Archive for the ‘Diabetes’ Category:

DR. PONDER: Diabetes often has long-term kidney effects

Written on August 10th, 2011 by larryno shouts

One of the most notorious long term complications of diabetes is kidney disease. In diabetic nephropathy, damage occurs to the small blood vessels inside the kidney, which are part of the mechanism responsible for filtering waste products from our blood. Doctors call this a micro-vascular diabetes complication. New research suggests that many people with undiagnosed diabetes and prediabetes may already have kidney disease and not know it. the best steps a known diabetic can take to lower the risk of diabetic nephropathy are to control high blood pressure and keep the blood sugar levels as close to a non-diabetic range as possible over time.

One lesser known way to protect diabetic kidneys is to be careful about certain prescription and non-prescription medicines that are commonly used by non-diabetics and diabetics alike.

Diabetics who have had a heart attack or have heart failure may not pump blood to the body as effectively as before. In these cases, the kidneys make internal adjustments to allow enough blood to keep flowing into them and keep working to remove water and waste products. Chemicals produced in the kidney, called prostaglandins, are responsible for this adjustment. But patients who take oral over-the-counter pain medicines called NSAIDS (such as ibuprofen or naproxen) may block this kidney adaptation and quickly reduce kidney function. Retaining fluid (swelling and puffiness) would be a first sign, plus an increase in a blood chemical marker called creatinine, ordered by your doctor.

If you’ve ever had an X-ray and were given a contrast dye, you’ve gotten a lot of questions about whether you have diabetes or bad reactions to these substances. the use of X-ray contrast agents in diabetics may cause sudden kidney failure in up to one in three diabetics, especially if there was already some pre-existing kidney disease. these drugs could cause the blood vessels in the kidney to clamp down and starve the kidney for oxygen. Preventing this complication is done by providing lots of fluids to the patient from an IV before the dye is given, plus using some chemically gentler dyes.

Two commonly prescribed classes of drugs to treat high blood pressure in diabetics are called ACE inhibitors and ARB’s. the generic name of an ACE ends with the letters –pril, and ARB’s with –artan. Research has proven that ACE and ARB drugs can protect the diabetic kidney from damage. But these same drugs also have the potential to lower kidney function in some situations. In up to one in five type 2 diabetics, the arteries feeding each kidney are narrowed, or stenosed. A little narrowing is tolerated, but when around two thirds of the blood flow through the arteries becomes reduced, it causes a problem with use of the ACE and ARB classes of blood pressure medications. If you’re taking an ACE or ARB for blood pressure control and the doctor measures the blood marker for kidney function called creatinine, then a rise of 50 percent or more in that test result would suggest narrowing of the arteries to the kidney and a need to change blood pressure medications quickly.

Diabetics who’ve had organ transplants are given daily medicines to prevent the body from rejecting the new organ. these medicines are meant to be taken forever. two of these drugs, called tacrolimus and cyclosporine, are known to lower kidney function if given in too high of a dose. They do this by slowing down the flow of blood to the kidney. this is one of several reasons why doctors carefully measure the blood levels of these medicines in transplant recipients.

Some types of antibiotics can affect kidney function. One antifungal drug in particular, called amphotericin B, can cause a problem called acute tubular necrosis, or ATN. Inflammation of the kidney, called nephritis, has been known to occur with penicillin and cephalosporin class antibiotics. Fortunately, it’s a rare event.

Just remember that all the medicines we take flow through the kidney in some form or another. Many are harmless, but others can have serious consequences. Diabetic or not, it’s always in your best interest to ask questions about how any prescribed or non-prescribed medicine will affect your kidney function.

Dr. Stephen Ponder has had type 1 diabetes since 1966. He has been a pediatric endocrinologist for 24 years. Contact him at swponder@gmail.com, or follow him at twitter.com/dr_steve_ponder.

