Avandia Increases Heart Attack Risk? I'm Not Convinced!
This week, in a widely publicized study, which is actually an analysis of a group of studies called a meta-analysis, it was concluded that use of the diabetes drug rosiglitazone (Avandia) causes a significant increase in the risk of having a heart attack. It also concludes that there is a greater risk of death from all cardiovascular diseases, which includes heart attack and stroke, while taking the drug. But is this true, or is it a trick of the statisticians? Let's look at a few of the details of this "study."
First, the author took a group of 42 studies that included the use of rosiglitazone. These studies were not specifically designed to look at heart disease risk, so this begs the question: if the studies didn't control for other causes of heart attack and stroke risk, how did the author of the meta-analysis determine that there were no other causes of these increased risks in the study?
For example, poorly controlled diabetes and elevated blood lipids both increase the risk for heart attack and stroke, so how did the author control for those factors if the original studies did not? Additionally many of these trials were small and short-term, with an inadequate number of participants and too little duration to really determine the long-term risk of developing cardiovascular disease (CVD).
Next, the author took the "publicly disclosed data summaries" from these 42 trials and used that information to draw his conclusions. This means that the author is drawing his numbers from the best "spin" on the original data, not the original study numbers themselves.
Finally, there is the little problem of the statistician's spin on the data, which is reported from analysis of the "odds ratio" rather than the "relative risk" of a particular event happening. Statistical analysis makes my eyes glaze over, but if you want a better understanding of these two ways of interpreting the data, you can read a pretty coherent explanation from Steve Simon, PhD, of Children's Mercy Hospital in Kansas City.
From my view of the world (and that's why I write this blog, isn't it?) the relative risk is the number that expresses how I think about the chance that something will actually happen to one of the many individual patients for whom I have prescribed Avandia (which is almost all of the individuals living with diabetes that I have written prescriptions for over the last three years).
In this analysis it was described that there is a 43% increase in the risk of having a heart attack while taking rosiglitazone, and a 64% increase in the risk of dying from heart attack or stroke while taking this medication. These numbers are based on the odds ratio. But if you look at the actual numbers of patients who had a heart attack or died from CVD they look like this:
By comparison, the risk of heaving a heart attack while taking a diabetes drug other than rosiglitazone is 72/11,634 or 0.0061% and of death from all CVD causes is 22/11,634 or 0.0018%
Following this line of reasoning you will note that:
There is currently a study underway called the Rosiglitazone Evaluated For Cardiac Outcomes & Regulation of Glycaemia in Diabetes ("RECORD") which is going to give us additional data on the safety of rosiglitazone as measured by heart disease and stroke outcomes. Until that data is available, I am not rushing to remove my patients from rosiglitazone based on this spin on the "evidence."
Take care,
Laurie
Related Topics: Technorati Tags: Avandia, rosiglitazone, diabets, heart disease, health and wellness
First, the author took a group of 42 studies that included the use of rosiglitazone. These studies were not specifically designed to look at heart disease risk, so this begs the question: if the studies didn't control for other causes of heart attack and stroke risk, how did the author of the meta-analysis determine that there were no other causes of these increased risks in the study?
For example, poorly controlled diabetes and elevated blood lipids both increase the risk for heart attack and stroke, so how did the author control for those factors if the original studies did not? Additionally many of these trials were small and short-term, with an inadequate number of participants and too little duration to really determine the long-term risk of developing cardiovascular disease (CVD).
Next, the author took the "publicly disclosed data summaries" from these 42 trials and used that information to draw his conclusions. This means that the author is drawing his numbers from the best "spin" on the original data, not the original study numbers themselves.
Finally, there is the little problem of the statistician's spin on the data, which is reported from analysis of the "odds ratio" rather than the "relative risk" of a particular event happening. Statistical analysis makes my eyes glaze over, but if you want a better understanding of these two ways of interpreting the data, you can read a pretty coherent explanation from Steve Simon, PhD, of Children's Mercy Hospital in Kansas City.
From my view of the world (and that's why I write this blog, isn't it?) the relative risk is the number that expresses how I think about the chance that something will actually happen to one of the many individual patients for whom I have prescribed Avandia (which is almost all of the individuals living with diabetes that I have written prescriptions for over the last three years).
In this analysis it was described that there is a 43% increase in the risk of having a heart attack while taking rosiglitazone, and a 64% increase in the risk of dying from heart attack or stroke while taking this medication. These numbers are based on the odds ratio. But if you look at the actual numbers of patients who had a heart attack or died from CVD they look like this:
- Total numbers drawn from 42 studies:
- 15,560 individuals randomly assigned to medication regimens that included rosiglitazone.
- 12,283 individuals randomly assigned to comparable groups that did not include rosiglitazone.
- Of those taking rosiglitazone and completing the study there were 14,371 individuals, 86 of whom had heart attacks and 39 of whom died from either these attacks or from stroke.
- Of those not taking rosiglitazone and completing the study there were 11,634 individuals, 72 of whom had a heart attack and 22 of whom died from that attack or from stroke.
