considered much earlier in the treatment of type 2 diabetes.

Gastric bypass surgery works by reducing the size of the stomach so a person can’t eat as much and shortening the length of the intestine so that the body doesn’t absorb too many calories. But it might also have the side effect of normalizing blood sugar.

Summary of the 39-Page Statement

• Obesity and type 2 diabetes are serious chronic diseases associated with complex metabolic dysfunctions that increase the risk for morbidity and mortality.

• The dramatic rise in the prevalence of obesity and diabetes has become a major global public health issue and demands urgent attention from governments, health care systems and the medical community.

• Continuing population-based efforts are essential to prevent the onset of obesity and type 2 diabetes. At the same time, effective treatment must also be available for people who have developed type 2 diabetes

• Faced with the escalating global diabetes crisis, health care providers require as potent an armamentarium of therapeutic interventions as possible.

• In addition to behavioral and medical approaches, various types of surgery on the gastrointestinal tract, originally developed to treat morbid obesity (“bariatric surgery”), constitute powerful options to ameliorate diabetes in severely obese patients, often normalizing blood glucose levels, reducing or avoiding the need for medications and providing a potentially cost-effective approach to treating the disease.

• Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially when there are other major co-morbidities.

• Surgery should be an accepted option in people who have type 2 diabetes and a BMI of 35 or more

• Surgery should be considered as an alternative treatment option in patients with a BMI between 30 and 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors.2

• In Asian, and some other ethnicities of increased risk, BMI action points may be reduced by 2.5 kg/m

• Clinically severe obesity is a complex and chronic medical condition. Societal prejudices about severe obesity, which also exist within the health care system, should not act as a barrier to the provision of clinically effective and cost-effective treatment options.

• Strategies to prioritize access to surgery may be required to ensure that the procedures are available to those most likely to benefit.

• Available evidence indicates that bariatric surgery for obese patients with type 2 diabetes is cost-effective.

• Bariatric surgery for type 2 diabetes must be performed within accepted international and national guidelines. This requires appropriate assessment for the procedure and comprehensive and ongoing multidisciplinary care, patient education, follow-up and clinical audit, as well as safe and effective surgical procedures. National guidelines for bariatric surgery in people with type 2 diabetes and a BMI of 35 or more need to be developed and promulgated.

• The morbidity and mortality associated with bariatric surgery is generally low, and similar to that of well-accepted procedures such as elective gall bladder or gall stone surgery.

• Bariatric surgery in severely obese patients with type 2 diabetes has a range of health benefits, including a reduction in all-cause mortality.

• A national registry of persons who have undergone bariatric surgery should be established in order to ensure quality patient care and to monitor both short and long-term outcomes. 1.17 In order to optimize the future use of bariatric surgery as a therapeutic modality for type 2 diabetes further research is required.

Although such operations cost anywhere from $20,000 to $30,000, they will reduce healthcare expenditures in the long run, according to a new IDF position paper on the subject. The surgery, the IDF explains, often normalizes blood glucose levels and reduces or avoids the need for medication.

In addition, curbing diabetes can stave off costly complications such as blindness, limb amputations, and dialysis, says Francesco Rubino, MD, director of the IDF’s 2nd World Congress on Interventional Therapies for Type 2 Diabetes.

“When we talk about whether we can afford bariatric surgery, we have to ask what will be the cost if we don’t treat the patient. Studies have shown the surgery to be cost-effective. So there is a return on investment,” says Francesco Rubino, MD, director of the IDF’s 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The IDF puts the lifetime cost of diabetes in the United States at $172,000 for a person diagnosed at age 50 years and $305,000 at age 30 years. More than 60% of this amount is incurred in the first 10 years after diagnosis.

The new recommended indications for performing bariatric surgery on patients who are both diabetic and obese match those announced last month by the US Food and Drug Administration for expanded use of the Lap-Band Adjustable Gastric Banding System (Allergan) to treat obesity.

The IDF recommendations dovetail with Dr Rubino’s previous research on how bariatric surgery alleviates diabetes. He showed that the effect on diabetes is not entirely explained by a person’s weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

However, the use of bariatric surgery to treat diabetes has sparked controversy in healthcare circles. Critics question the wisdom of wielding a scalpel to solve a medical problem, especially when clinicians have more drugs at their disposal to deal with diabetes.

