Are Cardiovascular Problems Ever Not a Risk?


Applied Clinical Trials

I’ve spent the last few days immersing myself in cardiovascular risks in drug safety—for two reasons. First, I was reviewing a previous podcast interview I conducted with Medpace’s Vice President of Medical and Regulatory Affairs David Orloff, MD. In this interview, he discussed the company’s experience with diabetes, obesity and metabolic drugs trials, as well as the regulatory issues involved.

The second reason? The upcoming 7th Annual Summit on Cardiovascular Risk and Safety being held January 24 and 25 in Washington, DC. I am a huge fan of this conference, and it’s not just because it’s produced by our conference division CBI []. I attended and spoke at this event last year and found both the audience and speakers very engaging. This audience of dedicated professionals truly rallies around their cause in a professional and unbiased way. It is inspiring to see that level of collaboration and interest in making sure that drugs in development are tested correctly for cardiovascular risk. So I’ve been in touch with CBI on our content for the event. I will be live tweeting at #CVSafety.

While on the subject of CV testing in clinical trials, Orloff noted, and as those in the CV and regulatory area will know, is that Type II diabetes is the only therapeutic class that specifically has an FDA guidance for cardiovascular risk assessment. However, there are other therapeutic areas where it is beneficial to get an early detection for risk, and those include oncology, any chemical entity that blocks hERG channels, and others that may have stopped drug trials because of a heart risk.

For example, in August, Bristol-Myers Squibb halted a Phase IIb clinical trial of its experimental hepatitis C treatment, when one patient experienced hear failure. The treatment was a 200mg dose of a nucleotide polymerase inhibitor. This adverse event, of course, raised serious concerns about potentially serious cardiovascular toxicity.

The reason I was back in the archives on the Medpace podcast was that it was recently named as the CRO of record for an upcoming Phase II clinical trial of Oramed Pharmaceuticals’s oral insulin capsule. While insulin may not be known for causing CV risk, Orloff noted that drugs for diabetes must be tested. “Increase in cardiovascular disease risk associated with the drug must be excluded within a certain level of confidence.” And this is based on the fact that the FDA and the medical community understands that “diabetes drugs are for lifelong use and the lives of diabetic patients are thankfully being extended as a result of multiple advances in the drugs used.”

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