ACCORD Trial Makes News
Today, the National Institutes of Health (NIH) announced a major change in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study - a large-scale North American trial with over 10,000 participants. One arm of the trial, which examined the impact of intensively-controlled type 2 diabetes management (i.e., an A1C goal of less than 6%) in preventing cardiovascular complications, was stopped eighteen months early. The National Heart, Lung, and Blood Institute (NHLBI) found that type 2 ACCORD participants at high risk for heart attack and stroke who were placed in the intensive diabetes management group had an increased risk of death compared with their peers who were placed in a less-intensive standard treatment (i.e., A1C of 7 to 7.9%) group. It's important to note that the increased risk was slight, and was specific to only a subset of patients who had two or more risk factors for heart disease outside of diabetes or who had pre-existing heart disease upon entering the study.
Read more about the ACCORD changes here.
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ADA Catches Up on Low-Carb...Sort Of
The American Diabetes Association has started to acknowledge the evidence that a low-carbohydrate diet is beneficial for people living with diabetes....sort of. In the newly-released "Nutrition Recommendations and Interventions for Diabetes," the ADA says that: "For weight loss, either low-carbohydrate or low-fat calorie-restricted diets may be effective in the short term (up to 1 year)." This marks the first time that the ADA has acknowledged the clinical benefit of low-carbohydrate diets in any capacity, and we applaud them for taking this step in the right direction.
However, for daily diabetes management, the ADA stands firm on its former dietary recommendations, continuing to recommend a minimum of 130 grams of carbohydrates daily. The authors noted that "(a)lthough brain fuel needs can be met on lower-carbohydrate diets, long-term metabolic effects of very-low-carbohydrate diets are unclear, and such diets eliminate many foods that are important sources of energy, fiber, vitamins, and minerals and are important in dietary palatability."
Of course, any dietary strategy needs to provide some level of taste enjoyment if it has any chance of long-term adherence, but the assumption that low-carb can't be a palatable dietary option is a cop out. There is no hesitancy on the ADA's part in officially recommending low saturated fat intake, yet it could be argued that low-saturated-fat diets can eliminate many foods that are important sources of nutrients and “dietary palatability.” And energy, fiber, and vitamin and mineral requirements can certainly be met within a healthy low-carb eating plan.
Yes, you have to work at low-carb, but let's give people with diabetes some credit in wanting to put in that hard work for better blood glucose control. Nutrition principles that promote our best chance at diabetes health should be the goal of all professional healthcare organizations. Let's not settle for less.
Read more about the new ADA nutrition guidelines and how low-carb advocates are reacting.
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Pfizer Drops Exubera
Since its market release in early 2006, Exubera has faced an uphill battle winning widespread physician and consumer adaption. Now, manufacturer Pfizer has decided to pull the product from its portfolio. From Pfizer's third quarter earnings release yesterday:
"[W]e made an important decision regarding Exubera, a product for which we initially had high expectations,” said Jeff Kindler, Chairman and Chief Executive Officer. “Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.”We will work with physicians to transition Exubera patients to other treatment options in the next three months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines.”
RELATED: Inhaled Insulin
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Managing Your Cardio Risk
Is focusing on controlling blood sugar levels enough? That's the question Gina Kolata of The New York Times asked yesterday in a feature story about heart disease risk in the diabetes population - and how high cholesterol and blood pressure remains seriously undertreated. It's also apparently misunderstood. In a recent ADA survey, only 18 percent of people with diabetes acknowledged that the disease put them at increased risk for cardiovascular disease.
The big takeaway is that while keeping blood glucose levels under control is important, and may decrease damage to small blood vessels, cholesterol reduction and blood pressure control are key to preventing cardiovascular disease. This may mean adding drugs, like statins, to an already complicated diabetes regimen, but in terms of preventing long-term heart problems, it's worth it.
Read The New York Times article.
RELATED: Take the Heart Disease Risk Quiz!
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Old Dog Does New Tricks
With all the latest advancements in type 2 oral medications, it may seem the newer the better. dLife Expert columnist Daniel Trecroci challenges that theory as he uncovers a recent study about the effectiveness of older medications. Read the latest now.
