Are You Risking Heart Disease with Diabetes Drug Avandia

Almost everyone has heard about the famous drug Avandia (rosiglitazone), which is used to control diabetes. Diabetes is one very serious hormonal disorder where the blood is over floated with glucose which in turn can’t be used by our cells, so, they are starving! Avandia has shown a great effectiveness in controlling the symptoms of this condition, but lately one another problem occurred: some studies have shown that you may be risking a heart disease when you use this medication! What of all this is really true and what Food and Drug Administration (FDA) is saying about all this?

 

Like we have already mentioned – Avandia is one very effective medication! In order to find out how really effective it is- experts suggested some studies! In one study of more than 5,000 people at high risk of developing diabetes, participants took either the medication Avandia or a placebo. What were the results? Well, after three years, diabetes occurred in 62 percent fewer people taking Avandia than taking a placebo. This study showed how really effective Avandia medication is! There are also several other medications used to treat diabetes, such as Glucophage, but, in another study, participants taking this drug also reduced their risk of developing diabetes — although by less striking percentages.

Now let we say something about some important aspects of Avandia usage, effectiveness and possible side effects! Everyone should know that recent studies showed that Avandia may increase a person's risk of heart attack and death due to heart disease. It is drug manufactured by company called GlaxoSmithKline! In company they sat that, after several clinical studies, that Avandia poses no significant risk to patients' heart health whatsoever!

So what’s the problem then? Well, the problem is that there is a new warning which comes from one short-term clinical study which showed that Avandia increases heart attack risk by 43% -- and increases risk of death from heart disease by 64%.

No meter what people talk about this medication- proven fact is that it really helps! The FDA in 1999 approved Avandia because it showed ability to reduce blood-sugar levels in people with type 2 diabetes. Why is diabetes so dangerous? Well, it has been linked to both microvascular problems such as blindness, kidney failure, and loss of circulation in the extremities. It has also been linked to heart disease. During this year, several tests have been done but none of the trials showed that the drug actually prevented the greatest threats to people with diabetes: microvascular problems, heart disease, or heart death. That’s why; some experts are saying that the possible heard disease or heart death isn't the consequence or side effect of this medication but rather- complication of primary disease- diabetes! What of all this is really true!?

 

Patients are obviously interested how big the risk of using Avandia is! Some of them are also ready to use it even if there is some small risk because the overall benefit is much more important! Well, experts are now saying that the overall risk appears to be small. What are those patients studies saying!? Well, according to these studies, there were:

 

 

What we can say when we read about these studies? Well, it is obvious- most of the experts concluded from this data that Avandia may be capable of provoking heart attacks or death from cardiovascular causes after relatively short-term exposure in patients who are already susceptible to these conditions.

 

Well, the fact is that GlaxoSmithKline, a company that produces the Avandia, has done its own analysis of Avandia's heart safety data. Using almost the newest techniques and technologies that can be found- the GSK study showed about a 30% increase in heart risk to patients taking Avandia. Therefore, there is no doubt- Avandia can increase the risk of heart disease! However, the fact is also that a study of 33,000 patients showed no increased heart risk in patients taking Avandia. That’s why- it could be difficult to talk about possible side effects when the results are different comparing the short term and long term studies! This is why the company still keeps the original opinion and recommendation: Avandia is completely safe! It is also important to point out that, recently, GlaxoSmithKline provided FDA with an analysis of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. What were the results? Well, this study suggested that patients receiving short-term (in the period of 6 months) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. Of course, this is still not officially confirmed!

 

So, what the FDA concluded from all these studies done on the safety of Avandia! Important thing to know is that the U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone). They agree that it is extremely effective drug approved to treat type 2 diabetes, but safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.  Because of all that- they think that, because of its effectiveness, the drug should still stay on the market but with some warnings! They point out that -patients who are taking Avandia, especially those who are at high risk of heart attack, should first talk to their doctor about this. FDA only counts on the studies they have done and have not confirmed the clinical significance of the reported increased risk in the context of other studies. They are also saying that there is a big risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. This is why- FDA is not claiming from GlaxoSmithKline, the drug's sponsor, to take any specific action at this time.  

After everything that has happen these last couple of years about the Avandia, patients are interested is there a generic equivalent of Avandia? Unfortunately, in this moment, Avandia is what's known as a single source brand, meaning there is no generic equivalent. Only in cases when a brand-name drug patent expires (which will not happen so soon) the Food and Drug Administration (FDA) can approve generic versions of the drug. This will not bring anything new or good because this “new drug” must match the brand name in dosage, strength, performance, use, quality, and safety. That’s why- it will have all the side effects like the original had before it!

 

·         Actos by Takeda Pharmaceutical Co.

It is also important to point out that Takeda Pharmaceutical Co. manufactured one drug called Actos. The fact is that this medication is very similar to Avandia (but bit the same) that doesn't have a heart risk. Unlike the Avandia, the active ingredient of this medication is called the pioglitazone, which is also in the thiazolidinedione class of drugs. There is no heart disease risk involved when you use this drug, although-there have been reports of hepatitis and elevated liver enzymes among patients who use this drug.  

·         Incretin mimetics by Eli Lilly & Co.

Patients should also be informed about one more drug! It is called Incretin mimetic and it has been manufactured by company called Eli Lilly & Co. It represents an injectable medication! These medications are called Incretin mimetics because they mimic the effects of naturally occurring hormones in the intestines. What is the purpose then? Well this can help the body make more of its own insulin. Like with any other medications- there are possible side effect that can occur when using this medication and the most common are: allergic reaction involving hives, difficulty breathing, and swelling of the face, lips, tongue, or throat.

·         Janumet by Merck & Co.

There is also one medication called Janumet manufactured by Merck & Co. unlike the previous one- this represent one oral medicine with active ingredient called sitagliptin phosphate with metformin hydrochloride. Who should use this medication? Well, experts are saying that it is literally designed for patients who need more than one oral medication to help control their blood sugar.