A study published online last week in the Archives of Surgery has raised doubts about the efficacy of LAGB. Researchers following 151 patients who underwent LAGB for obesity concluded that the procedure yielded “relatively poor long-term outcomes,” with nearly half the patients needing their bands removed and 60% overall requiring some kind of reoperation. The authors, who performed the surgeries in question during the mid-1990s, added a caveat: they had used an older dissection technique.

Indeed, the biggest danger is that new weight-loss options like EndoBarrier (developed in the UK), Lap-BandRoux-en-Y gastric bypass and sleeve gastrectomy surgery have the potential to encourage overweight people to abandon traditional diet and exercise for procedures that carry some serious risks. That should be a big worry for all diabetes educators and activists.

Dental Health Key to Diabetes Control

Did you know there is a “closed loop” between your dental health, gum disease/health, and dental care and the worsening or improvement of your ability to successfully control your blood sugar levels? And did you know: all dentists are not equally prepared to assist diabetics with their dental health, periodontal care, implant dentistry or restoration after years of inadequate care, if needed?

Along with eyes, feet, skin, hearing and heart complications that can arise when someone has diabetes, the American Diabetes Association also lists oral health factors into the equation as well. Indeed, having poor gum health, under the gum line low-level infections, loose teeth or other dental problems can be a secret enemy fighting your efforts to manage your diabetes.

“Research shows that there is an increased prevalence of gum disease among those with diabetes,” warns the American Diabetes Association, which includes the dentist as a key member of the healthcare team when someone is living with diabetes.

Connections Between Treatment of Diabetes and Gum Disease

It’s very important for people who have diabetes symptoms to work closely with their dental treatment team to keep their teeth and gums in great shape. Unfortunately, however, not all dentists understand the connections between treatment of diabetes and gum disease, let alone knowing how to lower blood sugar.

Putting the problem in perspective, Mayo clinic experts list how oral health ties into a person’s overall health. Like all infections, serious gum disease may be a factor in causing blood sugar to rise and may make diabetes harder to control.

“Diabetes reduces the body’s resistance to infection – putting the gums at risk. In addition, people who have inadequate blood sugar control may develop more frequent and severe infections of the gums and the bone that holds teeth in place, and they may lose more teeth than do people who have good blood sugar control,” experts warn.

Research also suggests that the relationship between serious gum disease and diabetes is two-way.  Not only are people with diabetes more susceptible to serious gum disease, but serious gum disease may have the potential to affect blood glucose control and contribute to the progression of diabetes.

People with diabetes are at higher risk for oral health problems, such as gingivitis (an early stage of gum disease) and periodontitis (serious gum disease) because they are generally more susceptible to bacterial infection, and have a decreased ability to fight bacteria that invade the gums.

Gum Disease (Periodontitis)

The American Dental Association lists systemic diseases, including diabetes, as a factor that can increase the risk of periodontal disease. Periodontitis involves the inflammation and infection of bones and ligaments that support the teeth.

Dentists should encourage diabetics to make sure they have periodontal charting or probing done. That process measures the space of the gums around a tooth. Two to 3 millimeters of space is in the normal range. The space deepens to 5-10 mm in someone with gum disease, and by 8-9 mm, teeth are getting mobile.

Many people have a misconception a tooth can just be replaced, but nothing functions as well as your own teeth. When someone has gum disease, it’s important to have cleanings more often. The process can include deep cleaning or surgery to treat gum disease.

According to the American Dental Association, plaque, a sticky film of bacteria, covers the teeth. After someone eats or drinks something that contains starch or sugar, the bacteria release acids that attack tooth enamel, and over time, the attacks can cause enamel to break down, which can lead to cavities.

Dry Mouth & Thrush

In addition to gum disease and tooth decay, other health conditions have connections to diabetes. For example, someone with diabetes might be prone to xerostomia (dry mouth), which also is a side effect with many medications, and candidiasis (thrush), an oral infection. Burning mouth syndrome is another condition that might affect someone who has diabetes.

When diabetes isn’t properly controlled, high glucose levels in saliva can create an environment favorable to these bacteria. The ADA recommends brushing twice a day and flossing daily to help remove plaque that could cause tooth decay.

Saliva contains enzymes and proteins that help control the bacteria in the mouth to help prevent oral infections, dental decay and gum disease. Yet for those with diabetes, higher sugar levels in the blood and saliva encourage bacterial growth.

