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Dr. Andrew Rynne
MD
Dr. Andrew Rynne

Family Physician

Exp 50 years

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How Can I Take Care Of My Heart While On Avandia?

My doctor prescribed Avandia in October. Now she will not return my calls about my concern for this latest? study about Avandia leading to cardiac problems. How can I take care of my heart while on Avandia?
Fri, 18 Dec 2009
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For the past year I have been encouraging patients to email me rather than call the office. So many calls come through a busy office during a single day that it is not uncommon for a call to be 'lost'. If you have called 2 or 3 times and not received an answer that would be - in my opinion - a breach of the physician patient covenant. Your concern however is what this recent study means - specifically - will taking rosiglitazone/Avandia lead to heart problems. The internet is a dangerous place and full of mis-information and half-truths. The study in question was a meta-analysis which by definition is statistically 'invalid'. A meta-analysis 'sums' up the results of various studies with different designs and end-points. Meta-analysis by its very nature has serious short comings. Such an analysis is utilized to suggest areas where further study is needed not to make direct or certain conclusions. The conclusion was that cardiovascular events and deaths were higher in the rosiglitazone patients but the analysis of the studies in question was flawed, the total number of patients studied 'small' relative to the end-points, the duration 'short', and actual numbers were small. For example 18 patients on rosiglitazone had events versus 12 patients not taking the drug or taking other drugs. Mathematically that is a 50% increase but simply because something is statistically 'significant' does not mean that it is clinically meaningful. The study which led to the universal use of the drug rtPA to dissolve blod clots in those with heart attacks is a good example. The conclusion was that there was a 20% reduction in death. The actual figure was a decrease from 15% to 12% which is a 20% decrease. Stated in another fashion however the increase in survival was 3%. Since there was a 3% incidence of serious bleeding complications the actual benefit of rtPA was quite small. The point is that researchers are capable of manipulating numbers to achieve headlines. The study in question regarding rosiglitazone/Avandia is going to become more of a legal than a medical issue. Companies have been forced to withdraw drugs from the marketplace in similar circumstances. The first drug in this class of drugs which reduce insulin resistance - troglitazone - was withdrawn because physicians ignored well publicized data suggesting that the drug was not appropriate for all patients rather than due to problems with the drug itself. The two remaining drugs in this very important class are rosiglitazone/Avandia and pioglitazone/Actos. I use pioglitazone but not because I believe it to be safer than rosiglitazone. There are repeated references in the medical literature that pioglitazone has been linked to heart failure and yet there is no data to support such claims. The quality of American medicine has declined rapidly over the past 20 years and we no longer rank in the top 20 countries in the world in terms of outcome measures. Nonetheless - studies such as the one you refer to do not help at all - unless you are an attorney. When such news appears you did what you should have done. You were concerned and that is appropriate. The physicians role includes being sensitive to such concerns. The physician should be committed to education which decreases patient anxiety. You did not leap to a conclusion - you consulted your physician - or at least you tried to. If your physician had returned your call you would not have needed to resort to receiving potentially incorrect and harmful information from non-physicians on the internet. The Food and Drug Administration - which I admit is rather weak and does a very poor job - has no intention at this time of placing additional warnings or restrictions on rosiglitazone/Avandia. Until you speak with your physician you should not stop taking the drug. The best way you can take care of your heart is to control your glucose and that is what the rosiglitazone is for. If you would like additional information please let me know although it would help if I knew your age, onset of diabetes, glucose readings, A1C readings. lipid values, cardiovascular risk profile, other medical problems, and other medications. I wish you the very best of health and hope that this may reduce your anxiety until you are able to speak with your physician. May God bless. johnerussomd@jhu.edu

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How Can I Take Care Of My Heart While On Avandia?

For the past year I have been encouraging patients to email me rather than call the office. So many calls come through a busy office during a single day that it is not uncommon for a call to be lost . If you have called 2 or 3 times and not received an answer that would be - in my opinion - a breach of the physician patient covenant. Your concern however is what this recent study means - specifically - will taking rosiglitazone/Avandia lead to heart problems. The internet is a dangerous place and full of mis-information and half-truths. The study in question was a meta-analysis which by definition is statistically invalid . A meta-analysis sums up the results of various studies with different designs and end-points. Meta-analysis by its very nature has serious short comings. Such an analysis is utilized to suggest areas where further study is needed not to make direct or certain conclusions. The conclusion was that cardiovascular events and deaths were higher in the rosiglitazone patients but the analysis of the studies in question was flawed, the total number of patients studied small relative to the end-points, the duration short , and actual numbers were small. For example 18 patients on rosiglitazone had events versus 12 patients not taking the drug or taking other drugs. Mathematically that is a 50% increase but simply because something is statistically significant does not mean that it is clinically meaningful. The study which led to the universal use of the drug rtPA to dissolve blod clots in those with heart attacks is a good example. The conclusion was that there was a 20% reduction in death. The actual figure was a decrease from 15% to 12% which is a 20% decrease. Stated in another fashion however the increase in survival was 3%. Since there was a 3% incidence of serious bleeding complications the actual benefit of rtPA was quite small. The point is that researchers are capable of manipulating numbers to achieve headlines. The study in question regarding rosiglitazone/Avandia is going to become more of a legal than a medical issue. Companies have been forced to withdraw drugs from the marketplace in similar circumstances. The first drug in this class of drugs which reduce insulin resistance - troglitazone - was withdrawn because physicians ignored well publicized data suggesting that the drug was not appropriate for all patients rather than due to problems with the drug itself. The two remaining drugs in this very important class are rosiglitazone/Avandia and pioglitazone/Actos. I use pioglitazone but not because I believe it to be safer than rosiglitazone. There are repeated references in the medical literature that pioglitazone has been linked to heart failure and yet there is no data to support such claims. The quality of American medicine has declined rapidly over the past 20 years and we no longer rank in the top 20 countries in the world in terms of outcome measures. Nonetheless - studies such as the one you refer to do not help at all - unless you are an attorney. When such news appears you did what you should have done. You were concerned and that is appropriate. The physicians role includes being sensitive to such concerns. The physician should be committed to education which decreases patient anxiety. You did not leap to a conclusion - you consulted your physician - or at least you tried to. If your physician had returned your call you would not have needed to resort to receiving potentially incorrect and harmful information from non-physicians on the internet. The Food and Drug Administration - which I admit is rather weak and does a very poor job - has no intention at this time of placing additional warnings or restrictions on rosiglitazone/Avandia. Until you speak with your physician you should not stop taking the drug. The best way you can take care of your heart is to control your glucose and that is what the rosiglitazone is for. If you would like additional information please let me know although it would help if I knew your age, onset of diabetes, glucose readings, A1C readings. lipid values, cardiovascular risk profile, other medical problems, and other medications. I wish you the very best of health and hope that this may reduce your anxiety until you are able to speak with your physician. May God bless. johnerussomd@jhu.edu