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FDA Committee Recommends Avandia Stay on Market
Yesterday, a U.S. Food and Drug Administration advisory panel recommended in a 22 to 1 vote that FDA keep the controversial type 2 diabetes drug Avandia on the market. The panel also voted 20 to 3 that the drug does raise heart disease risk, however, and backed the requirement of a "black-box" warning on Avandia labeling. An estimated one million Americans currently use Avandia to control their diabetes.
In May, the New England Journal of Medicine published a controversial metanalysis of research examining Avandia and heart disease risk, setting off a significant debate in the diabetes community and Congress, and prompting the FDA to accelerate the committee hearing process on the drug.
While the panel's decision is considered a 'recommendation' to the FDA, the agency historically has followed its advice. However, CNN reports that there is disagreement within the FDA itself over the fate of the drug, quoting Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs, as telling the panel: "It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn." GlaxoSmithKline, the manufacturer of Avandia, continues to stand by the safety record of the drug.
RELATED: More on Avandia
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Food for Thought
Recent research reveals that "Compounds found in pumpkin could potentially replace or at least drastically reduce the daily insulin injections that so many diabetics currently have to endure." Is this a story to follow or are we just waiting for the clock to strike midnight?
Talk about it in the dLife Community Forum.
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Avandia - What You Should Know
If you are taking Avandia as part of your diabetes treatment - or are considering it - you've probably been glued to news surrounding the potential cardiovascular risks. dLife columnist Daniel Trecroci has talked to the experts and now shares his findings with the dLife community. Before you do anything, read all about it here, then talk more with your doctor.
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Jump Start Your Exercise Program
If the fact that exercise can improve your diabetes control hasn’t motivated you to get moving, maybe the arrival of swimsuit season will. Exercise physiologist Dr. Sheri Colberg-Ochs has great tips to get you out of the couch potato rut and in beach-ready shape in no time.
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The Story on Avandia
Earlier this week, the New England Journal of Medicine published a Cleveland Clinic metanalysis of research on the type 2 diabetes drug rosaglitizone (Avandia) and the cardiovascular risk associated with the drug. The findings prompted the U.S. Food and Drug Administration to issue a safety warning on Avandia. GlaxoSmithKline (GSK), the drug's manufacturer, has issued a rebuttal to the study, citing their own "comprehensive and rigorous program of scientific analysis."
If you're currently taking Avandia and have concerns about the recent study, talk to your doctor.
GlaxoSmithKline Strongly Defends Its Record on Avandia
PBS: Online Newshour - Study Raises Concerns About Risk of Diabetes Drugs
New York Times: Heart Attack Risk Seen in Drug for Diabetes
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Fit For the Road
Truck driving is a tough occupation. Long days behind the wheel with little exercise, poor eating habits from miles of truck stop dining and fast food pit stops, and erratic schedules that limit access to regular health care all contribute to a growing obesity crisis in the industry.
Nancy Younger is one of five overweight truck drivers who are participating in The Fit for the Road program, a yearlong weight-loss and fitness program customized by a dietician and medical doctor and sponsored by Trucker's News Magazine. She was selected from a pool of over 350 applicants for her motivation and commitment level. Nancy also has type 2 diabetes, and is chronicling her weight loss journey across the highways of America in a Fit 4 the Road blog. She reports: "Now, my sugars are down to the low 100's and I have shed 15 pounds since December 1, 2006."
Keep on truckin', Nancy!
RELATED: Weight Management
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Pen Pal
Good news for gadget lovers. Lilly has debuted their new HumaPen MEMOIR, the first digital insulin pen. The MEMOIR, which dispenses Humalog insulin, allows patients to record and review their last 16 insulin doses by time and amount at a push of a button With its Waterman stylings and sleek chrome detail, It's not too shabby looking, either.
The Boston Herald reports that the reusuable unit will retail for around $100, with discount coupons at launch giving early adapters a $45 deal (insulin cartridges extra).