Dental researchers say there also may be a link between xerostomia and the medications prescribed to treat diabetics. According to recent studies, three-fourths of those who suffer from diabetes also have high blood pressure, and most drugs used to treat hypertension can cause the salivary glands to produce less saliva. Dryness can also be intensified by the use of other drugs, such as antidepressants and antihistamines. For diabetics it is a vicious cycle, so it is important to use products specially formulated to treat gum disease and dry mouth.

Plaque & Tartar

Plaque that isn’t removed can harden into tartar. When tartar builds above the gum line, it becomes more difficult to brush well and to clean between the teeth. This can ultimately lead to chronic inflammation and infection. Diabetes isn’t caused by gum disease, but gum disease can make it worse and vice versa, say dental hygienists.

If members of the dental team don’t achieve the progress they expect with a patient, they might send him to have a full workup done to see what might be affecting how the dental treatment is going. When someone is having trouble controlling blood sugars, taking care of their dental situation results in improvements a lot of times.

Indeed, just removing plaque every six months can help a lot. Bacteria in the mouth is a concern because if it gets into you bloodstream through your mouth, it can go systemic. It’s important to let your dentist know if you have been diagnosed with diabetes.

Nutritional Status

Good oral health also plays a role in a person’s nutritional status, which has a significant impact on overall health. A diet high in carbohydrates, which break down into sugar, could affect a person’s likelihood of developing cavities. Tooth loss can also affect a person’s ability to eat.

Giving up cigarettes is equally important because tobacco smoke dries out the mouth, besides being linked to a number of other health risks, including cancers. Use of other tobacco products also tightens the blood vessels. You need blood flow into your mouth.

To prevent dental problems associated with diabetes, first and foremost, control your blood glucose level. Then, take good care of your teeth and gums, along with regular checkups every six months. To control thrush, a fungal infection, maintain good diabetic control, avoid smoking and, if you wear them, remove and clean dentures daily. Good blood glucose control can also help prevent or relieve dry mouth caused by diabetes.

Remember, whatever has kept you from getting the optimum, complete dental care you need in the past should not concern you now. Today’s methods can actually be virtually pain free; you can be assured of respectful, compassionate care in a relaxed environment, never any criticism for having put off treatment. And every dental problem has a solution.

Bottom line: Managing diabetes includes everything from nutrition to exercise to medication to dental health.

Sources: American Diabetes Association, American Dental Association, Mayo Clinic, Colgate

Diabetes: Autonomic Neuropathy Far Worse Than ‘Pins & Needles’ in the Feet

For around 50 percent diabetics, living with diabetic peripheral neuropathy ‒ that “pins and needles” feeling you get after your foot falls asleep, along with a burning sensation, and possibly numbness and loss of balance and no way to relieve it ‒ is a daily reality. When the peripheral nervous system fails, the patient becomes a vegetable.

Diabetic neuropathy is categorized as autonomic and peripheral diabetic neuropathy, depending on which particular nervous system it affects. The third category, focal diabetic neuropathy, affects individual nerves, not a system.

Diabetes can cause dysfunction of any or every part of the autonomic nervous system, leading to a wide range of disorders. And these are serious. Among the most troublesome and dangerous of the conditions linked to autonomic neuropathy are known: silent myocardial infarction (MI), cardiac arrhythmias (abnormal heart rhythm), ulceration (formation or development of an ulcer), gangrene, and nephropathy (damage to or disease of the kidney).

The prognosis is bleak: While treatment relieves pain and can control some symptoms, the disease generally continues to get worse.

What is Autonomic Neuropathy?

The peripheral nervous system controls the sensory and motor functions. This helps us to become aware of our environment and to control muscular activity. Patients with diabetic neuropathy might also develop autonomic neuropathy, leading to incontinence, constipation, diarrhea, acid reflux, difficulty breathing, sexual dysfunction (impotence) and inability to regulate blood pressure.

This happens because autonomic neuropathies affect the nerves that regulate vital functions, including the heart muscle and smooth muscles. Indeed, the autonomic nervous system is at the very core of our existence. It controls the vital life functions like heartbeat and respiration. So, when the autonomic nervous system fails, the patient dies.

In other words, autonomic neuropathy is a form of peripheral neuropathy. It is a group of symptoms, not a specific disease. There are many causes. Damage to the autonomic nerves affects the function of areas connected to the problem nerve. For example, damage to the nerves of the gastrointestinal tract makes it harder to move food during digestion (decreased gastric motility). Damage to the nerves supplying blood vessels also causes problems with blood pressure and body temperature.

