Diabetes increases risk of developing and dying from breast and colon cancer

Sep. 27, 2013 — Diabetes is linked to an increased risk of developing cancer, and now researchers have performed a unique meta-analysis that excludes all other causes of death and found that diabetic patients not only have an increased risk of developing breast and colon cancer but an even higher risk of dying from them.

Dr Kirstin De Bruijn will tell the 2013 European Cancer Congress (ECC2013) that previous studies have examined the association between diabetes and dying from cancer but death from specific types of cancer has not been well-studied. "Our meta-analysis is the first to combine incidence and death from breast and colon cancer, while excluding all other causes of death. We have investigated the link between diabetes and the risk of developing as well as the risk of dying from these cancers," she will say.

Dr De Bruijn, a PhD student in the Surgery Department at the Erasmus University Medical Center in Rotterdam (The Netherlands), and colleagues analysed results from 20 trials that had taken place between 2007 and 2012, involving more than 1.9 million patients with breast or colon cancer, with or without diabetes.

They found that patients with diabetes had a 23% increased risk of developing breast cancer and a 38% increased risk of dying from the disease compared to non-diabetic patients. Diabetic patients had a 26% increased risk of developing colon cancer and a 30% increased risk of dying from it compared to non-diabetic patients.

Dr De Bruijn will say: "The results for breast and colon cancer incidence in patients with diabetes are consistent with other meta-analyses. Furthermore, this meta-analysis shows a higher risk and a stronger association between diabetes and death from breast and colon cancer than previously reported.

"Cancer patients who are obese and diabetic are an already more vulnerable group of individuals when it comes to surgery, as they have an increased risk of developing complications both during and after surgery. If more obese and diabetic patients have to have an operation because of cancer, healthcare costs will increase.

"Worldwide, the numbers of obese and subsequent diabetic patients are still increasing and it is a cause for concern that these individuals are at a higher risk of developing cancer and dying from it. Studies have already highlighted the increased risk of developing cancer for diabetics. Our meta-analysis, which is unique since it looks at the risks for breast and colon cancer while excluding all other causes of death, provides stronger evidence for the association between diabetes and the risk of developing and dying from these cancers. We want to make people more aware of this problem and we hope that prevention campaigns regarding obese and diabetic patients will focus on highlighting this increased risk."

Dr De Bruijn and her colleagues intend to follow up their work by investigating what effect other factors associated with diabetes have on cancer risk and death, such as the anti-diabetic medication, metformin, as well as insulin and the duration of diabetes.

"It is extremely important that prevention campaigns on obesity and diabetes are intensified and that they also focus on children, to prevent them from becoming obese and developing cancer later in life," she will conclude.

Professor Cornelis van de Velde, President of ECCO, said: "With the increase in incidence of both diabetes and breast cancer, this is an important update of the meta-analyses on this subject and an interesting addition to the literature as this study excluded other causes of death. As the results are consistent with earlier meta-analyses, the substantial increased risk of breast cancer should be part of prevention campaigns. For further research, it would be important to study how other, competing risk factors might affect survival, as elderly cancer patients with diabetes are usually diagnosed with other conditions as well. Additionally, the potential role of metformin in relation to improved survival and cancer recurrence needs to be studied."

Professor Hans-Joerg Senn, scientific director at the Tumor and Breast Centre ZeTuP, St Gallen, Switzerland, said: "The message from the Erasmus Medical Center is disturbing and highly important, for the medical community, as well as for the public and politicians. It highlights once more the importance of the negative interactions between lifestyle, metabolism, overweight and certain frequent types of cancers, such as here between diabetes, obesity and breast cancer as well as colon cancer. It is time for increased and more effective information and prevention campaigns, especially in the economically developed world, where caloric abundance is prevalent."

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Anti-depressants' 'link to diabetes'

24 September 2013 Last updated at 20:59 ETBy Michelle Roberts Health editor, BBC News online

In recent years, the prescription rate of antidepressants has been rising in the UK

People prescribed anti-depressants should be aware they could be at increased risk of type 2 diabetes, say UK researchers.

The University of Southampton team looked at available medical studies and found evidence the two were linked.

But there was no proof that one necessarily caused the other.

It may be that people taking anti-depressants put on weight which, in turn, increases their diabetes risk, the team told Diabetes Care journal.

Or the drugs themselves may interfere with blood sugar control.