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dLife Talks to Nancy Pelosi About Stem Cell Debate
dLifeTV recently sat down for a one-on-one interview with Speaker of the House Nancy Pelosi to discuss the controversial issue of embryonic stem cell research and what pending legislation means for people with diabetes and other chronic diseases everywhere. Don't miss this exclusive interview at dLife.com.
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Januvia: The New Kid On The Block
The DPP-IV inhibitors have arrived! Merck's Januvia (sitagliptin phosphate), the first in class of this new drug, received FDA approval yesterday. Januvia works by enhancing the body's ability to release insulin after blood sugar rises, such as after a meal. A second DPP-IV, Novartis's Galvus (vildagliptin), is expected to receive FDA approval later this year). Join the discussion about Januvia in the dLife Forum now, or post a comment below.
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Islet Cell Transplants: Hope or Hype?
The headline doesn’t look terrific: “A Diabetes Treatment Fails to Live Up to Early Promise.” Today’s New York Times reports on results of the International Trial of the Edmonton Protocol for Islet Transplantation, which were published today in the New England Journal of Medicine. Although 58% of patients followed by the trial attained insulin independence after transplant, within two years 86% of islet cell transplant recipients had returned to regular insulin injections. The good news is that severe hypoglycemic (low blood sugar) episodes were reduced in those who received transplants. The treatment also improved long-term blood sugar control.
Is this progress towards a cure? Or just another dangled carrot for the millions of people living with diabetes? What do you think?
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Avandia as a Type 2 Prevention Tool?
A drug that can slash the risk of developing type 2 diabetes by over sixty percent? That's the hot story out of Copenhagen, where the European Association for the Study of Diabetes held its annual meeting last week, and it could be the biggest news in diabetes prevention since the DPP trial findings were announced in 2002. But is rosiglitazone maleate (Avandia) the magic bullet for a global health crisis, or an expensive band-aid that gives us yet another reason not to invest in the healthy lifestyle changes that are known to slash type 2 diabetes risk by up to 70 percent?
The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial followed 5,269 people with pre-diabetes over three years to determine their likelihood of developing type 2 diabetes. Those who took Avandia (rosiglitazone maleate) reduced their risk of developing type 2 diabetes by 62 percent, compared to those who took a placebo. All study subjects were also counseled on healthy eating and exercise.
The DREAM results have been met with skepticism and caution by some in the diabetes community, who cite heart risks, expense, and lack of long-term data on Avandia as factors that may preclude the drug from widespread use as a preventative. And there is also some concern that media attention to the study could send the wrong message - that a pill is a substitute for healthy lifestyle changes. What we do know for certain is that diet and exercise remain the most effective tool we have for type 2 diabetes prevention. And while the Avandia results are impressive, they don't address the underlying problems of how to motivate behavioral and social changes to combat the inactivity and poor nutrition that are fueling the type 2 diabetes crisis.
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Actos and Alzheimer's
New research at the University of Virginia Health System and Case Western Reserve University shows that the type 2 diabetes drug pioglitazone (Actos) may hold promise in treating Alzheimer’s Disease. According to Dr. David Geldmacher, one of the study authors, “We believe that the drug may reduce the body’s inflammatory reaction to one of the toxic components that builds up in Alzheimer’s, called amyloid plaque,” said Dr. David Geldmacher, an associate professor of neurology at UVa.
A 2005 study out of Brown University found that insulin levels drop and insulin resistance increases significantly in the brains of patients with Alzheimer's. As a result, researchers postulated that Alzheimer's may actually be a "type 3 diabetes."
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Disetronic Pumpers Take Note
Disetronic Medical Systems Inc. has announced a voluntary nationwide recall of D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. Due to a design defect, the power packs could shut down the D-TRONplus Insulin Pump without any warning. The company is redesigning the power packs and is urging pump users to change out their power packs every two weeks until the situation is rectified. Power packs will be supplied free of charge via overnight UPS to all Disetronic D-TRONplus pumpers. Contact Disetronic at 1-800-688-4578 for more details.
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Forgive Yourself
Bad diabetes habits can do more than hurt your physical health. The emotional quicksand of anger and guilt can prevent you from forgiving yourself enough to change things. Janis Roszler, RD, CDE, LD/N shows you how to turn the page on the past and start taking better care of your body and soul.
