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FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes

Posted 22 Sep 2016 by Drugs.com

RARITAN, N.J., September 21, 2016 – Janssen Pharmaceuticals, Inc. (Janssen) announced today the U.S. Food and Drug Administration (FDA) has approved Invokamet XR - a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR)—for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate.[1] Invokamet XR combines Invokana (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million U.S. prescriptions since launch,[2] and an XR formulation of metformin. Metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes. “Invokamet XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs ... Read more

Related support groups: Diabetes, Type 2, Metformin, Invokana, Canagliflozin, Invokamet, Canagliflozin/metformin

Intensive Type 2 Diabetes Treatment Can Extend Survival: Study

Posted 8 Sep 2016 by Drugs.com

WEDNESDAY, Sept. 7, 2016 – Intensive management of type 2 diabetes can make a difference in how long and how well you live, even if you don't start until middle age, researchers report. People who were already at risk of type 2 diabetes complications were randomly selected to continue with their normal treatment or to be placed in an aggressive and multipronged treatment group. Two decades after the study began, the researchers found that people in the aggressive treatment group lived almost eight years longer. Not only that, they lived better – their risk of heart disease, kidney disease and blindness all dropped. The only complication that didn't seem to improve was nerve damage caused by diabetes. "Early, intensified intervention in type 2 diabetes patients with microalbuminuria with both target-driven pharmacological (medication) and behavioral actions increased life span. And, ... Read more

Related support groups: Diabetes, Type 2, Metformin, Insulin, Victoza, Lantus, Januvia, Glucophage, Novolog, Glipizide, Humalog, Janumet, Byetta, Glyburide, Saxenda, Bydureon, Lantus Solostar, Invokana, Actos, Levemir, Glimepiride

Older Drug May Help Type 1 Diabetics' Heart Health

Posted 6 Sep 2016 by Drugs.com

TUESDAY, Sept. 6, 2016 – An inexpensive medication normally given to people with type 2 diabetes may help preserve heart health in people with the less common form of diabetes – type 1, a small new study finds. Metformin is the standard first-line treatment for type 2 diabetes to help bring blood sugar levels down. It also appears to help repair damaged blood cells by increasing the number of blood vessel (vascular) stem cells, researchers said. "We have shown – both in test tube and in patients – the mechanism behind the cardioprotective effects of metformin," said the study's senior author, Dr. Jolanta Weaver. She's a senior lecturer in diabetes medicine at Newcastle University in England. "This is likely to lead to the development of new drugs for heart disease in diabetes," she added. Sanjoy Duttais is assistant vice president of translational development at JDRF, a nonprofit ... Read more

Related support groups: Metformin, Diabetes, Type 1, Glucophage, Janumet, Prevention of Cardiovascular Disease, Glucophage XR, Cardiovascular Risk Reduction, ActoPlus Met, Glumetza, Janumet XR, Glyburide/Metformin, Avandamet, Jentadueto, Glucovance, Metformin/Pioglitazone, Fortamet, Kombiglyze XR, Xigduo XR, Riomet, PrandiMet

Diabetes Drug May Help Kids With Autism Fight Unwanted Pounds

Posted 24 Aug 2016 by Drugs.com

WEDNESDAY, Aug. 24, 2016 – The diabetes drug metformin may help overweight children and teens with autism slim down, a new study suggests. The study included 60 people with autism, aged 6 to 17. The patients were overweight due to the side effects of taking antipsychotic medications for irritability and agitation. For the study, participants were given either metformin or an inactive placebo for 16 weeks. Those given metformin had much greater reductions in body mass index (BMI) than those who took the placebo, the findings showed. BMI is an estimate of body fat based on weight and height. "Our results showed that [gastrointestinal] side effects occurred for more days in the metformin group compared to placebo group, but the large majority of children taking metformin were able to maintain their treatment. Importantly, the metformin didn't cause behavioral changes, such as increased ... Read more

Related support groups: Obesity, Metformin, Weight Loss, Glucophage, Autism, Janumet, Asperger Syndrome, Glucophage XR, ActoPlus Met, Glumetza, Janumet XR, Glyburide/Metformin, Jentadueto, Avandamet, Glucovance, Metformin/Pioglitazone, Fortamet, Riomet, Kombiglyze XR, Xigduo XR

Which Diabetes Drug Is Best?

