Archive for the ‘Diabetes’ Category

Prescriptions for Diabetes Medications Go Unfilled

People with type 2 diabetes are often prescribed several drugs to help them control their blood sugar as well as conditions related to diabetes, such as high cholesterol and high blood pressure. However, startling research findings presented at the annual scientific meeting of the American Diabetes Association in San Antonio, Texas, suggest that many, if not most, of these patients do not take all the medication they are prescribed.

“We ask a lot of our diabetic patients,” stated Andrew Morris, MD of the University of Dundee in Scotland. He described a “typical diabetes patient” from his practice who was taking two drugs for her blood sugar, one for her high cholesterol, and three for lowering blood pressure. “This is a typical scenario for our patients with diabetes,” he noted.

He reported on a study that examined whether people with type 2 diabetes actually fill all of their prescriptions for diabetes medications. He and his colleagues analyzed prescription and pharmacy records for almost 3,000 people with diabetes. They found that only one-third refilled their prescriptions often enough to allow them to take at least 90 percent of their pills.

Because many patients with type 2 diabetes take more than one or two medications, the researchers also looked at whether there was any effect of the number of different drugs patients were prescribed. Morris reported that the more pills a patient was supposed to take in a day, and the more different medications they were supposed to take, the less likely they were to fill their prescriptions appropriately.

For example, two types of medications taken for diabetes are sulphonylurea drugs and metformin. About one-third of the patients who were supposed to take just one of these drug actually filled their prescriptions enough to take the medication consistently. But among patients who were supposed to be taking both drugs, only about 13 percent filled their prescriptions appropriately, Morris reported.

“The patients who were on one tablet a day, rather than two, three, or four tablets a day, tended to be better adherers,” noted Morris. In addition, the longer a patient had had diabetes, the less likely that patient was to comply fully with drug prescriptions.

“I’m a great believer in the phrase ‘diabetes fatigue’” Morris said. “It’s not as easy as we think. Type 2 diabetes is not a sprint, it’s a marathon. We ask our patients not only to adhere to their diet and their exercise, but sometimes as many as six or seven tablets a day, and it’s difficult. I think as a profession, we need to look at ways to try to simplify the regimen.”

“We don’t think this is unique to our region of Scotland,” concluded Morris. “We think this is a phenomenon not only in the U.K. and Europe, but world wide. Type 2 diabetes is a difficult condition for the patient, and the challenge is for us to understand the issues, and to try and deliver a simpler method of care.”

David Berenbeim, MD, of PacifiCare Health Systems in California agreed. He reported that when his organization did a similar survey among about 2,800 patients with type 2 diabetes in Texas a few years ago, there were similar findings — most patients were not taking their medications fully. As a result of their inconsistent use of the drugs prescribed, these people suffered more medical problems than they would have if they’d been able to keep better control over their blood sugar levels.

“What we found was that there was certainly a strong statistical relationship between the adherence rate for medication and the outcomes we looked at, at the end of the study,” such as emergency room visits, and other indications of poorly controlled diabetes, reported Berenbeim.

“The seriousness of diabetes is not appreciated,” stated Gerald Bernstein, M.D., past president of the American Diabetes Association and moderator of the session. “In the United States, diabetes is the leading cause of blindness, kidney failure, and non-traumatic amputation, and 50 to 60 percent of all heart disease comes from diabetes.”

“All of this is preventable,” he concluded. “When you lower blood sugar [by taking diabetes medications appropriately], you’re going to prevent and reduce complications.” The presenters agreed that the challenge for healthcare professionals is to help educate patients about the seriousness of diabetes and the degree to which patients can reduce their risk of serious complications by controlling their blood sugar early.

