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


Friday, February 10, 2012

Victoza: Less effective, more dangerous than Byetta.

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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.

Sunday, February 5, 2012

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

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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.

Friday, February 3, 2012

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

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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,