Essentially, diabetic autonomic neuropathy impairs the ability to conduct activities of daily living and lowers quality of life. Autonomic neuropathy is also associated with an increased risk of sudden death. It also accounts for a large portion of the cost of care. (See my earlier related post ‘Don’t Ignore Diabetic Nerve Pain’ here.)

Remember, diabetic autonomic neuropathy is a stealthy complication of diabetes, developing slowly over the years and quietly robbing diabetic patients of their ability to sense when they are becoming hypoglycemic or having a heart attack. It can affect any organ of the body, from the gastrointestinal system to the skin, and its appearance portends a marked increase in the mortality risk of diabetic patients.

Eventually, autonomic neuropathy damages the nerves that run through a part of the peripheral nervous system and are used for communication to and from the brain and spinal cord (central nervous system) and all other parts of the body, including the internal organs, muscles, skin, and blood vessels.

Telltale Signs

Clinical symptoms generally do not develop for many years after the onset of diabetes. However, subclinical autonomic neuropathy can often be identified by quantitative functional testing within 1 year of diagnosis in patients with type 2 diabetes and within 2 years in those with type 1 diabetes. The most important causative factors are poor glycemic control, long duration of diabetes, increasing age, female sex, and higher body mass index. (See my earlier related post ‘All Eyes on Research That May Provide Cure for Diabetic Neuropathy’ here.)

Leading causes of death in diabetic patients with either symptomatic or asymptomatic autonomic neuropathy are heart disease and nephropathy. Increased urinary albumin excretion is related to autonomic neuropathy in diabetic patients.

Impairments in the autonomic nervous system may also contribute to the pathogenesis of diabetic nephropathy and cardiovascular disease. Autonomic neuropathy is also an independent risk factor for stroke.

Consequences

The cardiovascular manifestations of autonomic neuropathy appear to be the most widely studied ones and justifiably so because they are likely to be potentially lethal. Postural giddiness and syncope (temporary loss of consciousness and posture, described as “fainting” or “passing out”) are the only autonomic symptoms referable to the cardiovascular systems.

Undeniably, the cardiovascular system bears the brunt of autonomic neuropathy in diabetics and this may be responsible for certain disabling symptoms, painless myocardial infarction and even sudden death during surgery. (It is therefore desirable to evaluate in detail the cardiovascular and autonomic status of all diabetics before major surgery.)

Cardiovascular autonomic neuropathy causes abnormalities of heart-rate control and vascular dynamics. It has been linked to postural hypotension, exercise intolerance, enhanced intraoperative cardiovascular lability (susceptible to change, error or instability), increased incidence of asymptomatic ischemia (showing no evidence of inadequate blood supply), myocardial infarction (heart attack), and decreased likelihood of survival after myocardial infarction.

Besides, failure to recognize symptoms in a diabetic as due to autonomic neuropathy may lead to a lot of unnecessary investigations and sometimes to wasteful treatment such as testosterone in sexual impotence.  Indeed, sexual impotence is now recognized to be a common and sometimes the only manifestation of autonomic neuropathy followed closely by nocturnal polyuria (passing large volumes of urine at night but normal amounts during the day).

Gastrointestinal manifestations of autonomic neuropathy also include nausea and vomiting due to diminished gastric motility (the ability to move spontaneously); diarrhea and nocturnal fecal incontinence (bedwetting) due to exaggerated sympathetic hypofunction (a diminished or inadequate level of activity of an organ system or its parts) during sleep; and asymptomatic, functional disturbances of the gall bladders and the esophagus. Localized bouts of sweating on the face during eating are also reported to be diagnostic of diabetic autonomic neuropathy.

Outlook (Prognosis)

Once autonomic abnormalities are present, they are permanent, sometimes showing progressive deterioration but rarely, if ever, improving. They can affect multiple organ systems in the body, can cause disabling symptoms and have a lethal potential. It is therefore, necessary to be constantly aware of them and to screen the diabetics periodically, and most certainly pre-operatively. Therein lies their safety.

Of patients with symptomatic autonomic dysfunction, 25% to 50% die within 5 to 10 years of diagnosis. The 5-year mortality rate in patients with diabetic autonomic neuropathy is three times higher than in diabetic patients without autonomic involvement.

Undeniably, neuropathy is one of the most common complications of diabetes. And when it affects the autonomic nervous system, it can damage the cardiovascular, gastrointestinal, and genitourinary (reproductive and urinary) systems and impair metabolic functions (necessary for the maintenance of a living organism) such as glucose counter-regulation (unrestrained eating).

