Sat, May-20-17, 03:22
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Plan: P:E/DDF
Stats: 225/150/169
BF:45%/28%/25%
Progress: 134%
Location: NC
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Incidentally, I would say this result is just another indictment of the idea of lowering blood sugar not being what it's all about.
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This is what Dr Fung claims in his talk...the lower blood sugar does not stop the progress of the disease. It may be with Innokana the patient felt good when FBG was low in the am, then goes on to eat the recommended ADA the rest of the day, while the disease progresses at the same pace. The placebo group didn't get lower BG and watched their diet more carefully rest of day? Though the difference is large enough to point to the drug mechanism of removing sugar through urine, as Meme says circulation.
There was an alert issued on this class of drugs last year, Europe added the warning early this year, and the FDA finally joined them. Dr Westman warned about them last year for the Keto acidosis and heart attack risk in a talk.
There are already lawsuits and PI attorneys circling around the drug.
http://www.drugdangers.com/invokana/lawsuit
The announcement on MedPage:
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WASHINGTON -- Labels for type 2 diabetes drugs containing canagliflozin (Invokana, Ivokamet, Invokamet XR) will now carry a boxed warning about increased risks of leg and foot amputation, the FDA said Tuesday.
The warning comes after the agency reviewed data from two randomized, placebo controlled trials (CANVAS and CANVAS-R) that showed rates of lower-extremity amputations were doubled in the active drug groups, irrespective of dose. Among nearly 6,000 patients receiving canagliflozin in the two trials, rates of amputations were 5.9 and 7.5 per 1,000 patient-years, compared with 2.8 and 4.2 per 1,000 patient-years in the placebo groups.
The differences were statistically significant. CANVAS was the FDA-required study investigating cardiovascular outcomes; CANVAS-R assessed renal endpoints. Lower-limb infections, gangrene, diabetic foot ulcers, and ischemia were the most common precipitating factors for amputations in the studies, the FDA said. Patients with previous amputations were more likely than others to need additional ones during the trial. Notably, patients in the two trials were included only if they had cardiovascular disease or risk factors for it other than type 2 diabetes.
However, the new warning applies to all patients regardless of cardiovascular risk. The FDA urged prescribers to consider individual patients' risks for amputation before initiating canagliflozin. Patients currently on the drug should be monitored closely for conditions such as infections and foot ulcers that may lead to amputation; the drug should be discontinued if these appear. Almost exactly 1 year ago, the FDA issued an alert about interim results from the two trials that suggested the increased amputation risk, and promised an update when fuller data were available.
Canagliflozin is one of the new class of SGLT-2 inhibitors that reduce blood glucose levels by inducing sugar to be excreted in urine. The FDA has not said other SGLT-2 inhibitors may have the same risk of amputations, but in February, the European Medicines Agency indicated that it may be a class effect. Other SGLT-2 inhibitors include dapagliflozin (Farxiga) and empagliflozin (Jardiance).
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