Category Archives: Drugs for Diabetes

Warning: Canaglflozin (Invokana) Doubles the Risk of Amputation in T2 Diabetes

Open wide!

Yesterday the U.S. Food and Drug Administration ruled that Invokana doubles the risk of foot and leg amputations in type 2 diabetics, compared to treatment with placebo. Invokana is an SGLT2 inhibitor called canagliflozin. There are several other drugs in that class, and we don’t know about the risk of amputations with them.

I don’t start any of my T2 diabetic patients on SGLT2 inhibitors. Instead of taking a pill to make your kidneys excrete carbohydrate, it’s smarter to reduce dietary carbohydrate consumption.

Steve Parker, M.D.

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Do SGLT2 Inhibitors Increase Risk of Amputation?

Good question. But we don’t know the answer yet.

European authorities and even the U.S. Food and Drug Administration are looking into the possible connection. Stay tuned. Visit The Low Carb Diabetic site (link below) for more details.

“The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has extended the scope of its investigation into the possible link between the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Vokanamet, Janssen) and amputations to include other drugs of the same class.

Now, the PRAC’s review will include the other SGLT2 inhibitor medicines dapagliflozin (Farxiga, Xigduo XR, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim), based on the determination that the potential risk may be relevant for them as well.”

Source: The Low Carb Diabetic: EMA Extends Amputation Investigation to All SGLT2 Inhibitors

Steve Parker, M.D.

PS: SGLT2 inhibitors are the drugs that reduce blood glucose by shunting it into your urine. Makes more sense to me instead to reduce your blood sugar by eating fewer carbohydrates, the primary source of blood sugar in most folks.

 

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New Evidence Supports Extreme Carbohydrate Restriction in Type 2 Diabetes

Low-Carb Spaghetti Squash With Meat Sauce

Diabetes is a disease of carbohydrate intolerance. Doesn’t that suggest to you that diabetics should reduce or avoid dietary carbohydrates?

The new study at hand was done in Indiana, involving 262 folks with type 2 diabetes. Characteristics of the study subjects:

  • average age 54
  • 66% women
  • BMI 41 (very fat)
  • average Hemoglobin A1c 7.6%

The authors don’t use the term “ketogenic diet,” preferring instead “a diet designed to induce nutritional ketosis” (I’m paraphrasing). For most folks, that’s a diet with under 30 grams of carbohydrate daily, according to the researchers. The study lasted for only 10 weeks.

The drop-out rate was about 10% (25 participants), which is not bad.

Results:

  • Hemoglobin A1c (a test of diabetes control) dropped to 6.5%, a move in the right direction and equivalent or better than that seen with many diabetes drugs.
  • Average weight loss was 7.2% of initial body weight.
  • No severe symptomatic hypoglycemic events.
  • Number and dose of necessary diabetes drugs were reduced “substantially.”

What’s not to love? Why isn’t this the standard of care?

Click the link below to look for details of the Virta Clinic program used in this study.

I put together a Ketogenic Mediterranean Diet for my patients with diabetes. It reduces dietary carbs to 20-30 grams/day. There’s a free version, but consider the low-cost version that includes recipes and extensive initiation and management advice.

Steve Parker, M.D.

McKenzie AL, Hallberg SJ, Creighton BC, Volk BM, Link TM, Abner MK, Glon RM, McCarter JP, Volek JS, Phinney SD
A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes
JMIR Diabetes 2017;2(1):e5
DOI: 10.2196/diabetes.6981

low-carb mediterranean diet

Front cover of book

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Filed under Carbohydrate, Drugs for Diabetes, Weight Loss

DPP-4 Inhibitors Increase Risk of Pancreatitis

…although the risk of getting pancreatitis is pretty small in any case.

DPP-4 inhibitors are sometimes called gliptins. They’re used to treat type 2 diabetes.

From Diabetes Care:

“CONCLUSIONS Treatment with gliptins significantly increased the risk for acute pancreatitis in a combined analysis of three large controlled randomized trials.”

Source: Diabetes Care

Speaking of risk reduction, lower your risk of being prescribed a gliptin by reducing your carbohydrate consumption.

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I Told You So: Low-Carb Diets Help Control Diabetes

Reviewers at London Metropolitan University wondered if carbohydrate restriction was a legitimate approach to controlling diabetes. No surprise to me, they conclude that it is:

“A carbohydrate restricted diet can provide a safe and effective solution for improving diabetes management and should have a place within the diabetic guidelines. The diet was effective in reducing postprandial hyperglycemia and glycaemic variability resulting in low levels of glycaemia without the risk of hypoglycaemia. The ability of the diet to reduce the symptoms of dyslipidemia is of particular importance and when compared to the traditional low fat diet for weight loss, the low carbohydrate diet was comparable and in some instances better. There were significant reductions or cessation of diabetic medication reported throughout the literature alongside a reduction in the psychological aspects of living with a long-term disease. It is possible that the current dietary advice may actually accelerate beta cell exhaustion with elevated blood glucose diminishing the islet cells ability to produce insulin.”

Action Plan. But it’s expensive: $16.95.

low-carb mediterranean diet

Front cover of book

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FDA Says Jardiance Can Claim Cardiovascular Death Prevention 

Jardiance is a diabetes drug in the class called SGLT2 inhibitors.

How do they work? Our kidneys filter glucose (sugar) out of our bloodstream, then reabsorb that glucose back into the bloodstream. SGLT2 inhibitors impair that reabsorption process, allowing some glucose to be excreted in our urine. You could call it a diuretic effect. For example, an SGLT 2 inhibitor called dapagliflozin, at a dose of 10 mg/day, causes the urinary loss of 70 grams of glucose daily.

How drugs like this could prevent cardiovascular disease in type 2 diabetics is a mystery to me.

From MPT:

“The diabetes drug empagliflozin (Jardiance) may be marketed for prevention of cardiovascular death in patients with type 2 diabetes and co-existing cardiovascular disease, the FDA said Friday.

It’s the first such claim ever allowed for a diabetes drug.

Empagliflozin, first approved in 2014, is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) pathway, reducing blood glucose by causing it to be excreted in urine.Its benefit for cardiovascular risk reduction was demonstrated in the so-called EMPA-REG trial, results of which were reported in 2015.”

Source: Jardiance Wins CV Prevention Indication | Medpage Today

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Benefits of T2D Triple Therapy Hold Up Over Time

“Treating newly diagnosed diabetes patients upfront with metformin/pioglitazone/exenatide therapy appeared to lower blood glucose and reduce hypoglycemic events better than standard sequential therapy, researchers reported here.

After 36 months of treatment, patients who were treated with the combination had a HbA1c of 5.8% compared with an HbA1c of 6.71% if they were treated with metformin, had a sulfonylurea added on and, then had basal insulin added (P<0.0001), according to Muhammed Abdul-Ghani, MD, PhD, at the University of Texas Health Science Center at San Antonio, and colleagues, in a poster presentation at the European Association for the Study of Diabetes.”

Source: EASD: Benefits of T2D Triple Therapy Hold Up Over Time | Medpage Today

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