This is because the autonomic nervous system is primarily efferent (conveying away from a center), transmitting impulses from the central nervous system to peripheral organs. However, it also has an afferent (carrying toward the center) component. Its two divisions—the parasympathetic (part of nervous system that serves to slow the heart rate, increase intestinal and gland activity, and relax the sphincter muscles) and the sympathetic (that accelerates the heart rate, constricts blood vessels, and raises blood pressure) nervous systems— work in balanced opposition to control the heart rate, force of cardiac contraction, dilatation and constriction of blood vessels, contraction and relaxation of smooth muscle in the digestive and urogenital systems, the secretions of glands, and pupillary (affecting the pupil of the eye) size.

Ipso facto, the reported prevalence of diabetic autonomic neuropathy varies, with community-based studies finding lower rates than clinic-based and hospital-based studies, in which the prevalence may be as high as 100%.

Prevention

Intensive glycemic control is critical in preventing the onset and slowing the progression of diabetic autonomic neuropathy. The Diabetes Complications and Control Trial (DCCT) showed that intensive glycemic control reduced the prevalence of autonomic dysfunction by 53%.

It is also the first therapy to be considered when diabetic autonomic neuropathy is diagnosed. In addition, a variety of pharmacologic and nonpharmacologic therapies are available to treat the symptoms of autonomic neuropathy.

In addition, regular foot care can prevent a small infection from getting worse. This is why no appointment for diabetes care is complete without a thorough foot examination.

Treatment

For patients with both type 1 or type 2 diabetes, glycemic control is important, although methods to achieve target levels may differ. The methods for achieving euglycemia (normal glucose content of the blood) and the target blood glucose and HbA1c levels are given in a position statement from the American Diabetes Association.

The goals of treating diabetic neuropathy are to prevent the disease from getting worse and to reduce the symptoms of the disease. Tight control of blood sugar (glucose) is important to prevent symptoms and problems from getting worse.

Medications may be used to reduce the symptoms in the feet, legs, and arms. These medications include antidepressant drugs, such as amitriptyline (Elavil), doxepin (Sinequan), or duloxetine (Cymbalta); antiseizure medications, such as gabapentin (Neurontin), pregabalin (Lyrica), carbamazepine (Tegretol), and valproate (Depakote); drugs that block bladder contractions may be used to help with urinary control problems.

Erythromycin, domperidone (Motilium), or metoclopramide (Reglan) may help with nausea and vomiting. Pain medications (analgesics) may work for some patients on a short-term basis, but in most cases they do not provide much benefit. Capsaicin can be used topically to reduce pain.

Phosphodiesterase type 5 (PDE-5) drugs, such as sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis) are safe and effective for treating impotence in patients with diabetes.

Regular foot exams are important to identify small infections and prevent foot injuries from getting worse. If foot injuries go unnoticed for too long, amputation may be required.

Possible Complications

Injury to the feet due to loss of feeling; muscle breakdown and imbalance; poor blood sugar control due to nausea and vomiting; skin and soft tissue breakdown (ulceration) that may require amputation.

In addition, neuropathy may mask angina, the warning chest pain for heart disease and heart attack.

When to Contact a Medical Professional

Promptly call your health care provider if you develop symptoms of diabetic neuropathy.

Sources: American Diabetes Association (ADA)NeurologyNational Institute of Health (NIH)Aaron I VinikNational Diabetes Information Clearinghouse (NDIC)

Diabetic Diet: Is Determining Glycemic Load Better Than Counting Carbs?

 

 

 

 

 

 

 

To count carbs or discount them ‒ the debate continues. Being type 2 insulin dependent, I’m trying to make sense of the differing conclusions of two studies that have been published recently. It’s hard to say what these studies really show ‒ it can get confusing with all the information out there ‒ especially when pilaf (pilao) is on Sunday’s lunch menu!

Dr. Andrea Laurenzi of San Raffaele Vita-Salute University in Milan suggests that diabetes patients may benefit from counting the number of carbohydrates in their diet. In a small study ‒ published online in the America Diabetes Association journal Diabetes Care ‒ the Milan researchers looked at 61 adults on insulin pump therapy and found that those who learned to count carbs had a small reduction in weight and waist size after 6 months. Additionally, they reported gains in quality of life and an improvement in blood sugar levels.