<a href="http://www.oaoa.com/articles/kidney-69916-blood-diabetic.htmltag:news.google.com,2005:cluster=http://www.oaoa.com/articles/kidney-69916-blood-diabetic.htmlMon, 08 Aug 2011 02:33:40 GMT 00:00″>DR. PONDER: Diabetes often has long-term kidney effects

Related Reading:

Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >
The Starvation Treatment of DiabetesThe Starvation Treatment of DiabetesThis anthology is a thorough introduction to classic literature for those who have not yet experienced these literary masterworks. For those who have ... Read More >
Dr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without DrugsDr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without Drugs Until Dr. Barnard’s scientific breakthrough, most health professionals believed that once you developed diabetes, you were stuck with it—and coul... Read More >

Is it possible to use human stem cells to cure juvenile diabetes?

Written on August 10th, 2011 by larryno shouts

Is it possible to use human stem cells to cure juvenile diabetes?

It is theoretically possible but a great deal of research still needs to be done. it is promising but I'm not holding out for a cure in my lifetime. I can hope that there will be for the younger generation though. I wouldn't wish diabetes on my worst enemy.

EMT
type 1, use a pump.

That is one of the reasons for stem cell research!! and yet the government is so against the research. Maybe they don't want any cures for a lot of conditions and diseases that would be possible.

Not with current technology, maybe in the near future.
there is no cure for diabetes stem cells can help regrow cells damaged by cancer and can rebuild nerve fibers from what I know.
insulin production does not fall into those categories.

Is it possible to use human stem cells to cure juvenile diabetes?

Related Reading:

Blood Sugar 101: What They Don't Tell You About DiabetesBlood Sugar 101: What They Don't Tell You About DiabetesBased on the award winning Bloodsugar101.com web site, this book explains what peer-reviewed research published in top medical journals has to say abo... Read More >
The Starvation Treatment of DiabetesThe Starvation Treatment of DiabetesThis anthology is a thorough introduction to classic literature for those who have not yet experienced these literary masterworks. For those who have ... Read More >
Diabetes For Dummies®, Mini EditionDiabetes For Dummies®, Mini EditionTreat diabetes successfully and lead a full life

Want to know how to manage diabetes? You'll learn about all the advances in monitoring glucose, the... Read More >

Dark neck and rings only in pictures?

Written on August 10th, 2011 by larryno shouts

I was wonder why my neck is always dark with rings around it when i take pictures, i dont see it in the mirror only in pictures… could this still be a sign of diabetes? please help. (My dad's side of the family can get diabetes) I am at normal weight. please help.

Dark neck and rings only in pictures?

Related Reading:

Diabetes For Dummies®, Mini EditionDiabetes For Dummies®, Mini EditionTreat diabetes successfully and lead a full life

Want to know how to manage diabetes? You'll learn about all the advances in monitoring glucose, the... Read More >

Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >
The Starvation Treatment of DiabetesThe Starvation Treatment of DiabetesThis book was converted from its physical edition to the digital format by a community of volunteers. You may find it for free on the web. Purchase of the Kindle edition includes wireless delivery.

Advice wanted on best way to sweeten for pre-diabetes guy?

Written on August 10th, 2011 by larryno shouts

Tried stevia – hate the taste

Tried Xylitol, making 1 litre of icecream with 3/4 cup of it. Two scoops of it and flatulence the rest of the day. should I give up on it?

Agave nectar doesn't seems as good as the above two but seems promising.

Perhaps I could experiment with combinations.

I've heard some recipes can hide the unpleasant bitternets of agave nectar.

Any suggestions?

Splenda is good.
With Stevia, you have to use a fraction of what is suggested. My gal uses like 1/4 of a packet to sweeten a cup of tea. More than that is bitter.

1) Use artificial sweeteners like Splenda. no, they are NOT dangerous, IF you eat them normally, like 3-4 tablespoons a day. And that INCLUDES the sweeteners in things like Diet Coke, and other diet foods.

2) Chemicals like Xylitol and Sorbital are NATURAL laxatives. If you eat these you are going to have problems with digestion, often times a lot messier than flatulence!

The limit for xylitol and sorbitol is about two TEASPOONS a day, not 3/4 cup!! 2-3 teaspoons is about 4 hard sugar-free candies — a DAY

3) the BIGGEST secret is to give up the sugar habit. Learn to eat WITHOUT sweeteners. Basically put, that means no desserts and no sweet snaks. Eating of sweets, especially dessert, is more of a cultural habit, and is NOT a physical necessity. You CAN learn to do without them.