Their analysis of 22 studies involving thousands of patients on anti-depressants could not single out any class of drug or type of person as high risk.

Prof Richard Holt and colleagues say more research is needed to investigate what factors lie behind the findings.

And they say doctors should keep a closer check for early warning signs of diabetes in patients who have been prescribed these drugs.

With 46 million anti-depressant prescriptions a year in the UK, this potential increased risk is worrying, they say.

Prof Holt said: "Some of this may be coincidence but there's a signal that people who are being treated with anti-depressants then have an increased risk of going on to develop diabetes.

"We need to think about screening and look at means to reduce that risk."

Diabetes is easy to diagnose with a blood test, and Prof Holt says this ought to be part of a doctor's consultation.

"Diabetes is potentially preventable by changing your diet and being more physically active.

"Physical activity is also good for your mental health so there's a double reason to be thinking about lifestyle changes."

Around three million people in the UK are thought to have diabetes, with most cases being type 2.

Dr Matthew Hobbs of Diabetes UK, said: "These findings fall short of being strong evidence that taking anti-depressants directly increases risk of type 2 diabetes. In this review, even the studies that did suggest a link showed only a small effect and just because two things tend to occur together, it doesn't necessarily mean that one is causing the other.

"But what is clear is that some anti-depressants lead to weight gain and that putting on weight increases risk of type 2 diabetes. Anyone who is currently taking, or considering taking, anti-depressants and is concerned about this should discuss their concerns with their GP."

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Skin drug may treat type 1 diabetes

22 September 2013 Last updated at 19:30 ET

A drug that was used to treat a skin disorder has shown signs of being able to treat aspects of type 1 diabetes.

A small trial on US patients suggests that alefacept helps the body produce its own insulin, which is key for people with type 1 diabetes.

Type 1 diabetes affects around 400,000 people in the UK.

Researchers said the drug could be better than other treatments because it protects the immune system - but more research was needed.

The findings are published in The Lancet Diabetes & Endocrinology.

Alefacept (sold as Amevive) was used to treat the skin disorder psoriasis in the US before it was withdrawn by its manufacturer in 2011. The drug was never approved for the European drug market.

Psoriasis, like type 1 diabetes, is an autoimmune disorder that occurs when the immune system attacks healthy skin cells.

In clinical trials of the drug on psoriasis, the drug was found to attack specific types of T-cells that were also involved in attacking insulin-producing cells in type 1 diabetes.

So researchers, led by a team at Indiana University, Indianapolis, decided to investigate if it could have any effect on newly diagnosed type 1 patients.

Preserve insulin

In the trial, which is continuing, 33 patients received weekly injections of alefacept for 12 weeks, followed by a break of 12 weeks, and then another 12 weekly doses.

Another 16 participants were given placebo injections following the same schedule.

The researchers found no difference in how well the pancreas produced insulin two hours after eating food, but they did find "significant differences" between the two groups four hours after eating.

At this point, the group who received the drug showed they were able to preserve insulin while the placebo group's insulin levels decreased.

Continue reading the main story

What is type 1 diabetes?

Type 1 diabetes is an autoimmune condition, where the immune system attacks the cells of the pancreas that produce insulin.

This results in insulin deficiency and the body being unable to regulate blood sugar.

It tends to affect people before the age of 40, and often follows a trigger such as a viral infection.

• Living with type 1 diabetes

After 12 months, the same group showed no significant increase in insulin use, yet those in the placebo group did.

The first group also had fewer episodes of hypoglycaemia, low blood glucose levels. which are common in people with type 1 diabetes.

'Small successes'

Lead researcher Prof Mark Rigby, of Indiana University, said the first 12 months of the trial were encouraging.

"Although the primary endpoint was not met, several key secondary endpoints were significantly different between treatment groups, suggesting that alefacept might preserve pancreas cell function during the first 12 months after diagnosis."

He said the initial findings meant that in the future the drug "could be used to stabilise type 1 diabetes and prevent its progression" - but it was unlikely to be a cure.

He added that the trial would continue and further measurements would be taken after 18 months and 24 months.

Writing about the study in The Lancet, Dr Kevan Herold, of Yale University, said: "It is important to underscore these small successes since, as in other fields such as oncology and infectious diseases, the small achievements acquire greater significance when they are combined."

Karen Addington, chief executive of JDRF, the type 1 diabetes charity that helped fund the study, said the outcome was promising.

