The reports were prompted by a July 1 ‘clinical report’ from the American Academy of Pediatrics (AAP). If you skip down to the summary at the end of the article, the good news is that unless the ‘bad’ cholesterol or LDL is extremely high, children 8 years or older who are just overweight or obese will never need to take a statin. However, if the child is obese and has an additional chronic condition such as high blood pressure, diabetes mellitus or tobacco abuse and diet is to no avail, drug treatment, depending on the LDL level, is recommended.
The notion of starting children on long-term statin therapy is not new. Other conditions including kidney disease, heart transplants, Kawasaki disease and surviving cancer treatment have been treated with statins for many years. The good news is that in these populations, the incidence of side effects has been very low.
On the other hand, the DMCB – who is the first to admit that it knows little about pediatrics – is wondering if the AAP is recommending an overly aggressive treatment approach. While it is true that even children are developing early signs of atherosclerotic vascular disease, the science here is one of primary prevention. Even among adults, the ‘yield’ from using statins to prevent disease in persons without a prior heart attack is quite low. Decreases cardiovascular events are measured in single percentage points over 5 years or single digits per 1000 patient years. Ironically, even though heart attack rates may go down, there are no data showing there is a decrease in mortality. Can we generalize the data from adults to children without the benefit of good evidence from long term prospective randomized clinical trials that go longer than just one year? What’s more, have enough children been exposed to statins over a long enough period of time to help us truly understand the long term health consequences? Last but not least, have we reached the point where our lifestyles have driven even our children into pills for all their ills?
But the DMCB isn’t about the harangue the pediatric community with rhetorical questions about the science. Instead, it is concerned that the AAP report has no mention of need for a dedicated long term drug safety registry in this age group. Lacking any insight from prospective clinical trials, we need this kind of database to assess the ongoing safety and value of statins in the pediatric population.
The DMCB also couldn’t help but notice that the AAP report did not list any potential conflicts of interests involving the authors – especially since the payoff to statin pharma manufacturers from this expansion in their market could be significant. Think there aren’t other bloggers digging into that potentially juicy possibility as I type this?
Last but not least, there is little mention of the contribution of disease management. The DMCB suggests a prescription for a statin should be accompanied by health coaching that not only engages patients in maximally managing diet and exercise, but helps assure medication adherence and is ready to help with potential side effects. And if the AAP isn’t going to lead the way, perhaps the disease management companies (or pharmacy benefit managers - who are getting into disease management) could use their considerable IT resources to help create the registries – adding even greater value to the services that could be provided in this area. If my colleagues in DM were particularly courageous, they could also open-source them.