Then, this problem no longer exists — you don;t need sweets, so you don't need artificial sweeteners.

Yes, that take a LOT of self-discipline and "Won't Power" (I WON'T eat this and I WON'T eat that), but it is the BEST possible answer.

The brand of Stevia my cousin brought me from the Health Food store tasted good. I liked it. so I bought a box of the Sams Club brand. It is horrid tasting like bitter weeds! Read on the box that one is to use less than half packet for normal sweetening. This was a coffee mug I put it in, about twice the normal size coffee cup???

Ok, zylitol is basically a laxitive!! In any amount more than one tiny mint it will give you the problems you had and more.

I haven't tried the Agave nectar, but will next time I am out shopping at the mall where the Health food store is.

I like the Splenda best of all the different sweeteners. It has the least after taste. I don't usually put any sweetener in my coffee or tea. I just learned to do without it.

Sweet stuff isn't the only issue for someone with diabetes (or even pre-diabetes). It's carbohydrates in general. a bowl of rice or pasta will raise your blood sugar up higher than a sugar cube in your coffee. Bread, wheat, corn, potatoes, and peas don't have sugar in them but are high carb foods which will have an effect on your blood sugar. what about the natually occuring sugar in fruit? even some vegetables like carrots and beets have some natural sugar in them.
There are low carb icecreams out there that taste good. You may be surprised to see that icrecream isn't that big of a deal because it's way more fat than sugar.

So what does a person do who is trying to limit carb consumption since every thing seems to have carbs in it? Follow a healthy meal plan and accurately count your carbohydrates in everything, measure your food to be accurate. Don't be too upset about sugar because it is only one of many types of carbs, just limit it to a reasonable amount. try to keep to 30 – 45 carbs per meal (unless your doctor has given you a different number to aim for).

If you are still confused about what to eat or not, make an appt with a dietician to help you understand the relationship between carbohydrates and your body. Look up the glycemic index on line and try to eat more foods that have low GI scores because these tend to keep your sugar level from spiking too high.

Splenda is good.

Also try fruit yogurt

Stevia is an all natural, zero calorie sweetener that is healthy for diabetic patients.

Some studies of this zero calorie sweetener have shown that it seems to stimulate the release of insulin allowing a more normal response to glucose.

It can be bought in liquid or powder form and of course there are different brands that you can try. You may have to play with it for a while to get it to your taste level.

Good luck to you.

Try stevia again. I find the taste varies among brands. the Nu Naturals brand is very good. I'd stay away from stuff like Splenda, if knew knew how they made it you'd be sick. It's available at most health food stores and a lot of supermarkets these days. worst case you can get it by mail.

Advice wanted on best way to sweeten for pre-diabetes guy?

Related Reading:

Nature Made Daily Diabetes Health PackNature Made Daily Diabetes Health PackFrom the Manufacturer The Nature Made Diabetes Health Pack is scientifically formulated to provide nutritional support for people with diabetes. Each ... Read More >
Diabetes For DummiesDiabetes For DummiesCovers the latest glucose meters and insulin treatments The straight facts on treating diabetes successfully and living a full life

Want to know how... Read More >

The Starvation Treatment of DiabetesThe Starvation Treatment of DiabetesThis anthology is a thorough introduction to classic literature for those who have not yet experienced these literary masterworks. For those who have ... Read More >

Link administered between cognitive training and biological structure of the brain – Health Jockey

Written on August 10th, 2011 by larryno shouts

A new study has first time revealed the complex interaction between cognition and the biological structure of the human brain. Through scans, they have shown that the active training of the working memory triggers noticeable changes in the number of dopamine D1 receptors in the brain cortex. this study was conducted by the Karolinska Institutet.

Professor Torkel Klingberg, who led the study, says that, “Brain biochemistry doesn’t just underpin our mental activity; our mental activity and thinking process can also affect the biochemistry. this hasn’t been demonstrated in humans before, and opens up a floodgate of fascinating questions.”

