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Studies now say that Avandia increases heart attacks by 43% . Of course GlaxoSmithKline stands behind the safety of the medication. There is a call for FDA action!
CHICAGO (Reuters) - Avandia, GlaxoSmithKline Plc's widely used drug for treating type 2 diabetes, increased the risk of heart death by 64 percent and the risk of heart attack by 43 percent, U.S. researchers said on Monday.
The substance is basically the same in the MedScape article and the one from ABC. What I got out of reading the entire article was that the study was very small.
Avandia aka rosiglitazone has been actively prescribed since 1999.
Quote:
The agency advises patients taking rosiglitazone, especially those who are known to have underlying heart disease or who are at high risk of heart attack, to talk to their doctor about this new information.
The source material for this analysis consisted of publicly available data submitted to the FDA as part of the approval package, another series of trials performed by the sponsor after approval, and two large prospective randomized trials designed to study additional indications for the drug (DREAM and ADOPT). In all, 42 trials met the inclusion criteria of a follow-up period of at least 24 weeks, the use of a randomized control group, and the availability of outcome data on MI and cardiovascular death. In these trials, 15 560 patients were assigned to rosiglitazone and 12 283 received placebo or an active comparator.
Results showed that rosiglitazone-treated patients had an odds ratio of 1.43 for MI and 1.64 for cardiovascular death compared with the control group.
Odds ratio for MI and CV death for rosiglitazone vs control
Outcome Odds ratio 95% CI p
MI 1.43 1.03–1.98 0.03
Cardiovascular death 1.64 0.98–2.74 0.06
Nissen and Wolski note that the increased risk associated with rosiglitazone is the same when compared with placebo or with an active comparator, suggesting that this observation was not due to a protective effect of comparator drugs.
They point out that this meta-analysis is limited by a lack of access to original source data, which would have enabled time-to-event analysis, and on a relatively small number of events (there were 86 MIs and 39 cardiovascular deaths in the rosiglitazone patients vs 72 MIs and 22 cardiovascular deaths in control patients). But they say that despite these limitations, patients and providers should consider the potential for serious adverse cardiac effects of treatment with rosiglitazone.
Because the media likes to scare people, I prefer medical resources for the data.
The new warning comes from an analysis of publicly available, short-term clinical studies comparing Avandia to other diabetes treatments. It shows that Avandia increases heart attack risk by 43% -- and increases risk of death from heart disease by 64%.
However, the overall risk was small. Among the 15,560 Avandia patients there were 86 heart attacks and 39 deaths, compared with 72 heart attacks and 22 deaths among the 12,283 patients not taking Avandia.
The thing is, even before this study, there was a warning against use of this drug by those with CV issues as evidenced by this page on medicinenet that was last updated in Mar 2005: http://www.medicinenet.com/rosiglitazone-oral/page2.htm
Quote:
PRECAUTIONS: Before taking rosiglitazone, tell your doctor or pharmacist if you are allergic to it; or to other "glitazones" such as pioglitazone, troglitazone; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: type 1 diabetes (insulin-dependent diabetes), very high blood glucose (diabetic ketoacidosis), newly diagnosed or worsening heart failure (acute congestive heart failure), active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chronic congestive heart failure), liver problems, fluid in your lungs, swelling (edema), anemia, high blood cholesterol. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcohol while taking this medication because it can increase the risk of your blood sugar getting too low (hypoglycemia). During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as additional medication may be required. This medication can cause changes in the menstrual cycle (ovulation) in women with certain fertility problems. Consult your doctor or pharmacist about the use of reliable birth control while taking this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully. It is unknown if this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
The MI numbers are barely statistically significant. The cardiac death numbers are statistically insignificant. We've known for some time that Avandia can increase LDL levels, the MI thing isn't too much of a surprise from a physiological standpoint. I'll guess the FDA takes a long look at it. Another study is coming down the pike on roughly the same subject, if it is as damning, expect the FDA to do something about it. If you are worried to death, switching to the other drug in the class, Actos, is an option. It does the same thing in the body by helping your body use insulin more efficiently, but doesn't carry the same cardio risk as Avandia. I wouldn't freak out yet, though. This was a metaanalysis, where they pool a bunch of older studies together to come up with a conclusion. There are some issues that have been brought up, but I have a feeling it will stick.
I stumbled across this thread today. I am currently taking Avandia along with Byetta injections for type 2 diabetes. Now that I have read this thread and read the articles from your links, I will be talking to my doc about this.
After reading the study some more, the degree to which the media has sensationalized this is terrible. Unless you have bad cholesterol problems, I wouldn't worry about it too much. Even the study itself said that more information and further studies are needed before people start freaking out.
I think the media in this country does more harm than good, You really need to be careful when listening to thier coverage on subjects, especially if it impacts your life. I think these findings are beyond just avandia, I did research on my meds glyburide and it definitely mentions increased heart risk while on this med. Most likely we will hear of other drugs real soon thru the media.
Usually these new studies tell the public stuff we've known forever. They found out Avandia increases LDL cholesterol years ago. Logically, if a group of people take it, some of those with higher LDL levels will have their LDL increased enough to cause a heart attack. It's logical that over a large group of people more problems would arise. The risk is very low, too. It's something like 0.43% for Avandia had MI vs. 0.36% for non-Avandia had MI when they pooled the smaller studies together. The benefit from lowing blood sugar probably outweighs the low risk of increased MI. That's like 1 in 1400 or something. If 1400 people out there just stopped taking Avandia without switching to Actos or something first, I'd bet much more than 1 would have problems.
Better studies are coming out soon to clear this mess up, thank God...
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