"The results of this study appear worthy of further exploration. Small steps forward such as this take us closer to a world without type 1 diabetes.

"It is a challenging and complex condition. But type 1 diabetes will one day be cured. It's a matter of time, money and excellent research."

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Cancer Drug May Be Helpful for Diabetes, Mouse Study Hints

SUNDAY, Sept. 15 (HealthDay News) -- The cancer drug Zaltrap (aflibercept) could help treat diabetes, suggest findings from research using mice.

Scientists say they've identified a molecular pathway (a series of interactions among proteins) involved in the development of diabetes, and also found that the drug can regulate this pathway.

Zaltrap is approved in the United States to treat metastatic (spreading) colorectal cancer and the wet form of the eye disease macular degeneration. The drug inhibits the vascular endothelial growth factor (VEGF) pathway, thereby blocking the growth of blood vessels into tumors and starving them of oxygen.

The researchers, from the Stanford University School of Medicine, identified a series of proteins that link VEGF inhibitors and blood glucose levels.

"We were surprised to find that this drug currently used in patients for cancer treatment had beneficial effects on diabetes in laboratory mice and could, potentially, in humans," Dr. Calvin Kuo, a professor of medicine, said in a university news release.

Scientists caution, however, that research with animals often fails to provide similar results in humans.

"Proteins involved in this pathway could be targeted for the development of new diabetes therapies," Amato Giaccia, a professor of cancer biology and director of radiation oncology, said in the news release.

The findings appeared online Sept. 15 in two articles in the journal Nature Medicine.

The researchers said there have been indications that VEGF inhibitors such as Zaltrap could influence blood glucose levels in people, but no human studies have been conducted.

"Anecdotally, there have been reports that diabetic patients who have been prescribed VEGF inhibitors to treat their cancer are better able to control their diabetes," Kuo said.

Three co-authors of Kuo's study are employees at Regeneron Pharmaceuticals, which makes aflibercept.

More information

The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about diabetes.

Copyright c 2013?HealthDay. All rights reserved.

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Correction: Diabetes Drugs story

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TRENTON, N.J. (AP) — In a June 10 story about diabetes treatment research, The Associated Press reported erroneously that LY2605541 is a short-acting insulin. It is a long-acting insulin.

Also, Johnson & Johnson applied for U.S. approval to sell its experimental diabetes pill canagliflozin on May 31, not May 29.

Diabetes Can Take a Toll on Your Emotions

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THURSDAY, May 17 (HealthDay News) -- Many people know diabetes -- both type 1 and type 2 -- can take a serious toll on physical health. But these blood-sugar disorders also can affect your emotions and, in turn, your emotions can wreak havoc on your diabetes control.

Extremes in blood-sugar levels can cause significant mood changes, and new research suggests that frequent changes in blood-sugar levels (called glycemic variability) also can affect mood and quality of life for those with diabetes.

Depression has long been linked to diabetes, especially type 2. It's still not clear, however, whether depression somehow triggers diabetes or if having diabetes leads to being depressed.

More recent research in people with type 1 diabetes has found that long periods of high blood-sugar levels can trigger the production of a hormone linked to the development of depression.

People with type 1 diabetes no longer can make their own insulin; people with type 2 diabetes need insulin treatment because their bodies can no longer produce it in sufficient quantities.

"Diabetes gives you so much to worry about that it's exhausting. It can make you feel powerless," said Joe Solowiejczyk, a certified diabetes educator and a manager of diabetes counseling and training at the Johnson & Johnson Diabetes Institute in Milpitas, Calif. "I think it's important to acknowledge that, from time to time, you're going to have a meltdown. You're going to have days when you feel exasperated, frustrated, sad, in denial and physically exhausted."

Solowiejczyk, who has type 1 diabetes himself, said these feelings become a problem "when you're not able to get on with your life, and you're persistently not taking care of your diabetes."

Not only does diabetes increase the risk of serious health complications, but uncontrolled diabetes also may worsen depression, causing a vicious cycle.

In addition to an increased risk of depression, diabetes can affect mood even from minute to minute. For example, someone who experiences low blood sugar may suddenly become irritable, even combative, and may act as if they are drunk, slurring their words.

Low blood-sugar levels (also known as hypoglycemia) occur when someone has taken too much insulin or hasn't eaten enough food. Exercise, alcohol and many other factors can lower blood-sugar levels unpredictably.