It is stated that the neurotransmitter dopamine is a key element in certain functions of the brain. Thus, a disturbance in the dopamine system could adversely affect the process of the memory, which could in turn make recollection of data over a short period of time difficult. Impaired working memory is found to be, in turn, linked to various cognitive related complications like schizophrenia and ADHD.

The study investigators had earlier revealed that an enhancement of the working memory could be undertaken through a few weeks of intensive training. In unison with the Stockholm Brain Institute, these investigators attempted to better understand this issue. In the present study, through the use of Positron Emission Tomography they have assessed the brain.

The study authors say that the answer to poor working memory cannot be given by the changes noticed in the number of dopamine receptors in the brain. these changes could have taken place as a result of the absence of memory training, or even other environmental factors. they hope to soon discover new treatments that include both memory training and treatment drugs.

They state that their findings could benefit patients suffering from cognitive impairments linked to stroke, chronic fatigue syndrome, ageing, etc.

Their findings are published in the Science journal.

<a href="http://www.healthjockey.com/2011/08/02/myvisiontrack-app-apparently-detects-precise-vision-changes/tag:news.google.com,2005:cluster=http://www.healthjockey.com/2011/08/02/myvisiontrack-app-apparently-detects-precise-vision-changes/Tue, 02 Aug 2011 07:59:06 GMT 00:00″>Link administered between cognitive training and biological structure of the brain – Health Jockey

Related Reading:

Diabetes For DummiesDiabetes For DummiesCovers the latest glucose meters and insulin treatments The straight facts on treating diabetes successfully and living a full life

Want to know how... Read More >

The Starvation Treatment of DiabetesThe Starvation Treatment of DiabetesThis book was converted from its physical edition to the digital format by a community of volunteers. You may find it for free on the web. Purchase of the Kindle edition includes wireless delivery.
Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >

What are some successful diets for diabetes 2?

Written on August 10th, 2011 by larryno shouts

for a senior with high blood pressure and gout too?

Zone diet, Atkins and South Beach phase 2, any low carb with sufficient natural fats and protein in them.

These 3 food plans above give all the nutrients in small quantities a person needs for good health! Don't mess with phase 1 of either Atkins or South Beach. They are not healthy for anyone.

By the way: "diet" is a very dirty 4 letter word!!
Quit thinking in terms of "diet" and think in terms of Lifestyle Food plan.

honestly there isn't any it all depends on you

My husband and I are both type 2 diabetics. My husband also suffers with high blood pressure. we are seniors also. we have lost weight on this diet. My husband ,60lbs and I ,24lbs!
This is a low fat diet, but it is packed with food.

Our doctor sent us to a registered dietitian who taught us how to count carbohydrates. it has been the biggest blessing and help that we could have ever asked for! My husband gets 5 carbs. at a meal and I get 4 each meal. this is just a sample of what we eat:

Breakfast:

1/2 cup oatmeal cooked in water = 2 carbs
1 cup 1% milk = 1 carb
1/2 grape fruit = 1 carb
1 slice 100% whole wheat bread = 1 carb
Plus — 1 meat= 1 egg, cooked in Pam
Plus —- 1 fat = 1 Tablespoon light margarine

Lunch & Dinner :

3oz. lean meat ( about the size of a deck of cards )= example boneless chicken breast, baked, broiled or grilled.

Here are the 5 carb choices:

1/2 cup starchy vegetable, Example : 1/2 cup corn = 1 carb.
1 small fruit or 1/2 cup canned fruit without sugar = 1 carb.
1 cup low fat butter milk or 1% sweet milk = 1 carb.
1 slice whole wheat bread = 1 carb.
1 serving of sugar free cookies, 3 or 4 depending on serving size on package. Read labels= 1 carb.

Also, we get a small side salad with 2 tablespoons of light dressing .

Every person is different, with different needs. I would suggest that you ask your doctor to send you to a registered dietitian that can design a diet just for your special needs.

This diet has been very sucessful for us. we have been on it for 1 year. we plan to stay on it the rest of our lives.

Since my husband has high blood pressure, his doctor took him off of salt also. this has helped his blood pressure.