Posted 19 Jul 2016 by Drugs.com

TUESDAY, July 19, 2016 – No single drug to treat type 2 diabetes stands out from the pack when it comes to reducing the risks of heart disease, stroke or premature death, a new research review finds. The analysis of hundreds of clinical trials found no evidence that any one diabetes drug, or drug combination, beats out the others. Researchers said the results bolster current recommendations to first try an older, cheaper drug – metformin (Glumetza, Glucophage) – for most patients with type 2 diabetes. "There are very few things experts agree on, but this is one of them," said Dr. Kevin Pantalone, a diabetes specialist at the Cleveland Clinic and a member of the Endocrine Society. "Metformin, in the absence of contraindications or intolerability, should be the first-line agent to treat patients with type 2 diabetes," he said. Metformin can cause upset stomach and diarrhea, so some ... Read more

Related support groups: Diabetes, Type 2, Metformin, Glucophage, Janumet, Prevention of Cardiovascular Disease, Glucophage XR, Cardiovascular Risk Reduction, ActoPlus Met, Glumetza, Janumet XR, Glyburide/Metformin, Avandamet, Jentadueto, Glucovance, Metformin/Pioglitazone, Fortamet, Kombiglyze XR, Xigduo XR, Riomet, PrandiMet

FDA Medwatch Alert: Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

Posted 15 Jun 2016 by Drugs.com

ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk. BACKGROUND: Canagliflozin and dapagliflozin are prescription medicines used with diet and exercise to help lower blood sugar in adults with type 2 diabetes.  They belong to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors.  Canagliflozin and dapagliflozin lower blood sugar by causing the kidneys to remove sugar from the body through the urine. From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring ho ... Read more

Related support groups: Diabetes, Type 2, Invokana, Farxiga, Xigduo XR, Canagliflozin, Dapagliflozin, Invokamet, Canagliflozin/metformin, Dapagliflozin/metformin

Intensive Blood Sugar Control May Be Too Much for Some With Type 2 Diabetes

Posted 6 Jun 2016 by Drugs.com

MONDAY, June 6, 2016 – Intensive treatment of blood sugar levels in some people with type 2 diabetes may cause serious complications, new research suggests. "In this study, we found that, particularly among older patients and patients with serious chronic conditions, intensive treatment nearly doubled the risk of severe hypoglycemia requiring medical attention, including hospitalization," said lead author Dr. Rozalina McCoy. She is an endocrinologist at the Mayo Clinic in Rochester, Minn. Hypoglycemia (low blood sugar) is a serious potential complication of diabetes treatment. The researchers said it can worsen quality of life and has been linked with cardiovascular events, dementia and death. The researchers reviewed information from more than 31,500 American adults. All had stable and controlled type 2 diabetes. None was taking insulin. None had a prior history of severe ... Read more

Related support groups: Diabetes, Type 2, Metformin, Insulin, Lantus, Dementia, Glucophage, Novolog, Glipizide, Humalog, Hypoglycemia, Janumet, Glyburide, Lantus Solostar, Invokana, Actos, Levemir, Glimepiride, Amaryl, Novolin R, Mild Cognitive Impairment

FDA Expands Indication of Invokamet (canagliflozin/metformin HCl) to Include First-Line Treatment of Type 2 Diabetes

