Disputed Diabetes Drug Avandia Okay to Sell

For a while it looked as though the diabetes drug Avandia was heading toward its demise after an FDA scientist said the drug was too risky. But an advisory committee may have just secured a longer shelf life for the widely-used drug.

With his recent diagnosis, Henderson resident Ron Buehler suddenly found himself caught up in the world of chronic disease. And like millions of other diabetics, he's also has to trust a huge pharmaceutical industry for safe drugs.

Buehler said, "How does the average diabetic know? He doesn't until somebody tests that drug and says uh-huh."

However, testing doesn't always ease concerns. Several months ago, a federal scientist said the widely used diabetes drug Avandia increases the risk of heart attack and suggested it be removed from the market. Government health advisers have now recommended that Avandia stay.

Dr. Reid Litchfield, Henderson endocrinologist, is relieved. "I think the overall risk of heart disease, of inducing a heart attack with this drug is quite low."

About one million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. Dr. Litchfield says studies haven't produced significant proof that it raises the risk of heart attack.

In fact, because diabetics already have a high incidence of heart disease, it's hard to isolate any effect from Avandia. "You're looking for a needle in a haystack full of needles," Dr. Reid Litchfield said.

The non-binding recommendation by the panel keeps Avandia on the shelf until a final decision by the FDA, which is not required to follow the panel's advice, but usually does.

Source:www.klas-tv.com

Bridging The Gap In the Fight Against Alzheimer's

Dementia has struck hard in Maritza Ciliberto's family. First, it was her grandmother. And then her mother, diagnosed even though she's just 61.

One relative said the family, rooted in Puerto Rico, is cursed - reflecting a common misconception among some in the Latino community, Ciliberto says, where a lot of folk beliefs about disease persist. Some say Alzheimer's is caused by spirits. For others, the disease carries so much stigma that they don't seek diagnosis or care.

Ciliberto chose another path, and as she helped her mother get treatment, she decided she wanted to do more. She recently took a newly created job at the Massachusetts chapter of the Alzheimer's Association, reaching out to Latinos and teaching health professionals how they can break down some of the barriers posed by language and culture.

"Our people are not receiving the care and the education they need" about the disease, said Ciliberto, who lives in Allston.

Ciliberto's outreach is part of a stepped up effort nationally by the Alzheimer's Association and others to address cultural barriers to dementia care. The effort targets African-Americans, Asian-Americans, and Latinos, among other ethnic and racial groups. The association is creating and distributing educational materials in English and Spanish for patients and clinicians, planning a bilingual media campaign, and trying to help doctors identify people at risk.

Driving the initiatives is concern that increasing numbers of African-Americans and Latinos are at high risk of Alzheimer's and other types of dementia because they have cardiovascular disease or diabetes, and because they are reaching their 60s, 70s, and 80s, when dementia typically strikes. In addition, new treatments are on the horizon.

"As we enter an era in which there will be treatments to slow progression of dementia, it's going to be very important to make sure that such treatments move" into ethnic communities as well, said Dr. Robert C. Green, a neurology professor at the Boston University School of Medicine.

The outreach efforts are drawing on research suggesting that dementia may affect different races and ethnic groups in different ways.

A study of residents in upper Manhattan found that Caribbean Hispanics and African-Americans were twice as likely as whites to develop Alzheimer's, even when researchers controlled for other health differences. And a study of African-Americans across the country - led by Green - found that they were 80 percent more likely to develop all types of dementia than whites. But other research has found rates of the disease that are about equal across racial and ethnic groups within the United States.

Scientists are increasing research on these potential differences and looking for possible explanations that could help prevent the disease. So far, neither genetics nor the higher rates of cardiovascular diseases among African-Americans and diabetes among Hispanics has explained possible differences.

One line of research seems particularly applicable to Ciliberto's family. A study conducted by University of Pennsylvania researchers found that Latinos developed symptoms of Alzheimer's about seven years earlier than other people, according to material presented at an international Alzheimer's conference in 2004.

And when Latinos and African-Americans seek diagnosis, they frequently run up against a shortage of bilingual health professionals and bias in cognitive testing that can hinder the process and slow access to treatment, the Alzheimer's Association says.

Some researchers also suggest that testing bias might account in part for higher rates of diagnosed Alzheimer's in African-Americans.

"The real issue is the norms that we have for these tests and the issue of cultural fairness," said Yaakov Stern, a neuropsychologist at Columbia University Medical Center who studies cognitive testing. For example, the scores considered normal are often adjusted for years of schooling, but that may set false expectations if the schooling was poor, due to segregation or other factors, Stern said. Or tests may use shapes or objects that are unfamiliar to new immigrants, he added. Most memory clinics and academic medical centers are aware of these problems and use multiple tests for diagnosis, he said. But that's not always true for community doctors.