The problem, Solowiejczyk said, is "that the brain operates totally on glucose. When you don't have enough glucose, things start breaking down and your cognitive function doesn't work that well. This is a physiological, not an emotional, response."

Dr. Vivian Fonseca, president of medicine and science for the American Diabetes Association, said, "Hypoglycemia reactions are very understandable. There are also some fluctuations that are not quite in the hypoglycemia range that may affect anxiety levels."

High blood-sugar levels (hyperglycemia) also can lead to mood changes. "Hyperglycemia can affect your ability to concentrate and can make you feel grouchy," Solowiejczyk said. "Any change in the blood sugar outside of the normal ranges makes you feel weird and uncomfortable."

A small study in the April issue of the journal Diabetes Technology & Therapeutics found that frequent fluctuations in blood-sugar levels in women with type 2 diabetes were associated with a lower quality of life and negative moods.

Fonseca said, however, it's important for these findings to be replicated in a larger population.

Although diabetes and blood-sugar levels can affect emotions, emotions also can affect patients' blood-sugar levels and diabetes control.

In another study in the same journal issue, researchers tested blood-sugar levels in non-diabetic bungee jumpers, and found that the stress of the jump caused their blood-sugar levels to rise significantly. Not surprisingly, their stress hormones also were higher due to the body's normal fight-or-flight response. When this happens, the liver releases glucose to make energy available to the body's cells, according to the American Diabetes Association.

People with diabetes don't have sufficient insulin to let that glucose into the body's cells, however, so instead of providing energy, the sugar just builds up in the blood.

Another emotional minefield often associated with type 2 diabetes is the concept of blame. Most people with type 2 diabetes are overweight, and many are sedentary. Being overweight alone, however, doesn't cause type 2 diabetes. There are other factors, such as a genetic predisposition, at play. But because exercise and losing weight can help prevent -- or, in some cases, reverse -- type 2 diabetes, society often blames people with the disease. (Type 1 diabetes is an autoimmune disease that is not caused by diet or lack of exercise.)

"I think there is a prejudice against overweight people and people with type 2 diabetes, and that's something they have to deal with," Solowiejczyk noted.

What's important, he said, is that if you're persistently having trouble dealing with any of the emotions that come with diabetes, you talk with your doctor, diabetes educator or therapist.

"You should be feeling bad or resentful or angry sometimes," he said. "Diabetes is hard, and all of those feelings come along with the disease. But if you're [irritable] and angry or if you're sad all the time, you're not going to take care of yourself."

The same advice is true for partners of people with diabetes and parents of children with diabetes, he said.

More information

Learn more about the emotional side of diabetes, and the signs of depression, from the American Diabetes Association.

Copyright c 2012?HealthDay. All rights reserved.

Diabetes Drug Metformin May Cut Breast Cancer Risk in Older Women

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MONDAY, June 11 (HealthDay News) -- A widely prescribed drug, metformin, may lower the risk of invasive breast cancer in postmenopausal women with diabetes, a new study indicates.

The research, published online June 11 in the Journal of Clinical Oncology, echoes other recent studies that have suggested the diabetes drug may help cut the chances of prostate, pancreatic, liver and oral cancer, as well as certain forms of melanoma.

The researchers found that the incidence of invasive breast cancer was 25 percent lower in women with diabetes who were taking metformin than it was in women who weren't taking the drug.

Approximately 25.8 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention. Between 90 percent and 95 percent of these cases are type 2 diabetes, in which the body's ability to make and use insulin deteriorates.

"Type 2 diabetes is a disease of insulin resistance," said study co-author Dr. Rowan Chlebowski, a medical oncologist with the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, in Torrance, Calif.

Insulin is a hormone that helps regulate the level of glucose (sugar) in the body. With type 2 diabetes, the body manufactures larger quantities of insulin to maintain normal levels of glucose in the blood.

Metformin, commonly used to treat type 2 diabetes, increases insulin sensitivity and improves the control of blood sugar. "It makes the insulin you have more effective," Chlebowski explained. The drug, approved in the United Kingdom in 1958 and in Canada in 1972, was introduced in the United States in 1994.

The new research looked at relationships among diabetes, metformin use and breast cancer among over 68,000 women between 50 and 79 years old in the national Women's Health Initiative project. In this group, 3,401 had diabetes and 3,273 invasive breast cancers were diagnosed during the study.