Posted 31 May 2016 by Drugs.com

RARITAN, N.J., May 24, 2016 – Janssen Pharmaceuticals, Inc. (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved Invokamet, a fixed-dose combination therapy of INVOKANA® (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes. With this new approval, Invokamet may now be prescribed in adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.[1] Invokamet, the first combination of a sodium glucose co–transporter 2 (SGLT2) inhibitor and metformin available in the United States, was previously approved by the FDA in August 2014 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes not adequately controlled by either canagliflozin or metformin, or who are already being treated with both medications sep ... Read more

Related support groups: Diabetes, Type 2, Metformin, Canagliflozin, Invokamet, Canagliflozin/metformin

FDA Medwatch Alert: Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations

Posted 19 May 2016 by Drugs.com

ISSUE: FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA is currently investigating this new safety issue and will update the public when we have more information. See the FDA Drug Safety Communication for additional details regarding the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial. BACKGROUND: Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to ... Read more

Related support groups: Diabetes, Type 2, Invokana, Canagliflozin, Invokamet, Canagliflozin/metformin

Coffee, Wine Good for Healthy Gut, Sodas May Be Bad

Posted 28 Apr 2016 by Drugs.com

THURSDAY, April 28, 2016 – The food you eat and the medicines you take can alter your gut bacteria in ways that either help or harm your health, two new studies suggest. Foods like fruits, vegetables, coffee, tea, wine, yogurt and buttermilk can increase the diversity of bacteria in a person's intestines. And that diversity can help ward off illness, said Dr. Jingyuan Fu, senior author of one of the studies. "It is believed that higher diversity and richness [in gut bacteria] is beneficial," explained Fu. She is an associate professor of genetics at the University of Groningen in the Netherlands. On the other hand, foods containing loads of simple carbohydrates appear to reduce bacterial diversity in the gut, Fu and colleagues found. These include high-fat whole milk and sugar-sweetened soda. In addition, medications can also play a part in the makeup of your gut bacteria. Antibiotics, ... Read more

Related support groups: Metformin, Smoking, Heart Attack, Smoking Cessation, Caffeine, Glucophage, Fioricet, Excedrin, Janumet, Alert, Myocardial Infarction, Gastroenteritis, Fiorinal, Excedrin Migraine, Cafergot, Glucophage XR, Esgic, Fiorinal with Codeine, Stay Awake, Norgesic

Metformin Safer for Heart Than Other Common Type 2 Diabetes Drugs: Study

Posted 18 Apr 2016 by Drugs.com

MONDAY, April 18, 2016 – Metformin, the most frequently prescribed standalone drug for type 2 diabetes, is better for the heart than its closest competitors, a large analysis suggests. Metformin reduced the risk of dying from heart attack and stroke by about 30 percent to 40 percent compared with other commonly used drugs called sulfonylureas, such as glibenclamide, glimepiride, glipizide and tolbutamide, researchers report. "Pharmaceutical companies continue to make new drugs to reduce blood sugar and improve on safety concerns of the older drugs," said senior study author Dr. Shari Bolen. But, "while adults with diabetes often need more than one medication to control blood sugar, the newer medications do not appear to be safer than the older drugs," added Bolen. Metformin is still the safest and most effective type 2 diabetes medication, said Bolen. She is an assistant professor of ... Read more

Related support groups: Diabetes, Type 2, Metformin, Glucophage, Glipizide, Janumet, Glimepiride, Amaryl, Prevention of Cardiovascular Disease, Glucophage XR, GlipiZIDE XL, Glucotrol, Cardiovascular Risk Reduction, ActoPlus Met, Glucotrol XL, Glumetza, Glyburide/Metformin, Janumet XR, Avandamet, Jentadueto, Glucovance