"In primary care, a doctor might rely on a mental status exam for an initial diagnosis," he said, "so they have to be aware that relying on a fixed cut ((off)) score is not valid."

Studies of the attitudes of caregivers, done in Boston, have found cultural beliefs that may pose barriers to care. Chinese families told researchers that they tried to hide loved ones with dementia because of perceived stigma. Ironically, in some cases, this harmful reaction was exacerbated by a positive tradition of respect and protection of elders. It's a reaction that Ciliberto hopes to change, with cultural sensitivity.

"We can't keep hiding people," Ciliberto said. "We need to get them help."

"We need to be respectful of what people believe and what gives people hope," she said. "But we also need to present the alternatives."

For example, she said, if a family thinks there's a curse and wants to pray about it, she supports the prayer, but explains that Alzheimer's is a disease.

"Let's fight it with prayer," she tells the family. But let's also "fight it with every weapon available. Let's go get the medication, let's go participate in research."

Ciliberto's mother is enthusiastic about her daughter's work. "I've been very concerned and worried about what's happening in our family and in other families as well," she said in Spanish, as her daughter translated.

Her illness is in the early stages, and she is still working as a teacher's assistant in a private school in Puerto Rico. From her daughter and her doctor, she is learning about Alzheimer's and getting treatment, and she no longer dismisses her forgetfulness as a normal sign of aging.

Misconceptions about dementia are also widespread in African-American communities, researchers say. In some studies, African-Americans were more likely than whites to dismiss memory loss as typical of old age and to feel that they were not at risk for the illness. That may help explain why studies find that African-Americans often don't get care until the disease has progressed significantly.

"We missed the opportunity to have our Magic Johnson in the world of Alzheimer's, to show everyone that this is not a predominantly white disease," said Michael Kincade, coordinator of medical and community outreach for the state Alzheimer's Association chapter. Kincade said there have been several prominent African-Americans with Alzheimer's, but they have not been public about their illness, in the way that Johnson was about HIV. "The most frustrating thing is trying to get people to grasp that the memory loss and other symptoms are not normal."

Kincade and Ciliberto work on parallel tracks and are expanding their efforts in Boston and Springfield, funded by two small grants received this month. They are targeting middle-aged people with diabetes, obesity or heart disease - who are at higher risk for Alzheimer's and whose parents may already be suffering from it - and educating primary care physicians about risks for, or early signs of dementia.

"If an African-American women is being seen for diabetes and hypertension, there should be red flags that go up," said Gerald Flaherty, director of medical and scientific programs for the Alzheimer's Association in Massachusetts. "We hope to uncover that untreated parent at home."

"There's clear evidence that by intervening with the family and treating the stress of caregiving, the patient will do better," he said.

Source:health.theledger.com

Article; In Matters of the Heart, Prevention Is Key

If you were a cardiologist or an optimist, you might say the glass was half-full. But if you were an epidemiologist or pessimist, you would be more inclined to say the glass was half-empty.The glass, in this case, is the death rate from coronary heart disease in the United States, which declined sharply in the last two decades of the 20th century. From 1980 through 2000, the age-adjusted death rate for coronary heart disease fell to 266.8 deaths per 100,000 men from 542.9 deaths, and to 134.4 deaths per 100,000 women from 263.3.

This change, which meant 341,745 fewer coronary deaths in 2000 than would otherwise have occurred (along with a continued decline in such deaths in the years since), catapulted cancer last year into the lead position as a killer of Americans under age 85, even though cancer death rates are also declining.

Nonetheless, the pessimists would say, far more people are still dying of heart disease than should be, often before reaching age 30, even though the tools are at hand to virtually eliminate this scourge. And there are now strong indications that as Americans continue to get fatter and fatter, the decline in heart disease deaths will soon grind to a halt and may even reverse itself.

Furthermore, the pessimists note, the direct and indirect costs of coronary heart disease are still breaking the health care bank, at $142.5 billion last year and rising.

Why the Death Rate Fell

In the June 7 issue of The New England Journal of Medicine, a team led by public health specialists from the national Centers for Disease Control and Prevention analyzed the changes that have occurred in American medicine and habits to account for the impressive drop in deaths from coronary heart disease (the most common kind of heart disease, which results from blocked blood vessels feeding the heart).

About 47 percent of the decrease in coronary deaths among Americans aged 25 to 84, the researchers concluded, could be attributed to “a revolution in the treatments for established coronary heart disease”: the use of medical or surgical therapies that help prevent or postpone deaths from heart disease in patients already afflicted. These are therapies administered to patients who have suffered and survived a heart attack, people with chest pains indicative of blocked coronary arteries and patients with heart failure.