Because of the design of the Women's Health Initiative trials, detailed information was available for this large and diverse population in many areas, including breast cancer risk factors, baseline mammograms, clinical breast exams and verification of breast cancers when they occurred. Researchers were also able to know which participants had diabetes -- along with their use of diabetes medication.

The trials excluded women who had already had breast cancer. Women who had developed diabetes before adulthood (suggesting they were type 1 diabetics) were also excluded from the study.

How can a drug that treats people with high blood sugar play a role in reducing breast cancer risk? Chlebowski suggested that metformin "may inhibit the master regulator of the cell, 'mTOR,' changing critical pathways involved in cancer."

The mTOR pathway is affected by a wide range of cellular signals, including growth factors, hormones such as insulin, nutrients including glucose and amino acids, cellular energy levels and stress. A key cell pathway associated with mTOR is critically involved in cell reproduction and survival.

Chlebowski and other experts cautioned against looking to metformin as a cancer prevention drug just yet.

"It's too soon to change clinical practice," said Jennifer Ligibel, a medical oncologist in the Women's Cancer Program at the Dana-Farber Cancer Institute in Boston. "While a number of other studies have suggested metformin has a role in preventing breast cancer and its recurrence, I would not recommend women take metformin for breast cancer prevention based on the data we have now."

As to the question of whether metformin could ever be used more broadly beyond diabetic patients to reduce the risk of breast cancer, Chlebowski said the answer is unclear and more studies are necessary to further analyze the linkage.

While the study uncovered an association between metformin use and lower breast cancer risk in diabetic postmenopausal women, it did not prove a cause-and-effect relationship.

The U.S. Food and Drug Administration has issued warnings about metformin in recent years. It requires product inserts for physicians and patients to say that the drug has been associated with increased cardiovascular risks, including heart attack and stroke, and lactic acidosis, which causes fatigue, muscle pain, difficulty breathing and other symptoms. The FDA also stipulates that the drug literature include a warning that the drug should only be used by patients with type 2 diabetes who cannot control their blood sugar with lifestyle or other medications.

More information

The U.S. National Library of Medicine has more on type 2 diabetes.

Copyright c 2012?HealthDay. All rights reserved.

Diabetes Rising Rapidly Among U.S. Kids

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SATURDAY, June 9 (HealthDay News) -- Diabetes is increasing among U.S. children at an alarming rate, say researchers who report jumps of more than 20 percent since 2001 for type 2 disease, which is linked to excessive weight and sedentary lifestyles, and type 1 diabetes, which is an autoimmune disease.

"Both types of diabetes are increasing," said study co-author Dr. Dana Dabelea, associate dean for faculty affairs at the University of Colorado School of Public Health in Aurora. "For type 2, we have some clues as to why it's increasing, but for type 1, we still need to better understand the triggers of this disease."

Many of the type 2 diagnoses are explained by the rise in overweight and obese children. According to the U.S. Centers for Disease Control and Prevention, 17 percent of U.S. children and teens are obese -- three times the number of a generation ago.

Type 1 diabetes occurs when the body's immune system mistakenly turns on healthy cells responsible for producing insulin, a hormone needed to metabolize the carbohydrates in food. It's been suggested that exposure to certain viruses may trigger the onset of type 1 diabetes. It is not linked to lifestyle factors, such as being overweight.

The exact cause of type 2 diabetes is less clear. People with type 2 either don't produce enough insulin, or their bodies don't use insulin efficiently. The disease is linked to sedentary lifestyles and to being overweight. However, other factors may be responsible, too. The disease can often be controlled in its early stages with lifestyle changes that include losing weight and becoming more active.

The first study found that about 189,000 people under the age of 20 had diabetes in the United States. Of those, 168,000 had type 1, and more than 19,000 had type 2.

From 2001 to 2009, the number of American children with type 2 diabetes increased 21 percent, and cases of type 1 ballooned 23 percent, the researchers found.

The study also found that children with type 2 were more likely to have protein in their urine than children with type 1 diabetes, suggesting that they might be at greater risk for early kidney damage. Youngsters with both types of diabetes also showed early indications of damage to the nerve system that regulates the heart and its blood vessels, according to the study.

The researchers also found that children with diabetes who watched more than three hours of television daily had poorer blood sugar control and higher levels of triglycerides, a blood fat, than children who watched less TV.