Editorial Commentary: The results of this study are similar to others in which patients are less likely to take medication if they have to take pills more frequently or take more pills each day. In general, no-one likes to take medication and patients with diabetes may need to take 6 to 10 different drugs per day. Additionally, they often don’t feel sick and the medications they take are to prevent disease rather than to treat an acute illness. On the other hand, patients who take their pills regularly have a tremendous amount to gain. Drugs to lower blood sugar levels prevent blindness, kidney failure, amputation, impotence and other diabetic complications. Drugs to lower cholesterol and blood pressure lower the risk of heart disease and stroke. Clearly these benefits cannot be realized unless medication is taken. Often it helps for people to understand what each drug does and why they should be taking it. Therefore, it is important for people to talk to their healthcare providers to devise a drug regimen that will maximize health goals as well as simplify how drugs are taken. If you have a problem taking a particular drug, this should also be discussed so an alternative can be considered.

Insulin Inhalers

Diabetics who inject themselves with insulin several times a day are eager for news about inhaled insulin, which has been in clinical trials in the United States for several years. They’ll be glad to hear that inhaling insulin, rather than injecting it, may not be too far in the future.

The results of several studies were presented at the scientific sessions of the American Diabetes Association in San Antonio, Texas. Several reported on the bioavailability of inhaled insulin — how quickly it becomes available for the body to use — and several more reported on effectiveness and patient satisfaction when used by those with type 1 and type 2 diabetes.

More than one device has been developed, but basically, the inhalers work like asthma inhalers. In one system, dry insulin powder is put into the device and breathed into the lungs, where it quickly enters the blood stream. In another, liquid insulin is used in the inhaler.

An international group of researchers led by Tim Heise and Klaus Rave, both of Mainz, Germany, presented findings from their studies with healthy volunteers. Each of 12 subjects received insulin three ways: using the inhaler with powdered insulin, using a normal injection method, and intravenously. The researchers report that inhaled insulin, as expected, showed a faster onset of action than regular insulin, and took about the same time to peak in the blood as intravenous insulin.

These researchers also reported that the action of inhaled insulin is dose-dependent — that is, when subjects inhaled larger amounts of insulin, measurements of insulin in their blood showed corresponding increases.

Another group of researchers led by Robert Fishman of Sunnyvale, California, tested a liquid insulin inhaler with 12 healthy volunteers, comparing this to injection. They also report that the inhaled insulin was absorbed more quickly than when injected under the skin.

These findings came from studying inhaled insulin in healthy participants, but researchers also presented findings from the clinical trials that have been using inhaled insulin to actually treat diabetes.

A group of researchers led by Joseph Cappelleri and Robert Gerber of Groton, Connecticut, reported that when 56 adult patients with type 2 diabetes were randomized to receive either inhaled insulin or insulin injections for 12 weeks, both groups maintained blood glucose control. But on a measure of patient satisfaction, the patients using the inhaler scored much higher. In particular, they found the inhaler easier to use, more comfortable, and more convenient than injections.

This same group also reported on 70 patients with type 1 diabetes. At the end of their 12 week clinical trial, in which half had taken inhaled insulin and half injections, the patients were offered the opportunity to continue therapy with either method for another year. Eighty one percent of those in the inhaler group and 79 percent of those in the injection group, chose to use the inhaler for the year. These patients reported significantly greater satisfaction with their treatment than the patients that chose to use injections for the year. In addition, those from the original inhaler group who chose to switch back to injections tended to have lower satisfaction scores after they made the switch. Patients from the injection group who switched to the inhalers, on the other hand, had significantly higher satisfaction scores after the switch. Again, all of the patients were able to maintain good blood sugar control.

“These data suggest that [inhaled insulin] is preferred over [injected insulin] and results in better patient satisfaction… not only in the short-term, but also during long-term treatment to at least one year. Improved satisfaction may, in clinical practice, increase willingness of patients to initiate and comply with insulin therapy and hence achieve better glycemic control,” the researchers concluded.

Another report, presented by William Cafalu of Burlington, Vermont, also said that inhaled insulin appears to be both safe and effective over the long term as well as for short periods. Again, patients with type 1 or type 2 diabetes who had completed any one of three 12-week clinical trials were offered the chance to use the inhaler for two years. These patients had good blood sugar control and normal lung function over this longer period.

“These results suggest that the clinical efficacy and pulmonary safety of [inhaled insulin], shown previously in short-term trials, are sustained long-term,” the researchers concluded.

