Last week I wrote about constructing a framework for comparable safety research (CSR) to compliment the work being done ­­­­with comparable effectiveness research (CER). Careful and continuous post-approval monitoring is vital to the evaluation of a drug’s safety profile, and with the proper framework and tools in place can be done quite easily.

A great example of what a CSR framework looks like can be found in our recent special report, The Comparative Safety of Type 2 Diabetes Medications.

By adding post-approval side effect data to the workflow, our analyses of Type 2 Diabetes Mellitus drugs suggest that:

1) Both GLP-1 and DPP-4 inhibitors (especially sitagliptin) have elevated associations with pancreatitis and pancreatic cancer, but neither class appears to have strong links to presumed renal and hepatic complications.

2) Bydureon may be a safer choice within the GLP-1 inhibitor class.

3) DPP-4 inhibitors may be linked to more serious side effects than is widely believed, with Nesina of particular concern.

4) SLGT2 inhibitors are, as expected, associated with elevated urinary infection risks but may also be linked to more serious events.

CSR can be used in virtually all aspects of the P&T process. Whether making evidence based decisions on new drugs to market like GlaxoSmithKline’s (GSK) drug albiglutide (now called Tanzeum) that was just approved this week, or doing regular class reviews, CSR will provide for a systematic process for assessing a drugs comparable safety.

To learn how you can easily apply CSR into your workflow, sign up for a 7-day free trial of AdverseEvents Explorer.

To see all of the data, conclusions, and the framework used to evaluate the Diabetes drugs, download our Special Report, The Comparative Safety of Type 2 Diabetes Medications.


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Jim Davis

Jim Davis

Executive Vice President

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Topics: Drug / Indication Information

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.