The remedies range from cheap (bystander CPR to forestall death from a heart attack, for example, and daily aspirin to prevent clots that can precipitate an attack) to costly and sometimes hazardous (angioplasty, stents and coronary bypass surgery to open or circumvent blocked arteries). Other therapies include clot-dissolving drugs, drugs that lower blood pressure and cholesterol levels and rehabilitation programs to improve cardiac function.

All told, the researchers estimated, nearly 160,000 of the coronary deaths that were prevented or postponed in 2000 “were attributable to medical therapies” administered to patients already known to have had heart disease.

While patients and their loved ones are no doubt extremely grateful for the ability of modern medicine to keep people alive and often well when their hearts are on the verge of giving out, the therapeutic approach to curbing the coronary death rate is like shutting the barn door after the horse has escaped. A more economical, not to mention less terrifying, approach is to prevent the development of this life-threatening and costly disease.

According to the new analysis, about 44 percent of the decline in coronary mortality during the 20 years studied was due to improvements in risk factors for heart disease: reduced cholesterol levels, better control of high blood pressure, a decline in smoking and a small rise in physical activity.

These changes have occurred largely through the seriously underfinanced efforts of public health advocates who for decades have championed the cause of primary prevention of heart disease. They started in the early 1960s with campaigns against smoking, continued with efforts to curb saturated fats, cholesterol and salt in the American diet and moved on to still-lagging efforts to get more Americans to be physically active.

The pharmaceutical industry, which spends billions of dollars to develop and test new drugs and convince doctors to prescribe them for their patients, has also contributed to better control of risk factors, often in people not yet known to have heart disease. There is now a plethora of risk-reducing medications available both to healthy people and to those already afflicted, including old-school but still front-line diuretics to lower blood pressure and relatively new (and very effective) statins to lower dangerously high cholesterol levels.

There are also many aids sold over the counter and by prescription, as well as therapies like hypnosis, to help people quit smoking. In addition, a growing public intolerance for tobacco smoke, increasing limits on where people can smoke and the rising cost of cigarettes have prompted many people to quit smoking or at least cut down on how much they smoke.

What Next?

But there are two countertrends that are cause for serious concern about the future of heart disease in this country: the overall increase in weight and the accompanying increase in the prevalence of diabetes. The researchers calculated that “increases in the body-mass index accounted over all for about 26,000 additional deaths from coronary heart disease in 2000, and increases in the prevalence of diabetes for about 33,500 additional deaths.”

So far, there is no indication of a reversal of these trends. But unless the weight issue is brought under control, two other risk factors for heart disease will also increase: serum cholesterol levels will rise, and so will blood pressure. And along with Type 2 diabetes, these increases can change the direction of coronary mortality.

No one would argue that it’s better to shut the barn door while the horse is still inside. So let’s talk about primary prevention.

¶We’re doing a lot better with controlling elevated cholesterol through diet and drugs, and the recent widespread elimination of trans fats from processed foods will help even more.

¶We’ve done a lot, but could still do a lot more, to control hypertension by making sure not only that everyone with high blood pressure gets a diagnosis and treatment, but that the treatment effectively controls blood pressure and is maintained indefinitely.

¶Smoking, a major cause of heart attacks and sudden cardiac death, declined among adults by 50 percent from 1965 to 2005. But 45 million American adults and 20 percent of teenagers still smoke, and more effort is needed to eliminate this noxious behavior and to keep youngsters from taking it up.

¶Most important, perhaps, is to nip in the bud the current rise in weight and diabetes. These increases in coronary risk are environmental, not genetic, and can only be resolved by changing how and what people eat and how much they exercise.

So, my fellow Americans, I urge you to tighten your lips to culinary temptation and instead expand your lungs and blood vessels by exercising more and more often. Your heart, which will become a more efficient and effective pump, will thank you for it.

Source:www.nytimes.com

Scientists grow insulin in tobacco plants

U.S. researchers have discovered insulin grown in plants can resolve diabetes in mice -- a finding holding promise for humans afflicted with the disease.

University of Central Florida biomedical scientists led by Professor Henry Daniell found insulin might someday be grown in genetically modified plants and then be used to prevent diabetes before symptoms appear or to treat the disease in its later stages

Daniell's research team genetically engineered tobacco plants with the insulin gene and then administered freeze-dried plant cells to five-week-old diabetic mice as a powder for eight weeks. By the end of the study, the scientists found the diabetic mice had normal blood and urine sugar levels, and their cells were producing normal levels of insulin.

