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Avandia Alternatives

May 20, 2011 Written by JP       [Font too small?]

As of November 18, 2011, the antidiabetic drug Avandia (rosiglitazone) will no longer be available at retail pharmacies. New guidelines set forth by the US Food and Drug Administration now require that the medication only be prescribed to patients who are already benefiting from it and/or those who don’t respond to other drugs used to control blood sugar. This reversal in policy is largely due to post marketing data indicating an elevated risk of heart attacks in patients who use it.

One of the leading critics of rosigltazone, a drug that promotes insulin sensitivity, is Dr. Steven Nissen of the prestigious Cleveland Clinic. He recently remarked about the Avandia debacle – “It’s like a decade long nightmare coming to an end”. He went on to summarize the current status of the drug as such: “Eleven years after this drug was introduced, it will be so restricted in access that virtually no one will be able to get it.” Dr. Nissen’s outrage is understandable given his participation in a 2007 trial that determined that use of Avandia increased heart attack risk in type 2 diabetics by over 40%. (1,2,3,4,5)

The obvious route to take here is to bash the current drug approval and review process and/or vilify pharmaceutical companies. It’s easy enough to do and many are hopping on that bandwagon. But I think a more constructive response is to take a look at why in 2010 over 500,000 patients in the US “required” a prescription for Avandia. In large part, the answer can be found in underpopulated parks and gyms, poorly stocked kitchens and barren supplement cabinets throughout the world.

I’m convinced that the implementation of five diet and lifestyle strategies would revolutionize the way diabetes is treated in the modern world. What’s more, the following suggestions will not only help manage blood sugar irregularities, but also protect against them in the first place and combat many of the peripheral health consequences related to type 2 diabetes. But here is the catch. This is a program that requires that you earn back your good health. Popping a pill isn’t enough.

Step 1 - Consider Adopting a Modified Mediterranean Diet

A Mediterranean-style way of eating is gaining acceptance as a means of addressing “modifiable factors” that lead to the development of diabetes. Slightly tweaking the current concept of a Mediterranean diet by increasing fiber and protein intake and reducing the amount of refined carbohydrates improves upon an already positive plan of action. This modified diet promotes a healthier weight and impacts virtually every marker relating to diabetes and metabolic syndrome (blood pressure and sugar, cholesterol, insulin, triglycerides and waist circumference). (6,7,8,9,10)

Step 2 – Go Nuts, No Matter What Diet You Choose

On the acute front, adding select nuts (almond and pistachios) to carbohydrate-rich meals lowers post meal blood glucose response. Over the long term, eating a daily serving of almonds can also reduce hemoglobin A(1c) levels – a measure of chronic blood sugar control. Nuts also tend to reduce cardiovascular events which are more common in diabetics. (11,12,13)

Step 3 - Exercise Enough and Get Some Sun

A just published review in the Journal of the American Medical Association (JAMA) examined 47 randomized, controlled trials pertaining to exercise and diabetic health. The conclusion of the report emphasizes the need to stay adequately active. In practical terms, this means combining both aerobic and resistance exercises or “structured exercise training” for a minimum of 150 minutes a week. Exercising outdoors contributes an added dimension of diabetic health promotion. Exposure to the sun will increase serum 25-hydroxyvitamin D levels, which are associated with healthier insulin sensitivity, lower long term blood sugar HbA(1c) and reduced type 2 diabetes incidence. Vitamin D status of 50 nmol/L or over appears to confer the greatest benefit. (14,15,16,17,18,19,20)

Step 4 - Make Sleep a Priority

From a health maintenance perspective, sleep is a lot more than the thing we do when we’re not awake. Sleep restriction is an independent risk factor for cardiovascular disease, diabetes and obesity. A recent examination in the journal The Diabetes Educator reveals that “poor sleep is common in type 2 diabetics and may adversely impact quality of life”. The authors of the paper go on say that “Interventions to improve sleep hygiene can be suggested to patients by diabetes educators as part of diabetes self-management”. Part of the reason why sleep duration and quality are so important to diabetics is that a lack thereof raises the levels of select hormones (leptin and visfatin) that contribute to insulin resistance and systemic inflammation. (21,22,23)

Nutritional Supplement Reduces Postprandial Blood Sugar Levels

Source: Am J Transl Res. 2011 February 28; 3(2): 219–225. (link)

