HOTB 269: The imperfect nature of cholesterol-lowering drug trials

Healing Outside The Box

As most of us who sit through TV commercials are aware, any medications we are prescribed come with both benefits and possible risks. And the risk of side effects will go up when the dose goes up.

But how are these clinical drug trials put together and who decides whether or not the risk is acceptable? Today I tell you a story of the Lopid clinical study that I was involved in as a Registered Dietitian.

But first, I refer you to a layperson's article on possible side effects of Lopid, also called gemfibrozil. You can find the article here.

This Journal of the American Medical Association article discussed the benefit/risk ratio in more detail.

This FDA report gives a detailed analysis of possible side effects of taking Lopid or Clofibrate and concludes that the benefits do not outweigh the risks. The risks include gallbladder disease, gallstones, pancreatitis, and even cancer.

In this later report of a rat study with higher doses, there was a significantly higher incidence of liver tumors in these treated rats.

As always, if you have any questions or would like to suggest topics for future episodes, feel free to contact me on my website contact page, Healing Outside the Box.