Daniell has since proposed using lettuce instead of tobacco since lettuce can be produced cheaply and avoids the stigma associated with tobacco.

The National Institutes of Health provided $2 million to fund the UCF study, which is reported in the July issue of the Plant Biotechnology Journal.

Source:www.earthtimes.org

Sex Differences In Brains Reflect Disease Risks

Women’s brains are different from men’s. That’s not news. What is news is that the differences are smaller than most people believe. They are not big enough to say that one sex is smarter or better at math than the other. What is also news is that the small differences can be significant when it comes to memory, arousal, reasoning, and risk of some diseases. The latter include depression, anxiety, schizophrenia, drug abuse, Alzheimer’s, diabetes, and heart disease.

“Brain differences, though small, help us to understand the nature of sex differences in disease, and thus will hopefully aid in devising sex-specific treatments and prevention strategies,” notes Jill Goldstein, a professor of psychiatry and medicine at Harvard Medical School (HMS).

Here are some examples. Medical experts advise men to take a baby aspirin a day to help protect them against heart attacks. But Julie Buring, a Harvard professor of medicine who works at the Brigham and Women’s Hospital in Boston, found that aspirin does not work the same in women.

More women suffer from Alzheimer’s disease than men, and it’s not just because they live longer. They also have a much greater risk than men for contracting type 1 diabetes, rheumatoid arthritis, lupus, and other diseases caused by a defective metabolic and immune system. Premenopausal women recover from stroke sooner and with less disability than men of the same age or postmenopausal women.

Why? Goldstein and her many colleagues at the Connors Center for Women’s Health and Gender Biology at Brigham and Women’s are working on answers. They have found a number of brain regions that are significantly different in size in men and women. This has led many people to think that such variations result in sex differences in function and behavior, such as memory and emotionality.

For example, part of the hippocampus at the center of the brain and other areas at the front of the brain contribute to short-term memory, and are larger in women. Does this mean they have better working memories? Other areas in the brain, believed to be seats of mating and arousal, grow larger in males, leading to conclusions that men are more aggressive. “This is not always the case,” Goldstein points out. “Size alone does not drive function.”

In tests of short-term memory, Goldstein and her colleagues showed that although brain activity differs between sexes, their short-term memory performance is the same. “Such results show that male and female brains can take different actions to arrive at the same behavioral response,” she notes. However, these variations in activity may account for a small advantage that women have over men in verbal fluency and speed of perception.

Stressing research

Research to date leads to the conclusion that more variability exists in the size of brain regions and behavior within each sex than between the sexes. “The great value in exploring this variability is to understand the role that these differences play in certain diseases,” Goldstein explains.

Another conclusion is that specific behaviors are not driven solely by one region of the brain, notwithstanding those neat diagrams of how the brain works in popular magazines and Sunday supplements. “No single brain region controls a particular behavior,” is the way Goldstein puts it. “The hippocampus is important in memory but other brain regions are involved. Most functions are regulated by a network of brain regions.”

Both hormones and genes drive these subtle but significant sex differences in human brains from the womb to puberty and beyond. Goldstein’s team studies normal sex differences in order to better understand what goes wrong in mental disorders. The tools they use include scanning techniques that produce images of activity in various brain regions as men and women engage in various tasks.

In a series of experiments, Goldstein’s team investigated sex differences in response to stress. While in a scanner, women watched a series of pictures showing both neutral scenes, like cows grazing in a pasture, and those that stimulate high arousal, like horrible car crashes. The women were tested at the beginning of their menstrual cycles and again at ovulation, after eggs leave the ovaries.

Stress regions showed greater activity during the beginning of the cycle than during ovulation, but, surprisingly, the women felt no change in mood. When the same brain networks were examined in men, their brains looked similar to those in women at the cycle start. Goldstein and her team are now mapping out which hormones, like estrogen and progesterone, are associated with the differences.

“This is only one of many studies to identify the role of hormones and genes in regulating sex differences in response to stress,” Goldstein notes. “We hope that these findings help us understand the higher rates of depression and anxiety in women than in men.” Such findings could also shed light on the diminished sensitivity to trauma in men with depression and anxiety disorders. This new understanding of normal reactions to stress is the first step in putting together sex-specific treatments for women and men who must deal with these mental disorders.

As an aside, the natural lessening of anxiety during ovulation may increase a woman’s availability, receptivity, and desire to mate during this crucial time. “That idea goes beyond what our data shows us,” admits Goldstein, “but it’s reasonable to think it may be adaptive for survival of the species.”