Dabelea and her colleagues were scheduled to present their findings on Saturday at the American Diabetes Association annual meeting in Philadelphia. The study was funded by the CDC and the U.S. National Institutes of Health.

In another presentation planned for the meeting, researchers who are also from the University of Colorado studied children with type 2 diabetes and found the disease may progress more rapidly in young people than in older folks. With an average follow-up of just four years, this study found that about one-third of children with type 2 diabetes had high blood pressure, compared to 12 percent at the start of the study. Almost 17 percent showed early signs of kidney damage, and 13 percent had early signs of eye disease.

"Type 2 is not a benign condition in children," said Dabelea.

Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said he wasn't surprised by either study's findings on type 2 diabetes.

"We're seeing more children with type 2, and at younger ages. They often have more aggressive disease at the time of diagnosis and other conditions, such as [abnormal cholesterol levels]," he said. "I'm concerned because these are young people being diagnosed with an adult disease, and they will probably progress to cardiovascular disease much faster."

Zonszein was surprised at the dramatic rise in the rates of type 1 diabetes. "I don't know what would cause more autoimmune disease in type 1," he said.

While there are no known ways to prevent type 1 diabetes, both experts said that a healthy lifestyle can go a long way to preventing type 2 in children. Zonszein's first recommendation is to get TVs out of children's bedrooms.

Both Zonszein and Dabelea recommended a healthy diet with lots of fruits and vegetables, and an active lifestyle, not just for the children, but for the whole family.

Data and conclusions presented at meetings should be considered preliminary until published in a peer-reviewed medical journal.

More information

The American Diabetes Association has more information on type 1 diabetes, and type 2 diabetes.

Copyright c 2012?HealthDay. All rights reserved.

Diabetes Drugs Avandia, Actos Linked to Vision Woes

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MONDAY, June 11 (HealthDay News) -- British researchers report that thiazolidinediones, diabetes medications that are used to help control blood sugar levels, may cause eye problems in those who take them.

The drugs that fall into this group include Avandia and Actos, which have been tied to increased risk of heart attack in the case of Avandia and bladder cancer in the case of Actos. Now it is possible that these drugs may also cause diabetic macular edema, the study authors said.

"Patients who received a thiazolidinedione were at two- to three-fold increased risk of developing macular edema," said lead researcher Dr. Iskandar Idris, an associate professor in diabetes medicine at the University of Nottingham.

However, the risk of macular edema is very small, about 0.2 percent, so the increased relative risk translates into an absolute risk of less than 1 percent.

"More aggressive management of risk factors for macular edema should be implemented in patients who take thiazolidinedione. In addition, routine screening for visual acuity should be performed during routine diabetes review, especially for patients who take thiazolidinediones," he added.

The report was published in the June 11 online edition of the Archives of Internal Medicine.

For the study, Idris' team collected data on more than 100,000 people with type 2 diabetes included in the British Health Improvement Network database.

At the start of the study, none of these patients suffered from diabetic macular edema, the researchers noted.

After one year, 1.3 percent of patients taking thiazolidinedione developed diabetic macular edema, compared with 0.2 percent of those not taking these drugs, Idris' group found.

The association was seen whether patients were taking Actos (pioglitazone) or Avandia (rosiglitazone), they added.

Macular edema is a swelling of the part or the eye called the macula, which is responsible for sharp vision when looking straight ahead.

Swelling occurs when fluid leaks into the center of the macula, blurring vision. About 20 percent of people with diabetes have this problem, the researchers noted.

For people taking these drugs there are alternatives that effectively lower blood sugar, such as metformin and insulin.

Dr. Sonal Singh, an assistant professor of medicine at Johns Hopkins University School of Medicine, in Baltimore, and co-author of an accompanying journal editorial, said that "the major limitation of this study is the inability to completely separate out whether the effect of these drugs on macular edema is due to the drug or the underlying disease -- diabetes."

However, the study adds more weight to the concern that Avandia and Actos may cause fluid buildup behind the eyes, he said.

"Clinicians and patients need to balance the benefits of these drugs on lowering blood sugar against their risks," Singh said. "Despite this uncertainty, patients with diabetes should seek prompt referral to an eye doctor if patients experience visual symptoms while taking Avandia or Actos."

More information

For more on hypertension, visit the American Diabetes Association.

Copyright c 2012?HealthDay. All rights reserved.