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Penny Wise and Pound Foolish?
The idea of universal health care - coverage for every American man, woman, and child - probably sounds pretty appealing to many people living with diabetes. No more out-of-pocket expenses and deductibles, and the uninsured would get the treatment they need. As we often hear, other countries have been doing it for years, and they're the model of efficiency....or are they?
A recent UK decision highlights one of the problems with universal coverage, and interestingly enough, it isn't that different from an issue faced by Americans under many managed care programs - cost pressures that deny life-enhancing drugs. The National Institute for Health and Clinical Excellence (NICE) has recommended that Exubera inhaled insulin not be prescribed by national health care physicians for the treatment of type 1 or type 2 diabetes. The reason? The hefty pricetag.
Exubera, which already has regulatory approval in the UK and throughout Europe, is predicted to cost £1,100 per person per year (about $1,763) - and that doesn't include the cost of injected insulin that type 1 patients will have to continue to take. The UK has had government-run, universal healthcare coverage since the formation of the National Health Service (NHS) in 1948. NICE is the branch of the NHS charged with the task of determing which medical technologies and treatments should be adapted based on their clinical and cost effectiveness. Although NICE acknowledged that published clinical trials of patients taking the drug have reported a high degree of patient statisfaction and improved quality of life, deputy chief executive Andrea Sutcliffe told the BBC: "Our review of the evidence indicated that inhaled insulin should not be recommended because it could not be proven to be more clinically or cost effective than existing treatments."
She added: "The clinical experts we asked advised us that using injected insulin is not usually a concern for the majority of people with diabetes." We wonder if they asked any 'patient experts' how they felt about the topic.
It will be interesting to see how high U.S. managed care organizations set the bar for coverage of the drug once Pfizer announces retail pricing for the product and releases it to the marketplace this summer.
The NHS is taking public comment on NICE's preliminary decision until May 10, and will issue final guidelines later that month.
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Good News/Bad News
The latest Annals of Internal Medicine* features a report card on diabetes care in the U.S. - and it looks like we continue to squeak by as C students. CDC researchers, using data from several national population-based surveys, looked at data from people with diabetes between the ages of 18 and 75. Among the findings:
The Good
- The proportion of people with an A1c between 6 and 8% increased to 47 percent.
- The proportion of people with fair to good lipid control was up 21.9 percent.
- Annual flu vaccination, recommended for people with diabetes, was also up by 6.8 percent.
- Annual cholesterol testing, dilated eye eamination, and foot examination increased by 8.3, 4.5, and 2.8 percent respectively.
The Bad
- The number of people with an A1c of less than 6% dropped from 23.4 percent to 16.4 percent (down 7 percent).
- One in five Americans with diabetes still have poor glycemic control.
- Two in five people with diabetes have poor LDL cholesterol control.
- One in three people with diabetes have poor blood pressure control.
The Status Quo
- Mean hemoglobin A1c did not change (7.7 percent is the national average for this patient population).
Clearly we still have some work to do.
*Source: Ann Intern Med. 2006; 144:465-474.
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Of Mice and Men
Dr. Denise Faustman raised eyebrows in 2003 when she announced curing type 1 diabetes in mice by short-circuiting the autoimmune attack responsible for wiping out insulin-producing beta cells. And when major cure-focused non-profits eschewed her research in favor of funding more "promising" techniques like islet cell transplant, philanthropist Lee Iacocca stepped up to the plate and began a nationwide campaign to further Faustman's work.
But now the non-profits and the NIH may just sit up and take notice. In the current issue of Science, not just one but three separate studies confirm that Faustman's technique works - at least in mice. It's important to remember that it's a big leap from animal studies to human success, and the new research did not confirm that new beta cell growth came from spleen cells, as Faustman had previously hypothesized. Still, the new studies boost her case for a potential type 1 diabetes cure without the need for transplant.
Meanwhile, Faustman and colleague Dr. David Nathan continue their work at Massachusetts General Hospital, with a phase I human clinical trial planned for 2007. Now that the story is making headline news across the country, it will be interesting to see where the money goes in the ongoing search for a cure.