1 carb has 22 grams or less.

I hope I explained it were you can understand. Good luck!

Have a blessed day!

What are some successful diets for diabetes 2?

Related Reading:

The Starvation Treatment of DiabetesThe Starvation Treatment of DiabetesThis anthology is a thorough introduction to classic literature for those who have not yet experienced these literary masterworks. For those who have ... Read More >
Diabetes For DummiesDiabetes For DummiesCovers the latest glucose meters and insulin treatments The straight facts on treating diabetes successfully and living a full life

Want to know how... Read More >

Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >

Where can I find a doctor that supports a low carb/high fat diet approach to controlling type 1 diabetes?

Written on August 10th, 2011 by larryno shouts

I am a type 1 diabetic living in Houston, Texas who is looking for a doctor who would support a low carbohydrate/high fat approach to control my blood sugars. I have made large improvements using this approach/way of eating but I need a doctor who would support this approach. Does anybody know of any doctors in Houston that are supportive of this approach?
Thank you

I have been Type 1 insulin dependant since 1976. I follow my own low carb, high protein and high vegetable fibre diet. It is recommended that Type 1 diabetics follow a low fat diet. this is because diabetics are high risk for coronary artery disease (the biggest killer of type 1 diabetics worldwide is heart attack, the second biggest is stroke). Coronary artery disease is caused by arteries becoming blocked not only from fatty acids (cholesterol) but also from the excess of glucose in your bloodstream. Therefor, a high fat diet is only going to add to your risk of heart problems later (or not so later) in life. I had a coronary arrest in 1999 (aged 29) due to severely blocked arteries. this is when I stopped following my diabetic specialist and dietitians advice of consuming mainly low GI carbohydrates, and started consuming less carbohydrates and more 'friendly' low cholesterol proteins.

As for finding a good diabetic specialist that you can relate to??? I guess it's just trial and error until you find the doctor for you.

Good luck!

Where can I find a doctor that supports a low carb/high fat diet approach to controlling type 1 diabetes?

Related Reading:

Diabetes For DummiesDiabetes For DummiesCovers the latest glucose meters and insulin treatments The straight facts on treating diabetes successfully and living a full life

Want to know how... Read More >

Dr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without DrugsDr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without Drugs Until Dr. Barnard’s scientific breakthrough, most health professionals believed that once you developed diabetes, you were stuck with it—and coul... Read More >
Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >

What causes diabetes 1 besides genes? If you have the genes, does it definitely mean you will get diabetes?

Written on August 9th, 2011 by larryno shouts

I'm worried because my grandma has diabetes.

Yes,definitely there are a number of factors that predispose to the emergence of diabetes. in the first place should be hereditary predisposition. Virtually all experts agree that the risk of falling ill diabetics increases, if in your family who is ill or sick diabetes – one of your parents, brother or sister. however, different sources are given different numbers that determine the likelihood of disease.There are observations that diabetes type one is inherited with a probability of 3-7% of the mothers and 10% probability of the father. if both parents are ill, the risk of disease increases by several times and up to 70%. Type two diabetes is inherited with a probability of 80% of both the maternal and paternal lines, as if diabetics are sick both parents, the likelihood of its manifestation in children is approaching 100%. According to other sources, no particular differences in the likelihood of diabetes first and second type. It is believed that if the pain in your diabetic father or mother, then the probability that you are too sick to be about 30%. if both parents are sick, then your chance of disease is about 60%.
You can refer here for more info:

Just because the disease is in your genes, does NOT mean you will DEFINITELY get it. same with if your family has no history at all, you can still get it. (That happened with me)

Scientists are still unsure about causes or cures. some people think it could be the ever changing environment triggering the disease and dis-function of the pancreas.

Best thing to do is eat healthy, exercise regularly and go to your GP and get a test done if you're worried.