Overall, the research presented at the ADA sessions suggests that inhaled insulin is both safe and effective, allowing those with either type 1 or type 2 diabetes to control their blood sugar without causing any lung problems.

Because it’s faster-acting than injections, researchers suggest that it will be particularly helpful for those who take insulin just before eating — they won’t have to wait as long, and it’s much more convenient, especially in public.

Inhaled insulin is still in clinical trials, but if its safety and effectiveness continue to be shown in future studies, patients with diabetes can look forward to a much easier way to take their insulin in the future.

Editorial Commentary: The goal of treating diabetes, whether type 1 or type 2, is to maintain normal blood glucose levels over time. For many this means giving insulin injections. Although giving injections is relatively painless with shorter, smaller needles, many patients still dislike performing this task. Inhaled insulin has been developed as a means to avoid insulin injections while still providing adequate amounts of insulin for the body to use. In the clinical trials that have been performed thus far, inhaled insulin appears to be effective and well accepted by patients. Many prefer it to injections. I look forward to using this technology in my patients when it becomes available. However, there are several caveats. First, patients must still test their blood sugar levels to monitor their diabetic control. For many, the task of pricking their fingers is far more painful than giving insulin injections. Second, this is a new treatment and with any new medication there are potential risks. Doses of insulin that are inhaled into the lungs are far greater than those given by injection. Although we have data on small numbers of patients followed for up to two years, it is unknown what the effect of insulin on lung tissue will be after 5 or 10 years of use. Therefore, it will be important to follow patients over time on inhaled insulin to be sure that their lung function remains consistently normal. Third, inhaled insulin is relatively short acting, so an injection or two of longer acting insulin may still need to be given. With these considerations in mind, for some patients, inhaled insulin will provide a welcome relief from the need to give daytime insulin injections.

High Blood Pressure an Added Risk in Some Groups of Patients

Public awareness of the importance of treating high blood pressure has actually gone down in the past decade, and so has the percentage of people with this condition who are treating it successfully, according to a nationally recognized expert in this area. The potential consequences of this lack of awareness and appropriate treatment: increased rates of cardiovascular disease and death.

Jerome D. Cohen, M.D. of the St. Louis University Health Sciences Center in Missouri, talked to a group of physicians about treating hypertension this week during the annual meeting of the American College of Physicians/American Society for Internal Medicine, in Philadelphia.

According to Cohen, there are three groups of patients that need special attention during doctors’ efforts to reduce cardiovascular disease and heart-related death: people with multiple cardiovascular risk factors, people with diabetes and the elderly.

The National Institutes of Health has called for a multi-pronged attack on heart disease that attempts to prevent it by controlling cholesterol, regulating glucose metabolism, and getting patients to quit smoking. (These factors increase the risk of heart disease dramatically.) But the problem, Cohen said, is that patients with normal blood pressure who have more than one of these risk factors are often not identified.

“These are the most common patients [doctors] see, and are also the most undertreated. They have multiple risk factors, and we must recognize that,” Cohen stated. He noted that patients with high cholesterol, poor glucose regulation, and a history of smoking have 10 times the risk of developing and dying from heart disease compared to those without these risk factors, even if they don’t have high blood pressure.

One recommendation for addressing this is to begin treating patients who have blood pressure in the high normal range, if they also have certain conditions that add to their risk of heart disease. This would include patients with diabetes, kidney failure, and heart failure. Cohen reported that putting these patients on blood pressure medications has been shown to reduce their risk.

“We have compelling data that shows that we can change the natural progress of [heart] disease and prevent morbidity and mortality,” stated Cohen.

Diabetics are a particularly important group, said Cohen, because high blood pressure in this group is a serious risk factor for heart disease and death. For example, hypertensive patients with diabetes are just as likely to die as those who have already had heart attacks. On the other hand, research shows that when blood pressure is tightly controlled in diabetics, their chances of developing diabetic complications, having a heart attack, and having a stroke are significantly reduced.

