Invokana: Diabetes Drug Gets Black Box Warning For Amputation Risks

Invokana: Diabetes Drug Gets Black Box Warning for Amputation Risks

Invokana (canagliflozin), an SGLT-2 drug for use in type 2 diabetes and off-label in those with type 1 diabetes has been required by the FDA to carry the prominent boxed warning due to a higher risk for leg and foot amputations.
This new requirement is a result of two clinical trials whose data revealed these elevated risks. Canagliflozin is the drug present in the marketed products: Invokana, Invokamet, and Invokamet XR.
The clinical trials called CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) revealed that leg and foot amputations happened about twice as often in those taking canagliflozin compared to those taking a placebo.
Over the span of a year the amputation risk for CANVAS trial patients was equal to 5.9 out of every 1,000 patients taking canagliflozin and 2.8 out of every 1,000 patients taking a placebo.
Over the span of a year the amputation risk for CANVAS-R trial patients was equal to 7.5 out of every 1,000 patients taking canagliflozin and 4.2 out of every 1,000 patients taking a placebo.
Most common was toe and middle the foot amputations but below and above the knee leg amputations were also observed. Some patients needed multiple amputations, “some involving both limbs.”
This warning is in addition to last year’s FDA strengthened warning to users of canagliflozin for an increased risk of acute kidney injury and in 2015 the strengthened “warning for canagliflozin related to the increased risk of bone fractures,”
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Studies Show Diabetes Drug Invokana Increases Amputation Risk

People with diabetes who take a class of drugs known as sodium–glucose cotransporter 2 (SGLT2) inhibitors will now need to weigh benefits against risks after studies showed the medications significantly reduce heart problems in subjects, but, surprisingly, also increase the risk of amputation.
The results of the studies on the Johnson & Johnson drug canagliflozin, marketed under the name Invokana, confirm cardiovascular benefits not only for that particular medication, but also for others in its class. Those same results, however, call into question whether other drugs in the class also contribute to increased amputation.
“Drugs to treat diabetes have been undergoing a positive transformation in the last three or four years,” says Dr. Bruce Neal, lead investigator in the study and professor of medicine for University of New South Wales Sydney, and senior director, the George Institute for Global Health in Sydney, Australia. “It used to be we would test diabetes drugs to see if they lowered glucose levels and did not cause heart problems. Now, we test drugs and expect to see them not only lower glucose but improve cardiovascular health. It’s been extraordinary. But, now we might be finding out that there are glitches along the way.”
Neal led a team of six other academic researchers combining data from two studies, the first a clinical trial before the drug was approved by the Food and Drug Administration in 2013 and the second a post-marketing study designed to detect any cardiovascular risks from the drug. Such studies are a recent requirement of the FDA to ensu Continue reading

Type 1 Diabetes Originates in the Gut But Probiotics Could Offer Cure

Two separat
e pieces of research have found that the development of type 1 diabetes is likely caused by the gut, and therefore, a type of probiotic could be the cure.
Scientists from several European and US institutions studied 33 Finnish infants over three years from birth who were genetically predisposed to type 1 diabetes.
Their study, entitled “The Dynamics of the Human Infant Gut Microbiome in Development and in Progression toward Type 1 Diabetes” is published in the journal Cell Host & Microbe.
They discovered that four children in the group that developed type 1 diabetes had 25% less types of bacteria in their guts than other children.
The same four infants were also found to have more amounts of a specific bacteria that is known to trigger gut inflammation. This could be a prelude to type 1 diabetes as the bacteria causes the immune system to mistakenly attack and destroy beta cells in the pancreas that usually make insulin and monitor glucose levels.
“We know from previous human studies that changes in gut bacterial composition correlate with the early development of type 1 diabetes, and that the interactions between bacterial networks may be a contributing factor in why some people at risk for the disease develop type 1 diabetes and others don’t,” said Jessica Dunne, Director of Discovery Research at Juvenile Diabetes Research Foundation (JDRF), a UK charity which funded the study.
“This is the first study to show how specific changes in the microbiome are affecting the progression to symptomatic T1D.”
By being able to understand how the community of Continue reading

Can Diabetes Be Reversed? Study Claims Weight Loss And Cutting Calories Cure Condition, Even In Long-Term Patients

Roughly 330 million people around the world have Type 2 diabetes; the cure for it may be as simple as adhering to a strict diet. In 2011, a team of United Kingdom researchers from Newcastle University published a study that showed Type 2 diabetes could be reversed in overweight and obese patients who followed a very low-calorie diet over the course of eight weeks to stimulate fat removal from around the pancreas.
The team set out to replicate their findings on a larger scale to see if the weight loss successfully kept diabetes at bay over the long term, and published their findings in the journal Diabetes Care. They found that in Type 2 diabetes patients, restrictive diets weren’t just a quick fix. Once the weight came off and insulin production began to function normally, patients stayed diabetes-free and were allowed to resume normal, healthy diets.
"The study answered the question that people often ask me — if I lose the weight and keep the weight off, will I stay free of diabetes? Yes!” said the study’s lead author Roy Taylor, a metabolism and medicine professor at Newcastle University. "What we have shown is that it is possible to reverse your diabetes, even if you have had the condition for a long time, up to around 10 years.”
For the study, researchers followed 30 participants over the course of six months as they maintained a calorie-restrictive diet of 600 to 700 calories a day — a third of what they were normally eating each day. According to the U.S. Department of Agriculture, the average adult should eat between 2,000 and 3,000 calories a day, depend Continue reading

Cure for type 1 diabetes a step closer

Research into a possible cure for type 1 diabetes has taken an "important step forward," according to the latest research by scientists at the Massachusetts Institute of Technology and Harvard University.
The study, which was published in journals Nature Medicine and Nature Biotechnology on Monday, builds on work by the Harvard Stem Cell Institute which last year discovered a way of creating beta cells (whose primary function is to store and release insulin) which could then be implanted in mice and, it is hoped in future, humans with diabetes.
Now, in the latest development, scientists and researchers at MIT and Harvard, in collaboration with other university experts, have developed an implantable device that could prevent those implanted insulin-producing cells from being attacked by the immune system for six months – effectively allowing the insulin-producing cells to do their job.
Diabetes is a lifelong condition that causes a person's blood sugar (glucose) level to become too high. Type 1 diabetes is an autoimmune disease in which the immune system kills off the insulin-producing beta cells in the pancreas. Daily injections of insulin are the primary treatment, but are only partially successful in regulating patients' metabolism.
If a device could be implanted into diabetics that could prevent those insulin-producing cells from being attacked, it could be a huge leap forward in terms of research. The results could have an impact on health provision around the world as diabetes ranks as one of the leading causes of death in America.
Type 1 diabetes differs from type 2 Continue reading