FDA finally stepped in yesterday with a safety announcement updating the product insert labeling and patient Medication Guide with details of the above noted study (not yet completed as of today). |
Given that there's no clinical outcome benefit to using this drug in diabetics, the bigger question to be raised is whether there's any benefit for use in the larger population as a whole. In fact, the FDA is requiring the manufacturer to sponsor a randomized, double-blind, placebo-controlled trial to study whether the use of fibrates can reduce residual risk in those patients who've already achieved the lowest LDL goals. Stay tuned!