On the other hand, Jiansong Bao at the University of Sydney in Australia, says the number of carbs alone might not be the best way to go. Writing in the American Journal of Clinical Nutrition, he feels that how many carbs you eat might be less important for your blood sugar than your food’s glycemic load, a measure that also takes into account how quickly you absorb those carbs.

Dr. Sanjeev Mehta, of the Joslin Diabetes Center and Harvard Medical School in Boston says while Laurenzi’s findings do not prove that carb counting is the answer for people with type 1 diabetes, it is widely recommended that people on insulin try to estimate the carbohydrate content of their meals to help calculate their insulin doses. Indeed, a few other studies too have suggested that carbohydrate counting can help people with type 1 diabetes control their blood sugar levels.

There are books and online resources available for people who are interested in learning how to count carbs. However, some people have difficulty learning or sticking with the method, Mehta noted, and benefit from help from a professional, such as a dietitian or certified diabetes educator.

Mayo Clinic nutritionist Katherine Zeratsky, R.D., L.D. explains counting carbohydrates is a method for controlling the amount of carbohydrates you eat at meals and snacks. This is because they have the greatest impact on your blood sugar. Eating consistent amounts of carbohydrates every day helps you control your blood glucose level.

But carbohydrates aren’t the only dietary consideration when you have diabetes. You need to also limit fat and cholesterol and control the number of calories you consume. The best way to do this is to control portion sizes, she says.

“Eating a healthy diet helps you control your diabetes and reduces your risk of diabetes-related conditions, such as heart disease and stroke. So, just because a food contains no carbohydrates doesn’t mean that you can eat it in unlimited amounts,” she cautions.

However, Bao claims the so-called glycemic load of a food, which also takes into account how quickly it makes the blood sugar rise, might work better. Foods with soluble fiber, such as apples and rolled oats, typically have a low glycemic index, one of the contributors to glycemic load. Foods with a low glycemic index cause the blood sugar to rise slowly, and so put little pressure on the pancreas to produce insulin.

The glycemic load is calculated by multiplying the amount of carbs in grams per serving by the food’s glycemic index divided by 100. (The glycemic index for a variety of foods can be found here.)

The Sydney researchers say their findings also suggest that eating foods with high glycemic loads could be linked to chronic disease like type 2 diabetes ‒ which does not require insulin injections ‒ and heart disease by raising blood sugar and insulin levels.

The researchers took finger-prick blood samples from 10 healthy young people who ate a total of 120 different types of food ‒ all with the same calorie content. They also had two groups of volunteers eat meals with various staples from the Western diet, such as cereal, bread, eggs and steak. And the glycemic load repeatedly trumped the carb count in predicting the blood sugar and insulin rise after a meal.

A Reuters report quotes Dr. Edward J. Boyko ‒ a diabetes expert at the University of Washington in Seattle who wasn’t involved in the Sydney study ‒ saying it wasn’t certain the findings would hold up in people who aren’t completely healthy, adding, long-term effects and other nutrients in the food might also be important for disease risk.

“It would just be speculation whether a dietary change like this would help people with type 2 diabetes.” The most important problem, Boyko points out, remains pure and simple overeating. “The excess weight is the main thing we ought to focus on…The simplest message would be, eat less.”

Diabetes: The Omega-3 Files Revisited

Doctors have long recognized that the unsaturated fats in fish, called omega-3 fatty acids, appear to reduce the risk of dying of heart disease. For many years, the American Heart Association has recommended that people eat fish rich in omega-3 fatty acids at least twice a week.

Now, a Fred Hutchinson Cancer Research Center study on Yup’ik Eskimos living in the remote Yukon Kuskokwim Delta region of southwest Alaska who eat a large amount of fatty fish has again confirmed that a diet high in omega-3 fats may help prevent obesity-related diseases, including diabetes. (See my earlier post ‘Omega-3s May Fight Diabetic Retinopathy’)

Yup’ik Eskimos have a prevalence of type 2 diabetes of 3.3 percent, versus 7.7 percent in the U.S. overall, even though the Yup’ik Eskimos have overweight/obesity levels similar to the rest of the U.S. (See an earlier CANHR study ‘Metabolic Syndrome in Yup’ik Eskimos’ here.)

Residents of Yup’ik villages joined this research because they were interested in their communities’ health and were particularly concerned about the health effects of moving away from their traditional ways and adopting lifestyle patterns similar to those of residents in the lower 48 states.