I believe a lot of type 1 diabetes is caused by viral infections. Genes may not be involved at all. I've talked to a lot of type 1 diabetics either IRL or online. Every single type 1 diabetic had a viral infection of some type in the months before they were diagnosed as a type 1 diabetic.
The prevailing medical paradigm that type 1 diabetes is an auto- immune disease where insulin producing beta cells are constantly attacked throughout a life time is due for a paradigm shift. I've been a type 1 diabetic for 53 years, 9 months and counting, and I'm healthier than a lot of my similarly aged friends and acquaintances. my prescriptions are for two high blood pressure drugs. I buy my insulin OTC. I haven't had a flu shot since 2004, and the last time I had a cold with a fever was so long ago that I've forgotten the year, 1998 I think. Does that sound like my immune system is seriously compromised by an auto-immune disease?

What causes diabetes 1 besides genes? If you have the genes, does it definitely mean you will get diabetes?

Related Reading:

The First Year: Type 2 Diabetes: An Essential Guide for the Newly DiagnosedThe First Year: Type 2 Diabetes: An Essential Guide for the Newly DiagnosedAfter Gretchen Becker was diagnosed with type 2 diabetes in 1996, she educated herself on every aspect of this chronic condition — by reading medica... Read More >
Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >
Blood Sugar 101: What They Don't Tell You About DiabetesBlood Sugar 101: What They Don't Tell You About DiabetesBased on the award winning Bloodsugar101.com web site, this book explains what peer-reviewed research published in top medical journals has to say abo... Read More >

What is the best treatment for diabetic retinopathy? Like retinal detachment!?

Written on August 9th, 2011 by larryno shouts

Yoga,exercise and walking is the best method.

Don't listen to the walking advice. I think that person is thinking of diabetic Neuropathy. I had laser surgeries on my eyes for treatment. About 10 on each eye, but it wasn't too bad. it helped quite a bit, actually.

What is the best treatment for diabetic retinopathy? Like retinal detachment!?

Related Reading:

Diabetes Diet: The 101 Best Diabetic FoodsDiabetes Diet: The 101 Best Diabetic FoodsStuck in a meal rut and tired of the same old foods?

If you’re someone who is dealing with diabetes, there’s no question that you must... Read More >
Diabetes For DummiesDiabetes For DummiesCovers the latest glucose meters and insulin treatments The straight facts on treating diabetes successfully and living a full life

Want to know how... Read More >

What Do I Eat Now?: A Step-by-Step Guide to Eating Right with Type 2 DiabetesWhat Do I Eat Now?: A Step-by-Step Guide to Eating Right with Type 2 Diabetes

The DIY approach to a diabetes diet!

What Do I Eat Now? is the single best resource for people with diabetes to learn how to eat r... Read More >

FDA Panel Rejects Diabetes Drug Citing Cancer Risks

Written on August 9th, 2011 by larryno shouts

SILVER SPRING, Md. — an FDA advisory committee has voted 9-6 against recommending approval for the novel diabetes drug dapagliflozin. The panel has concerns about potential breast and bladder cancer risks and wants more data.

The FDA’s Endocrinologic and Metabolic Advisory Committee voted Tuesday against endorsing the first-of-its-kind drug as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Dapagliflozin is an inhibitor of sodium glucose cotransporter-2 (SGLT2) which works by increasing renal glucose elimination, allowing more sugar to be excreted with urine rather than being absorbed into the bloodstream.

The committee members all praised Bristol-Myers Squibb and AstraZeneca for developing such an innovative drug that doesn’t attempt to regulate insulin in the body like other diabetes treatments, but just simply flushes glucose from the body.

“To a hepatologist, it seems brilliant in its simplicity,” said panelist Doris Strader, MD, associate professor of medicine at the University of Vermont.

Another bonus of the dapagliflozin: unlike drugs that work by regulating insulin, which can cause weight gain, patients on dapagliflozin actually lost a little weight: Between an average of 2.4 lbs and 3.7 lbs, depending on the dose. (Meanwhile, patients in the control arm of the Bristol-Myers Squibb and AstraZeneca trials gained a few pounds).

In an FDA review of six of Bristol-Myers Squibb and AstraZeneca’s 11 phase III clinical trials, dapagliflozin plus metformin-treated patients achieved superior glycemic control compared with patients treated with metformin plus placebo.