Step 5 - Use Nutritional Supplements Wisely

The diets of some diabetics and pre-diabetics are lacking in essential nutrients. Supplementing with a multivitamin/mineral that emphasizes select nutrients such as chromium, magnesium, Vitamins B12, D, and zinc may help address nutritional deficiencies, improve glycemic control, lipid profiles and support immune function in type 2 diabetics. If additional support is necessary, functional foods (brewer’s yeast) and “nutraceuticals” containing ingredients such as cinnamon and enzymes may be of value as well. The formula highlighted in the image above contains: a “transglucosidase, lipase, protease (Glucoreductase™) blend, chromium picolinate, zinc gluconate, and cinnamon extract”. (24,25,26,27,28)

The unfortunate reality is that in the coming years I’ll likely report on other prescribed medications that are yanked from pharmacies due to safety concerns. Unsuspecting patients will suffer side effects and sometimes lose their lives. No one wants this, but there is an attitude and system in place which contributes to it. Changing that system isn’t exclusively the domain of consumer activists and watchdog organizations that oversee the medical community. We all have a role to play as well. The more we decide to take personal responsibility for our own wellness, the more doctors will understand that relying too heavily on questionable drugs isn’t necessary.

Note: Please check out the “Comments & Updates” section of this blog – at the bottom of the page. You can find the latest research about this topic there!

Be well!

JP

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4 Comments & Updates to “Avandia Alternatives”

  1. Terence Mix Says:

    Avandia was approved for marketing by the FDA on May 25, 1999, and was cleared only 6 months after GlaxoSmithKline’s predecessor submitted its New Drug Application. At the time, the assigned medical officer expressed concern about the premarket studies and wanted to include warnings about EKG changes and chest pain. This recommendation was ignored by the FDA brass.

    In the fall of 1999, the manufacturer secretly began a study comparing its drug with a competitor, Actos, and found that Avandia was no more effective than Actos and had a greater risk of heart problems. A March 29, 2001 e-mail from a company exec states, “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”

    This is just the tip of the iceberg of what went on with Avandia and what goes on in the drug industry. The truth is that what is scheduled to take place next November is how the drug should have been introduced in June 1999, when it entered the market. But then, GSK would not have received the billions of dollars in sales over the intervening decade plus – and tens of thousands of Americans would not have suffered heart attacks and deaths.

    The FDA is broken and needs a major repair job. For those in agreement I would urge you to go to http://www.FDAReformPetition.com and sign up. Congress needs to hear our complaint.

  2. JP Says:

    Update: Supplemental Vitamin K1 improves insulin sensitivity …

    http://www.nature.com/ejcn/journal/vaop/ncurrent/full/ejcn201517a.html

    Eur J Clin Nutr. 2015 Mar 18.

    The effect of vitamin K1 supplementation on sensitivity and insulin resistance via osteocalcin in prediabetic women: a double-blind randomized controlled clinical trial.

    BACKGROUND/OBJECTIVES: A relationship between osteocalcin (OC) levels and factors associated with energy metabolism and insulin resistance has been reported recently. The aim of this study was to investigate whether modulation of ostecalcin isoforms via vitamin K1 supplementation would affect glucose metabolism or insulin sensitivity in prediabetic and premenopause women.

    SUBJECTS/METHODS: Eighty-two prediabetic women were randomized to consume vitamin K1 supplement (n=39) or placebo (n=43) for 4 weeks. Participants in the vitamin K1 supplement group received one pearl softgel capsule containing 1000 μm of phylloquinone, and the placebo group received one placebo capsule daily for 4 weeks. Blood samples were collected at baseline and after the 4-week intervention period to quantify carboxylated OC (cOC), undercarboxylated OC (ucOC) and relevant variables.

    RESULTS: Phylloquinone supplementation increased the serum levels of cOC and decreased ucOC, compared with placebo (12.53±5.95 compared with 7.43±4.85 ng/ml and 2.47±1.91 compared with 4.79±2.43 ng/ml, respectively; P<0.001). Furthermore, intake of phylloquinone supplement led to significant decreases in %ucOC (17.97±12.24 compared with 43.80±19.86) and 2-h post-oral glucose tolerance test (OGTT) glucose (7.32±1.50 compared with 8.62±1.45 mmol/l), and 2- h post-OGTT insulin level (80.34±42.24 compared with 112.43±53.19 μIU/ml) and increased insulin sensitivity index (2.46±0.71 compared with 1.75±0.61) compared with placebo. Overall, a significant association was found between changes in %ucOC and changes in 2-h post-OGTT glucose (r=0.308, P=0.028).