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Downsizing Inhalable Insulin
Technosphere inhaled insulin is entering phase III clinical trials, according to manufacturer MannKind Corporation. Successful phase III trials are typically the last step before a drug is submitted to the U.S. FDA for regulatory review.
The drug, which was developed by insulin pump pioneer Al Mann, uses the proprietary MedTone inhaler device that administers the insulin. The inhaler fits in the palm of your hand and, all other things being equal, the convenience of the device over Exubera's comparatively bulkier delivery system could be a big plus when it finally comes to market.
RELATED:
Find out more about inhaled insulin.
dLifeTV video - See the MedTone inhaler in "New Diabetes Products."
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Byetta In The News
Good press for the Amylin/Eli Lilly injectable type 2 drug Byetta this morning, as The New York Times publishes a piece on the weight loss benefits of the drug.
Byetta manufacturers Amylin Pharmaceuticals and Eli Lilly announced yesterday that they have filed a new drug application with FDA for Byetta to be used with thiazolidinediones drugs (or TZDs - such as Actos and Avandia). Currently Byetta is only approved for use as a standalone type 2 therapy or with sulfonylurea drugs.
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Exubera Approved
The U.S. Food and Drug Administration announced yesterday that the agency had approved the first inhaled insulin - Exubera - for use in adults with type 1 and type 2 diabetes. The FDA has also required that Pfizer, the drug's manufacturer, conduct a long-term study in 5,000 Exubera patients with type 1 and type 2 diabetes to monitor whether lung function decreases over time. In clinical trials, the drug caused a short term decrease in lung function in some patients.
Find out more about Exubera's approval here.
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World Diabetes Day
Today is World Diabetes Day 2005, co-sponsored by the International Diabetes Federation (IDF) and the World Health Organization (WHO). This year, the international day of diabetes awareness and education focuses on proper diabetic foot care and amputation prevention. Up to 80% of all diabetic foot amputations could be prevented with basic foot care and diabetes management.
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The Glycemic Index
The glycemic index ranks foods on how they affect blood sugar levels. This index measures how much your blood sugar increases after you eat. David Mendosa has the low-down on what the GI means to you.
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Flu Shot Season
A gentle reminder from the U.S. Centers for Disease Control that it's time to get your flu shot. And we quote...
"To ensure that those who are at highest risk of complications from influenza have access to vaccine this season, CDC recommends that people in certain priority groups receive inactivated influenza vaccine (i.e., the “flu shot”) until October 24, 2005:
Starting October 24th, people that don't fall into these high risk categories are eligible to get the vaccine, so beat the rush and schedule your shot today.
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Are Insulin Options Dwindling?
Back in July, we reported on Eli Lilly's announcement that they would be discontinuing production of Iletin II, the last remaining animal-based insulin on the U.S. market, in addition to its human lente and ultralente insulins - leaving some patients faced with tough treatment decisions.
Overseas, UK residents who are dependant on insulin are facing similar hard choices. Novo Nordisk has now discontinued several genetically modified (or GM) human insulins, including the pen form of its Actrapid GM product. The move follows a 2004 Eli Lilly UK withdrawal of several human GM insulins. As of October, when the Novo withdrawal is complete, many Brits will be forced to switch to insulin analogs.
The Insulin Dependent Diabetes Trust has been a vocal opponent of the narrowing of insulin options based on what the IDDT calls a "commercial decision," and what they consider insufficient study of the potential adverse effects of insulin analogs. Diabetes UK Health Care and Policy Director Simon O'Neill also voiced concern at the Novo withdrawal, stating that "this reduces patient choice and could cause some people problems with managing their diabetes. Changing insulin to a newer version is not like trading in a car"
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PROactive: Cutting Cardio Risk
Results from the landmark PROactive study were announced today at the 41st Annual Meeting of the European Association for the Study of Diabetes (EASD). Researchers found that the type 2 diabetes drug Actos (pioglitazone) "significantly reduces the combined risk of death, stroke, or heart attack by 16% in high-risk patients with type 2 diabetes who were already receiving optimised standard of care." PROactive is the first study to demonstrate that a glucose-lowering drug has a significant impact on lowering cardiovascular risk in type 2 patients.