Johnson & Johnson diabetes drug tops older therapies in studies

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(Reuters) - An experimental treatment for type 2 diabetes developed by Johnson & Johnson demonstrated greater reduction in blood sugar than Merck & Co's Januvia and an older common treatment, glimepiride, according to data from a pair of late stage clinical trials.

The J&J drug, canagliflozin, also led to significantly greater weight loss than both of the other drugs and far fewer incidents of hypoglycemia, or potentially dangerous drops in blood sugar levels, than glimepiride, a member of the sulfonylurea class of medicines.

Weight loss is an especially attractive effect as obesity is a leading cause of type 2 diabetes and some older medicines cause weight gain.

Canagliflozin, belongs to a new class of diabetes treatments called SGLT2 inhibitors that work by blocking reabsorption of glucose by the kidney and increases glucose excretion in the urine to lower blood sugar.

The data from the two 52-week studies, presented on Saturday at the American Diabetes Association (ADA) meeting in Philadelphia, are part of a massive approval application J&J submitted to the U.S. Food and Drug Administration last week that comprised nine separate Phase III trials involving more than 10,000 patients. If approved it would be the giant healthcare conglomerate's first diabetes medicine.

"There are clearly some unmet needs in diabetes to get glucose control. Hypoglycemia is a big limitation and right now we don't have effective weight loss therapy, so this class of drugs clearly provides clinical benefits," said Dr. William Cefalu, the primary researcher on the glimepiride study.

"This would be another viable option, another tool in the tool box," Cefalu said of canagliflozin.

In the 755-patient study comparing 300 milligram once-daily canagliflozin to Januvia, the J&J drug provided statistically significant reductions in A1C levels -- a commonly used measure of blood sugar over time.

Canagliflozin led an average drop in A1C levels of 1 percent compared with a drop of 0.6 percent for Januvia, a DPP4 inhibitor known chemically as sitagliptin. Some 47 percent of canagliflozin patients got A1C down to the ADA guideline of 7 or less compared with 35 percent of Januvia patients, J&J said.

The J&J drug led to an average weight loss of 2.5 percent, or about 2.3 kilograms (5 pounds) compared with virtually no impact on weight for the Merck drug. The weight loss for canagliflozin was even more pronounced in the other study.

Patients in the study were already taking metformin -- the most common first treatment option after diet and exercise fails -- and a sulfonylurea.

The rate of hypoglycemia was similar and over 40 percent for both groups, likely largely due to the solfonylureas, which have been associated with high rates of hypoglycemia.

More patients dropped out of the study due to loss of glycemic control in the Januvia group -- 22.5 percent versus 10.6 percent. The rate of serious side effects was low and similar for both drugs, but discontinuation due to serious side effects was higher for canagliflozin -- 5.3 percent vs 2.9 percent.

STRIKING WEIGHT LOSS

The 1,450-patient canagliflozin versus glimepiride trial studied two doses of the J&J drug -- 100 mg and 300 mg -- in subjects already on maximally effective doses of metformin.

A1C reductions were nearly identical for glimepiride and the lower dose of the J&J drug. The 300 mg dose proved to be statistically superior with an average A1C reduction of 0.93 pct compared with 0.81 for glimepiride.

Glimepiride patients on average added about 1 percent to their weight after 52 weeks. The 100 mg canagliflozin led to a 4.2 percent weight reduction and there was a 4.7 percent weight reduction for 300 mg patients, or a difference of about 10 pounds (4.5 kg) versus the older drug.

There was also a big difference in incidence of hypoglycemia in the study. The percentage of patients with at least one episode of hypoglycemia was 4.9 for 300 mg dapagliflozin, 5.6 percent for 300 mg and 34.2 percent for glimepiride.

Aside from glucose control, "the other striking thing was the weight loss and the lack of hypoglycemia," said Cefalu, head of diabetes at the Pennington Biomedical Research Center at Louisiana State University.

In both studies, the J&J drug led to increases in both good and bad cholesterol and a small but favorable decrease in blood pressure.

Canagliflozin was also associated with higher rates of genital infections, urinary tract infections and need for increased urination.

Researchers, however, did not run into concerns over liver damage that contributed to the FDA rejection of dapagliflozin, a drug from AstraZeneca and Bristol-Myers Squibb that belongs to the same class as the J&J drug.

"We reported some favorable reduction in liver enzymes," Cefalu said.

(Reporting By Bill Berkrot; Editing by Bernard Orr)