Hutchinson researchers working with the Center for Alaska Native Health Research at the University of Alaska-Fairbanks on the study ‒ published online this week in the European Journal of Clinical Nutrition ‒ found the Yup’ik consume 20 times the overall U.S. average of fish and other marine foods, boosting their intake of omega-3 fats. Because of all that fish consumption, this population does not have some of the risk factors normally associated with obesity.

The fats the researchers were interested in measuring were those found in salmon, sardines and other fatty fish: docosahexaenoic acid, or DHA, and eicosapentaenoic acid, or EPA.

“Because Yup’ik Eskimos have a traditional diet that includes large amounts of fatty fish and have a prevalence of overweight or obesity that is similar to that of the general U.S. population, this offered a unique opportunity to study whether omega-3 fats change the association between obesity and chronic disease risk,” said lead author Zeina Makhoul, a postdoctoral researcher in the Cancer Prevention Program of the Hutchinson Center’s Public Health Sciences Division, in a press release.

She said that in the 330 Yup’ik Eskimos (total population 24,000 according to the 2000 U.S. Census) who were studied, 70 percent of whom were obese or overweight, high intakes of omega-3-rich seafood seemed to protect them from some of the harmful effects of obesity. The median age of the participants was 45 and slightly more than half were female. The women were more likely than the men to be heavy, and body mass index (height-to-weight ratio) for all increased with age.

“Interestingly, we found that obese persons with high blood levels of omega-3 fats had triglyceride (a blood lipid abnormality) and CRP (a measure of overall body inflammation) concentrations that did not differ from those of normal-weight persons,” Makhoul said. “It appeared that high intakes of omega-3-rich seafood protected Yup’ik Eskimos from some of the harmful effects of obesity.” High levels of triglycerides and CRP increase the risk of heart disease and, perhaps, diabetes.

“These results mimic those found in populations living in the Lower 48 who have similarly low blood levels of EPA and DHA,” said senior author Alan Kristal, Dr. P.H., a member of the Hutchinson Center’s Public Health Sciences Division. “However, the new finding was that obesity did not increase these risk factors among study participants with high blood levels of omega-3 fats,” he said.

“While genetic, lifestyle and dietary factors may account for this difference,” Makhoul said, “it is reasonable to ask, based on our findings, whether the lower prevalence of diabetes in this population might be attributed, at least in part, to their high consumption of omega-3-rich fish.”

So does that mean you should you load up on fish oil supplements? Not so fast, Makhoul cautions, as more studies need to be done to find out if there’s something else going on with the Yup’iks. “They have a pretty unique lifestyle and of course genetics could play a role,” she points out.

Nonetheless, it’s still a good idea to follow the American Heart Association recommendations and include more fish in your diet, at least two servings a week. Fish contain unsaturated fatty acids, which, when substituted for saturated fatty acids such as those in meat, may lower your cholesterol.  Omega-3 fatty acids are a type of unsaturated fatty acid that’s thought to reduce inflammation throughout the body.

Inflammation in the body can damage your blood vessels and lead to heart disease. And as the Hutchinson study shows, Omega-3 fatty acids decrease triglycerides. Besides, Omega-3s also lower blood pressure, reduce blood clotting, boost immunity and improve arthritis symptoms, and in children may improve learning ability.

Fatty fish, such as salmon, herring and to a lesser extent tuna, contain the most omega-3 fatty acids and therefore the most benefit, but many types of seafood contain small amounts of omega-3 fatty acids. Most freshwater fish have less omega-3 fatty acids than do fatty saltwater fish though some varieties of freshwater trout have relatively high levels of omega-3 fatty acids.

But many people are still concerned about mercury or other contaminants in fish. However, when it comes to a healthier heart, the benefits of eating fish usually outweigh the possible risks of exposure to contaminants. The main types of toxins in fish are mercury, dioxins and polychlorinated biphenyls (PCBs) and depend on the type of fish and where it’s caught. And the risk of getting too much mercury or other contaminants from fish is generally outweighed by the health benefits that omega-3 fatty acids have, say researchers at the Mayo Clinic.

Anyway, not all fish are rich in Omega-3. The main beneficial nutrient appears to be omega-3 fatty acids in fatty fish. Some fish, such as tilapia and catfish, don’t appear to be as heart healthy because they contain higher levels of unhealthy fatty acids. Also, some researchers are concerned about eating fish produced on farms as opposed to wild-caught fish. Researchers think antibiotics, pesticides and other chemicals used in raising farmed fish may have harmful effects to people who eat the fish.