What’s more, the brain’s stress response network has been implicated in other mental disorders, such as psychosis in which a person loses contact with reality, and in medical problems that include heart disease and diabetes. Stress and anxiety disorders are co-companions with a host of physical problems that show critical sex differences. Studies are under way by Goldstein and others to understand the connections and, perhaps, find effective ways to treat them.

Source:www.sciencedaily.com

Aging U.S. population at risk for eye disease

More than 43 million Americans will develop age-related eye diseases by 2020, and the majority of those who are most at risk are unaware, an eye doctors' association reports today.

To reverse the trend, the American Academy of Ophthalmology is launching its EyeSmart campaign — which includes a new set of screening recommendations and a website, geteyesmart.org.

"Many of these diseases are preventable, but people don't get checked until they begin experiencing symptoms," says H. Dunbar Hoskins, executive vice president of the academy. "And at that point, it might be too late in the process."

The academy now recommends all adults be screened for eye disease at age 40, when symptoms and vision changes typically appear.

Everyone considered "at risk" — those with a family history of eye disease, diabetes or high blood pressure — should be screened immediately, Hoskins says. The campaign aims to raise awareness about and prevent five major eye diseases: age-related macular degeneration, cataracts, diabetic retinopathy, dry eye and glaucoma. Symptoms include pain or redness in the eye and impaired vision, Hoskins says. If untreated, serious vision loss or blindness is likely to occur.

"The earlier you begin treatment, the more likely it is to be successful," Hoskins says. "But most Americans either don't think they're at risk or think it's a trivial issue."

The academy today released a 1,200-person survey that reports only 11% of Americans consider themselves at risk for eye disease. The academy estimates that each year, eye disease costs the U.S. about $51.4 billion. Medicare costs for indirect eye disease expenses — including nursing care and assisted-living facilities — are about $2 billion.

Source:www.usatoday.com

Experimental Therapy Reverses Type 1 Diabetes in Mice

Researchers have accomplished what might be a cure of type 1 diabetes -- at least in mice --- and they're taking the first steps toward a human trial.

Type 1 diabetes is the autoimmune form of the disease, affecting about five percent of diabetics. It usually emerges in childhood and occurs when the body's immune system attacks insulin-producing beta cells in the pancreas.

Now, a three-drug regimen that not only stops the destruction of beta cells but also preserves the function of cells that receive and metabolize insulin has eliminated type 1 diabetes in laboratory mice, said lead researcher Maria Koulmanda, director of nonhuman primate research at the Transplant Research Center, Beth Israel Deaconess Medical Center in Boston.

Her team published its report July 30 in this week's online edition of the Proceedings of the National Academy of Sciences.

"We stopped the progression of automimmunity. The animals could become normoglycemic," meaning they had normal levels of blood sugar, Koulmanda said.

Another major discovery is that inflammation appears to play a major role in type 1 diabetes, she added. In fact, one drug used in the treatment regimen reduced the inflammation of cells that metabolize insulin.

"Basically, by blocking inflammation, we were getting the animals to be insulin-sensitive," Koulmanda said.

Another drug successfully reduced the autoimmune destruction of beta cells, but that was not the key to reversing the disease, she said. Instead, success was linked to blocking inflammatory processes that impair cells' responses to insulin.

Some of the cells involved in insulin metabolism were found to be resistant to insulin's effects -- a common phenomenon seen in much more common, adult-onset, obesity-linked type 2 diabetes, Koulmanda said. "This is the first time anyone has seen insulin-resistant cells in type 1 diabetes," she noted.

A course of treatment lasting less than four weeks restored normal blood sugar function in the test mice. In contrast, mice that did not get the treatment died during that month-long period.

Based on these promising results, the first work need to start a human trial of the regimen are about to begin, said Dr. Terry B. Strom, director of the Transplant Research Center.

"We have tried something like this for monkey models," he said. "The results have been very good."

The next step will be tests to ensure that the regimen is safe for human use.

"We anticipate toxicology trials very soon," Strom said. "We are making the proteins needed for those trials."

The fact that success was achieved in the mice trials with a relatively short course of treatment indicates that, for humans, "one might be able to use relatively brief periods of treatment to restore normal function," he said.

Source:www.forbes.com

Avandia should come with warning on heart disease, FDA told

GlaxoSmithKline's diabetes drug Avandia should stay on the market with a strong warning about increased risks of heart diseases, an expert panel recommended to the Food and Drug Administration on Monday. The scientists on the panel said they were frustrated by the data presented at a day-long meeting. The committee of scientists voted 20-3 to conclude that Avandia does increase risks of heart disease in type 2 diabetes, but the committee declined to recommend that the drug be pulled from the market. The experts urged the FDA to study the effects of the drug and of a substitute drug, Actos, marketed by Takeda Pharmaceuticals.