The class of blood pressure drugs called ACE inhibitors “are clearly the drug of choice in diabetics with hypertension,” Cohen stated, citing the results of a number of large clinical trials.
In fact, in one recent study of patients with high blood pressure, those who took these drugs were significantly less likely to develop diabetes than those who took a placebo. The group receiving ACE inhibitors also had a large reduction in stroke, heart attack, and other cardiovascular events.

In the same study, hypertensive patients who already had diabetes and who received ACE inhibitors had about one-third the rate of cardiovascular disease, stroke, and death compared to those who took placebo. So, Cohen explained, these drugs are appropriate for treating patients who have high blood pressure with or without diabetes.

Another group that tends to be undertreated for their high blood pressure, Cohen stated, is the elderly. “Heart disease is by far the leading cause of death among older folks,” he noted, but many doctors are reluctant to treat hypertension in this age group. One reason for this is that elderly patients often have an elevated systolic blood pressure — the first and higher number of the two measured when blood pressure is taken—while their diastolic pressure remains normal.

In the past, physicians have focused on this lower diastolic number when diagnosing hypertension. More recent research, Cohen explained, clearly shows that high systolic pressure needs to be treated regardless of whether the diastolic pressure is high or not. Appropriate treatment, he said, can reduce heart failure by 55 percent, stroke by 33 percent and overall cardiovascular disease by 32 percent.

“There is no reason not to treat an otherwise healthy person in their 80s for high blood pressure,” Cohen concluded, noting that without treatment, “they are at increased risk for stroke and sudden death.”

By looking at the whole patient and considering each person’s overall risk factors, Cohen explained, doctors can do a lot toward reducing cardiovascular disease and its fatalities in these often overlooked groups of patients.

Liver’s Role in Diabetes Gets Closer Look

Ordinarily, the organ most associated with diabetes is the pancreas. After all, that’s where insulin is made. However, researchers from Boston suggest that the liver deserves a closer look.

This team of researchers bred genetically altered mice, so the insulin receptor cells in their livers would not respond to insulin. Under normal conditions, when an increase in insulin is detected the liver stops producing glucose and starts storing excess glucose as glycogen in your liver and muscles. Both processes lower your blood sugar level.

Since the mice livers couldn’t detect whether or not insulin was present, the liver had no way of knowing how much glucose was in the blood. A significant increase in blood sugar was found, a condition called hyperglycemia.

Sometimes your cells become desensitized to insulin, and glucose can’t get into your cells even if insulin is present. This is called insulin resistance, and it too can cause hyperglycemia.

Despite the pancreas releasing more insulin, glucose remained high, leading researchers to believe that the cause was the liver’s inability to detect high insulin levels. This, in turn, indicates that the liver plays a much larger role in keeping blood sugar levels stable than previously thought.

A few other interesting observations were made about these mice. Their livers had not developed properly. They had dysfunctional tissue, damaged cells, and more fat in their liver tissue. Albumin, a protein that helps keep the fluid content of the blood constant, decreased by 50 percent.

From these congenital malformations of the mice’s liver, the researchers concluded that insulin must play an important role in normal liver development. They also noted that the mice’s pancreases produced less insulin.

Having the insulin receptor knocked out caused these mice to become hyperglycemic and their cells to become insulin resistant.

Since all this knowledge has only recently been discovered, further research into the liver’s role in diabetes is needed, and this new information must be incorporated into current understanding of diabetes.

Treatment Regimen for Pregnant Diabetics Challenged

Standards of therapy call for women who are taking oral hypoglycemic agents to change to insulin when they become pregnant. If a woman develops gestational diabetes that can’t be controlled with diet and exercise, she too is put on insulin. Researchers at the University of Texas have completed a study challenging this premise.

The goal of any diabetic therapy is to control hyperglycemia. In pregnant women, this is particularly important. Glucose passes through the placenta, but insulin doesn’t. High glucose levels in fetal circulation can overwhelm the fetus’s capacity to make insulin. The excess glucose results in macrosomia (large baby) as well as birth defects and sometimes stillbirth. Macrosomic babies have been found to have a higher rate of insulin resistance and to be at greater risk for future development of diabetes.

