September 23, 2010

A little help for docs and patients (still) thinking about rosiglitazone


As of today, GSK will cease promoting Avandia (rosiglitazone) following rulings in Europe that removed the drug from the market and from the FDA that severely restricted its use.  At the time of these actions, Avandia was used by a small percentage yet sizable number of patients with diabetes.  In the United States, the FDA ruling indicates these patients may be able to continue to use Avandia and new patients may consider using Avandia. The FDA ruling requires that these patients be told about all the available options and about the risk associated with using this medicine (best available evidence suggest an increased risk of myocardial infarction with this drug of OR 1.4).  The FDA states:

The FDA is restricting access to rosiglitazone by requiring the drug sponsor to submit a Risk Evaluation and Mitigation Strategy, or REMS. Under the Food and Drug Administration Amendments Act of 2007, the FDA can require a drug sponsor to issue a REMS to impose certain restrictions so that the benefits of a drug continue to outweigh its risks. When the REMS for rosiglitazone is implemented, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take pioglitazone for medical reasons. Current users of rosiglitazone will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns. The agency anticipates that the REMS will limit use of rosiglitazone significantly.

We cannot imagine who would be interested in this medicine (we did not prescribe it before the 2007 black boxed warning, and continued to not prescribe it after), but certainly complying with the FDA ruling will be difficult without a tool that would help communicate the risk increase associated with rosiglitazone.

To communicate the available options, you can use our diabetes cards (you can see them here).  We are evaluating an updated version (DA- Diabetes Choice Pamphlet) that includes gliptins as an option, and a cost card.

To estimate the 10-year coronary risk for patients with type 2 diabetes, you can use the UKPDS risk calculator.  Here is a version that requires no math! (Paper-basedestimatorCVriskinType2Diabetes)

Then based on the result, you choose which version to download and use from the three categories represented here: (1) ~10% (Avandia_AVG), (2) ~20% (Avandia_ELEV), and (3) ~50% (Avandia_HIGH).

Let us know if you find these tools helpful, although we are not sure if there will or should be many actual users for these.

It is very important to note that all these tools were designed for and should be used DURING a consultation with a clinician.

Tags: SDM in practice, Shared decision making

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