    CONCLUSIONS: The results of this study demonstrated that vitamin K1 supplementation for 4 weeks did not affect insulin resistance in premenopausal and prediabetic women but had beneficial effects on glycemic status and insulin sensitivity.

    Be well!

    JP

  3. JP Says:

    Updated 07/12/16:

    http://link.springer.com/article/10.1007%2Fs12020-016-1018-2

    Endocrine. 2016 Jul 9.

    Mediterranean diet for type 2 diabetes: cardiometabolic benefits.

    Dietary patterns influence various cardiometabolic risk factors, including body weight, lipoprotein concentrations, and function, blood pressure, glucose-insulin homeostasis, oxidative stress, inflammation, and endothelial health. The Mediterranean diet can be described as a dietary pattern characterized by the high consumption of plant-based foods, olive oil as the main source of fat, low-to-moderate consumption of fish, dairy products and poultry, low consumption of red and processed meat, and low-to-moderate consumption of wine with meals. The American Diabetes Association and the American Heart Association recommend Mediterranean diet for improving glycemic control and cardiovascular risk factors in type 2 diabetes. Prospective studies show that higher adherence to the Mediterranean diet is associated with a 20-23 % reduced risk of developing type 2 diabetes, while the results of randomized controlled trials show that Mediterranean diet reduces glycosylated hemoglobin levels by 0.30-0.47 %, and is also associated with a 28-30 % reduced risk for cardiovascular events. The mechanisms by which Mediterranean diet produces its cardiometabolic benefits in type 2 diabetes are, for the most, anti-inflammatory and antioxidative: increased consumption of high-quality foods may cool down the activation of the innate immune system, by reducing the production of proinflammatory cytokines while increasing that of anti-inflammatory cytokines. This may favor the generation of an anti-inflammatory milieu, which in turn may improve insulin sensitivity in the peripheral tissues and endothelial function at the vascular level and ultimately act as a barrier to the metabolic syndrome, type 2 diabetes and development of atherosclerosis.

    Be well!

    JP

  4. JP Says:

    Updated 10/17/16:

    http://link.springer.com/article/10.1007%2Fs00394-016-1315-9

    Eur J Nutr. 2016 Oct 12.

    Controlling type-2 diabetes by inclusion of Cr-enriched yeast bread in the daily dietary pattern: a randomized clinical trial.

    PURPOSE: Chromium (Cr)-enriched yeast supplementation to whole wheat bread (WWCrB) has been shown to ameliorate postprandial glycemic response in healthy subjects. The present study investigates the long-term benefit of WWCrB consumption for patients with type-2 diabetes mellitus (T2DM).

    METHODS: Thirty patients with T2DM were randomly assigned to a group receiving WWCrB or the plain whole wheat bread (WWB) group. Plasma glucose, insulin, glycosylated hemoglobin (HbA1c) and insulin resistance were determined, and oral glucose tolerance test (OGTT) was performed at the beginning and the end of the dietary intervention, which lasted for 12 weeks. Biochemical parameters related to the disease, markers of inflammation as well as body weight and energy balance were examined.

    RESULTS: At the end of the study, subjects of WWCrB group exerted lower levels of glucose, insulin and HbA1c and improved insulin resistance (P < 0.05 against before treatment). Area under the glucose curve attained during OGTT decreased after the intervention (28,117.5 ± 1266.4 vs. 31,588.5 ± 1187.5 mg min/dL before treatment, P < 0.05) with significantly lower values of glucose concentration at 0 and 60 min. A significant reduction in body weight and systolic blood pressure (SBP) was observed (P < 0.05 against before treatment). Markers of inflammation and lipid profiles were not affected by WWCrB consumption.

    CONCLUSIONS: Inclusion of WWCrB in the daily dietary pattern of diabetic patients resulted in improvement of glucose tolerance and insulin resistance, significant reduction in HbA1c, weight loss and lower SBP. Patients with inadequate glycemic control may benefit from the consumption of WWCrB.

    Be well!

    JP

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