Source:www.marketwatch.com

When the Kidney fails

How do you treat end-stage renal failure? Patients with ESRF can be treated by dialysis or kidney transplantation. Dialysis is of two varieties hemodialysis or blood dialysis and CAPD or water dialysis. Kidney transplantation is the best treatment that can be offered to a patient with ESRF.

What is kidney transplantation? Kidney transplantation or renal transplantation is the organ transplant of a kidney in a patient with ESRF. The main types of kidney transplant are living donor transplant and cadaveric. In the former, the kidney originates from a deceased (brain-stem-death) person.

In the latter, the kidney is being donated by an organ donor. It is possible to transplant a kidney from a living donor because the body can work just as well with one kidney as with two.

What are the tests done to evaluate a kidney transplant recipient? A transplant evaluation includes many tests to make sure that the recipient is healthy enough to have a transplant. To make sure that the new kidney will be a good match, tests will be done to find out the blood and tissue type. Other tests include a check-up for any active infections, blood clotting profile, a chest x-ray, an ECG and cardiac evaluation, and abdominal ultrasound. Women must be cleared by a gynecologist. Other tests may be required depending on the age and medical history of the patient.

Can patients with kidney failure (ESRF) due to diabetes undergo transplantation? Patients with diabetic kidney failure form the majority of patients in a dialysis unit these days. Some diabetics tend to have concurrent heart problems or blood vessel (vascular insufficiency) blockages, and this has to be attended to before they are cleared for transplantation.

What kind of testing does a living donor go through? A person who wants to be a living donor will go through a set of tests, which will increase the chances of a successful match. They will also make sure that the donor will not be placed at risk. The tests include blood tests, urine tests, chest x-ray, ultrasound scan of the abdomen and ECG. Like the recipient, the donor is also tested for any active infections. Also, a CT/MR scan or arteriogram (an examination of the blood vessels) of the kidney is done.

Potential donors will be examined by a surgeon and a nephrologist.

Anyone with kidney disease, diabetes or high blood pressure would not be considered.

Does the transplant recipient have to take special medications after the transplant? Yes, the patient will have to take immunosuppressive medications such as prednisolone, cyclosporine or tacrolimus, and mycofenolate, but with significant reductions in dosages with time.

What is the most common cause of chronic kidney failure?

Diabetic nephropathy is fast becoming the leading cause of chronic renal failure. It is also one of the most significant long-term complications in terms of morbidity for the individual patients with diabetes.

Diabetes is responsible for more than 50 per cent of all end-stage renal disease cases in India.

Although both type 1 diabetes mellitus (insulin-dependent diabetes mellitus (IDDM) and type 2 diabetes mellitus (non-insulin-dependent diabetes mellitus (NIDDM) lead to ESRD, the great majority of patients are those with NIDDM.

Are there any guidelines for patients at risk for kidney disease? Patients with diabetes mellitus and hypertension (high blood pressure) are at risk for developing kidney disease. Patients with glomerulonephritis (kidney inflammation) and recurrent urinary infections/ obstruction are also at risk of developing kidney failure. Such patients are advised to undergo regular follow-up with a nephrologist.

Regular checks on urine-protein levels (proteinuria) and kidney function (urea and creatinine levels) are mandatory. Aggressive blood pressure control (aim for BP 20/80 mm Hg) and the use of newer medicines (ACEI and ARB) hold the key to the management of such patients with a view to prevent progression of kidney disease.

Source:www.newindpress.com

New Study Demonstrates Colesevelam HCl Lowers Both A1C and LDL Cholesterol in Patients With Uncontrolled Type 2 Diabetes Mellitus on Metformin-Based R

Data to be presented at the American Diabetes Association's (ADA) 67th Annual Scientific Sessions in Chicago demonstrate that colesevelam HCl can lower both A1C and LDL cholesterol levels in patients with type 2 diabetes mellitus who were uncontrolled on a metformin-based regimen. The new colesevelam HCl clinical data findings from the pivotal studies are consistent with the pilot study findings. The data was included in Daiichi Sankyo's supplemental New Drug Application filed with the U.S. Food and Drug Administration (FDA) in December 2006. If approved, colesevelam HCl will be the first LDL cholesterol lowering medication also indicated for improving glycemic control in patients with type 2 diabetes mellitus (DM).

The 26-week study of colesevelam HCl included patients with type 2 DM who had previously failed to reach glycemic control (ADA target of A1C<7%) with metformin, a common oral medication for type 2 diabetes mellitus. Patients in the study were randomly assigned to two groups. The addition of colesevelam HCl tablets was compared to the addition of placebo in patients on a metformin-based regimen.

