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Cardiovascular Risk With Avandia?

With the current New England Journal Article on Avandia and it’s increased risks for cardiovascular problems, I believe we have missed the whole point of the article. Most people only looked at the editorials on the article and not the original article in the New England Journal of Medicine. If you had taken the time to look at the original article, you might have walked away with a better understanding of how diabetes should be treated and the really important information that came from the report.

Cardiovascular Risk With Avandia?
Let’s put it in perspective!
By Stephen Freed, Publisher, Diabetes Educator and Pharmacist 

With the current New England Journal Article on Avandia and it’s increased risks for cardiovascular problems, I believe we have missed the whole point of the article.  Most people only looked at the editorials on the article and not the original article in the New England Journal of Medicine. If you had taken the time to look at the original article, you might have walked away with a better understanding of how diabetes should be treated and the really important information that came from the report.
I called and spoke to Dr. Richard K. Bernstein, author of the Diabetes Solution to get his comments on the NEJM article.

Misreading Avandai

Dr. Richard K. Bernstein, MD, FACE, FACN, FCCWS

The recent ruckus over the drug rosiglitazone (Avandia) has been portrayed as another case of Big Pharma foisting a dangerous drug on the public while the overworked FDA can’t keep up.

Search Google for Avandia and Vioxx, and you’ll come up with more than three-quarters of a million hits, including ads from law firms ready to litigate.

There is an enormous difference between the two situations. In the case of Vioxx, it was alleged that otherwise healthy people suffered sudden cardiac disease and death after using the pain reliever. This new study, published in the New England Journal of Medicine on May 21, alleges that Avandia causes an unacceptable rise in risk of heart attack. This—at least from the evidence presented—is hard to believe.

From The New England Journal of Medicine , 21 May, 2007

There are several ways to read the statistics that “support” this study.

Those in the Avandia meta-study were not only diabetics, but diabetics whose disease was initially out of control, with average blood sugar levels approaching three times those of non-diabetics and blood sugars at the ends of the studies undisclosed. The complications of diabetes—in this case heart disease—are caused by the prolonged elevation of blood sugars.

With a little math, we can easily conclude, for example, that metformin is about 4.75*-fold more likely to cause more cardiac deaths than insulin. We can also conclude that placebo is about 4.4**-fold more likely to cause more cardiac deaths than insulin. Which should lead us to the conclusion that since insulin is the most effective of these medications at lowering blood sugars, it is likewise more effective at reducing diabetic complications such as the risk of cardiac death.

The other drugs are considerably less effective in doing that job—but the sulfonylureas, while more effective than metformin or rosiglitazone in the short term, are problematic because they can over time, burn out remaining insulin-producing beta cells.

The real story behind these figures is that there are a lot of health care professionals who are not doing their jobs. Anyone with an initial (as in this study) HgbA1c level of 8.2 percent (equating to sustained average blood sugar levels of about 228 milligrams per deciliter) should be treated with insulin (and a low carbohydrate diet) since no combination of the other drugs can get such blood sugars normalized. The other drugs can have marginal effects in reducing blood sugar levels, but are not nearly so effective as insulin.

Blood sugars of diabetics can be normalized. The real ‘scandal’ is that very few health care professionals think that diabetics have the right to the same blood sugars as non-diabetics. They therefore leave their patients wide open to an unnecessary “potential for serious adverse cardiovascular effects.”
___________
* 5.37/1.13 =  4.75
** 5.37/ 1.22 = 4.4

Richard K. Bernstein, MD, FACE, FACN, FACCWS
Mamaroneck, New York
Dr Bernstein is author of DIABETES SOLUTION, Little Brown, 2007 © 2007

Publishers comments:

So, we have the insulin sensitizers, Avandia,  Actos and Rezulin (which was removed from the marketplace for liver toxicity).  Risk factors for these include  heart attacks, cardiovascular death, fluid retention, bone fractures, weight increase, negative effect on lipids and possible unknown effects on genes.

