Andy

Senior Member
Diabetes Warning
AVANDIA Lawsuit Info

Have You Taken AVANDIA?



The New England Journal of Medicine has released the results from 42 studies
involving 15,560 diabetes patients who were prescribed Avandia.

Patients getting Avandia were 43 percent more likely to have a heart attack.
The study also suggested a trend toward higher death rates in the Avandia group.

Avandia (rosiglitazone) is manufactured by drug maker GlaxoSmithKline,
and is one of the most popular pharmaceuticals for the treatment of Type 2 Diabetes

If you or someone you know has taken Avandia you or that someone or their family may be entitled to monetary damages.
 
Diabetes Warning
I think this is a medicine more popular in the US than the UK and I am sure your GP or diabetic nurse would be aware of the side affects.
 

bryan

Member
Diabetes Warning
Andy - This news is 6 weeks old, and a good example of "Lies, damned lies and statistics". The headline refers to a 43% greater chance of a heart attack for patients taking Avandia, but 143% of not a lot is still not a lot. In fact there are 21 million people in the US suffering from diabetes, and this study compared results of trials covering 15,560 patients taking Avandia with 12,283 patients taking a placebo or another medecine. However the research techniques used in the study are very questionable, and the publisher admitted that the results may not be statistically significant. Most interesting however to see how eagerly the American legal profession chase ambulances, or even the remote chance that someone may need an ambulance!

If you interested here is part of Glaxo-Smith-Kline's response to the article:


"The NEJM paper is based on an analysis of summary information that combines a number of studies – a meta-analysis - which is not the most rigorous way to reach definite conclusions about adverse events. Each study is designed differently and looks at unique questions: for example, individual studies vary in size and length, in the type of patients who participated, and in the outcomes they investigate. The data compiled from these varied studies is complex and can be conflicting.

Importantly, the editorial in the NEJM states: “A few events either way might have changed the findings for myocardial infarction or for death from cardiovascular causes. In this setting, the possibility that the findings were due to chance cannot be excluded. In their discussion, the authors properly emphasize the fragility of their findings.”

In contrast to a meta-analysis, the most scientifically rigorous way to examine the safety and benefits of a medicine is to conduct large scale, long-term clinical trials in patients with the disease. Several trials of this type have been ongoing for many years. To date concerns regarding patient safety have not been identified by the independent Safety Monitoring Boards for these trials. Several trials have completed and the results published. For example, GSK’s long-term, landmark study ‘ADOPT’ (A Diabetes Outcome Progression Trial) - one of the longest clinical trials in people with type 2 diabetes to date - directly compared both the safety and effectiveness of Avandia with other oral anti-diabetic medicines in over 4,300 patients studied for up to 6 years.

Data from ADOPT showed that the overall risk of serious, cardiovascular events (CV death, myocardial infarction, and stroke, or MACE endpoint) for patients on Avandia was comparable to metformin and sulfonylurea (glyburide) – two of the most commonly used medicines to treat type 2 diabetes. ADOPT showed comparable rates of cardiovascular deaths: Avandia – 5 reports out of 1,456 patients, or 0.34%; metformin – 4 out of 1,454, or 0.28%; and glyburide – 8 out of 1,441 or 0.56%. The ADOPT clinical trial did show a small increase in reports of myocardial infarction among the Avandia-treated group (Avandia: 24 out of 1,456 or 1.65%) vs metformin (20 out of 1,454 or 1.38%) vs glyburide (14 out of 1,441 or 0.97%); however, the number of events is too small to reach a reliable conclusion about the role any of the medicines may have played in this finding. Importantly, ADOPT also demonstrated that Avandia was superior to metformin and sulfonylurea regarding long-term control of blood sugar over five years, which is a key goal in managing diabetes to avoid the long-term complications of the disease.

In another long-term study, DREAM – which followed over 5,200 patients at high risk of developing of type 2 diabetes for a period of three to five years - Avandia monotherapy showed no increase in cardiovascular risk when compared to placebo.

