Victoza: Less effective, more dangerous than Byetta.

Page Changed: Byetta and Victoza

Added the following text

Victoza

In January of 2010, The FDA finally approved Novo Nordisk's long delayed GLP-1 analog, Liraglutide, which is marketed under the name, "Victoza."

This drug was developed in the same time frame as Byetta and is similar in concept. But its side effect profile was more troubling, hence the delay. It was released with a warning that it might produce thyroid cancers, though its maker tried to suggest this was only a problem in rodents. In fact, its European prescribing information revealed this data from human trials :

The overall rates of thyroid adverse events in all intermediate and long-term trials are 33.5 [Victoza], 30.0 [Placebo] and 21.7 events per 1000 subject years of exposure for total liraglutide, placebo and total comparators; 5.4 [Victoza], 2.1 [Placebo] and 0.8 events, respectively concern serious thyroid adverse events. In liraglutide-treated patients, thyroid neoplasms [i.e. cancers], increased blood calcitonin and goiters are the most frequently thyroid adverse events and were reported in 0.5%, 1% and 0.8% of patients respectively.

You can read the full FDA-approved prescribing information for Victoza here:

Victoza Prescribing Information.

Based on what is reported there, in return for a more disturbing side effect profile, Victoze appears to produce less blood sugar control than Byetta does and it doesn't look as if Victoza has as good an impact on weight as Byetta does, either.

More importantly, the prescribing information now includes a new paragraph reporting that

There have been postmarketing reports of acute renal[kidney] failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients [see Adverse Reactions (6.2)]. Some of these events were reported in patients without known underlying renal disease.

With less impact than Byetta and more dangerous side effects this is a drug there is no reason for anyone to take.

Bydureon

Byetta is now available in a once a week form called Bydureon, however this drug, which was approved in early 2012 is so new, and its release was so long delayed by the FDA because of potential side effects, that it would be prudent to wait a few years to find out what the real side effects are before taking it.

With any long-acting GLP-1 analog drug the longer duration means that if you get the serious gastrointestinal reaction that GLP-1 analogs can cause, it's going to take a lot longer to wash out of your body. Don't try Bydureon unless you've taken Byetta for long enough to determine that it gives you dramatic improvements in both blood sugar and weight control without severe nausea.

A New Pill Combines Ineffectual, Expensive, Dangerous Trajenta with Metformin

Page changed: Onlyza and Tradjenta- Just like Januvia, But Worse

Added this text:

Trajenta is now being sold in combination with metformin, in a drug called Jentadueto.

If you are newly diagnosed and have not taken metformin before, don't don't let your doctor put you on this brand new, untested, extremely expensive, ineffectual combination drug. The practice guidelines published by all the major bodies who issue such guidelines recommend starting with plain metformin, which is a cheap generic drug that is highly effective and whose safety has been proven over 50 years of prescribing,unlike these new drugs that even in the acceptance testing gave hints that they may promote cancers and pancreatitis. The FDA has mandated follow-up reporting, but the history of follow-up reporting for other dangerous drugs is that it is useless as it is voluntary and relies on doctors recognizing the connection between the drug and the patient's disease. Very few doctors know anything about the relationship of any of the DPP-4 inhibitor drugs to cancer so when a patient develops a cancer after a few years of taking one of these drugs they are very unlikely to report that cancer as a side effect of the diabetes drug.

Measure of Protein Marking Heart Damage Rises when A1c is Greater than 5.6%

Page changed: A1c and Post-Meal Blood Sugars Predict Heart Attack

Added the following text:

Marker of Damage to Heart Muscle Rises with Rising A1cs in The Normal Range

A study published in February 2012 found that when a new high-sensitivity test that detects tiny amounts of a protein associated with heart muscle damage, troponin T, was used, study subjects were 24% more likely to have high cardiac troponin T if their A1c was between 5.7%-6.4%, compared to those whose A1c was below 5.7%. When their A1cs were over 6.4% that likelihood doubled. This suggests high blood sugars in the upper part of the range most doctors consider normal directly damage heart muscle.

Chronic Hyperglycemia and Subclinical Myocardial Injury.
Jonathan Rubin et al. J.Am.Col.Cardiology,Volume 59, Issue 5, 31 January 2012, Pages 484–489 http://dx.doi.org/10.1016/j.jacc.2011.10.875,

Why Thousands of Unregulated Supplements May Contain Dangerous Substances

Page changed: Worthless or Dangerous Supplements

Added this text (note reference to a NEJM article documenting these problems):
To cite only one example, in 2011, a large "well respected" Utah supplement company marketed a product, Zotrex supposedly containing an natural herb, Ophioglossum polyphyllous, it claimed could enhance potency. What the pills actually contained was sulfoaildenafil, a drug analog of Viagra that has never been tested in humans. Quite a few drug analogs of safe drugs, are toxic for humans, for example, phenformin, which is a close relative to the very safe, well-tested drug metformin.

In another case, a supposedly "herbal" diabetes supplement, when taken to the lab turned out to contain a cheap first generation sulfonyurea drug--one that can cause dangerous hypos and, which is also now known to act on the heart in a way that promotes heart attack.