Based on a few studies done long ago, physicians were warned not to give oral hypoglycemic agents to pregnant women. The fear was that the drug would cross the placenta and stop the growing fetus from getting needed glucose. Present researchers say these studies were flawed and should not be the basis for a sweeping generalized ban on these drugs. Their study found less than five percent of the glyburide crossed the placenta.

The study involved 400 pregnant diabetics, 200 of which took glyburide and the other 200 insulin. Both groups had the same number of physician visits, average age, gestational age (more than 11 weeks but less than 33 weeks), and dose. Measurements included fasting blood sugar, hypoglycemic events, macrosomia, ICU visits, congenital malformations, and metabolic, hematologic and respiratory complications. There were no significant differences between the groups in any category. Fetal mortality rates for both groups were the same as the general population.

Oral hypoglycemic agents are more cost effective than insulin, and most women will tell you they’d rather take a pill than inject themselves. Regardless of medication, blood glucose monitoring must be done on schedule.

While these results are promising, under no circumstances should a pregnant woman make any changes in her present diabetic regimen without first discussing it with her health-care professional.

Long-term Blood Sugar Control in Type II Diabetics

A new report suggests that most Type II diabetics need a variety of therapies to maintain proper long-term blood sugar control. Researchers involved with the United Kingdom Prospective Diabetes Study Group followed the cases of more than 4,000 Type II diabetics treated with diet alone or with drugs, such as insulin, sulfonylurea, or metformin to collect data. It was found that only 50 percent of patients treated with a single therapy maintained proper blood-sugar control three years after the study began; after nine years only 42 percent of people treated with insulin alone had control, 24 percent of those treated with sulfonylurea alone had , and eight percent of those treated with diet alone maintained proper blood-sugar levels. Authors say the data suggests that the majority of Type II diabetics need multiple therapies to attain target blood-sugar levels and note that severity of disease at diagnosis, obesity, and young age at diagnosis were all associated with the chance that a patient would need more than one therapy.

Finger Sticks May Become A Thing of the Past

As anyone with diabetes can tell you, pricking your finger several times a day to monitor blood sugar is no fun. But a recent study reports that a painless method of getting these essential measurements may be on the way.

Diabetics monitor their blood sugar so they’ll know when to take insulin. Up to now, this has to be done by pricking the finger and squeezing a drop of blood onto a test strip, But according to Robert Gabbay, MD, PhD, of the Pennsylvania State University’s School of Medicine, a new method using ultrasound may get rid of most of these finger-sticks.
“This method involves no needles and is completely painless,” reports Dr. Gabbay. “We hope that by developing this new painless method for measuring blood glucose we can help patients achieve better glucose control.”
Gabbay is part of an international research team that’s been developing the new technique. The group has found a way to temporarily open the protective barrier formed by the outer layer of the skin, using a single burst of ultrasound about as strong as that used by dentists to clean teeth. This burst allows glucose to cross the skin and be measured with a device worn on the forearm.
The device was tested on rats to make sure it doesn’t damage the skin, and then on seven human volunteers with type 1 diabetes. The researchers had the volunteers wear the device while they measured glucose in blood samples for comparison. The results were pretty consistent, suggesting that the ultrasound device is accurate.

A user would calibrate the device once by doing a finger stick measurement, and then be able to monitor blood sugar continuously for up to 15 hours.

The volunteers reported no pain while using the device, and there was no apparent damage to their skin. The researchers are doing more safety studies now.

The team is also developing a hand-held device that so patients will be able to do their own blood testing, reports Dr. Gabbay. The researchers hope that in the future, the device could be combined with system to deliver insulin when the monitor indicates it’s needed.

The idea of getting rid of finger sticks AND insulin shots will certainly keep diabetics hoping that this research program is a success!

Early Signs of Osteoporosis Noted in Teen Diabetics

The medical literature is replete with research showing that women who’ve been diabetic for a long time are likely to develop osteoporosis. Researchers at the University of Buffalo have recently completed a study indicating that this bone loss in diabetic girls begins after they enter their teens.