The efficacy of dapagliflozin is related to glucose clearance in the kidneys, so in patients with renal impairment, the drug works less well. In a study of patients with moderate renal impairment, the drug was not found to work. The companies are recommending that dapagliflozin not be used in patients with moderate to severe renal impairment.

But the apparent efficacy of a brand new type of diabetes drug was not good enough for the panel, in light of the potential of dapagliflozin to cause breast and bladder cancers.

Across the companies’ 11 clinical trials, there have been nine bladder cancers in 5,478 patients on the drug compared with one case in 3,156 controls; and there have also been nine cases of breast cancer in 2,223 women on the drug compared with just one in 1,053 female controls.

An FDA reviewer estimated that women taking dapagliflozin had a fourfold increased risk of developing breast cancer compared with those not taking the drug, and male diabetics had five times the risk for developing bladder cancer compared with the control group.

“Rates of both bladder and breast cancer are higher than what would be expected,” said FDA reviewer Somya Dunn, MD, who added that the clinical trial program wasn’t powered to distinguish a clinically meaningful difference in the incidence of breast or bladder cancer in the dapagliflozin arms versus the control arms.

Panelists also were concerned about one case of liver damage that was thought to be caused by dapagliflozin.

Dunn, who said, “It is difficult to make this estimate based off one case,” nonetheless estimated that one in 25,000 patients exposed to dapagliflozin for at least six months would develop serious liver injury.

While the panelists said they realized the difficulty of pinpointing liver damage to a specific drug, they were worried about the potential for liver damage if dapagliflozin were to be approved, especially since it would likely be used in millions of people.

Several panelists who voted that the drug should be approved said that more breast cancers may have been detected in the dapagliflozin groups because they lost weight, making it easier to detect tumors with a mammogram. likewise, bladder cancers may have been detected at a higher rate because dapagliflozin-treated patients were more likely to develop urinary tract infections, leading them to seek medical treatment during which the bladder cancer may have been spotted.

Because the drug causes patients to excrete more sugar, genital and bladder infections are also a side effect. another FDA reviewer estimated that there would be one additional genital tract infection for every 24 patients treated with dapagliflozin.

Panel chairman Abraham Thomas, MD, MPH, head of endocrinology at Henry Ford Hospital in Detroit, voted in favor of the drug, arguing that it would be unreasonable for a drug company to conduct a large enough study to rule out a cancer risk. Thomas and several other panelists said the cancer risk should be studied in post-approval trials.

But Strader said she couldn’t dismiss the breast and bladder cancers as “minor,” and didn’t want to wait until after approval to try to enroll enough patients to test whether the drug does have a link to breast and bladder cancers.

“I was concerned about the five-fold increase and the inability to explain why this happened,” she said. “I know it’s very hard to get these [enrollment] numbers in a pre-clinical trial but I feel very uncomfortable subjecting the diabetic population to a potentially life-threatening risk just to get more numbers.”

The FDA does not have to follow the advice of its advisory committees, but it often does.

<a href="http://www.medpagetoday.com/Endocrinology/Diabetes/27621?pfc=101&spc=224tag:news.google.com,2005:cluster=http://www.medpagetoday.com/Endocrinology/Diabetes/27621?pfc=101″>FDA Panel Rejects Diabetes Drug Citing Cancer Risks

Related Reading:

Dr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without DrugsDr. Neal Barnard's Program for Reversing Diabetes: The Scientifically Proven System for Reversing Diabetes without Drugs Until Dr. Barnard’s scientific breakthrough, most health professionals believed that once you developed diabetes, you were stuck with it—and coul... Read More >
Diabetes For Dummies®, Mini EditionDiabetes For Dummies®, Mini EditionTreat diabetes successfully and lead a full life

Want to know how to manage diabetes? You'll learn about all the advances in monitoring glucose, the... Read More >

The First Year: Type 2 Diabetes: An Essential Guide for the Newly DiagnosedThe First Year: Type 2 Diabetes: An Essential Guide for the Newly DiagnosedAfter Gretchen Becker was diagnosed with type 2 diabetes in 1996, she educated herself on every aspect of this chronic condition — by reading medica... Read More >
« Newer PostsOlder Posts »
Easy AdSense by Unreal