By comparison, the risk of heaving a heart attack while taking a diabetes drug other than rosiglitazone is 72/11,634 or 0.0061% and of death from all CVD causes is 22/11,634 or 0.0018%
Following this line of reasoning you will note that:
- the risk of having a heart attack on rosiglitazone is relatively small and
- the risk is nearly identical to the risk of having a heart attack while taking one of the other diabetes drugs (0.0059% versus 0.0061%).
There is currently a study underway called the Rosiglitazone Evaluated For Cardiac Outcomes & Regulation of Glycaemia in Diabetes ("RECORD") which is going to give us additional data on the safety of rosiglitazone as measured by heart disease and stroke outcomes. Until that data is available, I am not rushing to remove my patients from rosiglitazone based on this spin on the "evidence."
Take care,
Laurie
Related Topics: Technorati Tags: Avandia, rosiglitazone, diabets, heart disease, health and wellness
22 Comments:
What about alternatives like actos or januvia?
You sound like you are shilling for Big Pharma
Since when is it shilling for Big Pharma to concur with The Lancet that the New England Journal of Medicine drew a hasty conclusion on some of the most complex data going? If the public wants to be a meaningful participant in the healthcare debate, it will have to do better than utter bumper sticker slogans and harbor conspiratorial notions about the "Big Pharma" bogeyman.
How about a disclosure from Laurie. Any money or gifts of any kind from an Avandia salesperson is something we are entitled to know about. This drug has been a killer from day 1, a close cousin to the mass murderer Rezulin, it should be pulled NOW! The FDA outlawed androstenedione which never was shown to hurt anyone. Why the different standards when high priced prescription drugs are involved?
Laurie's affiliations are all posted in her bio linked on the left side of the page. An excerpt:
Her other professional memberships include the American Academy of Nurse Practitioners, the American Nurse's Association, and the Rhode Island State Nurses Association Nurse Practitioner Council. She is certified by the American Heart Association in advanced cardiac life support and as a basic life support instructor, and by the American Cancer Society as a Freedom From Smoking course instructor.
In addition, Laurie is the Director of Wellness Services for www.Fitness4Diabetics.com, an online service dedicated to diabetes management through healthy lifestyles.
I hope that helps answer your question.
o.k wait & see how the new study will prevail.
in the mean time how about using metformin 500 mg +pioligtazone 15mg to be in the safe side.
appreciate further comments.
addis
Well, apparently I hit a hot one here. I do not receive any monies from any pharma companies and I am not a spokesperson for any of them. I am however actively involved in the management of individuals with diabetes and am expressing a personal opinion that this "study" is a hasty jump to conclusions.
Each individual has to determine if there is a concern about a particular medication for them, and discuss that concern with their provider. If they reach a mutual decision that there are better choices in the management of that individual's diabetes, then the medication can be stopped and replaced with something else. But no one should be looking at glucose management or medications in isolation, that is as the only risk factor for cardiovascular disease (CVD). If the person is at risk for CVD for any other reason that has not been managed (hyperlipdemia, hypertension, obesity, or smoking for example), they you cannot safely assume that the rosiglitazone caused the problem. This is the problem with this "study;" those factors weren't controlled.
Thank you all for a interesting debate. I'm glad to see it. Laurie
You sound like you are shilling for Big Pharma
What are your credentials?
I used to take Avandia my ankles were puffed and every time I took a pill I would feel something funny in my heart
I don't know how specific these facts are, but I can say that I was on this medication for several months and did have a heart attack at 51 yrs of age with no warning at all prior to this event. No one in my family had an cardiac events before their 70s.
still will continue to use 4 of Avandia daily. Heart attacks can be caused by so many things. Maybe like "feeling funny" when holding the nurses hand !!! Am sure further tests will be made ..
Laurie, Would you continue to take Advandia if you have had a previous heart attack, & by-pass surgery if your doctor has prescibed it ? Bill
Laurie, thank you for presenting this information, I believe you are right on the money. I am a family nurse practitioner with 8 1/2 years of experience and 20 years of experience in the health care field. I have taken care of many diabetics and am currently working in an endocrinology practice. I consider myself to be an overly cautious provider. I can say that I would not recommend pulling a well controlled patient off of Avandia at this point. The data is not conclusive and needs to be researched further. For the individual who said their ankles became swollen and their heart felt funny on the medication, I would have pulled you off of the medication even if this recent data had not been present. With all medications, the risk and benefits must be weighed before prescribing the medication. Any good medical practitioner will present the use and the risk/benefits of the medication to the patient so that they can make an informed decision before starting any medication. I confess that I have likely eaten a meal provided by an avandia rep, but in the long run does that chicken sandwich from chic-fil-a weigh on my decision of what medication to prescribe, NO! I can honestly say that I choose the medication that I feel will best take care of my patient's need at the time I treat them. If that name brand med is the best, that's what I choose. If a cheaper generic medication will do a better job or equal job, guess what, that cheaper med is what I choose. For all the free time that I provide my patient's to go over and beyond what the average joe would do for their health and well being, I can say that a chicken sandwich provides little incentive to do something that I feel may be harmful. I would guarantee Laurie wants the best for her patient's as I do. For all of you who feel the need to bash her for her comments, get over it everyone in the world and medical field are not bad. It sounds as if you may need a new medical provider if that's all the faith that you have.