The study involved two groups of 15 adolescent girls, aged 13 to 19. One group of girls had insulin dependent diabetes for at least five years, the other group did not have diabetes. Bone density of the girls was measured at the hip, spine, and wrist. A total body bone mineral density measurement was also taken.

The diabetic girl’s bone density was within normal limits, but it was lower than their counterparts in the control group. When researchers made adjustments for their Body Mass Index (BMI), the diabetic girls had significantly lower bone mineral density in the spine and total body measurements.

Bone density did not appear to be related to either the high glucose levels of poorly controlled diabetics or high blood-insulin levels found immediately after injection of insulin.

Osteoporosis is a disorder consisting of low-bone mass and a deterioration of bone tissue, leading to fragile bones prone to fracture. Women with osteoporosis are particularly vulnerable to broken hips, wrist, and spines incurred during falls.

Lowering Cholesterol Lowers Risk of Heart Attack in Diabetics

Past research has shown that people with type 2 diabetes have at least twice the risk of developing coronary heart disease as those without diabetes. And once diabetics develop heart disease, their prognosis is worse than non-diabetics. Therefore, doing what it takes to avoid heart disease is important. This includes not only keeping the blood sugar within normal limits, but maintaining healthy cholesterol levels as well.

Ideally, a low-fat diet alone will lower cholesterol, but when this fails, patients should take cholesterol-lowering medication, according to a study at the University of Texas Health Sciences Center in San Antonio.

The study examined data gathered by a Scandanavian trial that investigated the ability of simvastatin (Zocor) to lower cholesterol and prevent heart attacks in diabetics.

The study involved three groups of patients: 483 people with type 2 diabetes; 678 people with elevated blood sugars but not full-blown diabetes; and 3,237 people with normal blood sugars. All of the patients, however, had elevated cholesterol levels (from 212 milligrams to 309 milligrams), and they all received either 20 milligrams of simvastatin daily or placebo.

If patients taking simvastatin did not achieve lower cholesterols, the dose was increased to 40 milligrams.

In patients with high cholesterol, diabetes and heart disease, the simvastatin reduced their risk of heart attacks, death from heart disease and cardiac arrest by 42 percent when compared to the placebo group. They also reduced the risk of undergoing vascular procedures, such as bypass by 48 percent.

In patients with high cholesterol, heart disease, and an elevated blood sugar without diabetes, simvastatin lowered the risk of major coronary events (such as heart attacks) by 38 percent.

The study also demonstrated that simvastatin reduced the risk of death from heart disease by more than half in people with high cholesterol and heart disease who were considered to be at risk for developing diabetes.

Depression Makes Your Diabetes Worse

In most cases, depression precedes the development of diabetes. Researchers from Washington University and the University of Oregon presented these findings from multiple studies regarding depression and Type II diabetes.

Although the link between depression and diabetes is well known, the order of the association was thought to be the same as for other chronic illnesses. Once a chronic illness begins to have a negative impact on people’s lives, they are more prone to depression. This holds true for diabetes, heart disease, multiple sclerosis, or any other disease.

In the course of trying to measure the quality-of-life for a diabetic who is also depressed, these research teams discovered that in as many as 90 percent of cases, depression begins first and up to 10 years before the diabetes develops. Reactive depression — depression that begins as a reaction to having diabetes — actually only accounts for a small number of depressed patients.

Physicians have serious concerns regarding the role depression plays in the development of Type II diabetes and even graver concerns that depression in many diabetics is undiagnosed and, therefore, untreated.

For a diabetic, being depressed carries additional risks. Depressed diabetics have poor glucose control and more diabetic complications. The good news is that treating the depression improves both the depression and the diabetes.

The researchers urge health-care providers, especially primary-care practitioners, to look for and treat depression in diabetic patients.

If you have Type II diabetes, you should be aware of your increased risk for depression and should report any depressive symptoms you may experience to your health-care provider. Because untreated, depression not only takes the joy of your life, it shortens it by making your diabetes worse.