Furthermore, in 2000, GSK initiated RECORD - a large, long-term clinical trial in people with diabetes- which has been prospectively designed to look at cardiovascular outcomes. The independent Safety Monitoring Boards responsible for overseeing the safety of this trial monitors patients closely, and in its regular operations has not found any safety risk that would interrupt continuation of the study.

In addition, in a comprehensive analysis of patients in a US managed care database of more than 33,000 people with diabetes – performed by independent investigators - there was no difference in ischemic cardiovascular events (including myocardial infarction) among patients taking Avandia-containing regimens versus other oral anti-diabetic medicines.

The totality of the data show that Avandia has a comparable cardiovascular profile to other oral anti-diabetic medicines. GSK stands firmly behind the safety of Avandia when used appropriately, and we believe its significant benefits continue to outweigh any treatment risks.

Because Avandia has been shown to control blood sugar for longer than other standard oral anti-diabetic medicines, it is an important treatment option for physicians who often need to prescribe two or three medicines to help their patients maintain their blood sugar levels. Type 2 diabetes is chronic, relentlessly progressive and life threatening; yet, two-thirds of diabetic patients suffer with uncontrolled disease. If left uncontrolled, diabetes can lead to heart disease, and is the leading cause of blindness, kidney disease and non-traumatic amputations in the US.

GSK has consistently shared its data on Avandia from meta-analyses and controlled studies with the FDA and other regulatory agencies. Data is also posted publicly on the company’s Clinical Trial Register. We continue to work closely with regulatory authorities and physicians to keep them fully informed so they can make the best decisions for patients based on both the safety and benefit of the medicine."

Regards

Bryan
 
Diabetes Warning
Thanks Bryan for an excellent posting, being a type 2 diabetic I do ask questions of my GP and diabetic nurse, what amazes me is the apathy of diabetics who reguarly miss appointments with the diabetic nurse at my clinic, and then moan when they get complications.
 

heyjude

Member
Diabetes Warning
Already struggling to loose weight I was put on Avandia..........I put on 2 stone in a short space of time and felt lousy, head aches etc.

I went to my GP and demanded to be taken off the drug.

Since then I have lost some weight, my blood sugar is down but not where it should be.

So are there any dangers with my current medication..........I'll bet there are!!!

I like so many others feel that often the side effects of a drug out weigh the benefits.

Thank you for this article I know I made the right choice.
 
Diabetes Warning
heyjude..you dont say what your current medication is.

being overweight is a risk factor for developing type 2 diabetes
there are many misconceptions about diabetes...sometimes a change in lifestyle ..eating less fats more veg and fruit..and being more active can control things...and there is no such thing as 'mild' diabetes..you either have the condition or you don't.
diabetic retinopathy is the main cause of blindness in the uk...in turkey şeker hastalığı..diabetes..is very widespread...
im amazed at yusufs father who has type 2 , tests his blood sugar every couple of days..yet takes no notice of the results which are never less than 300 sometimes as high as 500.....(normal non diabetic blood sugar ranges from 70 to around 100-110 )...now at almost 70 the affects of this are beginning to tell..his sight is going..his feet are losing sensation..diabetic neuropathy..he has high blood pressure..etc etc..he now takes insulin before breakfast..and the rest of the day consumes whatever he wants!! drinks loads of cola, loves baklava!..and lokum..he's a walking miracle. :)
if blood sugar is at a constant high then its affects many organs..eyes, blood vessels, nerves, kidneys
the body is a wonderful thing... when you have too much sugar in your urine which would gum up the tiny little filtering tubes in your kidneys ..your brain tells you that you are thirsty..and drinking apart from making you pee a lot means that the sugar is being diluted....your body is warning you that things are not ok.
very thirsty--losing weight-no energy-these are all symptoms that call for a check up. :)
 

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