The 1994 law stipulated that supplement makers were supposed to submit safty data to the FDA for any new ingredient they introduced that wasn't on sale prior to 1994. But the New England Journal of Medicine reported in January of 2012 (HERE) that since 1994,

..the number of available dietary supplements has skyrocketed from an estimated 4000 to more than 55,000...but the FDA has received adequate notification for only 170 new supplement ingredients since 1994 — undoubtedly a small fraction of the ingredients for which safety data should have been submitted.

Any time there is any attempt to reintroduce even the feeblest oversight into the marketing of bottles that can contain literally anything, the supplement companies send paid minions out who post all over the web about how big gumint's trying to take away your freedom. People deluge their congresspeople with complaints, and the supplement companies go back to earning billions selling you whatever they feel like putting into their magic pills this month.

===

Also removed paragraph about vitamins being manufactured in China.

Statins May Actually Cause Diabetes

Page changed: Other Dangerous Drugs for People with Diabetes

Added the following:

Statins May Cause Diabetes

The highly respected Womens Health Initiative study found that women without diabetes who were taking statins at the start of the study had almost twice the risk of developing diabetes. To quote from the study:

Statin use at baseline was associated with an increased risk of DM (hazard ratio [HR], 1.71; 95% CI, 1.61-1.83). This association remained after adjusting for other potential confounders (multivariate-adjusted HR, 1.48; 95% CI, 1.38-1.59) and was observed for all types of statin medications.

It is possible that the high cholesterol that motivated doctors to put these women on statins occurred because they had abnormally high blood sugars already that were missed because they manifested as high readings after high carb meals, rather than abnormally high fasting glucose. However, given the other studies that show a mechanism by which statins decrease insulin sensitivity, it is very possible that taking statins does independently worsen blood sugar control to the point it could push people into diabetes who would otherwise only be insulin resistant or pre-diabetic.

Statin Use and Risk of Diabetes Mellitus in Postmenopausal Women in the Women's Health Initiative. Annie L. Culver et al. Arch Intern Med. 2012;172(2):144-152. doi:10.1001/archinternmed.2011.625

This echoes the findings of a study published earlier in 2011 in the Journal of the American Medical Association which found that people taking high dose statins were 12% more likely to get diabetes than people who took lower doses. However, in this study there was no control group of people taking no statins, which might have shown that even the people taking low doses had a higher risk of getting diabetes.

Risk of Incident Diabetes With Intensive-Dose Compared With Moderate-Dose Statin Therapy: A Meta-analysis David Preiss et al. JAMA. 2011;305(24):2556-2564. doi: 10.1001/jama.2011.860

Ironically, the response of mainstream docor/thought leaders as reported in the media is that since statins help prevent the main diabetic complication--heart attack, this is nothing to worry about. Not so surprisingly, the doctors quoted are always those who get large speaking fees from, or are associated with organizations that get large research grants from, the drug companies that make statins. Apparently it doesn't matter that people with diabetes get nerve damage, diabetic blindness and kidney failure none of which are improved by taking statins.

Supplementing with Megadoses of Vitamin B6, B12 and Folic Acid Correlates with Double Stroke Risk and GFR Worsening

Page changed: Diabetic Kidney Disease

Added the following:

Do NOT Supplement with Higher than Normal Doses of Vitamins B6, B12 and Folic Acid

A study of people with both Type 1 and Type 2 diabetes who had been diagnosed with diabetic kidney disease found that supplementing daily with a "Single tablet of B vitamins containing folic acid (2.5 mg/d), vitamin B6 (25 mg/d), and vitamin B12 (1 mg/d)" for three years was associated with faster deterioration in GFR and a doubling of stroke risk.

Effect of B-Vitamin Therapy on Progression of Diabetic Nephropathy:A Randomized Controlled Trial. Andrew A. House et al. JAMA 2010;303(16):1603-1609. doi: 10.1001/jama.2010.490

It's important to note that the amounts used in this study were megadoses many times greater than the RDA (Recommended Daily Allowance) for each.

If you are eating a diet that does not include grains or other foods that supply natural forms of these vitamins you won't be getting them in your diet and will need to supplement, but when you do, confine your supplementation to the RDA. You can find the RDA for the B vitamins HERE.

Tight Control Decreases Kidney Deterioration by 50% in People with Type 1 Involved in DCCT

Page Changed: Diabetic Kidney Damage

Added the following:

Another study, that followed people with Type 1 diabetes for more than a decade found that those who had achieved "Tight control" in the DCCT (defined as A1cs near 7%) had half the risk of developing the condition leading to kidney failure than those who did not. The full text article explains that it took ten years for the impact of that early tight control to become evident.

Lower A1cs, in the 5% range--which are easier for people with Type 2 to achieve than for those with Type 1--would likely reduce this risk a lot further.

Intensive Diabetes Therapy and Glomerular Filtration Rate in Type 1 Diabetes: The DCCT/EDIC Research Group New England Journal of Medicine, November 12, 2011 (10.1056/NEJMoa1111732)