Two separate presentations of the study will be made at the ADA poster session on Sunday, June 24th. Dr. Harold Bays, MD, study investigator and Medical Director of the Louisville Metabolic and Atherosclerosis Research Center in Kentucky, will describe colesevelam HCl's effect on A1C and glycemic control in a poster presentation titled "Effect of Colesevelam HCl on Glycemic Control in Type 2 Diabetic Subjects Receiving Metformin Monotherapy." The study demonstrated that the colesevelam HCl treatment group with metformin monotherapy cohort achieved significantly greater reductions in A1C levels compared to the placebo group (mean=0.47%, p<0.0024). Further, the colesevelam HCl total treatment group (metformin monotherapy and combination therapy) achieved significantly greater reductions in A1C levels compared to placebo (mean=0.54%, p<0.001). Fructosamine, another indicator of glycemic control, was also significantly reduced in the patients receiving colesevelam HCl (mean=17.8 micro mol/L, p<0.05).

"Diabetes mellitus and hypercholesterolemia often coexist in patients," said Dr. Bays. "This study provides evidence that colesevelam HCl is not only safe and effective in improving cholesterol levels in patients with type 2 diabetes mellitus, but may also lower glucose levels as well."

The second presentation demonstrated colesevelam HCl's effect on LDL cholesterol and other lipid parameters. The poster presentation titled "Colesevelam HCl Improves the Lipid Profile in Type 2 Diabetic Subjects with Inadequate Glycemic Control on Metformin," notes that the colesevelam HCl treatment group achieved significantly lower LDL cholesterol levels compared to the placebo group (mean=15.9%, p<0.001). The colesevelam HCl group also achieved significant reductions in apolipoprotein B levels and C-reactive protein, two known cardiovascular risk factors. Significant weight gain, a common side effect of some oral anti-diabetic agents, was not observed in the colesevelam HCl group. In this study, colesevelam HCl had no significant effect on triglycerides compared to placebo (median percent change=11.8% vs. 6.6%, p=0.221).

"Given the prevalence of diabetes and high LDL cholesterol, a medication that can help lower both A1C and LDL cholesterol can be beneficial for many patients," said Ronald B. Goldberg, MD, a lead investigator in the study and Professor of Medicine at the Division of Diabetes and Metabolism and Associate Director of the Diabetes Research Institute at the University of Miami, Miller School of Medicine in Florida. "A new therapeutic option that would address these two chronic health conditions would provide physicians with a different therapeutic approach for treating patients with type 2 diabetes."

The ADA estimates that there are 20.8 million people in the United States with diabetes; 90-95% of this population are diagnosed as type 2.(1) The ADA recommends that patients with type 2 diabetes achieve an A1C level of <7%.(1) A1C is a common test for persistent hyperglycemia ("too much glucose in the blood").

People with diabetes face significantly higher risk of heart attacks and developing other forms of cardiovascular disease.(2) Accordingly, the National Cholesterol Education Program (NCEP) recommends that patients with type 2 diabetes adhere to a more stringent LDL cholesterol ("bad cholesterol") goal of <100 mg/dL.(3)

It is estimated that approximately half of all Americans have elevated blood cholesterol levels that can negatively impact their health and quality of life.(4) According to a recent Harris Interactive Survey, approximately 29% of adults previously diagnosed with hypercholesterolemia have also been diagnosed with diabetes.(5)

About the Study

The study was designed as a 26-week, prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center study. Three hundred and sixteen patients were randomized, with 222 patients completing the study. The sample consisted of subjects aged 18 to 75 years of age with type 2 diabetes (per ADA criteria) and A1C levels between 7.5%-9.5% (inclusive). Subjects were maintained on a stable dose of metformin. Following a 2-week placebo run-in period, subjects were randomized to receive either colesevelam HCl (3.75 g/day in 6 tablets/day) or matching placebo (6 tablets/day) for 26 weeks. The primary objective of the study was to evaluate the effect of colesevelam HCl on glycemic control in subjects with type 2 diabetes, measured by change in A1C from baseline to week 26 for the intent-to-treat population with last observation carried forward. Primary and secondary endpoints were presented in two separate posters at the ADA Scientific Sessions:

Poster #484 -- "Colesevelam HCl Improves the Lipid Profile in Type 2 Diabetic Subjects with Inadequate Glycemic Control on Metformin": Examines colesevelam HCl's effect on lipid parameters, including LDL cholesterol, total cholesterol, non-HDL cholesterol, apolipoprotein B, apolipoprotein A-1 and triglycerides in patients that have uncontrolled type 2 diabetes and are taking metformin.

