This blog tracks updates to the Blood Sugar 101 Web site.


Monday, February 13, 2017

EMA Orders SGLT-2 Drug Labels to Warn of Increased Risk of Lower Limb Amputations

Page Changed: SGLT2 Inhibitors, Farxiga, Invokana, Jardiance. Questionable New Drugs

Added Text: 

Increased Risk of Lower Limb Amputations

As reported on Medscape The European Medicines Agency (EMA) which is the European equivalent of the FDA announced on February 10, 2017 that a warning stating that the sodium glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes may increase the risk for lower-limb amputation should be included in the prescribing information for all drugs in this class.

In Medscape's words, "The warning from EMA's Pharmacovigilance Risk Assessment Committee (PRAC) issued today cites data from two ongoing clinical trials with canagliflozin (Invokana, Vokanamet, Janssen) in patients at high risk for cardiovascular events, Canagliflozin Cardiovascular Assessment Study (CANVAS) and a related study of renal end points, CANVAS-R."

Quoting the EMA the article points out that "In a 4.5-year interim analysis of CANVAS, the independent monitoring committee for the trial found that the rate of amputations per every 1000 patients was equivalent to seven for 100 mg/day and five for 300 mg/day of canagliflozin compared with three per 1000 patients taking placebo. Most of the amputations were of toes." Note that this means that there were from one and two thirds more to more than twice as many amputations in the group taking the drug as occurred in the placebo group.

As you can see if you read the comments to the Medscape new release, some people claiming to be doctors and a pharmacist immediately argued that this was because the patients given the SGLT-2 inhibitors were sicker and more likely to have amputations. People posting comments on Medscape are not required to reveal if they are on the payroll of the companies who are earning several billion dollars a year selling these heavily advertised new drugs. Nor are they required to validate their identity, so any employee of a drug company could post these comments using a made up doctor's name.

Lest you be swayed by their arguments against believing the EMA's experts, note that this data was from a controlled study. This means that both the group taking the drug and the group taking a placebo were matched for characteristics which would have included their blood sugars, age, and time since diagnosis. Since the groups had the same characteristics, the higher rate of amputations is very likely to be a result of something the drug does to the blood supply of the toes. The EMA doesn't lightly decide to add a serious warning to the label of a drug.

New Brazilian Portuguese version of the "How To Lower Your Blood Sugar" Flyer uploaded

Page Changed: How to Lower Your Blood Sugar

Added a link to a Brazilian Portuguese translation of the flyer.
The PDF can be downloaded here: http://www.phlaunt.com/diabetes/BrazilianPortugueseFlyer.pdf .

Friday, January 20, 2017

A link to The Blood Sugar 101 Monthly Challenge Has Been Added to Our Main Web Site

Page Added:Hold Yourself Accountable - Join the Blood Sugar 101 Monthly Challenge

This page links to the monthly diet/blood sugar challenge that was created in response to requests from members of our Blood Sugar 101 FaceBook Page .

A new challenge will start each month. The page describes how the challenge works and how we hope to collect useful real-world experience data from it.

Thursday, October 27, 2016

New Page Added: Common Phosphate Additives Damage Your Kidneys and Cardiovascular System

Page Added:Common Phosphate Additives Damage Your Kidneys and Cardiovascular System This new page on the main Blood Sugar 101 Web Site combines information that was posted in several blog posts in 2013. It is now also linked to from the Diabetic Kidney Disease page.

Friday, September 30, 2016

I report about my bad experience with Intermittent Fasting

Page Changed:  Is Your Low Carb Diet Safe?

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8. Intermittent Fasting--Another Way to Provoke the Starvation Response and Ruin Your Metabolism. Intermittent fasting diets like the 5:2 Diet are very popular now but most of us who have tried them for extended periods of time have learned they have all the problems seen with other extreme diets, though they don't seem like starvation diets, as you can eat "normally" when not fasting.

Encouraged by the success reported by some people I trust, I tested out a very strict 5:2 Fast Diet for two years. It took the whole two years for me to see the toll that this kind of dieting took on my body. During the two years I participated daily in an active online fasting-support group where I observed that the ultimately negative outcome I experienced was what most of the dedicated participants in the online group experienced: Very good weight loss results for the first seven months were followed by a sudden reversal where I first stalled and then then began to gain weight relentlessly eating exactly the way I'd been eating while losing so quickly. Worse, my appetite went out of control and by the end of the two years I had developed what felt like a binging disorder.

This was something I had never before experienced in 65 years of controlling my weight with various diet approaches, including 11 years of maintaining a substantial weight loss achieved eating a very low carb diet featuring occasional days off. At the end of my 2 years of intermittent fasting I ended up with far more jiggly subcutaneous fat than I had started with, even though I ended up at the same weight I started at.

I believe this happened because fasting lowered my estrogen levels dramatically.
This was evidenced by my developing menopausal symptoms after a year on the diet--a decade after last experiencing them, at the same time as the diet had, indeed gotten rid of subcutaneous tummy fat.
It took me a good year to get back to having a normal relationship with my appetite. During that year I had to give up entirely on dieting in any way. The tummy fat seems to have moved in permanently.

This experience was very much like what I saw others experience, too, including personal friends and people on the online support group. To me this suggests that long-term intermittent fasting changes your brain chemistry and hormonal balance in a way that makes it much more likely that you will eventually run into this kind of problem.

If you are considering trying intermittent fasting be aware that all the research that is currently used to promote fasting by the usual suspects who get rich selling celebrity doctor diet books is based on very short studies which lasted only a few weeks or, at most, months. Almost all the studies on fasting looked at the physiological changes caused by very short stints of medically supervised complete fasting. Almost none examine the kinds of intermittent fasting dieters use in the currently popular diets like 5:2. The truth is, there is zero data about the long term experience of intermittent fasters.
The sad outcomes most people in my online fasting support forum experienced and my own results suggest that the outcomes over extended periods of time are mostly poor.

Eating a low carb intermittent fasting diet doesn't seem to produce better results, either, based on the reports of those on the fasting support group, who were eating that way.Those dieters stalled and regained on very low carb diets too.

My experience and that of participants in low carb diet support groups suggest that those who figure out a way to cut carbs in a way that doesn't make them feel deprived are able to stick to their diets for far longer with much better results and, most importantly, without the rebound hunger and metabolic slowdown that is so characteristic of more extreme diets. It's worth noting, however, that my polling of those who ate low carb diets for extended periods after achieving weight loss goals showed that most of the successful dieters who did this maintained eating at a non-ketogenic intake level--one close to 110 g a day. It is possible that extended ketogenic dieting may also provoke the starvation response in some people.

Monday, August 22, 2016