Widely Used Type 2 Diabetes Drug May Reduce Cancer Death Risk

Posted 15 Apr 2016 by Drugs.com

FRIDAY, April 15, 2016 – Metformin, a commonly prescribed diabetes drug, may reduce the risk of dying from some cancers for postmenopausal women with type 2 diabetes, a new study suggests. The study found that for women with type 2 diabetes and cancer, the odds of dying from cancer appeared to be 45 percent higher compared to women with cancer who didn't have diabetes. But, in women with cancer who took metformin to treat their type 2 diabetes, the risk of dying from cancer seemed about the same as it was for women without diabetes. "Our findings from this large study may provide more evidence that postmenopausal women with diabetes and cancer may benefit from metformin therapy compared to other anti-diabetes therapy," said lead researcher Zhihong Gong. She's an assistant professor of oncology at the Roswell Park Cancer Institute, in Buffalo, N.Y. Gong cautioned, however, that this ... Read more

Related support groups: Diabetes, Type 2, Cancer, Metformin, Glucophage, Janumet, Glucophage XR, ActoPlus Met, Breast Cancer, Prevention, Glumetza, Janumet XR, Glyburide/Metformin, Avandamet, Jentadueto, Glucovance, Metformin/Pioglitazone, Fortamet, Kombiglyze XR, Xigduo XR, Riomet, PrandiMet

FDA Medwatch Alert: Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function

Posted 13 Apr 2016 by Drugs.com

ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin. FDA concluded, from the review of studies published in the medical literature, that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. FDA is requiring changes to the metformin labeling to r ... Read more

Related support groups: Diabetes, Type 2, Metformin, Glucophage, Janumet, Glucophage XR, ActoPlus Met, Glumetza, Glyburide/Metformin, Janumet XR, Avandamet, Jentadueto, Glucovance, Metformin/Pioglitazone, Kombiglyze XR, Fortamet, Xigduo XR, Riomet, PrandiMet, Metformin/Sitagliptin, Invokamet

Diabetes Cases Quadruple Worldwide Since 1980: Report

Posted 6 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The number of adults worldwide with diabetes has quadrupled in the past 35 years, a new report shows. Climbing from 108 million in 1980 to 422 million in 2014, the increases were particularly severe in low- and middle-income countries such as China and India, the researchers noted. Global diabetes rates rose from just over 4 percent to 9 percent among men, and from 5 percent to almost 8 percent among women, the findings showed. The price tag for treating and managing the disease and its complications now totals $825 billion a year, the report found. "Diabetes has become a defining issue for global public health. An aging population, and rising levels of obesity, mean that the number of people with diabetes has increased dramatically," said senior study author Majid Ezzati, a professor at Imperial College, London. The statistics were not divided between type 1 ... Read more

Related support groups: Diabetes, Type 2, Obesity, Metformin, Weight Loss, Glucophage, Janumet, Insulin Resistance, Pre-Diabetes, Diabetes Mellitus, Glucophage XR, ActoPlus Met, Glumetza, Glyburide/Metformin, Janumet XR, Jentadueto, Avandamet, Glucovance, Metformin/Pioglitazone, Abnormal Glucose Tolerance, Fortamet

Cost of Insulin Rises Threefold in Just a Decade: Study

Posted 5 Apr 2016 by Drugs.com

TUESDAY, April 5, 2016 – Americans with diabetes who rely on insulin to keep their blood sugar levels in check are facing sticker shock: A new study finds the price of insulin has tripled in only 10 years. Moreover, since 2010, per-person spending on insulin in the United States was more than spending on all other diabetes drugs, the study found. "The cost of insulin has risen rapidly over the last few years," said study senior author Philip Clarke, a professor of health economics at the University of Melbourne in Australia. Clarke added there should be an assessment to see whether this price hike is justifiable in terms of improved clinical outcomes. One reason for the price climb, he said, is a switch from human insulins to analog insulins, which cost more but may offer additional benefits. Also, doctors are more apt to prescribe insulin for people with type 2 diabetes now, Clarke ... Read more

Related support groups: Diabetes, Type 2, Metformin, Insulin, Victoza, Lantus, Diabetes, Type 1, Januvia, Glucophage, Novolog, Diabetic Neuropathy, Glipizide, Humalog, Janumet, Diabetic Nerve Damage, Insulin Resistance, Byetta, Glyburide, Saxenda, Bydureon, Lantus Solostar

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