For the individual who asked the serious question about having heart disease and whether Laurie would recommend continuing the medication. As I said, I am a very cautious provider and I would honestly consider not continuing the use of the medication until further data is available, but your provider will need to take into consideration how well you are controlled and what meds have been used in the past to try to control your diabetes. The sad part of diabetes is that all patients with diabetes are at a significantly higher risk of having heart disease, and the better control that you have the better off you are in the long run. I would recommend talking to your doctor to make the right decision for yourself, don't just stop the medication. Make an appointment and talk to your provider about the risks and benefits. You could talk to 10 different medical providers and get 10 different answers, but let your doctor who you trust explain the information and their views and together you decide what is right for you. I hope that you do well.
Thanks again to Laurie for this valuable information.
I have taken Avandamet for the past two years and have found it to be very effective in keeping my blood sugar under control. I have type 2 diabetes and I have tried other medications that have not worked well. Avandamet does the job. I have also had mitral valve surgery nad I do not have any complications from taking the Avandamet. No swelling or heart palpatations. I believe in it and will continue to use it.
Marina
I love it!!! When I first read the "researcher's" interpretation of these data I was beside myself. Then, his "research" was reported on the evening news. This researcher appears short on statistical skills and somehow got published. Unfortunately, the general public (and media reporters?) know little about n vs N much less "statistical significance". Perhaps the RECORD (and your expert analysis) will set the record straight.
My distrust in drugs out there has only increased. When the republican congressmen that was on CBS news only concern was that the stock dropped for this drug company instead of safety for the public that he represents. It won't be long before we won't have a choice in this democracy. In Texas, the governor was going to mandate that 6 graders were going to get the HPG virus because the lobbiest had more influence and money. They knew if choice was allowed that parents may not want their children to get it and as a result the drug company could not put those billions in their column.
I am a new user of Avandia and it is the first medication that has controlled my Type II diabetes.
I know of 2 people who have had serious complications from Avandia. One, 53 years old, has serious heart failure and the other, 75 died of a heart attack after serious heart complications. I took it for 3 months and while avoided a heart attack and possibly a stroke, my low blood sugar was far more often and dangerous than anything I experienced on Actos.
My mom is 62 years old... She has been taking Avandia for about 2 years now, and although it has stabalized her sugar level, it does have other side effects. Her ankles do get extremely swollen, to the point where sometimes it pains her to walk. However, her doctor did switch her to Metformin and even though it is strong on your stomach for the first week, the swelling in her ankles has gone down drastically. Furthermore, if you are diabetic, you're prone to have high blood pressure, if you have high blood pressure, you're prone to be diabetic... the end result is that no matter which of these pills you're taking they affect your kidneys.
I see all the focus going to Avandia but Actos (pioglitazone) is like a twin brother of the medication. My husband was taken off Avandia and Prescribe Actos. When I read the indications and Warning of the two medications THEY ARE IDENTICAL. The black box is also IDENTICAL. But it gets better. The Doctor that initiated the group of studies articles gets moneys for his organizations from TAKEDA, Yes! the company that makes Actors. I find it so incredible that no one is pointing focus to him and his gains and affiliations to the Actos brand. To me that is the real issue since both drugs seems to be so igual.
I have a history of heart disease in my family (paternal side) and diabetes (maternal side). For over two years, I took Avandia along with Metformin, and out of 1400 results, 800 were in my idea of a “normal” range (below 140) and 600 were above. It would have been difficult for a random test to ever reveal that I was a type 2 diabetic, it was that much in control. I am 56 and was only diagnosed a few years ago. I get good exercise but rarely am I able to maintain a 45 carb meal three times a day, which is why I keep up the exercise (cycling).
I was switched to Actos as a cautionary measure, and in my first 100 tests, 70 were over and 30 were “normal.” I asked my physician to let me go back to the Avandia, but instead, he added Januvia and things are getting back to normal. I understand his caution, but I suspect if I were back on the Avandia, I would be paying for one less medication and things would be back where they were.
I am not one to argue overmuch with physicians and I am giving this a chance, but if I were not covered on a Health Insurance plan, these experiments would be financially out of the question. I am concerned that there is such a disparity between the proportional numbers presented by Nurse Laura, and the proportional reaction from media which makes this medicine look like Vioxx.
I was put on advania about 3 weeks ago, and it did help with my sugar levels, but now I having trouble with tendonditis, and feel this might be from the drug.
I say, follow the advice of the FDA, this is what there job is, to look out for everyone's safety:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html
Heed to the warning.
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