The BiDil Saga: Much Ado About Nothing
BiDil is trade name of a drug that is a combination of two medicines, Isosorbide dinitrate and Hydrallazine. Studies revealed that this combination is particularly useful in African-American patients with heart failure. This study stimulated a welcome discussion about custom-made medicine for patients based on age, gender, ethnicity etc.
A recent Wall Street Journal article talks about the tension between insurance companies and the maker of BiDil. The maker says that the nitrate and Hydrallazine combination contained in BiDil is a unique one. They claim that the unique dosage combination has an effect that the combination of generic and much cheaper Isosorbide dinitrate and Hydrallazine does not have. Moreover, based on the study data, FDA approved this combination for heart failure in African-Americans.
The insurance companies have so far refused to cover BiDil contending that the benefits from BiDil could be obtained from the much cheaper generic Isosorbide dinitrate and Hydrallazine.
Here is my take on it
1. I do not see any magic in the dosing of BiDil. Moreover, in every day practice of medicine, many times we are not able to keep patients on the doses that are used in research protocols. This is for several reasons including side effects
2. The cardiologists have used the combination of these two medicines for decades in patients who had heart failure but could not tolerate ACE inhibitors. ACE inhibitors as a group are considered first line drugs.
3. Each tablet of BiDil includes 20 mgm of Isosorbide dinitrate and 37.5 mgm. of Hydrallazine. The generic forms of these medicines are available in strengths that make achieving this dose very easy.
Action points:
1. Based on the research, there may be a case for starting African-American patients with heart failure on Hydrallazine and Isosorbide dinitrate as first line of treatment
2. A physician’s job, first and foremost is to provide best possible care to his or her patients at best possible price. I do not see any reason for the combination of generic drugs to be inferior to the combination marketed as BiDil
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A recent Wall Street Journal article talks about the tension between insurance companies and the maker of BiDil. The maker says that the nitrate and Hydrallazine combination contained in BiDil is a unique one. They claim that the unique dosage combination has an effect that the combination of generic and much cheaper Isosorbide dinitrate and Hydrallazine does not have. Moreover, based on the study data, FDA approved this combination for heart failure in African-Americans.
The insurance companies have so far refused to cover BiDil contending that the benefits from BiDil could be obtained from the much cheaper generic Isosorbide dinitrate and Hydrallazine.
Here is my take on it
1. I do not see any magic in the dosing of BiDil. Moreover, in every day practice of medicine, many times we are not able to keep patients on the doses that are used in research protocols. This is for several reasons including side effects
2. The cardiologists have used the combination of these two medicines for decades in patients who had heart failure but could not tolerate ACE inhibitors. ACE inhibitors as a group are considered first line drugs.
3. Each tablet of BiDil includes 20 mgm of Isosorbide dinitrate and 37.5 mgm. of Hydrallazine. The generic forms of these medicines are available in strengths that make achieving this dose very easy.
Action points:
1. Based on the research, there may be a case for starting African-American patients with heart failure on Hydrallazine and Isosorbide dinitrate as first line of treatment
2. A physician’s job, first and foremost is to provide best possible care to his or her patients at best possible price. I do not see any reason for the combination of generic drugs to be inferior to the combination marketed as BiDil
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posted by kc at 8:36 PM
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