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The Power of Trust
A new study out of the University of Michigan has found that patients who don't trust their doctors are more likely to skip doses of prescribed medicine due to cost issues than those who report a high level of trust in their physicians.
The study involved over 900 VA patients with diabetes, and 41 percent of them were on insulin. Researchers found that nearly 30 percent of those people who reported low levels of trust in their doctors and had monthly drug costs over $100 said they skipped medicines due to cost, compared with 11 percent of those who had a more trusting relationship with their doctor. Those with lower trust levels were also more likely to suffer from depression.
The study results suggest that patients may feel more comfortable revealing financial problems that affect their medical care when they've established a good, trusting relationship with their doctor...and that doctors who have good patient-physician relationships may be more likely to proactively ask patients about financial issues they might face and work with them to find a resolution.
“Our findings suggest that a trusting patient-physician relationship can significantly influence whether a person sticks to prescriptions when that patient faces pressures from their medication costs,” commented lead study author Dr. John Piette.
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Ancient Chinese Secret?
An interesting new study designed to evaluate the effectiveness of Qigong and Tai Chi in diabetes control is underway in Australia. It's thought that both the stress reduction properties and muscle stimulating properties of these traditional Chinese healing arts may play a role in control blood glucose levels.
The study, which is funded in part by the Diabetes Australia Research Trust, will examine whether or not the ancient 5000-year-old practices of Quigong and Tai Chi improve insulin sensitivity in people with elevated fasting blood glucose levels.
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The Extinction of Animal Insulin?
Earlier this month, pharma giant Eli Lilly announced plans to discontinue production of Iletin II, the Company's lone non-synthetic insulin product. With Iletin out of the picture, there are now no animal-based insulins remaining on the U.S. market.
Animal insulins are manufactured by extracting insulin from cow (bovine insulin) and pig (porcine insulin) pancreases. Lilly discontinued its beef-pork Iletin product in 1998. These older insulins began to be phased out by their biosynethic counterparts in the mid-1980s.
So what's the problem? There have been anecdotal reports of long-time animal insulin users reporting sensitivity to synthetically-derived insulins, including an increased incidence of hypoglycemic unawareness when switching from animal insulin to human insulins or insulin analogues. This hasn't been demonostrated conclusively in the clinical literature, however. Several foreign manufacturers of animal insulins remain, and the FDA and USDA do have animal insulin import procedures in place for those patients that can prove a clinical need to import animal insulin for their diabetes control.
Lilly reports that the discontinuation will impact an estimated 2,000 U.S. and 700 Canadian consumers of Iletin insulin. Based on their current inventory, Eli Lilly predicts that patients should be able to continue to purchase Iletin in U.S. pharmacies through the end of 2005.
Read More on Animal Insulin: The IDF Position Statement on Animal, Human, and Analogue Insulins
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Creepy Crawlies
It's called biodebridement, and it is highly effective in the treatment of severe diabetic foot ulcers and other difficult-to-heal wounds - frequently saving feet and limbs that would have otherwise been lost to amputation.
So why doesn't everyone with diabetes know about biodebridement? The treatment, also called larval therapy or maggot therapy, has suffered from a bit of a PR problem.
The therapeutic value of maggots (or fly larvae) has been known for centuries. When used in biodebridement, they thoroughly clean and debride the wound (removing dead tissue) and are thought to actual hasten the healing process with the antimicrobial agents they produce during digestion. But because of their more common association with garbage dumps and animal carcasses, the maggots use in medicine is perhaps second only to leeches in gross out value.
Today's biodebridement procedures use medicinal, or sterile, maggots, which are specially bred for use in surgical environments. The procedure involves placing the maggots on the wound and covering them with a sterile, breathable dressing for up to 72 hours while the creatures do their work; they grow up to 5 times their original size during the process. Some patients may experience a tickling sensation, but that's typically the extent of any physical discomfort from the procedure.
Find a maggot therapist near you.
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