The New England Journal of Medicine published an article entitled, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes.” The conclusions of this analysis of previous studies of rosiglitazone (brand name, Avandia) suggest that this oral agent used to treat type 2 diabetes may be associated with increased risk of heart attack by 43 percent and and death from cardiovascular causes by 64 percent.

In an editorial review of the Avandia meta-analysis, also published in the New England Journal of Medicine, Drs. Psaty and Furberg indicated that the approval process for Avandia may have been insufficiently rigorous because rosiglitazone has so many effects on genes, many of which are unknown. Moreover, its approval was based upon studies that may have been too short to be really useful in identifying long-term adverse heart effects.

Previously, meta-analysis was instrumental in preventing Pargluva (muraglitazar), a drug similar to Avandia, from being approved, again because of heart problems. In 2000, another glitazone, Rezulin (troglitazone), was removed from the market due to liver toxicity. Earlier this year, the Cochrane Library published a meta-analysis of Actos (pioglitazone), a thiazolidinedione similar to Avandia, which implicated it in edema and heart failure.

In the meantime, patients using any of the insulin sensitizers should talk to their health care provider to determine the most appropriate course of action. Patients should not stop taking any prescribed medications without first discussing the issue with their health care provider.

Now is the time to talk to your patients about the risks associated with diabetes. Using any drug increases your risk for complications.  But, as the studies have shown, increasing your physical activity can provide the same benefits and even greater benefits in reducing your risk factors for the complications of diabetes and other diseases.

Just like we all know that physical activity is an effective treatment for diabetes, yet we would rather just write another prescription for a drug treatment, rather then write a prescription for physical activity, which we all know works and is effective.

Lets first look at the costs of treating diabetes with Avandia.  The cost to treat diabetes with Avandia can be $120 dollars a month, or 1500 a year or 15,000 for 10 years and increases your risk for DEATH!.  A pedometer costs $20 dollars over 10 years, and when used effectively will reduce the risk for heart failure and DEATH!

We can take the increased risk of death from cardiovascular of 64% and turn it around and decrease your risk for cardiovascular death by 64%, that is a change of 128%.

As in the DPT trials,  and even the Dream study, which used Avandia to reduce the risk of diabetes  physical activity was shown to be as effective, if not more then the oral treatments used in the studies.

Lets look at a couple of the studies that, shows this controversy has but only one conclusion.

In a Finish study with postmenopausal women over 10 years it was found that walking 1 mile or more a day reduced the risk for heart disease by 82%.

In a study in Washington State they found that walking at least 1 hour per week, which is less then 9 minutes a day can reduce the risk for sudden cardiac death by 73%.

In a study of 40,000 American females they found that walking at least 1 hour a week, (less then 10 minutes a day) reduced the risk for coronary artery disease by 51%.

In a study of over 73,000 American women aged 50-79, walking for 2.5 hours a week reduced the risk for all cardiovascular events by 30%.

In a study of 1500 men, walking at least 2.5 hours a week (14 minutes a day) lowered the risk of heat attack by 69%.
So, why replace one drug with another that has other risk factors, when we can simply provide a 20 dollar pedometer and tell our patients to increase their physical activity?

Now is a great time to have the discussion with your patients and let them know that there are other alternatives to taking drugs that are more effective with no risk factors.  But, just telling them may not be good enough, make them responsible for reporting to you their physical activity by using a pedometer and setting goals for the number of steps they take each and every day.

If they can report to you their blood sugars, then report their steps!  Now imagine what would happen if we also had them responsible for the number of carbohydrates that they consume each day and maybe reduce them by just 100 grams, what could happen?

And if all else fails, consider using the most safe and effective drug: INSULIN

If you would like to share your comments or for more information on how to implement a pedometer walking program in your practice, contact me at publisher@diabetesincontrol.com or call 800-798-6972

For a free subscription to Diabetes In Control, just go to www.diabetesincontrol.com and click on subscribe.
Steve Freed, Publisher