Five of the most commonly eaten fish or shellfish that are low in mercury are shrimp, canned light tuna, salmon, pollock, and catfish. Avoid eating shark, swordfish, king Mackerel, or tilefish because they contain high levels of mercury. Check out Fish 101 for amounts of omega-3 fatty acids and mercury levels for the top 10 fish and shellfish in the United States. Also check out frequently asked questions by consumers.

But remember, any fish can be unhealthy depending on how it’s prepared. For example, broiling or baking fish is a healthier option than is deep-frying. Choose low-sodium, low-fat seasonings such as spices, herbs, lemon juice and other flavorings in cooking and at the table.

Don’t like fish? Other non-fish food options that contain some omega-3 fatty acids include flaxseed, flaxseed oil, walnuts, canola oil, soybeans and soybean oil. However, similar to supplements, the evidence of heart-healthy benefits from eating these foods isn’t as strong as it is from eating fish.

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.”

Diabetes: Increased Use of Fibrates in US Could Be A Triumph Of ‘Marketing Over Medicine’

U.S. prescriptions for cholesterol-lowering medications predating statins have increased steadily despite uncertain benefit, suggesting that aggressive marketing has trumped scientific evidence.

These drugs, called fibrates, modestly reduce blood levels of artery-clogging bad cholesterol, raise good cholesterol and are most effective at lowering levels of other damaging blood fats called triglycerides, although the overall picture from clinical trials remains confusing.

Fibrates include gemfibrozil (Lopid), which got the regulatory nod in 1981; fenofibrate (TriCor, Triglide), approved in 2007, and the closely related drug fenofibric acid (TriLipix, Fibricor), which entered the U.S. pharmaceutical marketplace in December 2008. In 2009, fenofibrate and fenofibric acid together accounted for almost 74 percent of the U.S. market share of fibrates.

According to Dr. Cam Patterson, cardiology chief and physician-in-chief of the Center for Heart and Vascular Care at the University of North Carolina, Chapel Hill, “Statins are the only cholesterol-lowering drugs that have been shown conclusively to save lives. Fibrates may be an option as add-on therapy, but there is no compelling case to use them as first-line therapy” for patients with elevated cholesterol, he warns.

Patterson feels the substantial increase in fibrate use demonstrated “unfortunate tribal behavior by physicians that is no doubt driven by the big pharma marketing machinery” and expressed concern about the ramifications of “recommending costly medications that don’t confer real benefits to our patients. We’ve been burned before.”

“The use of fibrates in America is very troubling,” says Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation. Describing the increasing use of fibrates as an expensive failure to educate doctors and regulators, he notes that fibrates are among medications advertised directly to consumers. “This is a classical example of marketing triumphing over science,” he feels.

Dr. James H. Stein, director of preventive cardiology at the University of Wisconsin-Madison School of Medicine and Public Health, says most people don’t realize the influence of marketing on health care. Pointing out that negative studies about fibrates have been “spun to focus on the possible benefits”, he cautions that fenofibrate is associated with significant side effects, including “increased creatinine, which might indicate kidney dysfunction; gallstones, and more serious complications like pancreatitis, blood clots, and pulmonary embolism.”

In the past five years, two major studies have found fenofibrate failed to reduce heart disease risks among diabetic men and women. Last year, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which involved 10,000 patients with diabetes, found that those who took both simvastatin and fenofibrate suffered about as many heart attacks, strokes and deaths as diabetic patients treated with simvastatin alone.

The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial, which involved nearly 10,000 patients and has reported results since 2005, found that fenofibrate failed to decrease cardiovascular deaths more than a placebo.

Yet a new study published in the current issue of the Journal of the American Medical Association found that U.S. prescriptions for fibrates grew from 336 per 100,000 people in January 2002, to 730 per 100,000 people in December 2009. That’s a 117.1 percent hike. At the same time, Canadian prescriptions for fibrates held nearly steady, at 402 per 100,000 in early 2002 and 474 per 100,000 in late 2009.

The increase in fibrate prescriptions, driven by a 200 percent jump in the use of fenofibrate, has outpaced the growth of statins. But, to keep things in perspective: statins, which are among the most commonly prescribed medications, remain blockbuster drugs that dominate lipid-lowering treatment, with fibrates accounting for just 9.4 percent of the U.S. lipid-lowering market in 2009.

Based on a news report in ABC News

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.

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