Poster #485 -- "Effect of Colesevelam HCl on Glycemic Control in Type 2 Diabetic Subjects Receiving Metformin Monotherapy": Examines colesevelam HCl's effect on glycemic control parameters including A1C, fasting plasma glucose and fructosamine in patients that have uncontrolled type 2 diabetes and are taking metformin.

About WelChol(R)

WelChol (colesevelam HCl) is indicated for LDL-C lowering and was approved by the U.S. Food and Drug Administration (FDA) for marketing in May 2000. WelChol is the top-selling branded drug in the bile acid sequestrants (BAS) class. WelChol is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, WelChol is not expected to have drug-drug interactions via the cytochrome P-450 pathway. Systemic medications, which include statins, fibrates, and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.

WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa) when the response to diet and exercise has been inadequate. Liver-function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.

In clinical trials with patients with primary hypercholesterolemia, when WelChol was given alone in addition to a low-fat diet and exercise, it was shown to reduce LDL cholesterol by an average of 15% to 18%.

When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.8g provided up to an additional mean 16% (32 mg/dL) reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin.

WelChol is engineered for affinity and high capacity bile acid binding. It has been studied with four commonly prescribed statins - Lipitor(R) (atorvastatin calcium), Zocor(R) (simvastatin), Pravachol(R) (pravastatin sodium) and Mevacor(R) (lovastatin). Additionally, WelChol has been studied with fenofibrate and had no significant effect on the bioavailability of fenofibrate. Like most prescription drugs, WelChol has not been studied in combination with all medications or supplements. Patients should always tell their doctor about all medications and supplements they are taking before starting any new therapy, including WelChol.

WelChol is not for everyone, especially those with bowel blockage. Caution should be exercised when treating patients who have trouble swallowing or severe stomach or intestinal problems. Side effects may include constipation, indigestion and gas. WelChol, either alone or in combination with a statin or fenofibrate, has not been shown to prevent heart disease or heart attacks.

WelChol is only indicated for the reduction of LDL-C either alone or in combination with a statin in patients with primary hypercholesterolemia. Additionally, WelChol has demonstrated beneficial effects on other lipid parameters such as HDL-C and APO-B. WelChol has also been studied in combination with fenofibrate in patients with mixed dyslipidemia (Fredrickson Type II B), and provided additional LDL-C reductions in these patients when added to a stable fenofibrate regimen. WelChol is not indicated for use in the treatment of mixed dyslipidemia or lipid parameters other than LDL-C.

For more information on WelChol, call 877-4-DSPROD (877-431-7763), or go to the WelChol web site at http://www.welchol.com/.

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899. The company is dedicated to the discovery, development and commercialization of innovative medicines that improve the lives of patients throughout the world.

The primary focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. The company is also pursuing the discovery of new medicines in the areas of glucose metabolic disorders, infectious diseases, cancer, bone and joint diseases, and immune disorders.
source:sev.prnewswire.com

Diabetes Center

Diabetes Mellitus is a chronic disorder characterized by the inability to properly process sugar, thus causing fasting elevations of blood sugar (glucose) levels. Diabetes can occur when the pancreas does not secrete enough insulin (Type-I/Childhood Onset/Insulin-Dependent Diabetes Mellitus/IDDM) or if the cells of the body become resistant to insulin (Type II/Adult Onset/Non-Insulin-Dependent Diabetes Mellitus/NIDDM). Hence, the blood sugar cannot get into the cells. When this happens it leads to serious complications such as greatly increased risk of cardiovascular disease, kidney disease, infections, circulatory problems, and loss of nerve function. The classic symptoms of diabetes are increased thirst, increased hunger, and increased urination.

There are some nutrients and herbs that affect glucose metabolism which may help to control blood sugar such as chromium, fenugreek, gymnema, and ginseng. Ginkgo can help to prevent complications of poor blood sugar control by promoting healthy circulation. Supplementing with daily vitamins and minerals, plus antioxidants and essential fatty acids can also be beneficial. Especially important in this category are GLA, vitamin C, magnesium, and niacin. Diabetes may cause individuals to be deficient of various nutrients. Replacing these nutrients may not only help, but may also help prevent complications.

Effective control of diabetes requires an integrated approach which also includes exercise, weight control and a good diabetic diet. Controlling calories, reducing milk and dairy consumption, plus reducing simple carbohydrates (refined sugars) while increasing complex carbohydrates (starches) and soluble fiber is important to good diabetic management.

Lifestyle changes plus medical attention are both necessary. Diabetes can be a serious condition. Alternative treatments for diabetes should not be attempted without the permission of the treating physician.
source:www.drmamae.com